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Trump's congratulatory COVID-19 vaccine summit will not include manufacturers


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Trump's congratulatory COVID-19 vaccine summit will not include manufacturers

No biopharmaceutical manufacturers will be attending President Donald Trump's White House event to congratulate efforts to quickly get a COVID-19 vaccine to the U.S. market but a top regulator who will be making the final decision on those products will be the key speaker.

At his Dec. 8 event, Trump is also expected to sign a largely symbolic executive order emphasizing that he wants the U.S. to have first access to any COVID-19 vaccines purchased with taxpayer funds — what officials called an affirmation of his commitment to his "America First" agenda.

SNL Image
Peter Marks, director of FDA's Center for Biologics Evaluation and Research
Source: U.S. Food and Drug Administration

Peter Marks, director of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research, whose office is reviewing applications seeking emergency use authorization, or EUA, from Pfizer Inc. and its partner BioNTech SE and Moderna Inc., is the featured speaker at the Dec. 8 event, which the White House has dubbed a vaccine summit.

The event comes the same day the FDA will disclose more details about its review of the Pfizer-BioNTech vaccine in briefing documents ahead of the agency's Dec. 10 meeting of its Vaccines and Related Biological Products Advisory Committee.

The FDA will hold a similar meeting of its outside advisers Dec. 17 to vet Moderna's EUA application.

If the panel recommends granting EUAs to the companies at both all-day virtual forums, Marks' office could act swiftly in taking that advice — potentially allowing the use of the COVID-19 vaccines in the U.S. within hours after the committee meets.

It is unusual for a regulator to attend a largely political event like the White House's Dec. 8 vaccine summit ahead of a critical decision.

Trump has openly pressured the FDA to move faster on approving a COVID-19 vaccine and has made unsubstantiated claims that the agency's scientists were part of a "deep state" effort to undermine his 2020 political campaign. Trump also accused Pfizer without evidence of being part of that effort.

Pfizer spokeswoman Sharon Castillo told S&P Global Market Intelligence that her company will not be attending the Dec. 8 White House summit and declined any further comment.

Moderna was contacted by the White House's Operation Warp Speed project to be part of the summit and "indicated its willingness to participate," a spokesperson told Market Intelligence in an emailed response. "Subsequently, Moderna learned that, based on the meeting's agenda, its participation would not be required."

The White House spoke with "several vaccine manufacturers" and "in fact, some contacted us unsolicited and asked if they could come and we had early discussions with several of them," a senior administration official said in response to Market Intelligence's questions during a Dec. 7 briefing with reporters.

The official declined to reveal details about the discussions with the vaccine companies, but said "we wound up going in a different direction."

Having the FDA's Marks appear at the event rather than the biopharmaceutical manufacturers "would be more effective," the official said.

"Just from a regulatory perspective, we cannot have the person in the room who's going to adjudicate that emergency use authorization with those who have submitted it during that evaluation period, so we made the decision to deny, if you will, any participation by the pharmaceutical companies, in favor of having the chief regulator in the room describing the process," the official said.

Marks is participating in the congratulatory event "completely voluntarily" and was not forced to attend, the official said.

"There's no one who knows the process better than Peter Marks," the official said. "He is the guy in charge."

The FDA declined to comment on Marks' participation.

Other participants

FDA Commissioner Stephen Hahn was not listed among the Trump appointees that will be speaking at the White House event, which will include Health and Human Services Secretary Alex Azar, Assistant HHS Secretary for Health Brett Giroir, Operation Warp Speed senior scientific adviser Moncef Slaoui and Adam Boehler, CEO of the U.S. International Development Finance Corp., among others.

U.S. National Institute of Allergy and Infectious Diseases Director Anthony Fauci will not be attending, officials said.

A spokesperson for the agency told Market Intelligence that Fauci was already committed to attending the ceremonial presentation of the 2020 Nobel Prize in Physiology or Medicine for his "dear friend and colleague" Harvey Alter, a scientist emeritus at the U.S. National Institutes of Health, for his contributions to the discovery of the hepatitis C virus.

The Republican governors from Florida, Tennessee and Texas, as well as the Democratic governor from Louisiana will also take part in the summit.

While no biopharmaceutical manufacturers will be attending, a number of executives from other business sectors will be in the room, including representatives from McKesson Corp. — the U.S. government's vaccine distributor — CVS Health Corp., Walgreens Boots Alliance Inc., Thermo Fisher Scientific Inc., FedEx Corp. and United Parcel Service Inc., officials said.

Vaccinating Trump

On the call with reporters, the senior administration officials would not commit to whether Trump would volunteer to publicly get vaccinated against COVID-19 live on TV like his three predecessors — former Presidents Barack Obama, George W. Bush and Bill Clinton — have said they were willing to do.

The official said Trump may not be a "high priority" for receiving the vaccine because he had contracted COVID-19 and recovered, though there is no prohibition against people who have had the disease from getting the shot.

And in fact, at the Milken Institute's Future of Health Summit on Dec. 7, Fauci urged people who have had COVID-19 to get the vaccine.

"Once you get infected with the virus, it isn't certain how long that protection would [last] or whether or not you mounted good protection," Fauci said.

Trump was treated in October with Regeneron Pharmaceuticals, Inc.'s COVID-19 antibody cocktail casirivimab and imdevimab, formerly known as REGN-CoV2, Gilead Sciences Inc.'s antiviral remdesivir and the steroid dexamethasone. He spent four days at Walter Reed National Military Medical Center in Bethesda, Md.

The administration official told reporters "there is an open question as to whether, ultimately," Trump would "be one of the ones to take [the vaccine] on air."

The official suggested there are other "famous, shall we say, vaccine influencers and experts who I think have come forward and volunteered to participate in an effort to help instill public confidence."