Gottlieb, Pfizer board member, defends measure to deliver fewer vials of Covid vaccine

Dr. Scott Gottlieb, who is on Pfizer’s board of directors, defended the company’s move to deliver fewer vials of its Covid-19 vaccine and count six doses per vial, instead of five, saying it is the highest. good way to ensure that the extra dose gets used.

When the company began delivering vaccine vials last month, pharmacists found that they could often extract an extra dose from each vial that contained only five doses on paper. This finding 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 is that this is a very limited resource. We need to make sure every dose is used,” he told CNBC’s Squawk Box on Monday. “The only way to do that is to market this product as a six-dose vial and provide the right equipment to extract that six doses, which is what Pfizer is doing.”

The New York Times reported Friday that Pfizer executives have pushed Food and Drug Administration officials in recent weeks to review the wording of the vaccine’s emergency use authorization to formally count the sixth dose in its federal contract.

Some pharmacists were confused by the extra doses or did not have the right syringes to extract and discard.

“During this pandemic, with the number of people dying around the globe, it is essential to 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 others. people, it would be a tragedy, “said company spokeswoman Amy Rose.

Gottlieb said Monday in CNBC’s “Squawk Box” that the move will help the U.S. speed up the distribution of vaccine doses, adding that Pfizer can now deliver 120 million doses of vaccine in the first quarter of 2021, from 100 million. before changing the labeling. .

But the action puts pressure on American pharmacists to extract six doses from each vial, which requires special syringes called dead space syringes. The US government, which supplies kits that include syringes along with vaccine doses, has contracted with syringe manufacturers such as Becton Dickinson, the world’s largest syringe manufacturer, to supply local officials.

But Becton Dickinson does not have the ability to substantially increase the supply of syringes in the US, he told Reuters earlier Monday, questioning how many vials in the US will be able to extract six doses.

Gottlieb said the vaccines will only be considered six-dose vials if local jurisdictions also receive the appropriate syringes to extract the last dose.

Gottlieb noted that when Pfizer applied for emergency use of his vaccine, he knew that six doses could be withdrawn from each vial, but a review of the wording of the application would have delayed the authorization of the vaccine. Thus, the company proceeded and requested authorization with the intention of revising the wording at a later date to reflect the six-dose vials.

He added that the US FDA has taken more than regulatory agencies in other countries to make the change. He said authorities in the UK, Switzerland and Israel had already reviewed the wording of their Pfizer vaccine authorizations to reflect that each vial contained six doses.

Gottlieb, the former head of the FDA, clarified that the change will not be applied retroactively, which means that all previously shipped vials are considered to contain five doses.

But “at some point, you had to make the accommodation to properly consider the doses,” Gottlieb said.

Disclosure: Scott Gottlieb is a CNBC contributor and a board member of Pfizer, a genetic testing start-up Tempus, the healthcare company Aetion Inc. and the biotechnology company Illumina. He is also co-chair of the “Healthy Sail Panel” of Norwegian Cruise Line Holdings and Royal Caribbean.

.Source