FDA Expands Pfizer’s COVID Recall, Opens Additional Dose Until Age 16 | News Today

The United States is extending COVID-19 recalls, ruling that 16 and 17-year-olds can receive a third dose of Pfizer’s vaccine.

The United States and many other countries were already urging adults to be given booster shots to boost their immunity which can decline months after vaccination, calls that have escalated with the discovery of the disturbing new variant of omicron. .

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The Food and Drug Administration on Thursday authorized 16 and 17-year-olds to receive a third dose of the vaccine made by Pfizer and its partner BioNTech – if it has been six months since their last shot.

“Vaccination and getting a booster when eligible, along with other preventative measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods of combating the disease. COVID-19, “Dr. Janet Woodcock, acting commissioner of the FDA, said in a statement. .

There is one step left: The Centers for Disease Control and Prevention must officially recommend the recalls for this age group, and a decision is expected soon.

The Pfizer vaccine is the only option in the United States for anyone under the age of 18, whether for the initial vaccination or for use as a booster. It is not yet known if or when adolescents under the age of 16 might need a third dose of Pfizer.

“The booster vaccination increases the level of immunity and significantly improves protection against COVID-19 in all age groups studied so far,” BioNTech CEO Ugur Sahin said in a statement.

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Vaccinations for children as young as 5 years old began last month, using special low-dose Pfizer injections. This week, about 5 million children aged 5 to 11 had received a first dose.

The extra-contagious delta variant is the cause of nearly all COVID-19 infections in the United States and much of the world. It is not yet clear how the vaccines will resist the new and markedly different omicron mutant. But there is strong evidence that boosters offer increased protection against infections caused by delta, currently the biggest threat.

To complicate the decision to extend the boosters to 16 and 17 year olds, the Pfizer vaccine – and a similar vaccine made by Moderna – have been linked to a rare side effect. Called myocarditis, it is a type of inflammation of the heart seen mainly in younger men and adolescents.

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The FDA has said that the increase in COVID-19 cases in the United States means that the benefits of boosters far outweigh the potential risk of the rare side effect, especially since the coronavirus itself may cause more serious heart inflammation.

Health officials in Israel, who are already giving teen boosters, said the side effect continues to be rare with the third dose.

A US study this week offered additional reassurance. Researchers at children’s hospitals across the country have checked medical records and found that the rare side effect is usually mild and people recover quickly. The research was published Monday in the journal Circulation.