Introduction to the FDA’s Vaccine Approval Process
Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by imposing new regulatory hurdles on drugmakers, such as changing the requirements for approval or seeking additional clinical trial data.
The Food and Drug Administration confirmed Monday it was requiring drugmaker Novavax to run another clinical trial as part of the approval process for its Covid vaccine, which has been available under emergency use authorization since 2022. Dr. Marty Makary, the FDA’s commissioner, said the company is asking the agency to approve “a new product” based on old data.
Background on Novavax’s Covid Vaccine
Novavax’s shot uses traditional protein-based vaccine technology and is the only alternative to the mRNA shots from Pfizer and Moderna. The drugmaker’s application to the FDA was based on a 30,000-person randomized clinical trial conducted in 2021 in the U.S. and Mexico.
The agency missed an April 1 deadline decision, prompting concerns among investors that it wouldn’t be approved.
On Saturday, Makary suggested in a post on X that Novavax was seeking approval for a “new” vaccine because the strain used in its trial has since been updated to target a more recent Covid variant called JN.1.
“Under this administration, we are prioritizing the Gold Standard of Science–not what saves pharma companies ‘tens of millions of dollars,’” Makary said.
Novavax declined to comment on Makary’s remark. In a release issued Monday, Novavax said it responded to an earlier FDA request to commit to providing more data on the vaccine if approved — a standard practice.
Criticism from Health Experts
Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, criticized the administration’s move, pointing out that the seasonal flu vaccines are updated each year with new strains without the need for new clinical trials. The mRNA Covid vaccines have been similarly updated each year to target the most current strain.
“I mean, how exactly does he propose they do this?” said Offit, who also serves on an independent vaccine advisory committee for the FDA. “It just worries me that it’s part of an overall general strategy to weaken vaccine efforts.”
The FDA directs all media inquiries to the Department of Health and Human Services. In a written statement, an HHS spokesperson said the Biden administration waived clinical trial requirements for new Covid vaccines “using the COVID pandemic as an eternal justification for blanket approvals.”
Response from the Department of Health and Human Services
Under Makary, the spokesperson said, trials from four years ago “no longer suffice.”
“With Novavax seeking authorization for a new formulation targeting the JN.1 variant, the public deserves clear answers about its efficacy and if its benefits outweigh the risks,” the spokesperson said.
The Wall Street Journal first reported the FDA’s request for a new clinical trial.
Other Vaccine Approvals Possibly at Risk
Novavax’s shot isn’t the only Covid vaccine that officials say may be at risk.
Dr. Tracy Beth Høeg, who was announced as a special adviser to Makary earlier this month, has called for more scrutiny of vaccines, telling FDA staff and high-ranking officials in a meeting outlining priorities that the agency would be doing fewer vaccine approvals going forward, according to three former government officials familiar with the matter, who spoke on the condition of anonymity for fear of retribution.
Concerns About Upcoming FDA Deadlines
There are also concerns about several upcoming FDA deadlines related to Pfizer’s mRNA Covid vaccine, including a decision for the full approval for the shot in children under 11, according to two of the former officials. The vaccine currently has an emergency use authorization for ages 11 and under.
The mRNA vaccines are a particular target among anti-vaccine activists. The vaccines from Pfizer and Moderna are the first-ever approved using mRNA technology, which has led some to claim they pose a unique threat. Florida Surgeon General Joseph Ladapo has railed against mRNA vaccines, alleging they could possibly alter a person’s DNA. Several states have introduced legislation that would ban mRNA vaccines. The CDC says the mRNA Covid vaccines are safe and do not alter DNA; the technology had been studied for decades before its first approval in the U.S. in late 2020.
Potential Impact on Public Health
Last week, Politico reported, citing two people familiar with the discussions, that Kennedy is considering pulling the Covid vaccine from the Centers for Disease Control and Prevention’s list of recommended immunizations for children, a move that could affect insurance coverage and influence some pediatricians’ consideration of whether to administer them. NBC News has not independently confirmed the reporting.
Dorit Reiss, a vaccine policy expert at the University of California Law San Francisco, said that while Covid vaccine uptake in children is low, it’s important for parents to have the option available.
That’s especially true for children with underlying health conditions that make them more vulnerable to severe illness and death from the virus, she said.
Conclusion
The FDA’s decision to require additional clinical trials for Novavax’s Covid vaccine has raised concerns among health experts and former government officials. The move is seen as part of a broader effort to slow-walk vaccine approvals, which could have significant implications for public health. As the Covid pandemic continues to evolve, it is essential that vaccines are available and accessible to those who need them.
FAQs
Q: What is the FDA’s role in vaccine approval?
A: The FDA is responsible for ensuring the safety and efficacy of vaccines before they are approved for use in the United States.
Q: What is the concern about the FDA’s decision to require additional clinical trials for Novavax’s Covid vaccine?
A: The concern is that the decision may be part of a broader effort to slow-walk vaccine approvals, which could have significant implications for public health.
Q: What is the potential impact of the FDA’s decision on public health?
A: The potential impact is that it could limit access to vaccines, particularly for children and individuals with underlying health conditions who are more vulnerable to severe illness and death from the virus.
Q: What is the CDC’s stance on mRNA Covid vaccines?
A: The CDC says that mRNA Covid vaccines are safe and do not alter DNA.
Q: What is the potential risk of not having access to Covid vaccines?
A: The potential risk is that it could lead to increased transmission of the virus, particularly among vulnerable populations, and potentially more severe illness and death.
