By the end of the year, the United States government hopes to have close to 40 million doses of COVID-19 vaccine.
It plans to distribute half of those in December and hold back the other half to give the same people their second dose of the two-shot regimen.
But Dr. Scott Gottlieb, a Pfizer board member and former U.S. Food and Drug Administration commissioner, says that’s a bad idea. Instead, Gottlieb says he would give out 35 million doses now, and presume the second doses will be available when people need them.
That way, he says, a lot more people can be protected as the U.S. endures the worst of the COVID-19 pandemic.
“We should get as many shots in our arms as possible right away,” he told the USA TODAY Editorial Board on Monday. “The idea that we need to cut (the doses) in half and give half of it now and hold onto it, so we have supply in January to get the second dose … I just fundamentally disagree with that.”
As the U.S. continues to suffer from a surge with nearly 200,000 new cases each day, according to a USA TODAY analysis of Johns Hopkins data, Gottlieb says the government should focus on vaccinating as many people as possible with first doses. He anticipates another 40 million doses should be ready in time for the second shot of the two-dose regimen.
The inability to do so would indicate a manufacturing process problem exceeding that of people not getting their second dose on schedule, he argues.
“I don’t think we should be holding onto supply now, anticipating something goes wrong that’s going to cause a lot of other challenges,” said Gottlieb. “We should be taking some risk.”
Arthur Caplan, professor and founding head of the division of medical ethics at the NYU School of Medicine in New York City, agrees.
“Vaccinat(ing) as many as possible in the midst of a horrific deadly plague to maximize lives saved has to be our moral priority,” he said. “I will accept a bit of risk in terms of supply to get to that goal as long as manufacturers will promise that the second doses are highly, highly likely to be available for those who got the first dose.”
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Some experts however, are not convinced they would take that risk, especially after Pfizer and its partner BioNTech slashed the number of doses for the end of the year from an original estimate of 100 million. According to TIME magazine and the Wall Street Journal, a spokeswoman cited supply-chain issues, saying that scaling up the raw material supply chain “took longer than expected.”
“The hardest part of making vaccines is making vaccines,” said Dr. Paul Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia. “Mass production is always the hardest part.”
The Pifzer/BioNTech COVID-19 vaccine, as well as another frontrunner from Moderna, is based on messenger RNA technology. Offit says the lipid particles used to carry the mRNA into the body are the most difficult part of the vaccine to scale up. The lipid particles protect the mRNA from degenerating too quickly in the body before it gets delivered into the cell.
The benefit of vaccinating 40 million people may outweigh the risk of delaying a second dose if the first dose was at least 50% effective, he said, because people would be partially protected.
But not everyone agrees. Operation Warp Speed chief science adviser Dr. Moncef Slaoui said in an interview Sunday with Margaret Brennan on CBS’ Face the Nation “it would be inappropriate to partially immunize large numbers of people and not complete their immunization.”
Not only would it be taking a risk, he said, it also could decrease confidence in the vaccine.
“We don’t know how the behavior of the vaccine would be if we omit to give the second dose at three weeks or at four weeks after the first dose,” Slaoui said. “We want to do things by exactly how they were studied and how they have been approved.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.