The US Food and Drug Administration or FDA has approved the updated COVID-19 vaccine boosters. The new vaccine boosters are meant to target the BA.5 omicron subvariant.
However, the FDA has used a controversial strategy to evaluate the boosters because, for the first time, the agency tested the boosters in mice instead of humans.
FDA Approved Omicron Vaccines
According to CNBC, the boosters will be available around Labor Day to help prevent severe disease and protect people from the spread of the Omicron variant in the fall and winter.
Since the Biden administration wanted a fall booster campaign before the people travel for the holidays, Pfizer and Moderna have only had time to test the booster shots in mice and not people.
The FDA relied on mice trial data and human trial results from the same vaccine that targets the original Omicron variant BA.1 before it gave the two medical facilities the signal to start distributing the booster shots.
Potentially Risky Bet
Medical experts say that the FDA's decision to approve the booster shots without data from human trials is a gamble, and it could threaten to lower public trust in the vaccines if it does not work as it is supposed to.
Also Read: Australia's COVID-19 Patch for Omicron Now Tested! More Efficient Than Needle-Reliant Vaccines?
Federal health officials hope the new vaccines will protect against the Omicron variant. Still, since there are no human trials, they will only know if the vaccines worked after they were administered, according to NBC News.
John Moore, an immunologist at Weill Cornell Medicine, called FDA's move bizarre. Moore pointed out that mouse data will not predict what they would see in humans.
However, other medical experts defended FDA's approach, arguing that the US has had enough experience with the COVID-19 vaccines to be confident that the shots are safe.
Dr. Ofer Levy, a pediatrics and infectious disease researcher at Harvard Medical School, said there is not enough time to wait for data from human studies.
Dr. Levy said that there are 500 people a day dying of COVID-19 in the US, and there is a chance that the numbers will rise in the fall, so these booster shots are the only way that lives can be saved.
Targeting Dominant Omicron Subvariants
According to NRP, the United Kingdom also approved a new booster that targets COVID-19 and the original Omicron variant BA.1.
Although the same thing was proposed in the US, the FDA rejected it. Instead, the agency instructed Pfizer and Moderna to develop vaccines that target the dominant Omicron subvariants BA.4 and BA.5 because they offer stronger, longer-lasting protection.
Pfizer and Moderna will continue to gather more data from human studies, but the results won't be available until October or November.
Vaccination Rates in the US
According to the World Health Organization or WHO, the number of COVID-19 vaccine doses in the US is 609 million, and the number of fully vaccinated people in the country is around 224 million.
Approximately 68% of Americans have been vaccinated against COVID-19. WHO stated that it expects more Americans will get vaccinated in the fall as the vaccine boosters get distributed.
Related Article: Modified Pfizer Omicron-Based Vaccine Boosts Defense Against Variant? FDA To Discuss Tweaked COVID-19 Medicine
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Written by Sophie Webster
