“I think we have to assume that could be a problem and be prepared in case it is a problem,” said Paul Offit, a vaccine expert at the University of Pennsylvania who also sits on the Food and Beverage vaccine. Drug Administration. Consultative Committee.
Recall plans – or even versions of the original plans to prevent infections from the newer variants – can be built fairly quickly, he added. Rapid modifications to make a vaccine more adaptable would likely go through the first two phases of human trials to prove safety and the best dosage regimen. But enrolling tens of thousands of people for a large Phase III trial is impractical, Offit said.
A spokesperson for the Food and Drug Administration said the agency “had already considered to develop a potential pathway, if changes need to be made to licensed COVID-19 vaccines or other products based on information on emerging variants. “The agency is” committed to having a public and transparent process, “the spokesperson said, adding that the agency has related experience in modifying annual flu shots.
A White House spokesperson said that in addition to the work of his Covid response team, he has tasked a CDC team focused on emerging variants to monitor and run experiments related to the new strains, as well as to monitor incoming data on Covid cases.
Moderna medical director Tal Zaks said on an investor call on Monday evening that he had yet to have an “in-depth conversation” with the FDA, but regulators could treat the boosts as annual vaccines. against the flu. These plans are changed slightly each year as new variants of the flu appear.
Yet vaccine manufacturers face other potential challenges, such as quickly manufacturing enough booster doses.
“We are already learning how difficult it is to mass produce this vaccine, distribute it and administer it anyway. The problems associated with it are the same, ”Offit said.
Moderna and Pfizer / BioNTech are using messenger RNA technology to make their vaccines, a relatively new method that can be scaled up quickly, but only if the right unique tools are in place. Both manufacturers produced fewer doses of the Covid-19 vaccine than expected in 2020, while Pfizer cut production in Europe this month while modernizing its production lines.
Pfizer told POLITICO it is working to obtain data on the variants that have emerged in South Africa and the UK “in the hopes of better understanding how our vaccine might protect against COVID-19 caused by these new variants ”. While the British variant has been spotted in nearly two dozen US states, the country has still not reported any cases of the South African strain.
On Monday, public health officials in Minnesota reported the country’s first case of a variant first identified in Brazil, which shares some mutations with the South African strain.
The challenges the country has faced in distributing and administering doses of already authorized Covid-19 vaccines have raised doubts as to whether Biden can meet his goal of administering 100 million doses in his first 100 days in office. . If stopping the spread of the coronavirus variants requires different boosters or injections, it could block the president’s plan.
Biden on Monday nevertheless doubled his vow, floating the possibility of administering up to 1.5 million doses per day without offering a specific schedule. Still, he stressed that hitting that target would only represent the beginning of what will be needed to end the pandemic – continuing a concerted White House campaign to temper public expectations.
“I never said I would do it in two months,” he said, pressed Monday on his election campaign promise to “shut down” the virus. “That will take time. It will take a very long time.
In the meantime, the administration is scrambling to prevent the spread of the variants that have already reached the United States – and keep the South African strain from reaching the country. During a press briefing, Psaki stressed that the new variants were the main reason for Biden’s decision to maintain and further extend travel restrictions.
“With the pandemic worsening and more contagious variants spreading, now is not the time to lift restrictions on international travel,” she said, adding South Africa to a shortlist which already includes the UK, Ireland, Brazil and dozens of European countries. .
The move will slow the spread and “save us some time,” said Eric Toner, senior researcher at the Johns Hopkins Center for Health Security. But the different responses of variants to vaccines will need to be addressed at some point.
“It’s not like no one is considering this possibility,” Toner said. “But it’s a little unexpected and a bad surprise.”