Can the US Government Force Companies to Release Covid Vaccines Early?
(Thursday, September 10, 2020]​
This week CEOs of nine biotech companies publicly pledged that they will not file for FDA approval or emergency authorization for their Covid vaccines unless they meet FDA’s established standards but this pledge may be hard to hold in the current circumstances. It is an odd pledge as it states the obvious; companies do not file for approval unless they believe their product meets the regulatory standards, but this was needed to manage public image of the soon to be released vaccines by these companies. Similar pledges to follow the law to its letter have been made by the FDA commissioner, the Surgeon General, and the leaders of NIH. But what if the government leaders decide that vaccines need to be released despite some concerns to counter a national emergency such as the pandemic? The government has hedged all its bets to normalize life in the country on the availability of Covid vaccines. So, a delay in the release of a vaccine may not be politically acceptable. The Secretaries of the HHS and Defense, under the direction of the President, can technically authorize vaccines based on limited data and invoke the Defense Productions Act directing companies to release their vaccines to select sections of the population or even all people. This law has been used in the Covid emergency to direct companies to stop their normal operations to manufacture ventilators and PPEs. Although an action like this for a vaccine would be unprecedented but so is the pandemic. So far, FDA has been very conservative having set strict requirements for vaccine approval. FDA has not yet publicly discussed the back-up plan if none of the vaccines under clinical trials meet FDA’s current requirements. Actually, it seems that the FDA is pretty confident that at least one or more of the 15 vaccines being evaluated worldwide would show promise and FDA will not need to authorize a sub-standard one. The FDA has even scheduled its vaccine advisory committee meeting for 22 Oct, and with the CDC, asked the states to be ready to distribute Covid vaccines by 1 Nov, showing that it is bullish with the prospect of having a vaccine ready for release by that date. Not to trivialize the pledge, but apparently, the CEOs pledging to follow the law are similarly confident that their products would meet the requirements. But things could change quickly if trials show concerns. The emergency use authorization laws are designed to help when the conventional process cannot work. From a strategic perspective, FDA and the developers should not be putting themselves into corners that would make it hard to use the alternate options for preventive vaccines that may work for the majority while being unsafe for a minority of the population. No vaccine works in 100% of the vaccinated, and all vaccine elicit some adverse reactions in a portion of the population. Yes, it is important to wish for the best vaccine but less than perfect would still be better than nothing. For now, let’s hope it does not come to that.