Dr Scott Gottlieb, who sits on Pfizer’s board, defended the company’s defense by sending fewer vials of his Covid-19 vaccine and counting six doses per vial, instead of five, saying it was the best way. is to ensure that the extra dose gets used.
When the company began shipping vials with its vaccine last month, pharmacists discovered that they could often extract an extra dose from each vial that contained only five doses on paper. The discovery meant the United States could potentially get more doses of the vaccine than the $ 200 million the Department of Defense bought under its contract with Pfizer.
“The bottom line is that this is a very scarce resource. We need to make sure every dose is used,” he said on CNBC’s “Squawk Box” on Monday. “The only way to do that is to market it as a six-dose vial and the equipment needed to withdraw the sixth dose, which Pfizer actually does.”
The New York Times reported on Friday that Pfizer executives had successfully pushed Food and Drug Administration officials over the past few weeks to review the wording of the vaccine’s emergency authorization to formally count the sixth dose in the federal contract. .
Some pharmacists were confused by the extra doses, or did not have the right syringes to withdraw it, and threw it out.
“During this pandemic, with the number of people dying around the world, it is crucial that we use all available vaccine supplies and vaccinate as many people as possible. To leave an additional dose in each vial, which can be used to treat additional vaccinating people would be a tragedy, “said company spokeswoman Amy Rose.
Gottlieb said on CNBC’s Squawk Box on Monday that the move would help the US accelerate the distribution of vaccine doses, adding that Pfizer could now deliver 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 withdraw six doses from each vial, which requires special syringes, called low-dead space syringes. The U.S. government, which includes kits containing syringes and doses of the vaccine, has contracted with spray manufacturers such as Becton Dickinson, the world’s largest spray manufacturer, to supply supplies to local officials.
But Becton Dickinson does not have the ability to significantly increase U.S. spray supplies in the U.S., Reuters reported earlier Monday, raising doubts about how many vials the U.S. will be able to take six doses.
Gottlieb said the vaccines would only count as six dose vials where local jurisdictions also get the right syringes to withdraw the last dose.
Gottlieb noted that when Pfizer applied for the authorization of the emergency vaccine, he knew that six doses could be withdrawn from each vial, but reviewing the wording of the application would have delayed the authorization of the vaccine. The company therefore went ahead and asked for authorization with the aim of reviewing the wording later to reflect the six dose vials.
He added that the US FDA has taken longer than regulatory agencies in other countries to make the change. According to the government, the authorities in the United Kingdom, Switzerland and Israel have all reviewed the wording of their authorization of the Pfizer vaccine to indicate that each vial contains six doses.
Gottlieb, the former head of the FDA, explained that the change does not apply retrospectively, which means that all vials previously shipped are considered five doses.
But “at some point you had to make sure the accommodation had the doses properly accounted for,” Gottlieb said.
Disclosure: Scott Gottlieb is a contributor to CNBC and is a member of the boards of Pfizer, drafting genetic tests Tempus, the healthcare technology company Aetion Inc., and the biotechnology company Illumina. He also serves as co-chair of the ‘Healthy Sail Panel’ of Norwegian Cruise Line Holdings and Royal Caribbean.