The Food and Drug Administration has authorized Moderna’s and Pfizer-BioNTech’s updated COVID-19 booster vaccines that target the highly contagious omicron variant as the federal government prepares to roll out the boosters in the coming weeks.
Moderna’s has been authorized as a booster for individuals 18 and older, while Pfizer-BioNTech’s is for use in people 12 and older. People are eligible to receive the updated booster after at least two months have passed since they got their last booster or their primary two-dose vaccination series.
EFFECT OF OMICRON-SPECIFIC BOOSTERS ‘REMAINS TO BE SEEN’ VACCINE EXPERTS SAY
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert Califf. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
Half of the updated booster recipe targets the original strain of the virus from 2020, and the other half targets omicron subvariants BA.4 and BA.5., which now account for most COVID-19 cases circulating in the United States. The FDA said that the shots are expected to provide better protection against infection and severe disease in the face of the variant, though vaccine experts have said how much additional protection it provides is unclear.
The Biden administration has already secured agreements with Pfizer and BioNTech to purchase 171 million doses of their bivalent boosters to speed up distribution in anticipation of a spike in COVID-19 cases during the fall and winter. Vaccine manufacturers have previously said they could be ready to roll out the first doses to the public in early September.
Unlike previous vaccines, the updated boosters have not been widely tested on humans and are reliant on preclinical trials from testing on mice and previous data from earlier COVID vaccines. However, the FDA said the process was similar to how they approved yearly flu shots, assuring that the boosters meet their “rigorous safety, effectiveness and manufacturing quality standards.”
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The most commonly reported side effects from the updated boosters include pain, redness and swelling at the injection, nausea, and fever, the FDA said.
Fewer individuals in the U.S. have received each new shot offered, suggesting that the government could have a harder time convincing individuals to get the updated booster. Over 67% of the U.S. population got their first two doses of the COVID-19 vaccine, while only 48% of people have received their first booster, according to data from the Centers for Disease Control and Prevention.
