Placebo-controlled Trials Needed for Vaccines: HHS
FDA will soon require all new vaccines be evaluated in placebo-controlled trials before they’re licensed for use, and this could also apply to some seasonal vaccines for the flu and Covid-19, which are tweaked each year to provide protection against strains circulating around the world. “Under HHS secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices,” HHS said in a 4/30 statement.
An HHS spokesperson told FDA Webview 5/2 that FDA commissioner Marty Makary has “indicated that significant updates to existing vaccines — such as those addressing seasonal strain changes or antigenic drift — may be considered ‘new products’ requiring additional clinical evaluation. In a recent statement, he emphasized the need for robust data to support vaccine approvals, highlighting, ‘Rather than allow that void to be filled with opinions, I'd like to see some good data.’”
The spokesperson reiterated that Covid vaccine 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 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 new vaccine policy and ensuing confusion began with the delay of a Novavax BLA seeking approval of the company’s Covid-19 vaccine, which is currently available under an emergency use authorization (EUA). On 4/28, the company and HHS both clarified that the review decision delay on the vaccine was due to an FDA request for a post-approval study and not a clinical trial that must be conducted before approval (see story).
The new policy still leaves uncertainty surrounding whether a traditional trial would be required before Novavax’s vaccine approval and for updated versions of mRNA Covid-19 vaccines from Moderna and Pfizer that will be marketed this fall.
The policy is raising concerns among medical and public health experts who said the move could be a significant shift in how the country has ensured the safety of vaccines for decades, as well as cast doubt on vaccines that are safe and effective, according to the Washington Post. The change comes amid declining public trust in vaccines and worries over Kennedy’s mixed messaging about immunizations.
Experts also say that they are worried that extra and costly testing could limit vaccine production and access, leaving more Americans at risk of preventable disease, the Post says. “You are watching the gradual dissolution of the vaccine infrastructure in this country,” said Children’s Hospital of Philadelphia director of vaccine education Paul Offit.
Meanwhile, Moderna said in a 5/1 earnings call that a review extension is likely expected for its 12/24-submitted flu/Covid combination vaccine. FDA is requiring late-stage data demonstrating the shot’s efficacy against the flu, according to the company. In a reassuring tone, Moderna president Stephen Hoge said “It really has been business as usual” while describing interactions with FDA during its review. Additionally, he said there have been no indications that the review of its next-generation Covid-19 vaccine, which has a review decision expected at the end of the month, could be extended.