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The US Food and Drug Administration is preparing to authorize the Pfizer/BioNTech Covid vaccine for adolescents between ages 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency’s plans.
An approval is highly anticipated after the drugmakers said in March that the vaccine had been found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.
Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine’s emergency use authorization was continuing, but it did not provide further details.
The vaccine has already been cleared in the United States for people age 16 and above.
Pfizer declined to comment on the New York Times report.
The US Centers for Disease Control (CDC) director, Rochelle Walensky, said earlier in April that the vaccine could be approved by mid-May.
If an approval for the 12-15-year-olds is granted, the CDC’s vaccine advisory panel will probably meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents, the report said.
Approval of the vaccine would boost the country’s immunization drive and help allay fears of parents anxious to protect their children from Covid-19.
Moderna and Johnson & Johnson are also testing their vaccines in 12- to 18-year olds, with data from Moderna’s trial expected to come soon.
Pfizer and Moderna have also launched trials in even younger children, from six months to 11 years old. Both companies have said they hope to be able to vaccinate children under 11 as soon as early 2022.
Source: The Guardian
Keyword: US to authorize Pfizer vaccine for ages 12-15 early next week – report | US healthcare