“I think we have to assume it might be a problem and be ready if it is,” said Paul Offit, a vaccines expert at the University of Pennsylvania who is also on the Food and Drug Administration’s vaccine Advisory Board.
The booster shots – or even versions of the original shots designed to prevent infection from the new variants – can be created relatively quickly, he added. Rapid changes to make a more adaptable vaccine would likely go through the first two stages of human studies to prove safety and the best dosage regimen. However, it is impractical to get tens of thousands of people into a comprehensive Phase III study, Offit said.
A spokesman for the Food and Drug Administration said the agency had “already thought about it to Develop a potential avenue if changes need to be made to approved COVID-19 vaccines or other products based on information about emerging variants. “The agency is” obliged to have a public and transparent process, “said the spokesman, adding that the agency has relevant experience with modifying annual influenza vaccines.
A White House spokesman said that in addition to the work of its Covid response team, it has hired a CDC team to monitor and conduct experiments related to the new strains as well as monitoring incoming data on Covid cases on emerging variants concentrated.
Moderna chief medical officer Tal Zaks said in an investor call late Monday that he had not yet had a “deep dive” conversation with the FDA, but that regulators could treat booster vaccinations similar to annual flu vaccines. These recordings change slightly every year as new flu varieties emerge.
Nonetheless, vaccine manufacturers face other potential challenges, such as producing enough booster vaccinations quickly.
“We are already learning how difficult it is to mass-produce, distribute and administer this vaccine.” The problems involved are the same, ”said Offit.
Both Moderna and Pfizer / BioNTech use messenger RNA technology to make their vaccines. This relatively new method can be expanded quickly, but only if the right, unique tools are in place. Both manufacturers produced fewer Covid-19 vaccine doses in 2020 than expected, while Pfizer reduced its production in Europe and revamped production lines this month.
Pfizer told POLITICO that it was working to obtain data on the variants that appeared in South Africa and the UK, “in the hope of better understanding how our vaccine can protect against COVID-19 caused by these new variants.” While the British variant has been discovered in nearly two dozen US states, the country has yet to report a case from the South African tribe.
On Monday, state health officials in Minnesota reported the country’s first case of a variant first identified in Brazil that shares some mutations with the South African tribe.
The challenges the country faced in distributing and administering already approved Covid-19 vaccines has cast doubt on Biden’s ability to deliver 100 million doses in his first 100 days in office. If containing the spread of the coronavirus variants calls for boosters or other shots, it could bring the president’s plan to a halt.
Even so, Biden doubled his vows on Monday, floating the possibility of administering up to 1.5 million doses per day without offering a specific schedule. Still, he insisted that reaching that mark would only mark the beginning of what will be needed to end the pandemic – continuing a concerted White House campaign to soften public expectations.
“I never said I would do it in two months,” he said when he promised on Monday on his campaign path to “turn off” the virus. “It will take some time. It will take a hell of a lot of time.”
In the meantime, the government is working hard to prevent the spread of the variants that have already reached the US – and prevent the South African tribe from reaching the country. During a press conference, Psaki pointed to the new variants as the main reason for Biden’s decision to maintain and further expand the travel restrictions.
“With the pandemic worsening and the number of contagious variants growing, this is not the time to lift restrictions on international travel,” she said, adding South Africa to a restricted list that already includes the UK, Ireland, Brazil and dozen of European countries .
The move will slow the spread and “buy us some time,” said Eric Toner, a senior scientist at the Johns Hopkins Center for Health Security. However, the different responses of the variants to vaccines will have to be addressed at some point.
“It’s not that nobody considered the possibility,” said Toner. “But it’s a bit unexpected and a bad surprise.”