The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and less affordable,” according to vaccine expert Paul Offit. It could also further complicate the picture for companies like Novavax.
After a month that began with a missed PDUFA deadline for Novavax’s COVID-19 vaccine—and subsequent debate in both online and social media over FDA expectations for the company to complete another clinical trial—the picture might be becoming clearer. Or less so. Wednesday, the Department of Health and Human Services said it will require all new vaccines be tested in placebo-controlled trials before they are approved.
“All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices,” an HHS spokesperson told The Washington Post in response to an inquiry about HHS Secretary Robert F. Kennedy Jr.’s comments on the measles vaccine and general vaccine policy.
HHS did not clarify which vaccines this new policy would apply to, according to the Post. The Post noted that while vaccines for new pathogens are already tested versus placebo, new vaccines for other diseases are instead tested against existing interventions. Indeed, the FDA has to this point allowed vaccine makers to use prior clinical efficacy data rather than conduct new trials when submitting annual boosters such as for flu and COVID-19 for regulatory approval. The HHS did indicate to the Post that the new requirement would not affect the flu vaccine, which the agency stated “has been tried and tested for more than 80 years.”
In a note to investors Thursday morning, Leerink Partners wrote that the new policy “is negative news for vaccine manufacturers,” including Merck, BioNTech and Moderna. “HHS’s judgment appears questionable and risky, in our view,” the analysts continued, adding that “placebo-controlled trials are unnecessary and unethical for many populations,” and “the world will look to other countries’ health authorities as the gold standards for vaccine testing.”
Novavax’s vaccine, Nuvaxovid, which won emergency use authorization in July 2022, has been tested in in four randomized placebo-controlled trials. It was widely expected to win full approval on April 1. However, The Wall Street Journal reported last week that the FDA was requesting the company complete an additional randomized clinical trial, which vaccine experts told the publication could cost tens of millions of dollars.
Novavax has maintained that this would be a postmarketing commitment. However, in a rare regulatory communication on X regarding a pending decision, FDA Commissioner Marty Makary wrote: “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.” Apparently responding to the WSJ piece, Makary added, “Under this administration, we are prioritizing the Gold Standard of Science—not what saves pharma companies ‘tens of millions of dollars.’”
Based on this statement, it appears possible that Wednesday’s news could introduce more uncertainty for the Maryland-based company.
Kennedy has a long history as an anti-vaccine advocate—though HHS said in a statement that the secretary “is not anti-vaccine—he is pro-safety, pro-transparency, and pro-accountability,” according to the WSJ. Makary, for his part, has been critical of COVID-19 vaccines and mandates, particularly for boosters.
According to the Post, medical and public health experts expressed concern that this testing change could mean that COVID, and potentially other vaccines, will need to undergo “costly” and “unnecessary” studies that would limit vaccine production and access.
“You are watching the gradual dissolution of the vaccine infrastructure in this country,” Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told the publication. “The goal is to make vaccines less available and less affordable.”
On a parallel front, HHS and the National Institutes of Health announced the launch of a next-generation universal vaccine platform for pandemic-prone viruses. The initiative, which uses a beta-propiolactone (BPL)-inactivated, whole-virus platform, will fund “NIH’s in-house development of universal influenza and coronavirus vaccines,” according to a Thursday HHS release.
“Generation Gold Standard is a paradigm shift,” NIH Director Jay Bhattacharya said in a statement. “It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats—not just today’s, but tomorrow’s as well—using traditional vaccine technology brought into the 21st century.”
