US to approve COVID shot for teens
WASHINGTON (Reuters) – The US Food and Drug Administration is preparing to authorize Pfizer Inc. and German partner BioNTech’s COVID vaccine for adolescents aged between 12 and 15 by early next week, the New York Times reported on Monday, citing federal o
An approval is highly anticipated after the drugmakers said in March that the vaccine was 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 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 US Centers for Disease Control Director Rochelle Walensky said earlier in April that the vaccine could be approved by mid-May.
If an approval for the 12- to 15-yearolds 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.
Meanwhile, in Canada, the government advisory panel on Monday recommended the use of the Johnson & Johnson vaccine for people aged 30 years and over, despite blood clotting fears.
Health Canada in March authorized the jab’s use for all adults, but doses have yet to be administered, and authorities are still holding back the first shipment of 300,000 doses over possible quality issues.
Shelley Deeks of the National Advisory Committee on Immunization said the Johnson & Johnson vaccine has proven to be “highly effective” in preventing severe COVID infections and hospitalizations.
But she acknowledged there have been cases of blood clotting associated with it, citing 17 cases in the more than eight million jabs administered in the United States.
“The mRNA vaccines (such as Pfizer/ BioNTech and Moderna) are the preferred vaccine,” Deeks told a news conference. “The viral vector vaccines (J&J, AstraZeneca) are very effective vaccines, but there is a safety risk.”
“Although it’s very rare, it is very serious,” she said. “And so individuals need to have an informed choice to be vaccinated with the first vaccine that’s available or to wait for an mRNA vaccine.”
According to an AFP tally, the Johnson & Johnson vaccine is being used in 17 countries, including France, South Africa, the United States, Spain, Germany and Poland.