The US health authorities are preparing to declare Pfizer Covid-19 vaccine safe for children aged between 12 and 18, according to reports. The US Food and Drug Administration could authorize the vaccine made by Pfizer Inc and German partner BioNTech for adolescents, the New York Times reported on Monday.
The drugmaker had said in March that its vaccine was safe and effective in children. It said that clinical trials showed that the vaccine produced robust antibody responses in the adolescent age group.
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Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine's emergency use authorization is ongoing, but did not provide further details.
The vaccine has already been cleared in the United States for people aged 16 and above.
Pfizer declined to comment on the NYT report.
The U.S. 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 likely meet the following day to review the clinical trial data and make recommendations for the vaccine's use in adolescents, the report added.
A potential 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 Inc 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, aged 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.