Operation Warp Speed: We won’t fiddle with Pfizer dosing plan

Leaders of Operation Warp Speed said Wednesday they will not abandon plans to reserve half of the available Pfizer doses when the coronavirus vaccine campaign launches in the coming days, even though new data showed a level of protection after the first shot of the two-dose regimen.

There may come a time when production is humming along fast enough to distribute all doses in hand and bank on the second doses being in the pipeline, officials said.

For now, the operation will play it safe when it sends its first shipments of vaccine within 24 hours of Food and Drug Administration approval.

It is reserving 500,000 doses out of the initial tranche of 6.4 million, in case of mishaps, and splitting the remainder by half, to ensure the first recipients are guaranteed their second dose 21 days after the first one.

Human trials showed the initial dose and booster shot were incredibly effective in staving off the coronavirus disease that’s ravaged the world and killed over 287,000 in the U.S.

“I think it would be a mistake to knowingly distribute a vaccine in non-respect of the label,” said Moncef Slaoui, the science adviser to Operation Warp Speed — President Trump’s initiative to speed vaccines to approval and distribution in record time.

Former FDA Commissioner Scott Gottlieb and others argue the federal operation should accept some risk and use all the doses they have in hand at once, given the extent of the crisis and evidence that one shot offered some level of protection.

“Given the raging plague that is currently killing at a rate that exceeds almost everything that we’ve seen in this country, I’d rather take the partial protection and hope the second doses get there in time,” Arthur Caplan, a bioethics professor at New York University School of Medicine, told The Washington Times.

But making sudden changes to what was prescribed by trials would sow doubts in the rollout at a time when the U.S. can ill-afford greater vaccine hesitancy, Mr. Slaoui said.

Other federal officials said they did not want to mess with carefully laid plans for initial distribution to the states, and that they needed to account for the vagaries of medicine production in the early going.

The FDA is poised to grant emergency approval to the Pfizer vaccine in the next several days. The U.S. is stockpiling doses of the vaccine ahead of time and storing them in ultra-low freezers in Kalamazoo, Michigan. The vials last for up to six months if stored at minus-94 degrees Fahrenheit.

Operation Warp Speed said it expects to have enough doses to give 20 million people their first shots before the end of the year, noting Moderna is right behind Pfizer in the approval process. The week-by-week rollout will start with health workers and residents of long-term care facilities, before expanding outward to other priority groups as production ramps up and other vaccines come online.

 

All told, the operation expects to have enough doses to vaccinate 100 million people in the U.S. through the end of March and enough to vaccinate any American that wants the vaccines by the end of June.

Canadian regulators approved the Pfizer vaccine on Wednesday, paving the way for its vaccination campaign to start next week. It expects to receive about 250,000 doses this month.

The U.K. on Tuesday become the first country to use the Pfizer shots outside of clinical trials.

British regulators said people who’ve experienced severe allergic reactions in the past should not take the Pfizer shots while they investigate adverse reactions in a pair of National Health Services staffers with a history of allergies.

Operation Warp Speed officials said an advisory panel that will discuss the Pfizer vaccine with the FDA on Thursday will likely consider a similar warning.

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