FDA Permits Use Of The Pfizer-BioNTech Covid Vaccine In Adol
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The Food and Drug Administration on May 10 approved Pfizer and BioNTech’s request to allow their Covid-19 vaccine to be given to kids ages 12 to 15 on an emergency use basis, allowing states to get middle school students vaccinated before the fall. The two-dose vaccine is already authorized for use in people 16 and older.

The Centers for Disease Control and Prevention’s vaccine advisory committee has scheduled a meeting Wednesday to review the shots for kids. If approved by the CDC as expected, it could be distributed to adolescents as soon as this week. Acting FDA Commissioner Dr. Janet Woodcock said the decision brings “us closer to returning to a sense of normalcy and to ending the pandemic.” She assured parents that the agency “undertook a rigorous and thorough review of all available data” before clearing it for use in the teens.

The companies said in late March that the vaccine was found to be 100% effective in a clinical trial of more than 2,000 adolescents. They also said the vaccine elicited a “robust” antibody response in the children, exceeding those in an earlier trial of older teens and young adults. Side effects were generally consistent with those seen in adults, they added.

Vaccinating children is seen as crucial to ending the pandemic. The nation is unlikely to achieve herd immunity — when enough people in a given community have antibodies against a specific disease — until children can get vaccinated, health officials and experts say. The vaccine will be administered as a series of two doses, three weeks apart, the same regimen for 16 years of age and older, according to the FDA.

Approval by the FDA for kids under age 12 could come in the second half of this year. In a slide presentation that accompanied the company’s earnings release on May 4, Pfizer said it expects to apply for authorization for its vaccine for use in toddlers and young children in September and infants in November. It’s already begun the submission process seeking full FDA approval for its use in people ages 16 and up, the company said.

In late March, Pfizer and BioNTech started a clinical trial testing their vaccine in healthy 6-month to 11-year-old children. Moderna and Johnson & Johnson, whose vaccines are authorized for people 18 and older, are also testing their shots in younger age groups.

Source:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use
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