The Food and Drug Administration said on Wednesday that pharmacists can get additional doses from vials of the Pfizer coronavirus vaccine, potentially expanding the country’s offerings by millions of doses as the Trump administration negotiates with Pfizer to speed up the next round of vaccine deliveries.
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The existing offering of the government’s first authorized vaccine may be further expanded after pharmacists began noticing that vials contained more than the expected five doses.
The FDA is in contact with Pfizer about how to address this issue, the agency said. In the meantime, regulators say those extra doses can be used from a single vial.
At this point, given the public health emergency, the FDA advises that it is acceptable to use any full dose available – the sixth or possibly even a seventh – from each vial, pending resolution of the problem , a spokesman for the agency said, confirming news first reported by Politico.
That means that the stock of the remaining vaccine could be up to 40 percent larger, although the drug manufacturer warns that it is uncertain how many additional doses are available. The FDA and Pfizer also warn that a leftover vaccine from different vials that is smaller than a full dose should not be mixed together, which, according to experts, risks cross-contamination.
“The amount of vaccine left in the multi-dose vial after 5-dose disposal can vary depending on the type of needles and syringes used,” Sharon Castillo, a Pfizer spokeswoman, said in a statement.
The Pfizer-BioNTech vaccine is also getting a boost from the White House this week, with Vice President Pence expected to receive a vaccination on Friday, live in front of the camera. Second lady Karen Pence and Surgeon General Jerome Adams are also expected to be vaccinated.
Meanwhile, federal health officials said Wednesday they are in talks with Pfizer to buy tens of millions of additional doses this spring after the pharmaceutical company said the United States probably should wait until summer.
Alex Azar, Secretary of Health and Human Services, said he is “very optimistic” about the negotiations in which federal officials are trying to help Pfizer ramp up production to meet government demand for the second quarter of 2021.
“We are working with them to provide them with every possible assistance, now that they have identified some of the manufacturing challenges,” Azar said at a briefing on Wednesday.
The negotiations come after Pfizer told the Trump administration that other countries are rushing to buy most of the stock that will be available in the second quarter of the year. The federal government turned down another chance in October to double the purchase of 100 million doses of the Pfizer-BioNTech vaccine, the first approved in the United States, due to disagreements over delivery dates.
Jeanne Marrazzo, director of the infectious diseases division at the University of Alabama at Birmingham, said the potential for millions of additional doses is “incredibly good news,” especially in light of the dispute over Pfizer-BioNTech supplemental vaccines.
“If the vaccine is as good as it has been in the studies, it’s a silver lining to the fact that we didn’t get as much of the Pfizer vaccine as we could have originally gotten,” she said.
Federal officials have insisted they have adequate doses of other vaccines likely to receive emergency licensing, including the Moderna vaccine, which is expected to be approved by regulators in the coming days.
Azar noted that the federal government has been more closely involved in the development and manufacture of the five other coronavirus vaccines, which accepted government funding for research. Pfizer declined funding.
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That made it more difficult for the federal government to intervene when Pfizer ran into manufacturing problems, health officials said.
“Part of our ongoing discussions is to fix that and to better understand what they are doing and what challenges they face because they have made significant commitments to us and others,” said Azar.
Pfizer disputed Azar’s comments, saying through a spokeswoman that it “currently has no manufacturing issues” and has been transparent with the federal government about its manufacturing and distribution capabilities.
“They have visited our facilities, walked the production lines and were part of the most important decisions made,” said Castillo.
Pfizer CEO Albert Bourla said Monday that the company could provide an additional 100 million doses in the third quarter of the year and confirmed negotiations to deliver the supplemental vaccine earlier.
“We are working very closely with them to make sure we can find ways to produce more or to allocate the doses in their second quarter as well, but we have not yet signed this agreement,” Bourla said in an interview with Sanjay Gupta from CNN. .
Trump administration officials on Wednesday defended their earlier decision to refuse to purchase additional Pfizer-BioNTech vaccine doses.
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“You wouldn’t buy something until you knew it worked if you had six options to have one supplier provide what you needed,” said Moncef Slaoui, chief science adviser for Operation Warp Speed, the initiative overseeing vaccine distribution. .
Officials said they are on track to meet the first vaccination targets this week, with deliveries to 636 facilities to date and another 886 scheduled for Thursday.
An additional 2 million Pfizer-BioNTech doses are planned next week, and 5.9 million Moderna doses will be allocated if the vaccine clears regulatory hurdles in the coming days.
Laurie McGinley and Josh Dawsey contributed to this report.
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