Covid-19 vaccines shouldn’t be given emergency approval


Following their written and oral comments to the advisory board, the major vaccine manufacturers recognize the potential interference with subsequent clinical trials and seek advice from the FDA to correct them. While these considerations are daunting, I suspect manufacturers and the FDA could come up with workable answers. But even then, the public trust issues surrounding EUAs – which most citizens learned about first through the hydroxychloroquine debacle and again in connection with the convalescent plasma controversy – still make this tool ill-suited for vaccines.

If the data on vaccine trials are promising enough to give some people access to a Covid-19 vaccine prior to approval, the FDA should instead use a mechanism called "expanded access". While the FDA typically uses expanded access to provide experimental treatments to sick patients for whom no alternative treatment is available, it was previously used for vaccines and could now be used not to disrupt or disrupt ongoing clinical trials Promote public awareness that a vaccine was rushed because of an "emergency". Advanced access programs are also overseen by ethics committees and have patient consent forms beyond those with EEA approved products.

Not only must the public trust a Covid-19 vaccine sufficient to seek out the first wave of approved vaccines, but that trust must be resilient enough to withstand potential setbacks: protection below 100% (and possibly below 50%) , significant side effects (or rumors about them), and possible recalls. It takes time to restore that level of confidence once it has been eroded. And this is not just about slowing this pandemic. As former senior health official Andy Slavitt said recently, “Right, done, vaccines end pandemics. Done wrong, pandemics end vaccines. "

Clint Hermes, a former General Counsel of the Academic Medical Center, has advised universities, teaching hospitals, and life science companies on global health issues. He has helped set up vaccination, treatment and surveillance projects for infectious diseases in North and South America, Africa, Asia and the Middle East. The views expressed here are his own and not those of any organization with which he is affiliated, including his employer. The information presented here is not to be understood as legal advice.


Steven Gregory