EU Regulators Say Benefits Outweigh Risks for Johnson & Johnson Vaccine
April 20, 2021
Over the weekend, the U.S. surpassed an important milestone in its COVID-19 vaccination campaign: over half of all adultshave received at least one dose of a COVID-19 immunization. The U.S. now trails only six countries in its vaccination rate.
While the U.S. vaccinations continue swiftly, last week, the Food and Drug Administration (FDA) recommended a pause in the administration of the Johnson & Johnson vaccine. The FDA guidance followed reports of a handful of rare and severe blood clots after administration of the vaccine, leading to concerns it could slow the United States’ vaccination rate.
What’s New? As of April 7, over 7 million people in the United States had received the Johnson & Johnson vaccine, yet these blood clots have been reported in only eight people.
This morning, the European Medicines Agency (EMA) announced that the benefits of Johnson & Johnson’s vaccine outweigh the risks of side effects. The EMA recommended that a warning should be added about the “unusual blood clots” but left it to the countries to decide how specifically the guidance should be implemented.
Link with AstraZeneca? The Johnson & Johnson vaccine uses the same adenovirus vector technology as the AstraZeneca vaccine, the use of which was recently suspended in Europe following reports of rare blood clots.
While more data is needed to evaluate any link, public health experts emphasized “it remains the case that for the vast majority of adults in Europe and the USA, the risks associated with contracting COVID-19 far, far outweigh any risk of being vaccinated.”
What’s Next? On Friday, the U.S. is on deck to decide how to proceed. The CDC’s Advisory Committee on Immunization Practices will meet to discuss lifting the pause on administration of the Johnson & Johnson vaccine. Dr. Fauci suggested it was likely that the CDC would recommend “some sort of either warning or restriction” on the continued use of the vaccine.
Regardless of the outcome of Friday’s meeting, one thing remains clear: the innovative scientific community followed the science to the discovery of the three FDA-authorized vaccines, and consumers should rest assured they will continue to do so as the vaccination campaign continues across the country.
Promising Treatment for COVID-19 Reduces Infections by 81%
April 14, 2021
To date, over 36% of the U.S. population have received at least one dose of the COVID-19 vaccine. The swift distribution of the vaccine across the U.S. belies an important fact: COVID-19 cases continue to rise precipitously in parts of the country.
According to data from Johns Hopkins University, five states – Florida, Michigan, New Jersey, New York, and Pennsylvania – account for roughly 43% of total new cases in the United States, leading some state government officials to plead with the federal government for more doses of the vaccine.
In yesterday’s COVID-19 briefing, the White House announced the federal government will ensure that states experiencing a rise in cases have sufficient therapeutics for COVID-19 patients.
The White House strategy demonstrates on an important fact: effective treatments – and ongoing clinical research to identify them – will be critical to leading the global community beyond the COVID-19 crisis.
What’s New: On Monday, Regeneron and Roche announced their antibody cocktail can not only be used to treat COVID-19 but also reduce the risk of symptomatic COVID-19 infections by 81%.
Upon announcement of the Phase 3 study findings, Regeneron’s Chief Scientific Officer noted the company is conducting further research to understand how the antibody cocktail can be used to “provide ongoing protection for immunocompromised patients who may not respond well to vaccines.”
This will be particularly important given new data which shows that patients who take immunosuppressive drugs for autoimmune diseases have reduced antibody levels from the vaccine.
Taken together, the new data underscores a key point: we cannot simply “vaccinate our way out” of the global pandemic, as the CDC’s Dr. Rochelle Walensky noted yesterday.
Rather, a combination of continued vigilance, effective treatments, and the ongoing distribution of vaccines will be critical to our shared goal of a return to health, one which has alluded the global community for the last 13 months.
Vaccines Helping Americans Declare Independence from Coronavirus
March 16, 2021
With three authorized COVID-19 vaccines available in the U.S., the country is ramping up the largest vaccination campaign in history.
On Thursday, President Biden announced that every American should be eligible to receive a vaccine by May 1, with a goal of achieving our new normal by July 4th. With America’s birthday mere months away, let’s recap where things stand with the COVID-19 vaccine.
- Last week, Novavax announced their COVID-19 vaccine candidate was 96.4% effective against mild, moderate, and severe disease caused by the original COVID-19 strain. While the vaccine was 55.4% against the South African variant, the company stated the vaccine is 100% effective against hospitalization and death.
- Additionally, data from Israel – who leads the world in COVID-19 vaccinations – illustrated that the Pfizer vaccine was 97% effective against symptomatic disease and 94% effective against asymptomatic COVID-19. Because asymptomatic disease drives the spread of the virus, the new data illustrates that the vaccines are incredibly effective at stopping COVID-19 in its tracks.
- Meanwhile, as schools across the country race to re-open, earlier today, Moderna reported the start of a Phase 2/3 pediatric study to test the vaccine in children between the ages of 6 months to 12 years.
If we’re learned anything over the last year of the pandemic, it’s that this virus is relentless. But the science is, too.
If we continue to follow that science and invest in clinical research in the coming months, hopefully we will all be able to celebrate Independence Day together in four months’ time.
Event: Bridging the Racial Gap for COVID-19 Treatments and Vaccines
February 18, 2021
COVID-19 vaccines and treatments are critical to America’s recovery. In order to build trust and ensure they’re effective for all Americans, they must be tested and distributed among diverse populations.
As part of its Equality of Opportunity Initiative, the Chamber held an event today on how to bridge the racial gap for COVID-19 vaccines and treatments. Experts from industry, public health, and community organizers discussed building trust among minority communities.
Acknowledging racism: “For far too long the health of Black Americans have either been either ignored or abused in the name of science. That has been a fertile soil for mistrust,” explained Dr. Michelle Williams, Dean of Harvard T.H. Chan School of Public Health.
The response is good communication: A “consistent message” is needed said former Massachusetts Governor Deval Patrick, who is co-chair of the COVID Collaborative. “That is the safety of the vaccine and the importance of getting it for your own sake for your family’s sake and for the larger community’s sake.”
Don’t forget education. “One of the problems we found was being unaware,” explained Clarence Pierce, CEO, Hamilton Community Health Network, serving the Flint, MI area. “In our surveys we had a little less than 50% who wanted to get the vaccine.” However, through “word of mouth from peers and family and friends telling them that it’s okay” the community is beginning to “feel more comfortable to step up and get the vaccine.”
Business’ role: Dr. Jamie Freedman, Senior Vice President of U.S. Medical Affairs at Genentech, discussed how his company went to hospitals in underserved communities to get more diverse populations into clinical trials. Lessons learned in this effort are being applied to all the company’s clinical trials. For instance, “You have to have informed consent in multiple languages to enroll patients,” Freedman said.
As for vaccine distribution: Dr. Rina Shah, Group Vice President for Pharmacy Operations and Services at Walgreens, explained her company is “not only offering vaccine in our stores but going into the communities–working with our local partners, working with our local officials so that we can set up clinics in communities where we know access to care might be limited.”
- The Chamber’s COVID-19 Vaccines Digital Resource Center can help business leaders and associations navigate vaccine questions.
- This interactive map shows over 1,000 COVID-19 clinical trials are currently taking place across all 50 states and in 96% of Congressional Districts.
Making the Case for Diversity in Clinical Trials, Part 2
February 11, 2021
It is no secret that the COVID-19 pandemic has adversely impacted communities of color. According to new data from the Lancet Commission, the mortality gap between Black and white Americans has increased by more than 50% since the onset of the pandemic.
Why it matters: Given that communities color bore the brunt of the virus’ impact, the Chamber believes it is essential that COVID-19 treatments and vaccines are tested among diverse populations.
What’s happened? This week, the Chamber released the second part of “The Case for Clinical Trial Diversity” video series, featuring a conversation with Quita Highsmith, Vice President and Chief Diversity Officer at Genentech, and Nick Kenny, Chief Scientific Officer at Syneos Health.
- We must breakdown barriers to encourage more diverse clinical research. These barriers range from the health system’s failure to serve different demography’s to more simple issues like transportation and parking at clinical trial sites.
- To address these obstacles, we must be bold and intentional about clinical trial design. Kenny noted that that passive approach to clinical trial design – where you simply expect people to show up wherever the trial is located – is particularly problematic. To help facilitate participation, we must to bring the trials to the people in their local communities.
- Business community-driven solutions can help promote inclusive research. To start, companies can put in place policies to allow patients to participate in clinical research. Over the long term, the business community must also support a more diverse workforce in science and medicine by creating partnerships with universities and the scientific government agencies.
Learn more: Join us on February 16th at 1:00pm (ET) to discuss clinical trials diversity and addressing vaccine hesitancy in underrepresented communities.
Clinical Research Remains Essential as New COVID Variants Emerge
January 28, 2021
Emerging news about new variants of COVID-19 in the UK, South Africa, and Brazil have led to concerns the vaccine may be less effective against the evolving strains of the virus.
Yet, positive news this week from both Pfizer and Moderna indicate there may not be as much cause for concern as some initially feared, shedding light on the importance of ongoing clinical research.
What’s new: A study released Wednesday night indicated that the Pfizer-BioNTech vaccine is effective against the mutation in the UK. While there was a small difference in the antibodies produced against the South Africa strain, BioNTech stated the difference was “unlikely to lead to a significant reduction in the effectiveness of the vaccine.”
Additionally, on Monday, Moderna announced their vaccine remains effective against the variant in the UK, but there is a six-fold decrease in the antibodies produced against the strain in South Africa. “Out of an abundance of caution,” the company will begin to test a vaccine booster against the variant in South Africa.
What’s next: Pfizer-BioNTech and Moderna vaccines may not be the only game in town.
Early next week, Johnson & Johnson is expected to release the results of the 45,000-person Phase 3 clinical trial. Their one-dose vaccine candidate only requires refrigeration at standard temperatures, giving the vaccine two potential advantages as the countries around the world struggle to effectively deploy the current authorized vaccines.
Why it matters: We have long known that we must follow the science towards effective vaccines and therapeutics. Continued clinical research is critical to ensuring the science keeps pace with the emerging threats the virus poses.
Around the world, this important work continues. In the U.S. alone, there are over 1,000 clinical trials taking place in all 50 states across 96% percent of Congressional Districts.
This virus may seem relentless, but science is, too. We remain confident that the science will lead us where we need to go.
Making the Case for Diversity in Clinical Trials
January 21, 2021
Why it matters: Black Americans are dying of COVID-19 at 1.6 times the rate of their white neighbors. The Chamber believes it is imperative new COVID-19 treatments are tested in populations most impacted by the virus.
What happened? Quita Highsmith, Vice President and Chief Diversity Officer at Genentech, and Nick Kenny, Chief Scientific Officer at Syneos Health, joined a conversation with Rick Wade, the Chamber’s senior vice president of Strategic Alliances and Outreach, to discuss what the business community can do to support the inclusion of diverse communities in clinical research.
- This is a long-standing problem. There is a natural hesitancy for underrepresented communities to participate in clinical research, given the longstanding structural inequities and the historic mistrust in the healthcare system.
- We must start with education. Highsmith and Kenny both emphasized that we need to ensure that everyone involved in the clinical research study are educated about cultural sensitivity and the importance of ensuring communities of color are represented.
- We must be intentional about clinical trial design. We need to look at where the disease burden lies and identify ways to reach the patients in those communities. To do this, we need to meet people where they are, be it local community health centers, churches, barber shops, or beauty salons.
- Join us on February 16th at 1:00pm (ET) to discuss clinical trials diversity and addressing vaccine hesitancy in underrepresented communities
Continued Vaccine Developments Offer Hope in Challenging Times
January 14, 2021
While we are nearly halfway through the first month of 2021, for many, it may simply feel like 2020 2.0 as unprecedented political developments and ever-rising COVID-19 case numbers continue to dominate the news.
To date, 10.3 million people have received one dose of the COVID-19 vaccine, and 541,000 are now fully inoculated. However, over 19 million doses of the vaccines delivered to the states have yet to be distributed.
Yet, some developments over the last week provide new cause for hope.
- CDC guidelines: This week, the Centers for Disease Control and Prevention issued new guidelines to expedite the distribution process. The CDC recommended that states move forward with vaccinating individuals over 65 and people with underlying comorbid conditions. Across the country, the guidelines have trickled down to the states as individuals in this group from California to New Jersey began to receive the vaccine today.
- Prolonged immunity: This week, Moderna also sought to answer one of the key outstanding questions about the FDA-authorized vaccines: how long will immunity last? The company announced on Monday that they are confident the company’s vaccine will provide a year of immunity from COVID-19.
- Virus variants: As the new variant of coronavirus spread across the country, Pfizer and BioNTech stated their vaccine appears to be effective against the new virus mutations. And even if the virus mutates beyond the scope of protection provided by the current vaccine, the CEO of BioNTech noted that “one key advantage” of the mRNA vaccine is its adaptability, stating: “We can change the sequence of the vaccine within a few days and we could deliver a new vaccine within six weeks in principle.”
- Promising new data: On Wednesday, a study in the New England Journal of Medicine showed that the one-dose Johnson & Johnson vaccine created neutralizing antibodies in 90% of the trial participants. The company believes they may have the complete data from the Phase 3 trial by the end of January and could file for an Emergency Use Authorization (EUA) shortly thereafter.
At a time when there is so much darkness, it’s important to keep our eyes focused on the light ahead. The developments this week serve as a reminder that the science continues to deliver promising developments, giving us hope that an end is in sight.
First FDA-Authorized Coronavirus Vaccine Poised for Approval
December 11, 2020
Today, all eyes were on a little-known 23-member Food and Drug Advisory (FDA) meeting. While it may not have been on the formal agenda, the meeting was closely monitored to see if the committee could deliver one thing that has seemed out of reach in 2020: a light at the end of the tunnel.
The meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee discussed the emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine, the first shown to be safe and effective against the coronavirus.
Here is what we know:The vote: Over the course of the nine-hour meeting, the advisory committee considered whether there was sufficient data to grant an EUA for the vaccine. At the end of meeting, the committee held a vote recommending Emergency Use Authorization for people age 16 and older by a vote of 17 in favor, 4 against, with one abstention. While the committee’s vote is non-binding, the FDA is likely to move forward with their recommendation to issue the EUA as soon as Friday.
Distribution begins: Once the EUA is issued, the vaccine distribution can begin within 24 hours, and “we will start to have shots in arms within 96 hours” according to the Gustave Perna, the chief operations officer of Operation Warp Speed.
First recipients: Last week, the Center for Disease Control (CDC) Prevention Committee on Immunization practices recommended that front-line healthcare workers and residents of long-term care facilities – group 1a – receive the first doses of the coronavirus vaccine once the EUA is issued. The states subsequently submitted vaccine distribution plans and will now have to decide how to distribute the initial, limited batch of doses to group 1a recipients.
The unknowns: While today marks a tremendous step forward, as with any truly innovative medicine, there are still unknowns. Dr. Nancy Messonnier with the CDC notes that we don’t yet know whether the vaccine is “infection-blocking” or “disease-blocking.” We also don’t know how long immunity will last, making it all the more important that the rigorous clinical studies continue even after the EUA is granted.
What’s next: On December 17, the FDA Advisory Committee will meet again to discuss the EUA application for Moderna’s COVID-19 vaccine, meaning that before year’s end we may have authorized vaccines to combat COVID-19.
Thanks to the tremendous work of our brightest scientific minds and most innovative companies, there is cause for hope that brighter days lay ahead in 2021.
A December to Remember for Vaccine Progress
December 2, 2020
As people across the country gathered to give thanks and enjoy a four-day weekend, the scientific community was hard at work in the quest to get effective vaccines for COVID-19 across the finish line.
There have been a number of promising developments over the last 10 days. Let’s review where things stand.
- FDA Approval: On November 20, Pfizer submitted its application to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its COVID-19 vaccine. The FDA will meet to discuss the application on December 10. On Monday, Moderna announced they plan to submit an EUA, with the committee expected to meet to discuss the data on December 17.
- First Doses Administered: Should the vaccines be approved, Pfizer will supply 50 million doses globally in 2020, with the first vaccines administered in the middle to the end of December. Last Friday, the first “mass air shipment” of the vaccine arrived on a United flight from the Pfizer facility in Puurs, Belgium in anticipation of the administration of the vaccine later this month. Meanwhile, Moderna expects to have 20 million doses available in the U.S. by the end of 2020, with the first injections given as early as December 21.
- What about AstraZeneca? Last Monday, AstraZeneca announced their vaccine candidate was up to 90% effective at preventing COVID-19, based on two dosing criteria. The regimen that was 90% effective involved a half dose, followed by a second full dose shot a month later. The regimen with two full dose shots was only 62% effective. The company revealed the half dose regimen was given in error, but noted that it could prove to be “quite a useful mistake.” AstraZeneca is currently considering running an additional study to generate more data on the regimen with better efficacy.
As we enter the month of December with the end of a tumultuous year in sight, we believe it is within our grasp that we will have not one but two effective vaccinations against COVID-19 before the month’s end.
To learn more about this amazing progress, visit the U.S. Chamber’s Discover & Deliver Interactive Map—now showing an astounding 900+ clinical trials across the United States for COVID-related solutions.
How Do Moderna and Pfizer Vaccines Compare?
November 19, 2020
As the United States surpassed 11 million coronavirus cases this weekend, the scientific community continues to make great strides towards the discovery of an effective COVID-19 vaccine. Exciting news from Moderna reveals that we may be closer than ever before.
Big takeaway: On Monday, Moderna announced that the independent data safety monitoring board found that the company’s vaccine candidate was 94.5% effective following its first interim analysis. The news follows last week’s announcement by Pfizer that their vaccine candidates showed over 90% efficacy.
It is worth re-visiting the differences between the two vaccines:
- Type and Dosing: Both vaccines are using a previously unproved messenger RNA (mRNA) technology, delivered in two doses. Pfizer’s vaccine is delivered 21 days apart; Moderna’s requires 28 days between doses.
- Storage: While Pfizer’s vaccine must be stored at -94 degrees Fahrenheit, Moderna announced on Monday their vaccine can be stored at regular refrigeration temperatures for up to 30 days and at room temperature for up to 12 hours.
- Severity of cases and safety: Potentially the most exciting part of Moderna’s announcement was the implications for severe COVID-19 disease. All 11 of the trial participants who developed severe disease were in the placebo group, suggesting the vaccine may prevent patients from developing more advanced symptoms. While Pfizer has not yet released data on the severity of the disease, the first interim analysis of both trials did not show any significant safety concerns.
- Timing: Pfizer estimates they will have sufficient safety, efficacy, and manufacturing data to apply for an Emergency Use Authorization (EUA) by the third week in November, and Moderna’s application will follow closely behind. Moderna projects they will be ready to file for an EUA in the next few weeks. Their CEO estimates the FDA advisory committee could meet to discuss their vaccine December 7 or 14, with an EUA to follow a few days later. Once an EUA is authorized, the government could begin vaccinations as soon as 24 hours later.
With the announcement of Moderna’s efficacy data, their CEO noted, “Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters.”
The innovative scientific community wasted no time rising to the challenge. We are confident that the chase may soon be over, with the hope of multiple COVID-19 vaccines very much in sight.
An Injection of Hope with Pfizer’s Promising Vaccine Announcement
November 11, 2020
As the United States surpassed 10 million COVID-19 cases, the innovative life sciences community just provided Americans with one thing they desperately need: hope that we are on the cusp of an effective immunization against COVID-19.
On Monday, Pfizer and BioNTech released the results of the first efficiency analysis by the independent Data Monitoring Committee for their COVID vaccine candidate. The data illustrates the vaccine’s efficacy rate exceeded 90% at seven days after the second dose.
Why this is a big deal: To apply for an emergency use authorization (EUA), the FDA only requires that a vaccine be 50% effective in immunizing against COVID-19. At a time when there is much to disagree about, scientists concur that the preliminary results on the vaccine – which uses a previously unproven mRNA technology – vastly exceeded expectations.
What’s more: The committee did not report any serious safety concerns.
What happens next: While this announcement is promising, two more milestones must be reached before Pfizer can apply for an EUA:
- Pfizer must produce manufacturing data to demonstrate the vaccine can be produced with consistency and quality.
- The company must provide a median of two months of safety data following the second dose. The company anticipates that data will be available by the third week of November, a mere two weeks away.
Responding to positive data for the their vaccine candidate, Pfizer CEO Albert Bourla underscored just how high the stakes have become stating, “If we’re not successful, we are going to lose the billion dollars. But if we’re not successful, the world is losing hope.”
On the contrary, we believe the company is giving us an injection of the hope we very much need.
No October Surprise, But Promising Advances for a COVID Vaccine
October 30, 2020
While there may not have been an October surprise in the race to develop a COVID-19 vaccine, there have been a number of promising advances in the last week alone.
Here’s where things stand:
- Efficacy data: While Pfizer initially projected they would know whether the vaccine was effective by the end of October, the company announced on Tuesday it does not yet have the data needed to begin a review by the independent data safety monitoring board. Once that threshold is reached, Pfizer’s CEO stated it will likely take the company up to a week before they can release the data.
- Enrollment: Last Thursday, Moderna announced that it has fully enrolled it’s 30,000-person trial. Meanwhile, Pfizer announced the 44,000-person trial is near full enrollment, with less than 2,000 more volunteers needed to be completely registered. Nearly 36,000 of those volunteers have received both doses of the vaccine or the placebo.
- Additional trials advance: Both the Pfizer and Moderna vaccines are using a previously unproven messenger RNA (mRNA) technology to immunize against COVID-19. Should their scientific gamble fail to pay off, many other promising vaccine candidates are close behind in the pipeline. On Monday, AstraZeneca announced their Phase 3 trial illustrated that the vaccine candidate triggered an immune response in both younger and older adults. Meanwhile, Novavax stated their late-stage U.S. trial will begin by the end of November.
Taken together, what do both these developments mean? We are not there yet, but we are closer than ever before. When the global pandemic began, the scientific community could not have dreamed we could advance one promising vaccine candidate in such a short period of time, much less have more than one potential candidate.
We have long known that we will likely need multiple vaccines to effectively defeat COVID-19. And, only seven months later, we are on the cusp of that discovery.
Timelines for Leading Vaccine Candidates Show Safety and Effectiveness Are Top Priority
October 23, 2020
On Thursday, a little-known Food and Drug Administration committee met to discuss developments related to a COVID-19 vaccine. The meeting of the Vaccine and Related Biological Products Advisory Committee is particularly timely, as two companies enter the home stretch of the race to develop an immunization against COVID-19.
In the last week, both Pfizer and Moderna released an updated timeline for their Phase 3 clinical trials, based on their ability to meet three key criteria:
- Efficacy: Both trials need to demonstrate a certain number of COVID-19 cases occurred to illustrate the vaccine is more effective than the placebo. Pfizer estimatesthey will reach this threshold by the end of October. Moderna expects this will occur sometime in November.
- Safety: The Food and Drug Administration (FDA) requires companies provide two months of safety data following the final dose of the vaccine. Pfizer estimates the trial will surpass this milestone the third week of November. Similarly, Moderna projects they will have sufficient safety data by the end of November, but they caution the FDA may not issue a decision on the application until December.
- Manufacturing quality & consistency: Finally, if the vaccine candidate is deemed effective and safe, the company must provide manufacturing data to demonstrate the vaccine can be produced with consistency and quality. Pfizer has ramped up its manufacturing capacity in parallel with the clinical trial. Pfizer estimates they will have the data ready for submission prior to surpassing the safety milestone.
While some may lament the science isn’t moving fast enough, Pfizer’s CEO noted the company can only move as fast as the speed of science allows.
Both companies’ timelines to develop a vaccine at warp speed reaffirms what we already knew: the business community continues to lead the way in the fight against COVID-19.
—Kelly Anderson, Director of International Policy, Global Innovation Policy Center
A Pause for Some COVID-Related Clinical Trials are Routine and Necessary to Ensure Patient Safety and Effectiveness
October 15, 2020
Clinical trials for COVID-19 vaccines and treatments once again captured headlines this week.
- On Monday, Johnson & Johnson paused its 60,000-person Phase III vaccine trial due to an “unexplained illness” in one of the volunteers.
- On Tuesday, Eli Lilly temporarily stopped its 326-person Phase III antibody trial because of a “potential safety concern.”
- This week’s developments followed a similar pause in AstraZeneca’s Phase III vaccine trial due to “a single event of an unexplained illness” in September.Their trial was subsequently resumed in five countries following approval from regulatory authorities.
These three developments may seem worrisome. In fact, the opposite is true. Clinical trials are routinely paused to ensure the medicine being tested is truly safe and effective.
Experts have pointed out that, if anything, it would be more concerning if no adverse events were reported in a large, late stage trial like Johnson & Johnson’s.
A global spotlight: These developments shed light on yet another new phenomenon of the coronavirus pandemic: global consumers have never before paid such close attention to clinical trials.
But the spotlight merely reveals that the process is working. While time is of the essence, regulatory authorities have resolved not to cut corners. With over 38.5 million global cases and 1 million deaths from COVID-19 to date, there is simply too much at stake for us to expect any less.
This Week’s Promising COVID-19 Vaccine Developments
October 13, 2020
It has now been just over seven months since the World Health Organization declared COVID-19 a global pandemic. In that time, the science has evolved rapidly, with new advances to combat coronavirus occurring daily.
Here are a few of the most promising developments from the last week alone:
- Pfizer vaccine trial: On Monday, Pfizer announced plans to expand the clinical trial for their COVID-19 vaccine to include children as young as 12. The company will also increase the trial size to include 48,400 volunteers. To date, Pfizer has enrolled 37,864 participants, and 31,062 of those participants have received both doses of the vaccination.
- AstraZeneca antibody treatment: Regeneron’s antibody cocktail was in the spotlight last week after President Trump received the innovative treatment. However, AstraZeneca’s long-acting antibody (LAAB) treatment has also advanced significantly, with two Phase III clinical trials beginning in the next two weeks to test the antibody treatment in over 6,000 participants. Additionally, AstraZeneca received $486 million from the government to develop 100,000 doses of their antibody cocktail as part of Operation Warp Speed.
- New Abbott antibody test: On Monday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a new COVID-19 antibody test, AdviseDx, developed by Abbott Laboratories. While Abbott has received EUA for seven tests to date, AdviseDx is the newest test used to detect Immunoglobulin M (IgM) antibodies. Because IgM antibodies become undetectable weeks after infection, Abbott’s new test will be used to determine whether a patient recently suffered from COVID-19 and help healthcare providers determine if treatment or follow-up is needed.
What is the common thread that ties these three developments together, as well as the thousands of other promising scientific advances we have seen over the last seven months?
The business community is leading the way.
Whether it’s vaccines, therapeutics, or tests to combat coronavirus, the innovative scientific community has woken up every day over the last seven months dedicated to getting the world one step closer to our ultimate goal: defeating COVID-19.
Innovative COVID-19 Therapies are in the Spotlight
October 7, 2020
Innovative therapeutics were thrust into the spotlight following the announcement that President Trump contracted COVID-19. While much attention has been given to the race to discover a vaccine, the news brought renewed attention to the treatments currently being tested to combat the coronavirus.
President Trump has received three therapeutics to date. Here’s a recap of where each stand:
- Regeneron’s antibody treatment: Regeneron’s antibody cocktail, REGN-COV2, is a combination of two monoclonal antibodies which are designed to block the coronavirus infection. Last Tuesday, Regeneron announced the results of its 275-person, Phase 1/2/3 trial which showed that the treatment both reduced the viral load and alleviated symptoms in non-hospitalized COVID-19 patients. While REGN-COV2 has not yet received emergency use authorization (EUA) from the Food and Drug Administration (FDA), the treatment was provided following a compassionate use request from the President’s physicians.
- Gilead’s Veklury®: Even before President Trump received Veklury® (remdesivir), Gilead’s innovative medicine has been making headlines as the first antiviral treatment to demonstrate patient improvement in clinical studies for COVID-19. While the FDA originally authorized an EUA for those with severe disease, in August the EUA was expanded to include all hospitalized COVID-19 patients. The treatment is approved or authorized for temporary use to treat thousands of patients in about 50 countries.
- Dexamethasone: President Trump also received the commonly used corticosteroid Dexamethasone. In June, the medicine was found to be effective in patients with severe COVID-19 complications following a study in 6,425 patients the UK. To date, two dexamethasone studies have been conducted in the U.S. in 575 patients.
How did his physicians arrive at these three treatments? They followed the science, guided by the array of clinical data compiled from 797 trials conducted in the U.S. and thousands of others around the world.
The last week ultimately serves as reminder of what we already know: the science will lead us towards effective therapeutics against COVID-19, whether those treatments are used to aid in the recovery of the leader of the free world or in coronavirus patients around the globe.
10 COVID Vaccine Candidates are in Late-Stage Clinical Trials
September 29, 2020
Just last week, we highlighted three of the leading vaccine candidates in Phase 3 clinical trials, which are produced by Moderna, Pfizer, and AstraZeneca.
According to the WHO, there are now 10 vaccines in late-stage clinical trials, with two particularly promising candidates recently entering or announcing the start of Phase 3 trials.
What’s new: Last Wednesday, Johnson & Johnson launched its Phase 3 clinical trials for their COVID-19 vaccine candidates, while Novavax announced last Thursday that their late-stage trial will begin in mid-October.
With an increasingly crowded field of Phase 3 vaccines, what is the difference between the candidates?
- Trial size: The Johnson & Johnson vaccine will be tested in largest group to date, with a goal of enrolling 60,000 people in the trial. The next largest trial, led by Pfizer, aims to enroll 44,000 volunteers. And the Novavax vaccine – the other new-comer to the Phase 3 race – will be tested in 10,000 people in the UK.
- Vaccine type: The Pfizer and Moderna candidates are made of mRNA, a type of vaccine that has yet to be approved by the Food and Drug Administration. The Novavax candidate is using a tried and true protein-based vaccine, similar to the flu shot or shingles vaccine. Meanwhile, the Johnson & Johnson is a viral vector vaccine, similar to the Ebola vaccine.
- Dosing: The Johnson & Johnson vaccine is currently the only single-dose vaccine in the late stages of clinical trials. The Novavax, Pfizer, Moderna, and AstraZeneca all require two doses, spaced weeks apart.
- Storage: Perhaps the biggest difference that sets the Johnson & Johnson and Novavax vaccines apart are their refrigeration requirements. While the Pfizer and Moderna vaccines must be stored at sub-zero temperatures, both the Novavax and Johnson & Johnson vaccines candidate can be stored between 36 and 46 degrees Fahrenheit.
What’s next: If the vaccine proves safe and effective, Johnson & Johnson estimates their candidate will be ready for early use authorization (EUA) by early 2021. Similarly, Novavax plans to increase its manufacturing capacity to prepare doses to be distributed by mid-2021.
Frontrunners in the Coronavirus Vaccine Race
September 23, 2020
As the race continues to develop a COVID-19 vaccine, three front runners have emerged. While there are currently nine vaccines in late-stage Phase III clinical trials, the vaccine candidates produced by AstraZeneca, Pfizer, and Moderna are widely regarded as the most promising.
Just as the vaccines have been developed at an unprecedented speed, the companies are taking unprecedented steps to ensure transparency and to ease concerns about the safety and efficacy of a potential COVID-19 vaccine.
What’s New? Over the last week, AstraZeneca, Pfizer, and Moderna have each released detailed blueprints which describe the process for selecting and monitoring participants in the clinical trials and the clinical endpoints that must be reached to determine if the vaccine candidate is truly effective.
The blueprints also seek to answer the question at the top of everyone’s minds: when will we have a vaccine to defeat COVID-19?
What’s Next? To receive emergency use authorization (EUA) from the Food and Drug Administration (FDA), the companies must illustrate that the vaccine is at least 50% effective.
Each company must illustrate that a certain number of infections have occurred to surpass that threshold.
For Moderna, the company estimates they will know if vaccine is effective by December at the earliest; for Pfizer, July; and for AstraZeneca, the timing is a bit unclear. While AstraZeneca restarted its Phase 3 trial in the UK, South Africa, and Brazil, the trial remains on hold in the United States.
The Big Picture: Despite the difference in timing, one thing remains clear: the business community continues to lead the way to develop COVID-19 solutions. With the world’s top innovative and scientific minds on the task, we remain confident we will discover and deliver an effective COVID-19 vaccine soon.
Warp Speed Ahead for Promising COVID Vaccine Candidates
September 16, 2020
Over the last six months, the science to identify a coronavirus vaccine has advanced at warp speed. According to the World Health Organization, there are currently 35 vaccines in the clinical stage of evaluation, with another 145 in the preclinical phase.
What’s new: Just last week, AstraZeneca announced it was pausing the clinical trial for its Phase III vaccine candidate due to an adverse reaction with one of the trial’s participants.
While the announcement of the of clinical trial’s pause drew widespread media attention, the Director of the National Institutes of Health, Dr. Francis Collins, noted that placing a hold on a clinical trial – which routinely occurs during clinical research – “ought to be reassuring.”
Why? It illustrates that the companies will continue to follow the science to identify an effective vaccine. And those companies remain committed to adhering to the highest scientific standards, even though the innovative community knows all too well that time is of the essence.
This Saturday, AstraZeneca’s clinical trial resumed in the UK after the regulatory authority deemed it safe to restart the study.
What’s next: While the AstraZeneca trial received extensive coverage in the last week, two other importance vaccine developments should not be overlooked.
On Saturday, Pfizer announced they are seeking regulatory approval to expand the Phase III clinical trial to recruit 44,000 participants in order to ensure the trial is sufficiently diverse.
Meanwhile, Merck – one the companies selected to be part of Operation Warp Speed given the vast promise of their vaccine candidates – announced the company will start its Phase I/II trial for one of its two COVID-19 vaccines.
The bottom line: Creating incentives for companies to continue to invest in innovation is now more important than ever. This is why the Chamber is urging the administration to reconsider its misguided policy to import price controls from foreign countries.
Six months into the global pandemic, the stakes are simply too high for the U.S. government to move forward with policies that will substantially reduce investment in new drugs and cures at this critical time.
Biopharmaceutical Innovators Pledge Safety & Effectiveness as Top Priority for Coronavirus Vaccine
September 9, 2020
As children, teachers, and school administrators head back to school, a potential COVID-19 vaccine is top of mind for many.
There are currently over 700 clinical trials taking place for COVID-19-related vaccines and treatments across all 50 states. In communities large and small across the country, innovative companies, hospitals, and universities have banded together to identify scientific advancements to combat COVID-19.
The business community believes one thing is clear: we must continue to follow the science.
What’s new: Today, nine of the leading biopharmaceutical companies signed a pledge to uphold the integrity of the scientific process. Three of the signatory companies – AstraZeneca, Moderna, and Pfizer – are hosting late-stage clinical trials for promising COVID-19 vaccines, with the hope of identifying an effective candidate by early this fall.
While time is of the essence, the companies recognize that the safety and efficacy of the vaccine must continue to be their top priority.
What’s in the pledge: The companies commit to “developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles” to ensure that science – not speed – guides us to an effective vaccine candidate.
With the leading biopharmaceutical companies on the task, the Chamber trusts that we will soon have a vaccine to protect our students, teachers, and communities against COVID-19.
Abbott’s New COVID-19 Rapid Test Could be a Game Changer
September 2, 2020
In this critical moment in the pandemic, testing is fundamental to our ability to get back to life with a bit more confidence.
What’s new: To help advance testing across the country, Abbott is launching a new COVID-19 rapid antigen test, BinaxNOW™, along with a complementary mobile app. It’s being billed as a fast, reliable, affordable, and portable rapid test that Abbott will produce at mass scale to greatly expand access to testing to people who need it.
The rapid test also boasts unprecedented accuracy levels: the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
Big picture: The BinaxNOW COVID-19 test is the latest in a series of antigen tests produced by Abbott; it is the sixth test that the company is launching in the U.S. to help fight the coronavirus pandemic. To date, Abbott has provided more than 27 million COVID-19 tests in the U.S., including 14 million detection tests and 13 million antibody tests.
What’s next: As communities around the country prepare for a potential second wave in the fall, Abbott says that it wants to ensure that healthcare providers are adequately prepared. The company plans to ship tens of millions of tests in September and will ramp up manufacturing to 50 million tests a month in October.
To continue to combat COVID-19, testing must be at the core of the country’s coronavirus response. With companies like Abbott working in partnership to support communities worldwide with resources and technologies to fight this evolving threat, it is clear the business community is leading the way to ensure that we can defeat coronavirus and return to health and work once again.
Discover & Deliver Event with Rep. Darin LaHood Spotlights Western & Central Illinois Role in Combatting COVID-19
August 27, 2020
This week the Discover & Deliver campaign completed its second in-state event to tell the “all-of-nation effort” underway to beat COVID-19.
On Wednesday, the campaign hosted a discussion with Rep. Darin LaHood in partnership with the Peoria Chamber of Commerce. The Congressman spoke about COVID-19 related clinical trials taking place in Peoria and discussed how an effective IP framework has underpinned this investment in clinical research.
The event was featured in the local news outlets, including local CBS Affiliate WMBD and Peoria Public Radio–illustrating the value of spotlighting the innovation playing out in communities across the United States.
We hope you will join us next Friday for another Discover & Deliver regional event with Rep. Mikie Sherrill (D-NJ-11), along with these other confirmed events coming soon:
- Wednesday, Sept. 9 at 3:30pm ET: Rep. Stephanie Murphy (D-FL-07)
- Thursday, Sept. 10 at 11:00am MT (1:00pm ET): Rep. Ben McAdams (D-UT-04)
- Friday, Sept. 11 at 2:00pm ET: Senator Tom Carper (D-DE)
30 Coronavirus Vaccine Candidates in the Running
August 26, 2020
As the political world closely followed last week’s Democratic National Convention and watches the Republican National Convention, there continues to be much speculation around whether a vaccine will be ready before November 3.
There are currently 30 vaccine candidates in the clinical stage of evaluation, with another 139 in the preclinical stage of testing. While the pressure is on in the race to approve a COVID-19 vaccine, the innovative and scientific community remains committed to following the science to identify a vaccine that is safe and effective.
- There are 6 vaccines in late-stage, Phase 3 clinical trials. The University of Oxford and AstraZeneca vaccine is widely regarded as one of the leaders.
- Last Thursday, Pfizer and BioNTech released additional data from their Phase 1 trial on their leading vaccine candidate. The data showed that the vaccine elicited a strong immune response in both younger and older adults. The vaccine is currently undergoing a Phase 2/3 evaluation, and the companies believe they are on track to apply for regulatory approval as soon as this October.
Last Friday, Moderna announced the company has enrolled 13,194 participants in its Phase 3 vaccine trial. The Chamber’s interactive map reveals that the trial is taking place in communities large and small across the country, from Austin, TX to Newton, KS.
What’s Next: While the Johnson & Johnson vaccine is currently undergoing a Phase 1/2 clinical trial, the company announced they will begin a 60,000 person Phase 3 clinical trial in September, the largest late-stage trial planned to date.
With many promising vaccine candidates in development, all eyes will be on the innovative and scientific community as the world eagerly awaits a vaccine which will place us on the return to health once again.
Event: All-of-Nation Effort To Beat COVID 19 Featuring Rep. Donna Shalala (FL-27)
August 25, 2020
In August, the Greater Miami Chamber of Commerce, the Coral Gables Chamber of Commerce and the U.S. Chamber’s Global Innovation Policy Center hosted its first regional Discover & Deliver event, featuring Rep. Donna Shalala (FL-27).
As a former Secretary of Health and Human Services (HHS) and current representative for Florida’s 27th District, the Congresswoman discussed how effective innovation policy laid the groundwork for Southeast Florida’s response to COVID-19.
The event also featured the Executive Dean for Research at the University of Miami School of Medicine and the Chief Medical Officer at Mercy Hospital in Florida for a discussion about the ways innovative clinical trials helped deliver cutting-edge medical treatments to coronavirus patients across the region.
The event highlighted the Chamber’s Discover & Deliver interactive map, which shows 81 COVID-19-related clinical trials taking place across Southeast Florida.
The event was the first in a series of virtual regional events with Members of Congress to tell the local story of COVID-19-related innovation in communities across the country.
Vaccine and Therapeutic Candidates for Coronavirus Rapidly Accelerating
August 19, 2020
It’s been just over five months since the World Health Organization declared the coronavirus a global pandemic. While that may feel like an eternity for some, it’s important to remember how quickly the science has progressed towards a COVID-19 vaccine in a short period of time.
Just 3 months ago in mid-May, there were only 8 vaccines in the clinical stage of development. By early July, that number more than doubled to 17. Now, as our summer of social distancing draws to a close, the WHO reports there are 29 vaccines undergoing clinical trials, with another 138 in the pre-clinical stage of evaluation.
While that may not feel fast enough for many, in the scientific world, COVID-19-related innovation is taking place in the blink of an eye.
What’s new: As the science continues to evolve rapidly, a number of vaccine candidates have been in the news in recent days.
- The German biotech company, CureVac, is currently conducting early-stage clinical trials for a COVID-19 vaccine candidate. The company’s stock skyrocketed on Friday following their introduction on the Nasdaq, given the promise the vaccine may hold. While full clinical trial data will not be available until September or October, on Monday the company moved forward to register the mRNA vaccine candidate for a Phase 2 trial.
- Similarly, Novavax – one of the companies who received support from the Bill & Melinda Gates Foundation – announced the start of a Phase 2b trial in South Africa. The trial is notable because it will test the vaccine not just in healthy volunteers, but also in HIV positive individuals, which speaks to the scientific community’s recognition that vaccines must be tested in all segments of the population who could be adversely impacted by the disease.
What’s next: Given the unparalleled scientific progress to combat coronavirus since the global pandemic began five months ago, it begs the question: what will the next five months of scientific advances hold?
With the world’s most innovative companies, the brightest scientific minds, and the leading universities on the case, the Chamber is hopeful we may soon have an effective vaccine to defeat COVID-19.
Gilead Partnering with 40 Companies to Scale Up Production of Promising COVID-19 Treatment
August 12, 2020
As the dog days of summer drag on, the heat has proven to be no match for COVID-19. Yet, the business community remains confident that something else will come to the rescue: science.
There are currently 640 clinical trials for COVID-19 therapeutics and vaccines taking place across all 50 states. Gilead’s innovative medicine, remdesivir, has been making headlines as the first antiviral treatment for COVID-19 to demonstrate patient improvement in clinical studies–enabling patients to recover more quickly, potentially freeing up provider time and hospital resources.
On Monday, the company announced it is seeking full regulatory approval for remdesivir to treat COVID-19, the final milestone needed for the medicine to be used widely with coronavirus patients.
Because remdesivir is delivered intravenously and is complex to manufacture, Gilead is partnering with 40 companies across North America, Europe, and Asia, with a goal of meeting global demand for the medicine by October. Just last Friday, the company announced it would team up with Pfizer to produce remdesivir at Pfizer’s McPherson, Kansas facility.
The partnership illustrates the unprecedented scope of industry collaboration to combat COVID-19. Pfizer’s CEO Albert Bourla said it best: “Together, we are more powerful than alone.”
Indeed, the scope of industry collaboration also extends to R&D, with multiple studies of combination treatments underway in the hope of improving upon patient outcomes.
The National Institute of Allergy and Infectious Disease is evaluating a combination of Gilead’s remdesivir and Eli Lilly’s anti-inflammatory drug baricitinib; studies are also underway to determine the benefits of Roche’s rheumatoid arthritis therapy tocilizumab in combination with Gilead’s remdesivir.
Yet recently, some actors in the United States are threatening the ability of innovative companies to work together to invest in the science needed to combat COVID-19. Proposals to impose artificial price controls or override patent protection will hinder the research and development into life-saving treatments and cures at a time when they are desperately needed to defeat COVID-19.
Now, more than ever, innovators need to keep their eyes on the ball to deliver solutions to COVID-19, but they can’t do it alone.
The Chamber calls on policy makers across the U.S. to reject proposals which threaten the investment in innovation that is needed to lead us beyond the coronavirus crisis once and for all.
A Promising COVID-19 Antibody Treatment Enters Phase III Clinical Trials
August 5, 2020
While the global community eagerly awaits a COVID-19 vaccine, the science has progressed rapidly behind another form of preventative treatment: antibodies.
Because COVID-19 antibodies can be used to temporarily prevent infection, many in the scientific community believe that antibodies will provide a bridge until a safe and effective vaccine becomes widely available. In fact, Dr. Anthony Fauci recently stated that monoclonal antibodies are “almost a sure bet” to protect the body from the coronavirus.
There are over 620 clinical trials for COVID-19 vaccines and therapeutics–including antibody treatments–taking place across the United States.
Yet, for this investment in innovative treatments to continue, policymakers must support smart innovation policy and reject unnecessary regulations, including price controls. This will ensure that innovative companies can discover and deliver the treatments and vaccines which coronavirus patients desperately need.
One company leading the way in the race to deliver effective antibody treatments is Eli Lilly. The company started the first human trial of its potential antibody treatment in the beginning of June—and the clinical research has advanced rapidly in just two months. On Monday, Eli Lilly announced the company would begin a Phase 3 trial to test the antibody treatment in nursing homes.
Why nursing homes? The leading scientists and the innovative community recognize that we will only know if therapeutics are truly effective if they are tested in the communities most impacted by the disease. With a significant percentage of COVID-19-related deaths linked to nursing homes, there is an urgent need to test potential treatments in the most vulnerable populations among us.
If Eli Lilly’s antibody treatment proves successful, the drug could receive regulatory approval by the end of the year.
As Dr. Anthony Fauci said at a recent U.S. Chamber event, we must follow the science. The Chamber believes the science will soon lead us to effective therapeutics and vaccines which place us on the return to work and health once again.
Two Coronavirus Vaccines Enter Final Stages of Clinical Trials
July 28, 2020
As communities across the country consider whether to re-open schools and offices this fall, leaders are pinning their hopes to a COVID-19 vaccine that will soon be available.
The Chamber’s latest interactive map, released last Tuesday, breaks down where COVID-19 related clinical trials for vaccines and therapeutics are taking place in the United States. While there are currently 25 vaccines in the clinical stage of development, just yesterday, two entered the final stages of clinical trials.
On Monday, Moderna began a Phase 3, 30,000 person trial for its leading vaccine candidate, developed in partnership with the National Institute of Allergy and Infectious Diseases. A day ahead of the beginning of the trial, the U.S. government threw additional support behind Moderna’s vaccine, committing an additional $472 million to the Phase 3 trial.
Late Monday afternoon, Pfizer and BioNTech announced the start of a global Phase 2/3 30,000 person safety and efficacy clinical trial for their leading mRNA vaccine candidate. If the vaccine candidate proves effective, the companies plan to seek regulatory approval as early as October 2020, with a goal of providing up to 100 million doses globally by the end of the year.
The story of these three innovative companies sheds light on the risk required to invest in innovative life-saving treatments. While Moderna has been in the news for months and the company boasts a robust development pipeline, the vaccine candidate, if successful, would be company’s first FDA approved medicine.
What’s more: there has not yet been a successful mRNA vaccine developed to date. Should either the Moderna or Pfizer and BioNTech vaccine candidates be successful, it would be an unprecedented breakthrough not just for the companies but also for the global community who eagerly await an effective COVID-19 vaccine.
As these companies’ works at warp alongside the other innovative biopharmaceutical companies with vaccines in clinical development, the scientific community recognizes that an effective vaccine cannot come soon enough.
At a U.S. Chamber event last Tuesday, Dr. Michelle McMurry-Heath, the CEO the Biotechnology Innovation Organization, acknowledged that the scientific community has dedicated its full innovative capacity to identifying a COVID-19 vaccine. Dr. McMurry-Heath stated that we know it’s “not fast enough, but it’s faster than we would have ever dreamed possible.”
With our brightest scientific minds, the most innovative companies, and the nation’s leading universities on the task, the Chamber is confident that we will have an effective vaccine to help lead the global community out of this crisis soon.
COVID-19 Vaccine Innovators Making a House Call
July 15, 2020
Next Tuesday, July 21, the House Energy and Commerce Oversight and Investigations Subcommittee will hold a hearing with some of the innovative biopharmaceutical companies leading the coronavirus vaccine race. The companies will discuss their research and development efforts, as well as their ongoing preparations to manufacture and distribute resulting solutions.
Ahead of the hearing, let’s look at what we know about those efforts and preparations already.
Right now, there are two vaccine candidates in Phase 3 clinical trials – one is the result of a partnership between AstraZeneca and the University of Oxford. The University of Oxford recently embarked on a trial with 5,000 volunteers in Brazil – a coronavirus hotspot– to test efficacy of their vaccine candidate. Preliminary results are expected as soon as October.
Just yesterday, Moderna published data in the New England Journal of Medicine which showed that their vaccine produced an immune response in a Phase 1 study. The company will begin a Phase 3 trial testing the vaccine in 30,000 participants on July 27.
Other companies are tracking closely behind.
Merck plans to utilize its long-standing leadership in vaccine development to address COVID-19. CEO Ken Frazier recently noted that “In the last quarter century, there have only been seven, truly new vaccines introduced globally at the clinical practice… Merck has four.” The company soon hopes to add a fifth with a COVID-19 vaccine. Merck is currently investigating whether its previously approved Ebola and Measles vaccines can be re-engineered to combat COVID-19.
On Monday, Pfizer and its German partner BioNTech, received fast track designation from the FDA for two of its four vaccine candidates, which will help speed up regulatory approval should one of them prove to be effective during their Phase 1/2 clinical trial, happening now.
With the full innovative capacity of these companies dedicated to identifying an effective coronavirus vaccine, we remain hopeful that we will soon have an immunization to help place us on the return to a new normal in the wake of COVID-19.
Pfizer and BioNtech Partner Up to Develop COVID-19 Vaccine Candidate
July 9, 2020
Just last week two companies – Pfizer and its German partner, BioNTech –announced preliminary data as the companies race to develop a vaccine candidate to help prevent COVID-19.
While there are currently 19 vaccines in the clinical stages of evaluation by various companies, Pfizer and BioNTech have taken a unique approach to develop and test a potential COVID-19 vaccine.
Rather than test just one vaccine candidate, Pfizer’s Phase 1/2 clinical trial is designed to study the safety tolerability and immunogenicity of up to four mRNA vaccine candidates in order to identify which may be the most promising.
Last Thursday, the companies announced early positive results for one of those mRNA vaccine candidates, BNT162b1. The announcement stated, among other things, that the vaccine candidate was well-tolerated and generated a dose-dependent immune response.
Yet, this is just one of the many steps on the road to secure regulatory approval for a potential vaccine.
Pfizer and BioNTech are providing real-time data from its Phase 1/2 study with the goal of progressing into a global Phase 2b/3 study as early as this month.
Pfizer and BioNTech recognize that time is of the essence in the race to develop a vaccine in order to place our communities on the return to our new normal. Kathrin U. Jansen, Pfizer’s Senior Vice President and Head of Vaccine Research & Development noted “in the face of this global health crisis, we approach this goal with the utmost urgency.”
All colleagues in the biopharmaceutical industry – and in the business community as a whole – share that sense of urgency. We hope these colleagues are successful in their own respective efforts to deliver potential vaccines and therapeutics in the fight against COVID-19.
Another Promising Candidate in the Fight Against COVID-19
July 8, 2020
Our July 4th celebrations last weekend looked very different from years past, as America waits in anticipation to declare independence from the coronavirus.
While a number of vaccine candidates continue to make headlines as companies race to develop an effective immunization against COVID-19, scientists are making equally rapid progress on other therapies, including a cutting-edge antibody cocktail.
On Monday, the New York-based biotechnology company Regeneron announced the beginning of a Phase 3 trial to test whether the company’s double antibody cocktail can prevent and treat COVID-19 infection. The trial will take place in 100 locations with over 2,000 patients across the U.S.
Soon after the announcement of the Phase 3 trial, the U.S. government threw their weight – and funding – behind the innovative therapy. On Tuesday, Regeneron signed a $450 million contract with the U.S. government to manufacture and supply the double-antibody cocktail, should it receive regulatory approval.
Regeneron’s story provides a glimpse into the broader clinical trials process – and the public-private collaboration which supports it – occurring in communities large and small throughout the United States.
American biomedical innovation is one of this nation’s greatest strengths, and the numbers behind the search for coronavirus treatments and cures tells us this story. Right now, there are 513 clinical trials happening in hospitals and medical facilities in all 50 states.
Those trials are evaluating everything from new vaccines, to the use of existing innovative medicines, to the efficacy of different therapies.
The trials are sponsored by large pharmaceutical companies, small biotech operations, academic institutions, and hospitals, alike. With the most promising clinical efforts backed by the U.S. government as part of Operation Warp speed, it’s clear all everyone shares one common goal: ending the spread of COVID-19.
With the brightest scientific minds, the most innovative companies, and the backing of the U.S. government, we are hopeful that goal will soon be realized.
An Update on the Global Search for a Coronavirus Vaccine
July 1, 2020
As coronavirus cases increased in at least 35 U.S. states and the global number of cases surpassed 10 million, the question at the front of everyone’s minds is when will a vaccine be ready?
Scientists, industry, and the academic community are moving at unprecedented speed to identify a viable vaccine candidate, and progress is being made every day.
There are currently 17 vaccine candidates in the clinical stages of development, with another 132 under preclinical evaluation. So who leads the way?
The University of Oxford and AstraZeneca are currently conducting a Phase III trial to test the efficacy of their novel coronavirus candidate. As the number of cases in the UK decreased, the University of Oxford recently embarked on clinical trials in South Africa and Brazil to test the vaccine’s efficacy in countries where people have a higher risk of exposure to the coronavirus. They are also set to begin a large-scale Phase III trial in the U.S., following a $1.2 billion commitment by the U.S. government to invest in the vaccine as a part of Operation Warp Speed.
The innovative biotech company, Moderna, is close on the heels of the University of Oxford in the race to develop a vaccine. Moderna, which received widespread media coverage following the release of phase I data in May, will begin Phase III trials for its COVID-19 candidate in 30,000 participants in July. Just last week, Moderna announced a partnership with Catalent to prepare an initial 100 million doses of the vaccine, which could be distributed as early as October, should the vaccine receive FDA approval.
Governments, the biopharmaceutical industry, and the academic community recognize that a vaccine can’t come soon enough. The unparalleled level of public-private collaboration will help ensure that at least one – if not multiple – coronavirus vaccines should soon be available, which will place the global community on the path to a return to work, health, the new normal of life in a COVID-19 world.
Communities Across America are on the Frontlines to Identify Effective Treatments and Vaccines
June 25, 2020
When it comes to medicine, the most promising treatments may be those that already exist.
That’s why across the country, hospitals are conducting clinical trials with hundreds of existing therapeutics – therapeutics used to treat patients with other diseases – to measure their effectiveness in combating COVID-19.
For example Gilead’s promising anti-viral Remdesivir has made headlines for months, with data showing it helps shorten hospital recovery times. Now, Gilead is testing an easier-to-use inhaled version of the medicine.
Also in the pipeline to serve coronavirus patients: new drugs originally discovered to treat rheumatoid arthritis and a generic steroid that has been used for decades to treat patients suffering from everything from allergic reactions to spine and brain tumors.
These trials are happening everywhere – in 224 congressional districts and counting; in communities large and small; in hard-hit hot spots like New York City and in less affected regions like Dakota Dunes, SD.
In other words, the forefront of medical innovation might be right in your backyard. Soon, the U.S. Chamber will release a new, interactive map to show in real time where COVID-19 clinical trials are taking place throughout the United States.
We hope people will use the map to identify how they can support – and even participate in – important clinical trials. That support and participation could make all the difference in the fight against COVID-19.
Lilly Begins the World’s First Study of a Potential COVID-19 Antibody Treatment
June 16, 2020
Fully reopening the world economy is dependent on discovering safe and effective vaccines and treatments for coronavirus. As of today, there are over 320 vaccines and treatments in development to combat COVID-19.
While industry, academic institutions, and the government continue to collaborate at an unprecedented speed to develop a vaccine, scientists across the research community have also joined forces to develop another type of treatment to combat the virus: antibody therapies.
As one of the world’s leading biopharmaceutical companies, Eli Lilly and Company is dedicating its significant scientific prowess and medical expertise to attack COVID-19. On June 1, the company announced that it started the world’s first study in humans of a potential antibody treatment to fight COVID-19 infections.
Lilly believes the investigational medicine, LY-CoV555, holds promise because antibody therapies are designed specifically to attack the coronavirus. They may be particularly important for groups hardest hit by the disease, such as the elderly and those with compromised immune systems.
Lilly scientists developed the antibody in just three months after Lilly’s partner AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Should Phase 1 results show the antibody can be safely administered, Lilly expects to move into the next phase of testing, studying LY-CoV555 in non-hospitalized COVID-19 patients and in preventative settings with vulnerable patient populations. The company also has a second potential antibody therapy in development.
Following the announcement of the Phase 1 trial, Daniel Skovronsky, M.D., Ph.D., Lilly’s Chief Scientific Officer and president of Lilly Research Laboratories stated, “We are grateful to collaborate with colleagues at AbCellera, NIAID, and the many academic institutions who have helped us reach this milestone in humanity’s fight against COVID-19 — a disease first characterized only six months ago. We are privileged to help usher in this new era of drug development.”
Following the Science to a Vaccine
June 4, 2020
All signs point to the discovery of a coronavirus vaccine soon.
There are currently 10 vaccines in the clinical stage of development, with trials proceeding at warp speed. Last week, Moderna dosed the first patients in its Phase 2 study of its mRNA vaccine candidate. It’s just one of many positive developments.
Still, a broader, larger question looms: When will we be able to vaccinate the entire population against the coronavirus?
Scientists, physicians, and industry leaders agree that the world may need more than one coronavirus vaccine to meet global demand and adequately control the virus. Fortunately, plenty of companies have stepped up to the challenge.
Just last week, two of the world’s leading biopharmaceutical companies – Novartis and Merck – announced plans to begin trials to identify potential vaccine candidates.
In partnership with two Massachusetts hospitals and the University of Pennsylvania, Novartis will investigate whether a novel genetic vaccine will adequately immunize patients against the coronavirus. While safety and efficacy testing is still underway, Novartis subsidiary AveXis will begin manufacturing the vaccine, so it’s ready to distribute as soon as possible.
On the other hand, Merck will leverage its long-standing leadership in vaccine development to investigate whether two previously developed vaccines for measles and Ebola can be re-engineered to immunize against the coronavirus. Clinical trials for one of the vaccine candidates are set to begin as early as next month.
Recognizing the potential of both companies’ research, the White House has selected the Novartis and Merck vaccine candidates as two of the five leading immunizations currently under development.
Although the two companies are taking different paths to product, they each embody industry expertise: Any company developing a vaccine must first and foremost follow the science. We remain confident that soon, the science will lead us where we need to go.
Pfizer’s Unprecedented Approach to a Coronavirus Vaccine
May 26, 2020
As states across the U.S. slowly begin to reopen parts of their economies, a big question remains: When will a vaccine be available?
The scientific community recognizes that the unprecedented challenge of a global pandemic requires an equally unprecedented response in size, scale, and scope.
Take Pfizer, for example, one of the companies at the front of the race to create a vaccine. Today, Pfizer – in partnership with German biotech company BioNTech – has one of the 10 vaccines currently in the clinical stage of development.
What makes Pfizer’s approach unique is two-fold: First, Pfizer is one of only a handful of companies seeking to develop an mRNA vaccine candidate. Because an mRNA candidate is made from the genetic code of the virus itself, the vaccine can be produced and tested in a matter of months, rather than years. Second, Pfizer is simultaneously testing four mRNA vaccine candidates to determine which will be the most effective to immunize against COVID-19.
While the mRNA approach offers the advantage of speed, the biggest risk is that an mRNA vaccine has never been successful before. Yet the scientific team at Pfizer recognizes that the extraordinary challenge created by the global pandemic requires companies to think and act boldly.
Pfizer should know if the move will pay off by early July, with data available early this summer on which of the four mRNA candidates is the most promising.
Companies, communities, families, and individuals alike wait in anticipation to see if Pfizer’s investment in a previously unproven technology will help lead us out of the global pandemic.
The Sorrento Antibody Cocktail
May 19, 2020
Right now, there are 174 COVID-19 treatments and vaccines in the clinical stages of development, not to mention 81 additional therapies in the pre-clinical stage. The world is holding its breath for the data.
Already, early results are showing promise. And this week, a small San Diego biopharmaceutical company, Sorrento Therapeutics, released new laboratory evidence that could move the needle from promise to product.
Sorrento claims to have discovered a unique COVID-19 antibody – a blood protein the body makes in response to and in defense against a specific antigen – that can create “100% inhibition” of COVID-19. In other words, the unique antibody has so far been 100% effective in blocking COVID-19 from infecting healthy cells within just four days.
Sorrento, in partnership with Mount Sinai, is working to develop an antibody cocktail containing the unique antibody and other antibodies that they hope will prevent new COVID-19 infections. While the cocktail still needs to be tested in animal and human clinical trials, the initial laboratory performance has been positive.
According to Sorrento CEO Dr. Henry Ji, “Our […] antibody shows exceptional therapeutic potential and could potentially save lives.”
While the world awaits the discovery of a vaccine, the antibody cocktail could temporarily protect individuals from contracting COVID-19, which will be critical to getting America safely back to work. We hope to see that potential realized soon.
COVID-19 Vaccines in Development
May 13, 2020
Companies large and small, domestically and around the world, are devoting every resource to the discovery of a viable COVID-19 vaccine. According to the World Health Organization (WHO), there are 102 vaccine candidates in the pre-clinical stage of development; 8 vaccine candidates have reached the clinical stage of development, meaning human testing has already begun to assess safety and efficacy.
Last week, Moderna received approval from the U.S. Food and Drug Administration (FDA) to be become the second company to begin a Phase II COVID-19 vaccine trial. Just yesterday, Moderna received Fast Track designation from the FDA to help expedite the development and review of its potential vaccine.
The speed at which these innovators are working to develop and test vaccines is unprecedented. But perhaps even more unprecedented than this speed: the ongoing scale-ups of manufacturing in preparation to inoculate millions of people in need.
Pfizer and BioNTech began clinical trials in the U.S. last week for one of the leading COVID-19 vaccine candidates. Even before the vaccine completes clinical trials, Pfizer is bolstering their manufacturing capacity to deliver millions of vaccine doses by the end of 2020. In 2021, they will increase that capacity to deliver hundreds of millions of them. That kind of supply helps ensure broad access, bringing us one step closer to the herd immunity we need to control this virus for good.
It is worth noting: all of this investment in research and development is being made at risk. No one knows which vaccine candidates will be successful, and which ones will fail. That basic fact underscores the foundation of the life sciences community: A spirit of innovation coupled with a drive to serve patients and improve global health. It is clear that foundation is stronger than ever.
Putting Innovation to the Test for COVID-19
May 6, 2020
Moving forward, knowing who among us has previously contracted COVID-19 will help us understand the spread of the disease and the extent of societal prevalence.
Enter serological tests – or antibody tests – that can quickly identify who has been exposed to the virus but no longer carries an active infection.
The first COVID-19 antibody tests entered the U.S. in mid-March, but many of them lacked FDA review, and thus, did not meet FDA’s stringent standards for accuracy. Some were even maliciously intentioned.
FDA Deputy Commissioner Anand Shah and Director of the Center for Devices and Radiological Health Jeff Shuren warned of “unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”
So, this week, the FDA issued new guidance dictating stronger oversight of COVID-19 antibody tests. According to the guidance, manufacturers must submit an Emergency Use Authorization (EUA) request for their antibody tests, complete with data to prove the tests’ accuracy, within 10 days of entering the market.
To date, 12 antibody tests have an EUA, and 200 tests are undergoing review. One authorized test, delivered by Roche Holding, has 100% sensitivity in detecting the virus and 99.8% specificity, meaning only two in every 1,000 samples tested might produce a “false positive” result. In other words, it’s top of the line.
Thanks to productive collaboration between industry players like Roche and the government, we may soon have more data to help guide fact-based decision-making.
Enlisting Science to Help Solve COVID-19
April 29, 2020
Every year during the last week of April, the World Health Organization (WHO) celebrates World Immunization Week to promote all the ways vaccines are creating and perpetuating a healthier world. Never have vaccines been as top-of-mind as they are now in the midst of the COVID-19 crisis.
Public officials around the world are considering how best to re-open their businesses, schools, and ultimately, economies, in the coming weeks and months. One of the most critical factors in getting countries back up and running is the discovery of a vaccine to protect against COVID-19. It’s an unprecedented challenge that both the private and public sectors are meeting with equally unprecedented collaboration.
According to WHO, there are currently seven COVID-19 vaccines in the clinical stages of development. In the last week alone, the University of Oxford’s potential vaccine received widespread attention with the announcement that they could have doses available as early as September if the vaccine proves effective in clinical trials and receives emergency approval from regulators. Additionally, BioNTech and Pfizer announced a Phase I/II trial for their potential vaccine will begin in Germany.
Of the seven potential vaccines, two are the result of a partnership between a life sciences company and a public university or government. Additionally, there are 82 vaccines in the pre-clinical stage of development. Even in those instances, before human trials have begun, companies have announced partnerships with the public sector. For example, at Johnson & Johnson innovators are working with the U.S. government to produce more than one billion doses of an emerging vaccine.
These statistics inform an important conclusion: When we work together, we get more accomplished. Our collective work will help the world get back to work and more importantly, back to health for good.
Enlisting Science to Solve COVID-19
April 22, 2020
As governments take steps to re-open the economy, one sentiment prevails: Americans must get back to good health before we can get back to business as usual. That means we need reliable therapeutic treatments, diagnostic testing, and, eventually, an effective vaccine. The pharmaceutical industry is already delivering.
Right now, there are 173 vaccine and treatment candidates in the clinical stages of development for COVID-19, according to data released yesterday from BioCentury. With so many treatments under development, who is leading the way?
One of these leaders is Gilead. Early data from Gilead’s Phase 3 clinical trials for its investigational antiviral Remdesivir shows particular promise with coronavirus.
While Gilead first began to test Remdesivir in critically-ill patients in February 2020, the research that led to Remdesivir dates back to 2009. Remdesivir was used in clinical trials to combat Ebola from 2014-2016, and while Remdesivir ultimately proved less effective than other treatments, the story of Remdesivir sheds light on the drug development process more broadly. It often takes years of R&D, testing, and often times, failures, before a treatment reaches the market.
While Gilead awaits data from multiple ongoing studies exploring the safety and efficacy of Remdesivir, partial data last week from a University of Chicago Medicine study showed that nearly all enrolled patients were discharged from the hospital with no fever or respiratory symptoms in less than a week.
The early data has given scientists hope that Remdesivir could be one treatment which will help get patients back to health, and eventually, back to life.
It’s inspiring to see companies working around the clock to combat COVID-19. It’s even more inspiring to see their efforts pay off.