I read an Axios report this morning (here) written by Jonathan Swan, indicating that FDA commissioner Stephen Hahn has been summoned to the West Wing by White House Chief of Staff Mark Meadows to explain “why he hasn’t moved faster to approve the Pfizer coronavirus vaccine“.
This type of pressure has no place in science. FDA has moved incredibly fast to date by cooperating, aiding, and advising firms on the COVID-!9 vaccine process and has assisted firms along every step of the way. The Administration had pressed the FDA to have a vaccine approved before the November 3, 2020 election in a clear move to influence the election. When politics enters scientific decision making (as we all have seen during the progression of this pandemic), then the public suffers in one way or another. In my 44 years in the industry, I have never seen the FDA so politicized.
With the first vaccine emergency use authorization (EUA) submitted only last week and another on the way, the FDA has a lot of work to do. The authorization process being used (the EUA) in this crisis situation is quite different than the standard drug review and approval process that (at best) can take at least six (6) months (if it is a priority review) to 10 months or more after submission. In this crisis situation, FDA is being asked to move as quickly as possible and, while the Agency realizes the need to do so, so far it has resisted the intense pressure to make a decision before it has reviewed all of the safety and efficacy data generated to date (and it is much less that usually required), prior to authorizing a product or series of products that potentially could be administered to the entire US population, not to mention, the billions of people around the world.
Wait, did I say billions? Never before in modern history will a drug be administered so widely and thus the stakes can be no higher than they are today for the FDA to get this right. To have reviewed all the data, to be assured that the warnings, contraindications, precautions, dosing, labeling, and manufacturing information is evaluated, is something that usually takes (as noted above) months, if not years. The consequences of making the wrong decision, or missing something critical in the data could be disastrous. So, please, let the Agency do its job and let the expert advisory panel do their job. In order for the vaccine to help defeat the pandemic, it must be safe and effective, and have the public’s trust, because if they won’t take It, it won’t work, no matter how effective it is.
Finger pointing in this situation is pointless. The FDA must be given time to make a solid scientific decision so the American public can have confidence in the product. There is no room for error here, the stakes are too high. When Axios asked the FDA for comment, they reported that the FDA Commissioner, Dr. Hahn stated,“ “We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision. It is our job to get this right and make the correct decision regarding vaccine safety and efficacy.” He is absolutely correct. Give the Agency the space to do this right.