The Food and Drug Administration (FDA) announced Wednesday an advisory committee will meet on May 22 to discuss and make recommendations about the composition of this fall’s Covid-19 vaccines. In the past few years, the major manufacturers of the Covid-19 shots, Moderna, Pfizer, and Novavax have adjusted their formulas to target various strains of the virus circulating at that time.
Novavax Still Awaiting Full FDA Approval
Moderna and Pfizer each received FDA approval several years ago. However, Gaithersburg-based Novavax has distributed its Covid-19 vaccine under Emergency Use Authorization. The company still seeks full approval from the agency. Getting full approval will make Novavax’s vaccine more marketable in the United States. Moderna and Pfizer’s vaccine is based on mRNA technology. While the Novavax vaccine uses a more traditional protein-based shot.
An April 1 deadline set by the FDA to give full approval of the Novavax vaccine has come and gone. The company still awaits action from the agency.
FDA Makes New Demand
However, the FDA also has made a new demand of Novavax once it receives government approval. The agency wants Novavax to conduct a new clinical trial in part because the company wants to update its shot to target the new JN.1 variant.
MCM reached out to the Department of Health and Human Services (HHS). A spokesperson clarified the agency’s position.
“The Biden administration waived clinical trial requirements for new COVID booster shots. This was a highly favorable deal for the pharmaceutical industry justified by the urgency of a still novel pandemic that was straining our healthcare system. It’s now been years since COVID has presented the threat it once did. The urgency to rush approval of boosters without normal oversight no longer exists,” the spokesperson said.
HHS says if Novavax wants to update its vaccine to target the new strain circulating it will have to conduct new testing.
“The public deserves clear answers about its efficacy and if its benefits outweigh the risk. Trials from four years ago conducted in people without natural immunity no longer suffices. A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years. The public deserves transparency and Gold Standard Science especially with evolving products,” the spokesperson said.
FDA Change May Impact Other Covid-19 Vaccines
What is still unclear is whether the FDA‘s advisory committee will make similar demands of Moderna and Pfizer when it meets later this month. The issue is whether the committee will classify updated vaccines as ‘new products’. If that is the case, the companies will need to conduct new trials.
If that occurs, HHS said it wants placebo-controlled clinical trials. That means some people would get the actual vaccine while others would receive an inactive shot. Experts warn clinical trials take time. Therefore, it is possible new Covid-19 boosters would not be available this fall.
However, an HHS spokesperson tells MCM the FDA “remains on track with its regulatory responsibilities to ensure manufacturers can deliver updated Covid-19 vaccines on schedule.”
County Health Officer Reacts
Dr. Kisha Davis is Montgomery County’s Health Officer. She said conducting new Covid-19 trials for updated vaccines is unwarranted.
“Requiring new efficacy trials would be very costly. It would likely delay the availability of updated COVID-19 boosters before the fall when they are most needed to protect against seasonal surges. We have overwhelming real-world evidence that individuals who are unvaccinated or not up to date with the latest COVID-19 vaccine were more likely to be hospitalized or die from COVID-19. The vaccines are effective, and the platform is well established. The COVID-19 vaccines all went through rigorous testing, including phase 1 placebo controlled and safety trials,” Davis said.
“Immunogenicity—specifically, an increase in antibodies—is the appropriate and expected response, and a meaningful measure of vaccine effectiveness. To suggest otherwise risks undermining public understanding of how these vaccines work. This is the same approach used with annual flu vaccines. Scientists update them based on circulating strains but the flu shots do not undergo new efficacy trials each year,” Davis explained.
“Ethically, we don’t test new treatments against placebo when a known effective intervention exists. In medicine, the standard is to compare a new treatment to the current standard of care. It is not to deny participants an effective option. Requiring placebo-controlled trials for updated COVID vaccines would be like withholding insulin in a diabetes trial or antiretrovirals in an HIV trial—simply unethical,” she added.
Novavax Reaction
MCM also reached out to Novavax. A spokesperson could not comment on the status of the FDA’s decision to grant the company’s Covid-19 vaccine full approval instead of Emergency Use Authorization.
The company issued a statement last month after the April 1 deadline passed. It said in part, “Our application included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of Covid-19. We are confident our well-tolerated vaccine represents an important alternative to mRNA Covid-19 vaccines for the United States.”
Novavax says the company believes vaccination is the best tool to protect people from Covid-19.
“We will continue our efforts to make sure people have access to a protein-based Covid-19 vaccine option this fall vaccination season,” the spokesperson said.
Protection Against Covid-19
Davis agrees vaccination is critical to fighting off Covid-19. She advises elderly residents, people with weakened immune systems, or others at risk to stay up to date with the most recent COVID-19 vaccine.
“They may want to consider an additional vaccine now. COVID-19 rates are currently quite low. The general public is not recommended to get an additional vaccine now, but rather should wait for the updated version if or when it is available in the fall,” Davis said.
Prospects For New Flu-Covid Vaccine
Meanwhile, Novavax will work to develop a vaccine to protect against both Covid-19 and the flu. The combination vaccine is undergoing its Phase 3 trial. That testing began last December. Phase 3 is the last phase of testing. A regulatory agency would then review the results for possible approval.
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