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FDA Approves Pfizer COVID Vaccine Booster Shot for Americans Up to 16 Years Old

 


The Centers for Disease Control and Prevention is open to Americans up to the age of 16. Booster shot of COVID-19 (new coronavirus infection) vaccination. This decision was made hours after the Food and Drug Administration approved a third dose of Pfizer and BioNTech to that age group. Boosters used to be a green light over the age of 18.

“There aren’t all answers for Omicron variants, but early data suggest that COVID-19 boosters can help extend and enhance protection against Omicrons and other variants,” said CDC Director. Dr. Rochelle Walensky said. Said In the statement.

“We know that the COVID-19 vaccine is safe and effective. If adolescents 16 and 17 years have been at least 6 months old since the first Pfizer vaccination series, boost immunization. We highly recommend that you take it, “Walensky said.

The move comes a little over a week after Pfizer Presentation Their request as health officials are begging qualified Americans to look for third shots and strengthen their protection.Beyond the feared surge of breakthrough infections from Omicron variant, In some states, we have already seen a wave of cases of delta variants that are straining hospitals.

“Since we first approved the vaccine, new evidence is that the efficacy of the vaccine against COVID-19 has declined after the second dose of the vaccine for all adults and the 16 and 17 year old age groups. “We show that we are,” said Dr. Peter Marks, FDA’s Chief Vaccine Official. Said In the statement.

“A single booster dose of the vaccine for those vaccinated at least 6 months ago will help provide continued protection against COVID-19 in this and older age groups.” Marks said.

According to the CDC, only about 2.6 million Americans aged 16 and 17, or 31%, were fully vaccinated six months ago and are eligible for the next vaccination immediately. data.. Today, over half of teens in this age group are fully vaccinated.

Pfizer remains the only COVID-19 vaccine approved for use in. Americans under the age of 18.. The company also said on Wednesday that it would also submit a new request for full approval of the third dose by age 16. data From that study, the third dose showed 95.6% vaccine efficacy compared to those who did not receive boost immunization.

Meanwhile, the FDA has yet to reveal Moderna’s request to approve the first two shots against a 12-year-old American. Regulators have postponed that decision. Earlier this year Concerns about the risk of myocarditis, a rare side effect of cardiac inflammation seen after mRNA vaccination in most young men.

FDA and CDC last month We also changed the guidance on mRNA shots and found data suggesting that the risk of myocarditis may be higher with the Moderna vaccine than with Pfizer.

Recent research Keep showing it Many cases of myocarditis that occur after vaccination “resolve mildly and quickly” after vaccination. Data reviewed by the CDC’s external vaccine advisor last month It also suggests that the rate of side effects from shots, including myocarditis, appears lower after the third dose than after the second dose.

The FDA will “reassess the benefits and risks” of using the vaccine for young recipients on Thursday with “additional real-world data” on the increased number of cases of COVID-19 and the lower risk of myocarditis. Said I was able to.

The CDC’s Immunization Implementation Advisory Board was not asked to meet again to reconsider their recommendations, as it did in the past.Federal supply agreements were previously made by the Governor and local health authorities, but usually after the Commission discusses and votes on new recommendations and before deploying shots, vaccinated people have renewed the CDC. Requesting to wait for guidance I searched for a way Shortcut the process in those states.

Members of the CDC panel voted last month to support softer words that suggest young adults. “May” You will be allowed to receive booster shots, citing concerns about unanswered questions about safety and the need for additional doses.

But as the case Omicron variant CDC director moved unilaterally as it began to spread last week — Without panel input — to reinforce the agency’s recommendation to encourage all adults to receive booster shots.

Currently, at least one case of Omicron has been identified in more than 20 states. Health officials in several states say they believe the variant is now widespread in their communities after discovering infectious diseases inhabitants unrelated to overseas travel.

Overseas, UK authorities caveat At the end of Tuesday, their data on the growth of variants there suggest that Omicron “is likely to defeat the Delta” and could soon dominate domestic cases.

Preliminary data Presentation Fully vaccinated people may need booster immunity to gain protection against infection from highly mutated strains, according to BioNTech and Pfizer on Tuesday, but pharmaceutical companies and health authorities suggest. Both warn that more data will be needed to assess the true effect of Omicron on vaccine efficacy.

“Very preliminary new and initial data indicate that the first line of defense from two vaccinations could be compromised and that three vaccinations would be required to restore protection. “It shows,” said Özlem Türeci, Chief Medical Officer at BioNTech. Said Wednesday reporter.

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