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Dr Scott Gottlieb, who sits on Pfizer’s board of directors, defended the company’s decision to ship fewer vials of its Covid-19 vaccine and have six doses per vial, instead of five, saying this was the best way to ensure that the extra dose was used.
When the company started shipping vials of its vaccine last month, pharmacists found they could often extract an extra dose from each vial which, on paper, only contained five doses. The discovery meant that the United States could actually receive more doses of the vaccine than the 200 million the Department of Defense bought under its contract with Pfizer.
“The bottom line here is that this is a very scarce resource. We have to make sure every dose is used,” he said on CNBC’s “Squawk Box” Monday. “The only way to do that is to market this as a six-dose vial and provide the proper equipment to extract that sixth dose, which Pfizer actually does.
The New York Times reported on Friday that Pfizer executives have successfully pushed Food and Drug Administration officials in recent weeks to revise the wording of the emergency use authorization for the vaccine to officially account for the sixth dose. in its federal contract.
Some pharmacists were confused by the extra doses, or didn’t have the right syringes to extract them, and threw them away.
“During this pandemic, with the number of people dying around the world, it is essential that we use all available vaccines and vaccinate as many people as possible. To leave an extra dose in each vial, which could be used to vaccinate other people, would be a tragedy, ”said company spokeswoman Amy Rose.
Gottlieb told CNBC’s “Squawk Box” on Monday that the move would help the United States speed up vaccine doses, adding that Pfizer can now deliver 120 million doses of the vaccine in the first quarter of 2021, up from 100 million before. the change in labeling. .
But the move pushes US pharmacists to extract six doses from each vial, which requires special syringes, called low-dead space syringes. The U.S. government, which ships kits that include syringes and doses of vaccine, has contracted syringe makers like Becton Dickinson, the world’s largest syringe maker, to provide the supplies to local authorities.
But Becton Dickinson does not have the capacity to significantly increase the U.S. supply of syringes, Reuters reported earlier Monday, casting doubt on how many vials the United States will be able to extract six doses from.
Gottlieb said the vaccines will only count as six-dose vials where local jurisdictions also receive the appropriate syringes to extract the last dose.
Gottlieb noted that when Pfizer requested authorization for the emergency use of its vaccine, he knew that six doses could be taken from each vial, but the revised wording of the request would have delayed the authorization of the vaccine. So the company went ahead and applied for clearance with the intention of revising the wording later to reflect the six-dose vials.
He added that the US FDA took longer than regulatory agencies in other countries to make the change. Authorities in the UK, Switzerland and Israel, he said, had all already revised the wording of their authorizations for Pfizer vaccine to indicate that each vial contains six doses.
Gottlieb, the former head of the FDA, clarified that the change will not apply retroactively, which means all vials previously shipped are counted as containing five doses.
But “at one point you had to do the housing to properly account for the doses,” Gottlieb said.
Disclosure: Scott Gottlieb is a CNBC contributor and is a member of the board of directors of Pfizer, a genetic testing start-up Tempus, health technology company Aetion Inc., and biotechnology company Illumina. He is also co-chair of the Healthy Sail Panel for Norwegian Cruise Line Holdings and Royal Caribbean.
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