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Politics, Policy & Law

Controversy over Warp Speed’s decision to keep half of Pfizer, Moderna vaccine doses in reserve

Former FDA Commissioner Gottlieb says crisis demands taking risks on supply of second doses

Former FDA Commissioner Gottlieb says crisis demands taking risks on supply of second doses

Dec 12, 2020 | 3:02 AM GMT

Following FDA’s first authorization of a COVID-19 vaccine, controversy over the Trump administration’s management of pandemic countermeasures will shift from FDA’s reviews to Operation Warp Speed’s procurement and deployment strategies. One of the most consequential points of disagreement concerns Warp Speed’s decision to hold half of the U.S. vaccine supply in reserve to ensure the availability of the second dose of two-dose vaccine regimens.

Former FDA Commissioner Scott Gottlieb has criticized this approach as being unnecessarily conservative. He advocates maintaining a small reserve and getting as many first doses as quickly as possible into American arms. 

Gottlieb’s recommendation is based on data indicating that the first dose is protective, coupled with confidence that Pfizer Inc. (NYSE:PFE) will be able to manufacture sufficient doses to provide a second shot in time to meet demand for second vaccinations.

Gottlieb serves on Pfizer’s board of directors. His arguments apply both to the vaccine Pfizer is developing in partnership with BioNTech SE (NASDAQ:BNTX) and to the similar two-dose mRNA vaccine that Moderna Inc. (NASDAQ:MRNA) is developing.

The second dose of the Pfizer-BioNTech vaccine is administered 21 days after the first dose. There is a 28-day interval between doses of the Moderna vaccine.

In remarks to CBS television’s Face the Nation on Dec. 6, Moncef Slaoui, Operation Warp Speed’s chief scientific adviser, said reserving doses was prudent given the uncertainties associated with manufacturing a new vaccine. “As always, early in manufacturing, there may be challenges. Sometimes vaccine doses can be delayed by a week or a few days or, God forbid, by three weeks. It would be inappropriate to partially immunize large numbers of people and not complete their immunization.”

Failing to provide second doses on time, Slaoui said, “may actually decrease the confidence in the vaccine.”

The dispute is playing out as the pandemic is spiking in the U.S. and the need to protect the elderly, healthcare workers and individuals at high risk of developing severe COVID-19 is becoming ever more acute and urgent.

The Trump administration’s strategy is intended to ensure that everyone who gets vaccinated will receive the complete two-shot regimen. The cost for this certainty is reducing, potentially by millions, the number of individuals who will be protected in the critical period leading up to Christmas, which is expected to be especially dangerous as holiday travel and gatherings accelerate the spread of COVID-19.

At a meeting of the Council of Foreign Relations on Thursday, CDC Director Robert Redfield predicted, “Probably for the next 60 to 90 days we're going to have more deaths per day than we had at 9/11 or we had at Pearl Harbor.” 

Warp Speed’s plans

Paul Mango, HHS deputy chief of staff for policy, described Operation Warp Speed’s distribution plans on Dec. 7 in a press briefing.

“We already have somewhere between six and eight million doses of the [Pfizer-BioNTech] vaccine ready to ship today as soon as the EUA is approved,” he said.  “We will not be shipping all of those. We'll be shipping half of what we have, and the reason is this is a two-dose vaccine, and we don't want to get into a situation where we ship enough for let's say eight million doses, everyone gets their first shot, and then there's a manufacturing problem and we can't give them their second shot within 21 days.”

Mango acknowledged, “We're being a little bit conservative, but that's because we think we have an ethical commitment to making sure those who get the first dose actually get the second dose and we're still in a situation very early in the manufacturing process where those types of things could happen. As we get later into the season, so to speak, it'll be a lot easier for us to distribute every dose we get.”

Operation Warp Speed anticipates that 20 million Americans will receive a first dose of either the Pfizer-BioNTech vaccine or Moderna vaccine in December, and it will hold an additional 20 million doses in reserve for second doses, Mango said. He added that in January “another 25 to 30 million persons should be able to be vaccinated with two doses, and then in February and into March we're going to get closer to a hundred million.”

Speaking Dec. 6 on CBS television’s Face the Nation, Gottlieb argued that Warp Speed should deploy most of the vaccine doses it has on hand rather than keep half in warehouses. “I would be trying to push out as much vaccine as possible, recognizing that the supply ramps very quickly in 2021, and you have to take a little bit of a risk that the supply is going to be there in 2021 to give everyone who gets vaccinated in 2020 the second dose.”

Gottlieb added, “This is a crisis. We need to get as many vaccines in arms as possible in my view, and that means pushing out all the available supply or most of it. You might want to hold a little bit in reserve, but not much.”

Data from the Phase III trial of the Pfizer-BioNTech vaccine indicates that it starts providing protection about 10 days after the first dose. There is no data about the duration of protection from a single dose because almost everyone in the trial received both doses.

Assumptions about vaccine supplies assume that production will ramp up in 2021.

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