Trump to Hold COVID-19 Vaccine Summit Next Week Ahead of FDA Advisory Panel Meeting

President Trump has scheduled a COVID-19 vaccine summit for Dec. 8 with pharma executives, government leaders, scientific experts and others just days before an FDA advisory panel meets to discuss Emergency Use Authorization (EUA) for Pfizer’s vaccine candidate.

Though details about the meeting, which the White House confirmed, are scant, it has been speculated that the summit is another effort to apply more pressure on the FDA for a vaccine authorization. The meeting is occurring just two days before the FDA’s Vaccines and Related Biological Products Advisory Committee assembles to discuss an EUA for Pfizer’s vaccine.

It’s unclear if Moderna, Pfizer and other pharma executives invited to the event will attend because of the perception that the summit is politically motivated. Trump’s relationship with drugmakers has been strained, in large part due to his pricing policies — in particular, a “most favored nations” strategy that is strongly disliked by the industry and due to start in January.

The White House was forced to cancel a drug pricing meeting with industry reps in July after they declined to attend. Their refusal to show up followed a set of executive orders aimed at reducing drug prices, including the most favored nations policy that PhRMA has vowed to fight in court (DID, July 29). Drugmakers yesterday did not respond to questions about the December summit.

With the U.S. drawing ever closer to potentially clearing Pfizer’s vaccine, the administration continues to pressure the FDA to grant emergency clearance before the year ends or at least before Trump leaves office in January.

This week, FDA Commissioner Stephen Hahn was personally summoned to the White House to discuss the agency’s timeline on vaccine approval. On the day of the meeting, the agency chief, in a statement, defended the FDA’s evaluation process and independence from political interference (DID, Dec. 2).

Hahn has said that it’s possible vaccinations could start by the third week of December but not guaranteed.

“We need everything to fall into place. From an FDA perspective of when we issue the EUA, it will depend on what sort of questions and data come out of the vaccine advisory committee,” he said. “We have promised a process, and we don't want to get stuck in process per se, but if you think about how we've expedited this process from three to four months down to three weeks, we don't want to truncate that further, because we want our scientists to have the time that they need to analyze these data.” — James Miessler