The US Food and Drug Administration (FDA) is ready to approve the use of the Pfizer / BioNTech Covid-19 vaccine for individuals aged 12-15 starting next week, the New York Times reported yesterday, citing federal officials.
Approval is pending as the pharmaceutical industry announced in March that clinical trials showed the vaccine was safe, effective, and elicited a strong antibody response in children between the ages of 12 and 15.
In response to Reuters’ request for comment, the FDA (the FDA or USFDA is a federal agency of the Department of Health and Human Services) said it was in the process of renewing a fixed-term vaccine license, but did not provide any further details. …
The vaccine has already been approved in the United States for use in people 16 years of age and older. According to Greek news agency APE-MPE, Pfizer declined to comment on the New York Times article.
Rochelle Wallinsky, director of the US Centers for Disease Control and Prevention (CDC), said earlier in April that the vaccine could be approved for these ages by mid-May. If a vaccine is approved for children ages 12-15, the CDC’s Vaccine Advisory Committee is likely to meet the next day to review the clinical trial data and make recommendations for the use of the vaccine in adolescents, the report said.
The possible approval of the vaccine will strengthen the country’s immunization campaign and help allay fears of parents who want to protect their children from Covid-19.
In addition, yesterday, May 3, the European Medicines Agency (EMA) also announced the start of analytical studies (evaluation of use) of the Pfizer / BioNTech vaccine for use by persons aged 12-15 years.
Moderna and Johnson & Johnson Pharmaceuticals are also conducting clinical trials of their vaccines in children between the ages of 12 and 18, and Moderna trial data are expected to be published shortly.
Pfizer and Moderna have also begun clinical trials in children aged 6 months to 11 years. Both companies said they hope to vaccinate children under the age of 11 against Covid-19 by early 2022.