U.S. FDA clears first injection of COVID-19 for young children – .

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U.S. FDA clears first injection of COVID-19 for young children – .


October 29 (Reuters) – The United States Food and Drug Administration on Friday cleared the Pfizer Inc (PFE.N) and BioNTech SE coronavirus vaccine for children aged 5 to 11, making it the first vaccine COVID-19 for young children in the United States.

Shooting will not be immediately available for the age group. The U.S. Centers for Disease Control and Prevention is still to give advice on how the vaccine should be administered, which will be decided after a group of external advisers discuss the plan on Tuesday.

Pfizer said it would begin shipping pediatric vaccine vials to pharmacies, pediatricians’ offices and other places where injections could be given on Saturday.

The FDA’s decision is expected to make the vaccine available to 28 million American children, many of whom are back to school for in-person learning.

It comes after a panel of regulator advisers overwhelmingly voted to recommend the clearance on Tuesday.

Only a few other countries, including China, Cuba and the United Arab Emirates, have so far authorized COVID-19 vaccines for children in this age group and younger.

The FDA has cleared a dose of 10 micrograms of Pfizer vaccine for young children, less than the 30 micrograms of the original vaccine for ages 12 and older.

Advisors to the FDA panel said that a lower dose might help alleviate some of the rare side effects after paying particular attention to the rate of heart inflammation, or myocarditis, which has been linked to the Pfizer and Moderna vaccines ( MRNA.O), especially in young men.

The regulator said on Friday that the known and potential benefits of the Pfizer vaccine in people aged 5 to 11 outweigh the risks.

A child wears a face mask on the first day of New York City schools amid the coronavirus disease (COVID-19) pandemic in Brooklyn, New York, United States on September 13, 2021. REUTERS / Brendan McDermid / File Photo

For pediatric injections, the FDA has cleared a new version of the vaccine, which uses a new tampon and allows them to be stored in the refrigerator for up to 10 weeks.

In the United States, around 58% of the population is fully vaccinated, lagging behind other countries like the United Kingdom and France. Many adults, who have been hesitant to get vaccinated, may be more careful before getting their children vaccinated.

“We certainly hope that as people see children getting vaccinated, being protected and being able to participate in activities without worry, more people will get their children vaccinated,” said the acting commissioner of the FDA , Dr Janet Woodcock, at a press conference.

“And as we gain more experience with the vaccine, more comfort with safety will arise. “

Pfizer and BioNTech said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial in children aged 5 to 11.

“This is a day that so many parents, keen to protect their young children from this virus, have been waiting,” Pfizer chief executive Albert Bourla said in a statement.

The United States began administering the vaccine to adolescents aged 12 to 17 in May. Immunization coverage among the age group is lower than that of older groups, according to the CDC.

Pfizer’s vaccine was the first to be cleared for emergency use in the United States in December last year for people 16 years of age and older and gained full U.S. approval in August. .

Earlier this week, Moderna released provisional data showing that its vaccine elicited a strong immune response in children aged 6 to 11. She is awaiting a US regulatory decision on authorization for children between the ages of 12 and 17.

Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru and Michael Erman in New Jersey; additional reporting by Amruta Khandekar in Bengaluru and Ahmed Aboulenein in Washington; Editing by Bill Berkrot, Shinjini Ganguli and Arun Koyyur

Our Standards: The Thomson Reuters Trust Principles.

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