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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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