Earlier this week, the FDA released documents that summarized the data on a second SARS-CoV-2 vaccine candidate, this one from a company called Moderna. That document was the background for a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, which would consider whether the benefits of the vaccine outweigh its potential risks. That question is one of the key considerations for the Agency as it decides whether to grant an Emergency Use Authorization similar to the one it gave the Pfizer/BioNTech vaccine.
After an all-day meeting that frequently focused on other topics, the committee was near unanimous: 20 votes for approval, none against, and one abstention.
Emergency Use Authorizations have a number of requirements once a health emergency hsa been declared. There must be no alternatives that have achieved full FDA approval, there must be reasons to think that the treatment will be effective, and its benefits are considered likely to outweigh its risks. It’s that final question—the risk vs. benefit balance—that the advisory committee was called to address.
To make that determination, the committee heard testimony from people involved in the clinical trial and other experts that evaluated the data. It also took public comment on the question. But the data were so promising that it spent most of its time debating what should happen to the trial participants once an Emergency Use Authorization was granted. Those who received the placebo are expected to be immunized, but how that’s handled was a matter of extensive discussion.
Issues raised included the question of whether both vaccine and placebo groups should receive new injections in order to keep the study blinded, and whether the placebo group should be given the vaccine as if they were prioritized along withe the general population. Maintaining the trial long enough to get data from long-term safety monitoring may depend on how these issues are handled, but they’re secondary to the Emergency Use Authorization.
Let’s do this!
When the vote finally came for that, it was decisive: 20 committee members voted that the benefits are likely to outweigh the risks, and a single person abstained. There were zero votes against the proposition.
The FDA still has to consider the other requirements for an Emergency Use Authorization, but they’re unlikely to be major hurdles. While another vaccine has been approved for emergency use, nothing is at all close to having full FDA approval. And the same data that shows clear benefits would seem to handle the issue of there being reason to think the vaccine will be effective. In the case of the Pfizer/BioNTech vaccine, the FDA acted within 48 hours of the Advisory Committee’s thumbs-up, so we may have news before this weekend.