Dr. Scott Gottlieb, who sits on the board of Pfizer, on Monday defended the company’s move to ship fewer vials of its Covid-19 vaccine and count six doses per vial, instead of five, saying that it’s the best way to ensure the extra dose gets used.
When the company began shipping vials of its vaccine last month, pharmacists discovered that they could often extract an extra dose from each vial that, on paper, only contained five doses. That discovery meant that the United States might actually get more doses of the vaccine than the 200 million the Department of Defense purchased under its contract with Pfizer.
“The bottom line here is that this is a very scarce resource. We need to make sure every dose gets used,” Gottlieb said on CNBC’s “Squawk Box” on Monday. “The only way to do that is to market this as a vial that has six doses and provide the proper equipment to extract that sixth dose, which in fact Pfizer is doing.”
The New York Times reported Friday that Pfizer executives successfully pushed officials at the Food and Drug Administration in recent weeks to revise the wording of the vaccine’s emergency use authorization to formally count the sixth dose toward its federal contract.
Some pharmacists were confused by the extra doses, or didn’t have the right syringes to extract them, and were throwing them out.
“During this pandemic, with the number of people dying across the globe, it is critical that we utilize all available vaccine supply and vaccinate as many people as possible. To leave an additional dose in each vial, that could be used to vaccinate additional people, would be a tragedy,” company spokeswoman Amy Rose said.
Gottlieb said Monday the move will help the U.S. accelerate the distribution of vaccine doses, adding that Pfizer can now supply 120 million doses of the vaccine in the first quarter of 2021, up from 100 million before the labeling change.
But the move puts pressure on U.S. pharmacists to extract six doses from every vial, which requires some special syringes, called low dead space syringes. The U.S. government, which ships kits that include syringes along with doses of the vaccine, has contracted with syringe manufacturers such as Becton Dickinson, the world’s largest syringe maker, to provide the supplies to local officials.
But Becton Dickinson does not have the capacity to substantially increase the U.S. supply of the syringes, Reuters reported earlier Monday, casting doubt on how many vials the U.S. 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 proper syringes to extract the last dose.
Gottlieb noted that when Pfizer applied for emergency use authorization of its vaccine, it knew that six doses could be extracted from each vial, but revising the wording of the application would have delayed the authorization of the vaccine. So the company went ahead and sought authorization with the intent to revise the wording later on to reflect the six-dose vials.
He added the U.S. FDA took longer than regulatory agencies in other countries to make the change. Authorities in the United Kingdom, Switzerland and Israel, he said, had already revised the wording of their authorizations of the Pfizer vaccine to reflect that each vial contains six doses.
Gottlieb, the former head of the FDA, clarified that the change is not going to be applied retroactively, meaning that all vials previously shipped out are counted as containing five doses.
But “at some point, you had to make the accommodation to account properly for the doses,” Gottlieb said.
Disclosure: Scott Gottlieb is a CNBC contributor and is a member of the boards of Pfizer, genetic testing start-up Tempus, health-care tech company Aetion Inc. and biotech company Illumina. He also serves as co-chair of Norwegian Cruise Line Holdings’ and Royal Caribbean’s “Healthy Sail Panel.”
