President-elect Joe Biden plans to order the distribution of almost all available doses of the COVID-19 vaccines, in a striking departure from the Trump administration’s strategy of holding back roughly half of the stock to ensure those who have been vaccinated would receive their second dose.
The announcement from Biden’s transition team arrived as US deaths and hospitalizations from the coronavirus pandemic soar and the country struggles to administer its current vaccine stock. As of Friday, the Centers for Disease Control and Prevention had distributed 22.1 million doses of vaccines from Pfizer-BioNTech and Moderna, but only about 6.7 million people had received their first shot. Operation Warp Speed, the Trump administration’s initiative for accelerating vaccine production, had originally promised to inoculate 20 million Americans with their first dose by the end of 2020.
“The President-elect believes we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible. He supports releasing available doses immediately, and believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now,” TJ Ducklo, a spokesman for Biden’s transition, said in a statement Friday.
Biden plans to provide more details of the plan when he takes office Jan. 20.
The Pfizer and Moderna vaccines require two shots, administered three to four weeks apart, for approximately 95 percent efficacy. The Trump administration’s policy of withholding half of the doses has triggered debate among public health experts, some of whom believe all available doses should be delivered as quickly as possible to provide more people with at least partial protection.
That’s what the Biden team announced Friday.
A transition official said the incoming Biden administration believes vaccine manufacturers will be able to scale up production to ensure all recipients will get their second dose on schedule, and will use the Defense Production Act, as necessary, to guarantee supply.
A spokesman for the Department of Health and Human Services criticized Biden’s shift in strategy and defended Operation Warp Speed’s policy of reserving vaccine stock for second doses.
“If President-Elect Biden is calling for the distribution of vaccines knowing that there would not be a second dose available, that decision is without science or data and is contrary to the FDA’s approved label,” the spokesman said in a statement Friday. “If President-Elect Biden is suggesting that the maximum number of doses should be made available, consistent with ensuring that a second dose of vaccine will be there when the patient shows up, then that is already happening.”
In recent weeks, as the virus has surged and frustrations mounted over the sluggish vaccine rollout, public health experts have been divided on how best to inoculate as many Americans as quickly as possible. Indeed, earlier this week, officials at the Food and Drug Administration pushed back against calls from some public health specialists to alter the dosing schedules or lower the size of the individual doses in order to vaccinate more people, faster.
“We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccine to the public faster,” FDA Commissioner Stephen Hahn and Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said in a statement. “However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.”
Dr. Christopher Gill, an associate professor of global health at Boston University, has long advocated deploying as many first doses as possible, based on limited data on the efficacy of a single shot of the Pfizer and Moderna vaccines. The Pfizer vaccine, for example, has an efficacy rate of 52 percent between the first and second dose. Similarly, the Moderna vaccine showed 51 percent efficacy in the two weeks following the first shot.
Gill lauded the Biden plan as “the right policy move” for maximizing partial immunization coverage of the US population.
“How in good conscience can we possibly be holding back any doses of the vaccine when 4,000 people are dying a day?” Gill added. “It just doesn’t make any sense to me.”
Dr. Ashish Jha, dean of the Brown University School of Public Health and an outspoken supporter of front-loading first injections of the COVID-19 vaccines, said the risks of the Biden strategy are “minuscule,” compared with the upsides.
“The single biggest argument for keeping more than half the doses in reserve is, what if there’s a national catastrophe in terms of manufacturing, and all the manufacturing plants essentially fail or are not able to manufacture any doses and we have some people with only one dose?” Jha said in an interview Friday. “That just seems really, really unlikely to me.”
In a statement to the Globe, a spokesman for Pfizer said the company is confident in its ability to deliver 200 million doses of its vaccine to the US government six months from now, by July 31, and is “committed to collaborating with the Biden administration on common-sense solutions to the challenges in vaccine distribution.”
A Moderna spokesman said the Cambridge-based firm has already supplied 18 million doses of its vaccine to the federal government, and expects about 100 million doses will be available in the US by the end of the first quarter of 2021. By the end of the second quarter, Moderna expects that total to reach 200 million doses.
Dr. Peter Hotez, a vaccine scientist and dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said the Biden strategy should not be interpreted as a tacit endorsement of single-dose immunizations.
“We’re going to need both doses to get those high levels of viral-neutralizing antibodies to ensure protection, so the full release of the doses that are in stock needs to be with the understanding that there are more vaccines to follow,” Hotez said.
Hotez said there are still too many barriers in place to efficiently vaccinate large swaths of the population. Most vaccinations, he noted, are occurring in hospital settings and through pharmacy chains. He said states need to establish additional inoculation sites and open up the eligibility pool for vaccinations to “everyone who wants to get vaccinated.”
“It has to be a top national priority,” Hotez said. “We have squandered every opportunity to control COVID-19. This is our last hope — to vaccinate the American people. So we have to make this work and that means creating an infrastructure for vaccinating a large number of adults that we haven’t really done before.”
Asked about the Biden transition team’s announcement Friday, Marylou Sudders, the Massachusetts secretary of health and human services, said officials are awaiting more information on the timeline. As of Friday, the Commonwealth has received about 345,000 doses of the COVID-19 vaccines, and roughly 167,000 have been administered.
“We look forward to hearing more about what President-elect Biden, when he’s president, what the plans are for a vaccine,” Sudders said. “As we have said, vaccines can’t come soon enough into the Commonwealth of Massachusetts.”
Travis Andersen of the Globe staff contributed to this report.