Gottlieb: FDA Won’t Be Easily Cowed into Emergency Vaccine Approval

By Melanie Arter | September 21, 2020 | 10:15am EDT
Former FDA Commissioner Scott Gottlieb (Screenshot)
Former FDA Commissioner Scott Gottlieb (Screenshot)

( – Former FDA Commissioner Scott Gottlieb told CBS’ “Face the Nation” on Sunday he doesn’t see a scenario where President Donald Trump could override the Food and Drug Administration to greenlight a vaccine for emergency use.

“I don't see it, and I don't see a scenario where this can happen and people don't see it, where it's not readily apparent. This isn't like posting new guidelines on CDC's website in the middle of the night. In order to issue an authorization, an emergency use authorization or an approval, the only people capable of actually drafting that package are the people at FDA, and they're not going to be forced to do it unless they scientifically believe in it,” he said.

“I know the folks who are involved in this process, the career professionals who are engaged in this process, and they're not going to be easily cowed, and, remember, on the other side of this, you also need a manufacturer that's willing to commercialize a vaccine based on that authorization or approval.

The vaccine doesn't just ship into the supply chain, and I do not believe any manufacturer is going to commercialize a vaccine based on an authorization or an approval that doesn't have the consent and the agreement and the involvement of the career professionals inside the FDA. I just don't see that happening.

As to whether Trump was right in saying that the country is rounding the turn on COVID-19 even without a vaccine, Gottlieb predicted at least one more cycle of coronavirus heading into the fall and winter.

“If you look what's happening around the country right now, there's an unmistakable spike in new infections, and you're also seeing declines in hospitalizations that we were achieving starting to level off. I would expect them to start going up again as well. There's about 15 states where the positivity rate is 10 percent or higher, which is deeply concerning,” the former FDA commissioner said.

“There's about 30 states where the RT, the rate of transfer, is above one, meaning they have an expanding epidemic. So right now we're seeing a resurgence of infection. Now, whether or not that's a post Labor Day bump and will start to level off or this is the beginning of a resurgence heading into the fall and the winter, it's unclear, but I am deeply concerned that as we head into the fall and the winter, this is the season when a respiratory pathogen like coronavirus wants to spread, and so there's a lot of risk heading into this season,” he said.

Gottlieb was asked whether he agreed with Trump, who said that there will be enough vaccine available for everyone by April or with CDC Director Robert Redfield in predicting that a vaccine won’t be released to the public until third quarter 2021.

“Well, I'm on the board of Pfizer, which is one of the companies that has a vaccine in advanced development, so I have some insight into this from that, although everything I know is in the public domain at this point. I think that is possible, that you'll have enough doses available by April, May, but I do not believe that a vaccine will be licensed for general use by the population until, in an optimistic scenario, really the second quarter, probably the end of the second quarter in 2021 and perhaps a little later than that.

“I mean the reality is that as we come out of the winter and head into the spring, hopefully, this virus will start to dissipate in the summer. So what you really want is a vaccine available for mass inoculation before you head into the fall of 2021. So, hopefully, in a good scenario, whether you have the vaccine available in June or you have it available in August, isn't going to make that much of a difference because the virus won't be transferring as readily by then,” Gottlieb said. 

“But I do not believe that we'll have a vaccine available for general inoculation until probably the end of the second quarter of 2021 and maybe into the third quarter. Now, that said, I do think we can have a vaccine available sooner than that under an emergency use authorization for select groups who are at particularly high risk of bad outcomes from the virus,” he said.

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