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US to weigh authorization of Pfizer Covid vaccine for children aged 5-11

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The vaccine showed 90.7% efficacy against coronavirus in a clinical trial of children aged 5 to 11 years.

An expert panel will weigh in on Tuesday the authorization of Pfizer Inc. and BioNTech’s COVID-19 vaccine for children aged 5 to 11 as it prepares to vote on the US Food and Drug Administration’s recommendation.

The panel’s vote marks an important regulatory step in getting the vaccine into the arms of millions of children in the United States where schools are largely open to individualized learning.

The FDA is not required to follow the advice of its outside experts, but it usually does.

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

Consultants are expected to note the rate of rare cases of heart inflammation called myocarditis, which has been associated with both Pfizer/BioNTech and Moderna Vaccine, particularly in young men.

Pfizer and BioNTech are seeking approval for a lower, 10 microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot is authorized through May for ages 12-15 and is approved for everyone over 16. December.

The companies have said that their vaccine has shown 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11 years.

Following the FDA, a panel from the US Centers for Disease Control and Prevention will make recommendations on the administration of the vaccine. Agency directors will make the final call.

“If all goes well, and we get regulatory approval and recommendation from the CDC, it is entirely possible if not very likely that vaccines will be available for children ages 5 to 11 within the first week or two of November. Top US infectious disease expert Anthony Fauci said on Sunday.

FDA staff said in documents posted before the meeting that the benefits of a potential vaccine in that age group clearly outweigh the potential harms, including a rare risk of heart inflammation.

If the number of myocarditis cases in the younger age group becomes similar to that of 12- to 15-year-olds, the number of people analyzed for myocarditis prevented hospitalization for COVID-19 in most scenarios analyzed. Will, FDA staff reviewers said.

While children rarely become seriously ill or die from COVID-19, some develop complications, and cases of COVID-19 in non-vaccinated children may be associated with the infectious delta variant. reasons have increased.

Pediatric vaccination is an important public health tool for preventing infectious diseases, even those that do not cause high rates of mortality or hospitalization for children.

(This story has not been edited by NDTV staff and is auto-generated from a syndicated feed.)

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