President-elect Joe Biden confirmed he plans a major strategic change for the coronavirus vaccination campaign in America.
Rather than keeping 50% of the supply for the second dose that has to be administered three to four weeks after the first, Biden plans to release all doses to states so that as many people can be immunized as quickly as possible.
The FDA still argues that the vaccination protocols used in Phase 3 trials and authorized for emergency use should be respected.
A recent study shows that vaccinating more people with the doses available now could significantly reduce the COVID-19 caseload in the coming months.
Other countries have already changed or are contemplating changes to COVID-19 vaccination protocols.
President-elect Joe Biden confirmed a major strategy change for America’s coronavirus vaccination campaign. The Trump administration’s strategy is to hold 50% of the current vaccine supply in reserve, so that the people who received the first dose can get the second shot on time. The Pfizer/BioNTech vaccine is administered in two jabs 21 days apart, while the Moderna drug is given in two doses 28 days apart.
Other countries, including the UK, some EU states, and Canada, have considered delaying the second shot so that more people can be vaccinated with the initial supply. The UK went ahead and made that change, saying that vaccines can be mixed in certain situations, with the second dose recommended between 4 to 12 weeks after the first. Great Britain is experiencing a COVID-19 surge that’s breaking all previous records, fueled by the new coronavirus mutation discovered in the country. The WHO just said that a delay of up to 6 weeks between doses is acceptable during shortages.
Biden plans to release every available dose of the COVID vaccines when he takes office, CNN first reported. TJ Ducklo, a spokesman for Biden’s transition, confirmed the move:
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. He will share additional details next week on how his Administration will begin releasing available doses when he assumes office on January 20th.
The comment comes in response to a letter from a group of governors to Health and Human Services Secretary Alex Azar and Operation Warp Speed Chief Operating Officer Gen. Gustave Perna asking the government to release the reserved doses so that more people can be inoculated. A spokesman for HHS said that the current strategy won’t change:
Operation Warp Speed is continuing to ensure second doses are available to vaccine administration sites, at appropriate intervals, as directed by jurisdiction leaders. We would be delighted to learn that jurisdictions have actually administered many more doses than they are presently reporting. We are encouraging jurisdictions to expand their priority groups as needed to ensure no vaccine is sitting on the shelf after having been delivered to the jurisdiction-directed locations.
FDA officials, including Commissioner Stephen Hahn and Dr. Peter Marks, noted that the agency has been following the discussions about changing vaccination protocols.
“However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19,” they said.
Pfizer pushed back against Canada’s decision to delay the second dose. After the first dose in trials, vaccine efficacy hit 52.4%, reaching 95% only after the second jab.
A study published on Monday in the Annals of Internal Medicine found that administering first doses to more people may reduce the number of new cases. By reducing the vaccine reserve to 10% for the first three weeks and supplying 6 million doses per week, the US could avoid 29% more cases over eight weeks.
The researchers used several models and found that only an unlikely scenario would show any benefit for saving 50% of doses for the second shot. There would have to be a collapse in supply, correlated with minimal protection among individuals who have received the first jab, for the model where half of the doses are saved to provide better protection.
According to reports a few days ago, Operation Warp Speed officials had been considering administering two half-doses to people instead of two full doses to extend vaccine supply.