US FDA SET TO APPROVE PFIZER SHOTS FOR TEENS BY EARLY NEXT WEEK
Says its vaccine was effective in a trial of over 2k adolescents
The Food and Drug Administration is preparing to authorize use of the Pfizer-biontech coronavirus vaccine in adolescents 12 to 15 years old by early next week, according to federal officials familiar with the agency’s plans, opening up the US vaccination campaign to millions more people.
Some parents have been counting down the weeks since Pfizer announced results from its trial in adolescents showing that the vaccine is at least as effective in that age group as it is in adults. Vaccinating children is key to raising the level of immunity in the population and bringing down the numbers of hospitalisations and deaths.
Pfizer announced in March that its vaccine was highly effective in a trial of more than 2,000 adolescents and that the vaccine was "well tolerated" among those ages 12 to 15. Pfizer said the side effects of the vaccine experienced by that age group were similar to those of 16- to 25-year-olds.
The clearance, in the form of an amendment to the existing emergency use authorization for the Pfizer vaccine, could come as early as late this week. If it is granted, the Centers for Disease Control and Prevention’s vaccine advisory panel is likely to meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents.
The expansion would be a major development in the country’s vaccination campaign and welcome news to some parents who are anxious to protect their children during summer activities and before the start of the next school year. It also poses another challenge to policymakers who are struggling to vaccinate a large percentage of adults hesitant to get the shot. Many more could refuse to inoculate their children.
“I do think we need to have a national and global conversation about the ethics of our vaccinating kids, who are low risk for serious complications from the virus, when there aren’t enough vaccines in the world to protect high-risk adults from dying,” said Jennifer B. Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.
Biden has come under increasing pressure to give away some of the country’s supply of vaccines.