Dr. Scott Gottlieb, who sits on Pfizer’s board, defended the company’s decision to send fewer vials of its Covid-19 vaccine and count six doses per vial instead of five, saying it is the best way to ensure that the extra dose is used.
When the company started shipping vials of its vaccine last month, pharmacists found that they could often extract an extra dose from each vial that, on paper, contained only five doses. That discovery meant that the United States could actually get more doses of the vaccine than the $ 200 million that the Department of Defense bought under its contract with Pfizer.
“The main point here is that this is a very scarce resource. We need to make sure that each 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 bottle and provide the proper equipment to extract that sixth dose, which in fact Pfizer is doing.”
The New York Times reported on Friday that Pfizer executives have successfully lobbied Food and Drug Administration officials in recent weeks to revise the wording of the vaccine’s emergency use authorization to formally account for the sixth dose in their federal contract.
Some pharmacists were confused by the extra doses or did not have the right syringes to extract them and threw them away.
“During this pandemic, with the number of people dying worldwide, it is essential that we use all the vaccine stock available and vaccinate as many people as possible. To leave an additional dose in each bottle, which could be used to vaccinate others people, it would be a tragedy, “said company spokeswoman Amy Rose.
Gottlieb said on Monday on CNBC’s “Squawk Box” program that the measure will help the United States speed up the distribution of doses of the vaccine, adding that Pfizer can now supply 120 million doses of the vaccine in the first quarter of 2021, against 100 million before the change in labeling.
But the measure puts pressure on North American pharmacists to extract six doses from each vial, which requires some special syringes, called low dead space syringes. The United States government, which sends kits that include syringes along with doses of the vaccine, has signed contracts with syringe makers like Becton Dickinson, the world’s largest syringe maker, to supply supplies to local authorities.
But Becton Dickinson lacks the capacity to substantially increase the supply of syringes in the U.S., Reuters reported on Monday, casting doubt on how many vials the U.S. will be able to extract six doses of.
Gottlieb said that vaccines will count only 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, it knew that six doses could be extracted from each vial, but revising the order text would have delayed vaccine authorization. So the company went ahead and sought authorization with the intention of revising the text 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 already revised the text of their Pfizer vaccine permits to reflect that each vial contains six doses.
Gottlieb, the former FDA chief, clarified that the change will not be applied retroactively, meaning that all vials previously sent are counted as containing five doses.
But “at some point, you had to do the accommodation to properly count the doses,” said Gottlieb.
Disclosure: Scott Gottlieb is a CNBC contributor and board member of Pfizer, a beginner genetic testing company Tempus, health technology company Aetion Inc. and biotechnology company Illumina. He also serves as co-chair of the “Healthy Sail Panel” for Norwegian Cruise Line Holdings and Royal Caribbean.