Dr. Marty Makary commented as regulators consider Novavax’s application for a vaccine license.
Novavax’s updated COVID-19 vaccine needs further study, the commissioner of the Food and Drug Administration (FDA) said on April 26.
“To be clear, this is a new product that Novavax is trying to introduce to the market with a study of a different product from 2021. New products require new clinical studies,” Dr. Marty Makary
wrote on the social media platform X. “Under this administration, we are prioritizing the Gold Standard of Science—not what saves pharma companies ’tens of millions of dollars.'”
Makary was reacting to a report that the FDA was asking Novavax, a Maryland-based firm, to conduct a randomized clinical trial for its COVID-19 vaccine.
The report said that a trial could cost up to tens of millions of dollars and that the cost could be so prohibitive that it would derail the process.
Novavax
said in a statement on April 28 that it believes its application for a biologics license for the COVID-19 shot “is approvable upon alignment on the details” of a commitment to conduct a post-approval trial. The company declined to comment further on Monday.
Novavax makes one of the three COVID-19 vaccines available in the United States. The FDA
granted emergency authorization in 2024 to the latest version of Novavax’s vaccine, even though no clinical trial data was available.
Moderna and Pfizer have received a biologics license for their vaccines. Those shots, however, remain under emergency authorization for most children.
A biologics license has a higher threshold of safety and efficacy than emergency clearance.
Makary had previously
written in 2021, prior to becoming the FDA’s commissioner, that Novavax “may be the best COVID-19 vaccine to date” because it uses a more traditional protein-based platform.
Novavax has said the FDA was originally scheduled to decide on its application by April 2, but the deadline passed without a decision.
“Any delays to the FDA’s independent review process for the Novavax are a result of scientific review to ensure safety and efficacy,” an official with the Department of Health and Human Services, the FDA’s parent agency, told The Epoch Times previously.
An official with the department told The Epoch Times in an email on Monday that the FDA is “requiring new clinical trial data” from Novavax “to support its Biologics License Application.”
The official added: “Trials from four years ago conducted in people without natural immunity no longer suffice. A four-year-old trial is also not a blank check for new vaccines each year without updated clinical trial evidence, unlike the flu shot which has been tried and tested for more than 80 years.”
The original COVID-19 vaccines have been replaced multiple times as officials and companies try to increase their effectiveness. In 2023, the United States shifted to an influenza-like model, with the formulations updated once per year to match circulating strains.
According to Centers for Disease Control and Prevention
data, only 13 percent of children and 23.2 percent of adults received a COVID-19 vaccine in the 2024–2025 season.
Calley Means, a White House adviser,
wrote on X on Sunday that “it’s now been years since COVID has presented the threat it once did, and the urgency to rush approval of boosters without normal oversight no longer exists.”
Dr. Vinay Prasad, a professor with the Department of Epidemiology and Biostatistics at the University of California, San Francisco, expressed support for the position. “New products require new clinical trials. The American people aren’t research subjects for an uncontrolled experiment,” he
said on X.
Dr. Boghuma K. Titanji, an assistant professor of medicine at the Emory University School of Medicine,
said on the social media platform BlueSky that updates to strains for both COVID-19 and influenza vaccines should not require trials because that would delay the updated versions beyond the virus season, which runs from the fall through the spring.
“Also,” she wrote, “if we already know the platform is safe, it would be ethically problematic to withhold an updated vaccine from people just to re-prove safety for strains that change slightly each year.”
