- Both drugmakers have pending clearance applications at FDA
- With FDA officials attending summit, concern about conflicts
Pfizer Inc. and Moderna Inc., the two pharmaceutical companies closest to gaining U.S. clearance for a Covid-19 vaccine, won’t attend a White House summit intended to build confidence in the shots.
With the Food and Drug Administration expected to decide on whether to allow the companies’ vaccines to be distributed in the coming days, there was worry that regulators and executives shouldn’t be seen rubbing elbows at the Tuesday meeting.
Operation Warp Speed had early discussions with several vaccine makers about attending the event, according to a senior administration official. However, the focus of the gathering shifted after Peter Marks, the head of the FDA center that reviews vaccines, volunteered to make a presentation.
Since it would be would inappropriate to have vaccine company executives touting their shots while in the same room with their regulator, a decision was made not to include any drugmakers in the meeting, the official said on a call with reporters on Monday.
Pfizer said in a statement it had informed the White House that it wouldn’t attend the Tuesday event, but didn’t elaborate. Moderna spokesman Ray Jordan said in a statement the company was contacted by Operation Warp Speed to be part of the meeting and that it was willing to participate, but later learned that its participation wouldn’t be required, based on the agenda.
Both Pfizer and Moderna could soon gain authorization for their messenger RNA-based shots. A group of outside advisers to the FDA is scheduled to consider the case for clearing Pfizer’s vaccine, which it is developing with German drugmaker BioNTech SE, on Thursday. An advisory panel is set to scrutinize Moderna’s shot at a meeting on Dec. 17.
Soon after each of those meetings, the FDA could grant authorization for the shots, setting off what is expected to be one of the largest mass immunization efforts in history.
The Tuesday meeting hosted by President Donald Trump is designed to boost confidence in the shots at a time when some groups have voiced reluctance to take them. The summit is likely to focus on distribution, with Trump planning to sign an order directing his Department of Health and Human Services to prioritize getting them to people in the U.S. before helping other countries.
By Robert Langreth and Riley Griffin