FDA approves new COVID-19 vaccines to combat declining efficacy.
Exciting News: New COVID-19 Vaccines Authorized by U.S. Drug Regulators
The U.S. Food and Drug Administration (FDA) has given the green light to new COVID-19 vaccines from Moderna and Pfizer. These vaccines will soon be available to Americans as young as 6 months old.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” emphasized Dr. Peter Marks, a top FDA official. “We very much encourage those who are eligible to consider getting vaccinated.”
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The FDA has approved the Moderna and Pfizer vaccines for individuals aged 12 and older. Emergency authorization has been granted for children aged 6 months to 11 years.
It’s worth noting that Novavax’s vaccine is also available in the United States, although it was not mentioned in the announcement.
The newly authorized vaccines target XBB.1.5, a subvariant of the Omicron virus variant. According to the U.S. Centers for Disease Control and Prevention (CDC), this subvariant has already been largely replaced by newer strains, including EG.5.
The CDC will be meeting with its advisers to determine which populations should receive the new vaccines. If recommended, the federal government will cover the cost.
Interestingly, many countries have advised against COVID-19 vaccinations for younger, healthy individuals due to the decline in disease prevalence.
For example, the United Kingdom has recommended vaccination this fall only for select groups, including those designated as at-risk.
The CDC has also revised its recommendations earlier this year for certain populations.
Pfizer and Moderna have announced that the cost of the new shots will be approximately $110 to $130.
Another Replacement
In the fall of 2022, the FDA cleared and the CDC recommended updated shots due to waning effectiveness. These shots contained components of the Wuhan strain and Omicron.
However, the effectiveness of those shots has proven to be unimpressive, according to CDC data. Only 17 percent of the U.S. population had received a bivalent dose as of May 10.
Various reasons were cited for not receiving a bivalent dose, including prior infection providing protection, concerns about side effects, and doubts about the booster’s efficacy against infection.
Criticism
Some experts have criticized U.S. authorities for authorizing the new shots without sufficient data.
Florida Surgeon General Dr. Joseph Ladapo expressed concerns about the lack of data and potential red flags, including studies indicating a decline in vaccine effectiveness over time and the vaccines’ association with cardiac problems.
Dr. Paul Offit, an FDA adviser, suggested that younger, healthy individuals who have already been vaccinated may not need the new doses. He emphasized the importance of targeting booster doses to those most at risk.
This is a breaking story that will be updated.
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