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White House bet on Pfizer doses raises concerns about vaccine supply

White House bet on Pfizer doses raises concerns about vaccine supply
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The Trump administration's decision not to purchase additional doses of Pfizer's COVID-19 vaccine could prove to be a risky gamble resulting in a delay of an ambitious schedule to vaccinate Americans.

The administration has a contract in place for 100 million doses of Pfizer's vaccine, enough to vaccinate only 50 million people.  In addition, the company's commitments to other countries means that if the U.S. needs more doses, the company would not be able to fulfill them until the summer.

The administration has decided to rely on other companies for effective inoculation in addition to Pfizer, fueling concerns that the U.S. may not be able to meet its goal of vaccinating the entire U.S. population by the spring or summer of 2021.

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President TrumpDonald TrumpSchumer: Impeachment trial will be quick, doesn't need a lot of witnesses Nurse to be tapped by Biden as acting surgeon general: report Schumer calls for Biden to declare climate emergency MORE on Tuesday hinted that the administration could force Pfizer to provide additional doses if there are any “problems” securing more.

“If necessary, we’ll invoke the Defense Production Act, but we don’t think it will be necessary,” Trump said Tuesday.

Trump administration officials are denying there will be availability issues, and the president on Tuesday signed an executive order aimed at prioritizing shipment of a COVID-19 vaccine to Americans first.

Experts said it's not clear what effect Trump's executive order will have, especially as much of the work for distributing the vaccines will fall to the incoming Biden administration.

"We have been, and continue to, negotiate with Pfizer for additional doses. At no time did OWS [Operation Warp Speed] turn down an offer from Pfizer for any number of millions of doses having a firm delivery date and quantity," the Department of Health and Human Services (HHS) Department of Public Affairs tweeted on Tuesday.

The agency added that even before the data from Pfizer’s phase 3 trial became available, OWS "has been asking Pfizer for a delivery schedule for doses in excess of the original 100 million so that we could finalize an updated agreement with Pfizer."

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But the decision not to pursue additional doses, first reported by The New York Times, was confirmed Tuesday by former Food and Drug Administration (FDA) Commissioner Scott Gottlieb, a member of the Pfizer board of directors.

Gottlieb said Pfizer previously offered the Trump administration the chance to buy additional doses of its coronavirus vaccine multiple times.

The former FDA commissioner said the initial offer was made over the summer, and then again as recently as last month, when Pfizer and its partner BioNTech had already announced initial results. 

The administration turned down the offers, he said.

Gottlieb added that he believes the government gambled on a chance that they could potentially purchase highly effective vaccines from multiple manufacturers, not just Pfizer. 

"I think they're betting that more than one vaccine's going to get authorized and there will be more vaccines on the market and that perhaps could be why they didn't take up that additional 100 million option agreement," Gottlieb said.

The chief science adviser of OWS, Moncef Slaoui, emphasized that the administration is relying on six different companies, not just Pfizer, and that it wasn't appropriate to spend more money in the summer without knowing if the vaccine worked.

"In the summer if somebody came to us and said 'Let's buy more of this vaccine or that vaccine,' no one reasonable would buy more from any one of those vaccines because we didn't know which one would work and which one may be better than the other," Slaoui said.

So far, the most promising vaccines are from just two companies, Moderna and Pfizer. If more vaccines from other companies prove to be safe and effective, it would reduce the need for additional doses of the Pfizer candidate and the administration's strategy could still work out. 

But if Pfizer turns out to be the main source of effective vaccines, having a finite amount of its doses could be a problem.

Supply chain experts said it makes sense that government officials wanted to make sure they had the most options for a vaccine.

Amy Hartman, assistant professor at the University of Pittsburgh Center for Vaccine Research, said it appeared that the administration was hedging its bets.

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"I think it's easy in hindsight to say yeah, they should have [secured more doses]," Hartman said.

For example, if evidence came out that the brand-new RNA vaccines didn't work as well as a more standard vaccine, "then we wouldn't have wasted time and money on a candidate that isn't going anywhere," she said.

But Hartman said she was not sure why the U.S. would decline to buy more doses once they knew initial results were so promising. 

Prashant Yadav, a senior fellow at the Center for Global Development, noted that manufacturing challenges have already forced Pfizer to scale back its initial delivery, so buying more doses of the Pfizer-BioNTech vaccine would not have made a difference in the first wave.