- The Washington Times - Wednesday, December 9, 2020

The Trump administration is sticking to plans to reserve half of the initial supply of Pfizer’s COVID-19 shots when vaccinations begin, to ensure top-priority recipients receive the recommended second dose — despite calls to use all the medicine as soon as it’s available and hope production catches up.

Too risky, Trump coronavirus team officials said Wednesday, one day after the Food and Drug Administration said an initial Pfizer shot offers some protection from COVID-19 ahead of the booster shot given 21 days later.

For now, the team plans to play it safe when it sends out its first shipment of vaccine within 24 hours of FDA approval, which should occur within days.

It is reserving 500,000 doses out of the initial tranche of 6.4 million, in case of unforeseen problems, and splitting the remainder by half, to ensure the second dose will be available to the first recipients.

“As we get more experience on quality control on the production, we’ll get greater confidence — of course — in the level of supply-reserve we hold back for that second-dose administration,” Health and Human Services Secretary Alex Azar said. “But we will not distribute a vaccine knowing that the booster will not be available.”



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

Human trials showed a two-dose course of the Pfizer vaccine was incredibly effective in staving off the coronavirus disease that has ravaged the world and killed more than 288,000 people in the U.S.

Data from the trials formed the basis of Pfizer’s application for emergency approval from the FDA, which an advisory panel is scheduled to consider on Thursday.

“It would be a mistake, an unacceptable mistake, to knowingly distribute a vaccine in non-respect of the label,” said Moncef Slaoui, the science adviser to Operation Warp Speed, the moniker for Mr. Trump’s initiative to speed coronavirus vaccines to approval and distribution in record time.

Mr. Slaoui said sudden changes in the plan would sow doubt in the rollout at a time when the effort can ill-afford it.

“That would actually drive the hesitation of the vaccine high,” he said.

Only half of Americans say they are ready to get vaccinated once their turn arrives, according to a poll released Wednesday by The Associated Press-NORC Center for Public Affairs Research.

A quarter of U.S. adults aren’t sure if they want the shots and a quarter say they won’t get immunized, the poll said.

Mr. Trump’s team also said it did not want to upend carefully laid plans for early distribution, especially given the vagaries of producing medicines.

“We have a pandemic, we need to save people’s lives,” Mr. Slaoui said. “We’re going to roll [out] vaccine doses as they come, but we’re not certain they will come as per plan.”

Canadian regulators approved the Pfizer vaccine on Wednesday, paving the way for immunization to start at 14 sites in major cities 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 have 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 histories of allergies.

Operation Warp Speed officials said an FDA advisory panel will probably discus a similar warning during its Thursday meeting on the Pfizer vaccine.

The daylong meeting will include votes on whether the vaccine is safe for certain populations and if the FDA should grant the product an emergency-use authorization.

“We could then have an EUA within days, and be administrating doses of vaccine to our most vulnerable next week,” Mr. Azar said.

The U.S. is stockpiling doses of the vaccine ahead of approval and storing them in ultra-low freezers in Kalamazoo, Michigan. The vials are good 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, as Moderna seek approval of its messenger-RNA vaccine the week after Pfizer.

The week-by-week rollout of vaccines will start with health workers and residents of long-term care facilities, before moving to other priority groups as production ramps up and other vaccines come online.

Operation Warp Speed expects to have enough doses to vaccinate 100 million Americans by the end of March and enough to vaccinate anyone who wants the vaccine by the end of June.

Mr. Slaoui said the U.S. will bolster its capacity if Johnson and Johnson wins approval for its single-dose vaccine, likely in late January or early February.

The J&J vaccine, which is still in trials, would alleviate some of the thorny issues around the two-dose shots being rolled out now.

Dr. Gottlieb, who sits on Pfizer’s board, told USA Today in a recent Q&A the U.S. should “get as many shots in arms as possible, right away” instead of holding back half of the supply to guarantee the second dose.

“The reality is that one dose is partially protective,” he told the newspaper.

He said if sufficient doses weren’t available in January for those who received their first dose this month, as production ramps up in 2021, it would signal broader problems with the overall effort.

“They said the next six weeks are going to be the hardest period in the history of America,” Dr. Gottlieb said. “So during the hardest period in the history of America, you’re going to take some vaccine that could potentially be better for some people and lock it in a drawer? Fundamentally, that doesn’t make sense to me.”

Mr. Slaoui said they looked at the tradeoffs of vaccinating more people immediately versus the risks of not having the second doses for wide swaths of recipients.

“We decided that is not a risk we should take,” he said.

There is some slack involved — scientifically, it’s not the end of the world if a person doesn’t get the second Pfizer dose exactly 21 days later (or 28 days later for the Moderna version).

“The more you space the two doses of vaccine, the better immune response you get after the second dose, but the tradeoff is that you have a weaker — potentially weaker — protection between the two doses,” Mr. Slaoui said.

“So when you’re dealing with a disease that has low incidence, that’s OK, because your risk of contracting it is low in between the doses,” he said. “If there is significant transmission of disease, as is the case here, we should absolutely get the second dose exactly as has been studied.”

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