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FDA Miss Deadline

If ever a US FDA advisory committee could be very dramatic but also just a complete formality, the review of Pfizer Inc.’s COVID vaccine slated for 10 December would fit that bill. The company announced it would file for emergency use authorization on the morning of 20 November, FDA announced that evening it had scheduled an advisory committee, and Operation Warp Speed chief science officer Moncef Slaoui went on TV on 22 November to say that the vaccine could be cleared the day after the advisory committee.

“Our plan is to be able to ship vaccines to the immunization sites within 24 hours from the approval,” Slaoui told CNN’s State of the Union with Jake Tapper. “So, I would expect maybe on day two after approval, on the 11th or on the 12th of December, hopefully, the first people will be immunized across the United States, across all states, in all the areas where the state departments of health will have told us where to deliver the vaccine.”

That timetable suggests that the Center for Disease Control and Prevention and its Advisory Committee on Immunization Practices (ACIP) will recommend Pfizer’s vaccine in tandem with the decisions of FDA and its advisors, a scenario that HHS has already been preparing for. (Also see "COVID Vaccines Getting Parallel Review: ACIP To Begin Process Before FDA Decisions" - Pink Sheet, 18 Nov, 2020.)

Slaoui’s timetable also assumes a thumbs up from FDA’s Vaccines and Related Biological Products Advisory Committee. When the panel convened last month to discuss general development issues, though, members expressed concern that the agency’s guidance wasn’t seeking enough safety data from sponsors. (Also see "COVID-19 Vaccines: Advisory Committee Picks Apart US FDA Guidance On Efficacy Endpoints" - Pink Sheet, 22 Oct, 2020.)

[Editor’s note: Navigating the post-COVID regulatory and reimbursement landscape will be the focus of a panel including Pfizer’s Jeffrey Chasnow, FDA’s John Concato, and AstraZeneca’s Alicyn Campbell at the upcoming FDA-CMS Summit. Registration is now open for the virtual event, which runs from 7-9 December and will feature speakers from across industry and government discussing the range of challenges ahead, from drug pricing to diversity in clinical trials.]

Slaoui also laid out an ambitious vaccine schedule, which presumably also includes an EAU for Moderna, Inc.’s vaccine relatively quickly: The plan is to vaccinate 20 million people in December and perhaps another 30 million per month thereafter. “With the level of efficacy we have, 95%, 70% or so of the population being immunized would allow for true herd immunity to take place,” he said. “That is likely to happen somewhere in the month of May or something like that, based on our plans.”

The vaccine pronouncements weren’t the only weekend COVID news. On Saturday evening, FDA announced emergency use authorization for Regeneron Pharmaceuticals, Inc.’s monoclonal antibodies casirivimab and imdevimab.

Regeneron’s EUA follows one for Eli Lilly and Company’s bamlanivimab earlier this month. (Also see "Future US Purchases Of Lilly’s Bamlanivimab Will Depend On Success Of Outpatient Infusion Process" - Pink Sheet, 10 Nov, 2020.)

Casirivimab and imdevimab are the second antibodies available, though Regeneron notes they are the “first combination therapy to receive FDA emergency use authorization” and the “first treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2.”

They are also probably the better known of the monoclonal antibody products because they were used to treat President Trump’s COVID-19 infection and he lavished praise on the cocktail afterwards in a video. (Also see "Executive Privilege: How Giving Trump Special Access To Experimental COVID Treatment Could Backfire" - Pink Sheet, 4 Oct, 2020.)

Trump did not appear to remark on FDA’s 21 November EUA for the Regeneron product; his Twitter feed has been dominated by comments about his challenges to the election results. Earlier in the week he did note “Another Vaccine just announced. This time by Moderna, 95% effective. For those great ‘historians’, please remember that these great discoveries, which will end the China Plague, all took place on my watch!”

The president has offered no shortage of bitterness about the timing of the vaccine announcements, suggesting during a 20 November press conference on his pricing regs that “You wouldn't have a vaccine if it weren’t for me for another four years, because FDA would have never been able to do what they did, what I forced them to do.”

Pfizer “even decided to not assess” the results of their vaccine until just after the election “instead of their original plan to assess the data in October … because of what I did with favored nations,” the President maintained.

While industry opposes the most favored nations pricing plan, it’s enthusiastic about the rebate rule – though neither appear to have much staying power. (Also see "Democrats May Be Wary of Pushing Forward Trump’s Revamped International Reference Pricing Rule" - Pink Sheet, 22 Nov, 2020.)

It’s true that Pfizer could have been seen as playing footsie with Trump on the October date for the vaccine data. (Also see "Pfizer’s COVID-19 Vaccine Will Miss US Election, Bourla Clarifies" - Pink Sheet, 16 Oct, 2020.)

But it’s also true that the president’s actions after the election risk lowering public confidence in the vaccine, thus potentially tarnishing the legacy he hopes historians will consider. (Also see "Pfizer’s Bourla: State of US Presidential Transition Not ‘Ideal’ For Vaccine Rollout" - Pink Sheet, 17 Nov, 2020.)

One might imagine a different scenario in which President Trump spent his remaining days in office barnstorming the nation on behalf of the vaccine rather than focused on voter fraud theories that he says cost him the election. But a Trump inclined towards that kind of traditional approach to politics might not have lost reelection – or even become president in the first place.

As it stands now, pharma seems to have gotten its best-case scenario from the election – a non-mercurial president in Biden and a bulwark against a massive pricing overhaul in the likely Republican Senate. (Also see "Biden Administration May Push Rx Pricing To Back Burner With Senate That Stays Pharma Friendly" - Pink Sheet, 8 Nov, 2020.)

But the glass half empty perspective for industry is a landscape in which a sizable chunk of the public feels that pharma industry cost their champion the election because it withheld data. And another chunk of the public is grateful for the vaccine – but thinks the credit goes to government-directed research, not pharmaceutical innovation.

No amount of rapid FDA approvals or calming of the pricing debate would solve those problems.

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