The Biden government is “in talks” to ensure it can get COVID-19 shots if needed, a top official told lawmakers on Thursday. The announcement comes as drugmakers are stepping up their progress in developing additional shots, designed to boost the body’s immune response, months after administering the initial doses.
“We are currently in discussions to make sure we can secure the vaccines for a boost or variant. We are currently in the process,” said Dr. David Kessler, chief scientific officer for the government’s COVID-19 response, told the House. Select Subcommittee on Coronavirus Crisis.
Federal health officials and drugmakers have been saying for months that shots are likely to be needed at some point, though it is not yet clear when that will be. The shots are likely to be very similar to the original version of the vaccines, but can be administered in different doses or adjusted to protect against variants.
Kessler warned that “no decision” has been reached on the strategy for how the booster shots would be administered, citing ongoing research into how long the immunity created by the vaccines lasts. Recent studies by Pfizer and Moderna suggest that their COVID-19 shots remain effective for at least 6 months.
“With a lot of vaccines, we understand that we have to give a boost at some point, whether it’s 9 months, 12 months. And we’re preparing for that,” Kessler said.
The companies behind all three of the COVID-19 vaccines currently allowed in the United States have said they want to pursue additional shots.
“There is probably a need for a third dose, between 6 and 12 months. And then from there. It will be vaccinated again every year. But it all needs to be confirmed,” Pfizer CEO Albert Bourla said on Thursday. said in a virtual way. event hosted by CVS Health.
In February, Pfizer announced that it would begin a study with its German partners BioNTech to investigate a third dose of its vaccine, which was delivered 6 to 12 months after participants completed their first two doses. Moderna has announced plans to test an additional booster shot 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 have the best possible boost,” Moderna CEO Stéphane Bancel told Yahoo Finance on Wednesday, adding that he expects a “boost market” if governments work to secure booster doses.
The National Institutes of Health also announced in late March that they would launch early trials on a version of Moderna’s vaccine adapted to target the B.1.351 virus variant first spotted in South Africa. Pfizer is working on a potential version of its vaccine for B.1.351, though the drugmaker said earlier this month that the shots are very effective against the mutant strain.
Johnson & Johnson actively recruited for its “ENSEMBLE 2” study to evaluate a two-dose treatment instead of the current single-vaccine. However, the company has suspended trials due to concerns about the rare clotting events currently being investigated by the CDC and FDA.
The data from all three trials will have to be examined by the FDA, which sets out updated guidelines for authorizing additional doses of the vaccines earlier this year. Even small adjustments to subsequent generations of COVID-19 vaccines need to be supported by clinical research, although this is in smaller trials than the large number of people needed to test the initial doses.
“Probably after we’ve done it three or four times, we’ll look at everything and if everything seems consistent, then we can move more towards the flu-like model,” said Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, said in February.
But it can be difficult to find room for the increased dose. The government’s accountability office warned this week that the use of the Defense Production Act to prioritize the production of COVID-19 vaccines has limited capacity for other critical drugs, including the seasonal flu vaccine.
The next dose of doses for Americans could also delay a global vaccination effort already faced by what the WHO Director-General, Dr. Tedros Adhanom Ghebreyesus, described as “severe restrictions on supply.”
While the U.S. has already administered nearly 200 million doses, predicting nearly 1 in 2 adults with at least one shot, the World Health Organization on Wednesday warned that less than 0.2% of the global supply of vaccines has reached low-income countries.
“Global manufacturing capacity and supply chains have not been sufficient to deliver vaccines quickly and fairly where they are most needed. More funding is needed, but that’s only part of the solution. Money does not help when there are no vaccines to buy , “Ghebreyesus said.