The Biden government is “in talks” to make sure the booster can get COVID-19 shots if needed, a top official told lawmakers Thursday. The announcement comes as drug manufacturers are touting their progress in developing the additional injections, which are designed to increase the body’s immune response months after the first doses are administered.
“We are currently in discussion to ensure that we can secure those vaccines for a boost or variants. We are now in that process,” said Dr. David Kessler, chief science officer for the government’s COVID-19 response, to the House. Select Subcommittee on the Coronavirus Crisis.
Federal health officials and drug manufacturers have said for months that booster shots will likely be needed at some point, although it’s not yet clear when that will be. The shots will likely be very similar to the original version of the vaccines, but can be administered in different doses or adjusted to protect against variants.
Kessler cautioned that “no decision” had been made on the strategy of how the booster shots would be administered, citing ongoing research into the duration of immunity created by the vaccines. Recent studies from Pfizer and Moderna suggest their COVID-19 shots remain effective for at least 6 months.
“With many vaccines, we understand that at some point we need to get a boost, be it 9 months or 12 months. And we’re preparing for that,” said Kessler.
The companies behind all three COVID-19 vaccines currently authorized for use in the United States have said they are pursuing additional injections.
“A third dose will likely be required, somewhere between 6 and 12 months. And then from there. There will be an annual revaccination. But all of that needs to be confirmed,” Pfizer CEO Albert Bourla said Thursday at a virtual event hosted by CVS Health.
In February, Pfizer announced that it was starting a study with their German partners BioNTech to investigate a third dose of its vaccine, delivered 6 to 12 months after the participants completed their first two doses. Moderna has announced plans to test an additional booster shot itself at the end of January.
“We believe that especially high-risk people should get a boost in the fall, and we want to make sure we get the best possible boost,” said Moderna CEO Stéphane Bancel Wednesday to Yahoo Finance, adding that he expects a ‘boost market’. governments are working on booster doses.
The National Institutes of Health also announced in late March that it was launching early trials of a version of Moderna’s vaccine modified to target the B.1.351 virus variant first spotted in South Africa. Pfizer is working on a possible version of its vaccine for B.1.351, although the drugmaker said earlier this month that its injections were found to be very effective against the mutated strain.
Johnson & Johnson was actively recruiting for its “ENSEMBLE 2” study to evaluate a two-dose regimen in place of the current single-injection vaccine. But trials have been halted by the company due to concerns about the rare clotting events currently under investigation by the CDC and the FDA.
Data from all three studies will need to be scrutinized by the FDA, which earlier this year issued updated guidelines for approving additional doses of the vaccines. Even minor modifications to the next generations of COVID-19 vaccines will need to be supported by some clinical research, albeit in smaller studies than the large number of people it took to test the initial doses.
“Probably after we do that three or four times, we’ll look at everything and if everything seems consistent, we can move more towards the flu-like model,” says Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in February.
But finding room for the booster doses can be tricky. The Government Accountability Office warned this week that using the Defense Production Act to prioritize the production of COVID-19 vaccines has limited the capacity for other critical drugs, including the seasonal flu vaccine.
Making the next round of doses for Americans could also further slow down a global vaccination effort already facing some WHO Director General Dr. Tedros Adhanom Ghebreyesus described it as “severe supply restrictions.”
While the US has already administered nearly 200 million doses, with nearly 1 in 2 adults being touted with at least one injection, the World Health Organization warned on Wednesday that less than 0.2% of the global vaccine supply had reached low-income countries.
“Global manufacturing capacity and supply chains have not been enough to deliver vaccines quickly and fairly where they are needed most. More funding is needed, but that’s only part of the solution. Money doesn’t help when there are no vaccines for sale. . ” Ghebreyesus said.