The FDA is expected to approve a new COVID-19 booster shot this week.
Frederick J. Brown/AFP via Getty Images
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Frederick J. Brown/AFP via Getty Images
The FDA is expected to approve a new COVID-19 booster shot this week.
Frederick J. Brown/AFP via Getty Images
This week, the U.S. Food and Drug Administration will approve the first updated version of the COVID-19 booster since the pandemic began.
The new shots are reconditioned versions of the Moderna and Pfizer-BioNTech vaccines. They are known as ‘bivalent’ vaccines because they are designed to protect against the original strain and the highly contagious omicron variant.
Specifically, the vaccine is programmed to target the BA.4 and BA.5 omicron subvariants. These are the dominant strains that infect people and are the best at evading the immune system.
The hope is that the shots will strengthen people’s weakened immune systems, providing stronger protection against viral infection, spread, COVID and long-term COVID-induced illness.
The Biden administration plans to make the new shots available after Labor Day to blunt the impact of what could be another spike in infections this fall and winter.
Dr. Ashish Jha, the White House COVID-19 Response Coordinator, told NPR: “This is the first major upgrade to the vaccine, the first major change to the vaccine, in the last two and a half years.”
However, booster formulations and the process of approving them have sparked controversy among scientists.
For the first time, the FDA is determining how well a vaccine will work without the results of direct human trials. To save time, the FDA is evaluating the vaccine first with tests in mice and the results of tests done in people for the previous version of the bivalent vaccine.
Some experts are concerned that studies in mice are not very reliable in predicting how well vaccines will work in humans.
John Moore, an immunologist at Weill Cornell Medicine, said: “If the public thinks that the new bivalent booster is a very strong shield against infection, increasing their behavioral risk and exposing them to more virus, It could be a problem,” he said.
However, federal officials have defended the decision.
Mouse studies suggest that the new vaccine may be about 20 times more protective than the original shot and about 5 times more protective than the first attempt to create a bivalent vaccine specific for Omicron. I’m here. FDA evaluations and studies, he told NPR in an interview.
“This gives us confidence that they will do what they intend to do: generate a superior immune response against the BA.4/5 variant and refresh the overall response given the original ingredients of the vaccine. ” says Marks.
In June, the FDA rejected a new booster targeting Omicron’s original strain known as BA.1, instead asking vaccine companies to develop new shots targeting the strain that replaced it. Later, the decision to rely on mouse studies became necessary.
Some scientists believe the new shot may give people a longer-lasting immunity than the original, protecting them from new variants that emerge. More research is needed.
Some experts say the data from the BA.1 booster indicates that the potential improvements are rather modest at best.
“We want silver bullets. Boosters have become silver bullets. And we’re putting all our eggs in vaccine baskets,” said Celine, senior fellow at the Kaiser Family Foundation. “I am very skeptical about how much improvement these vaccines will make in terms of herd immunity and prevention of severe disease,” says Dr. Gownder.
Gownder is also concerned that the country is giving up other things to protect people, such as wearing masks and improving ventilation.
However, some are more optimistic about the new booster.
“I am personally very excited about the bivalent vaccine,” says Jenna Guthmiller, assistant professor of immunology at the University of Colorado.
“We really need a modern vaccine to provide protection not only against the current Omicron lineage of viruses, but also against future Omicron variants,” Guthmiller said.
After the FDA approves a vaccine, advisers from the Centers for Disease Control and Prevention will meet Thursday and Friday to decide whether to recommend the vaccine and who will get it. CDC Director Rochelle Walensky must then approve the recommendation.
Some experts say only those at higher risk due to age or underlying medical conditionsg The first injection still protects most people from serious illness, so health problems should get another booster. All of the above have stated that they need to get new shots.
E. John Welley, an immunologist at the University of Pennsylvania, said, “I think anyone who has been more than six months since a previous boost or infection should get a boost.
“The opportunity to bring more boosters into the population to increase vaccine uptake will help us get through this pandemic,” Welley says.
The Biden administration has purchased over 170 million doses of new boosters, which should be available after Labor Day.
Given that many qualified people have yet to get their hands on a first or second booster, it remains unclear how much demand there will be for new boosters.
