KUALA LUMPUR, Jan 4 – The United States’ Food and Drug Administration (FDA) yesterday authorised Pfizer-BioNTech Covid-19 vaccine booster shots for children aged 12 to 15 to cope with an Omicron surge as schools reopen.
The FDA also shortened the six-month interval between the second Pfizer dose and a booster shot to five months.
Additionally, it approved a third Pfizer vaccine shot for 5-to-11 year olds who have undergone organ transplants or have impaired immune system that prevents them from responding adequately to the primary two-dose vaccine series. The third vaccine dose can be administered 28 days after the second shot, the agency said.
The FDA said 5-to-11-year-olds who are not immunocompromised currently do not need boosters as they were cleared for initial shots in late October, with only 25 per cent of the age group having been vaccinated. But FDA officials said they will consider if the age group needs boosters.
The US Centers for Disease Control and Prevention (CDC) and its advisers are expected to review the decisions this week.
According to seven-day averages tracked by The Washington Post, the US averaged over 440,000 new Covid-19 cases each day as of Monday, double the previous week.
The number of patients hospitalised with confirmed or suspected Covid-19 is up 31 per cent from last week, with about 1,500 Americans dying each day, a 50 per cent increase since December 1.
FDA officials, in explaining their decisions, said they opted to broaden access to boosters, as data from real-world experience and laboratory tests point to strengthened protection from boosters, especially against Omicron.
They cited Israeli data involving over 6,300 12-to-15-year-olds that showed no new safety issues among those who received a third dose of the Pfizer vaccine.
FDA’s Center for Biologics Evaluation and Research director Peter Marks said the risk of myocarditis, which remains rare, was lower after a booster shot than after the second shot. Even when myocarditis has occurred after second shots, the cases have almost all been mild, he said, as reported by The Washington Post.
Marks said new data suggests the risk of myocarditis with third doses in the 12-to-15-year age range is “likely to be quite acceptable given the potential benefits” of preventing severe illnesses and hospitalisations.
The agency’s decision to shorten the interval between second and third doses of the vaccine for adolescents and adults is also based on Israeli data, whereby no new safety concerns were reported among more than four million people who received boosters at least five months after getting the second shot of the Pfizer vaccine.
The intervals for the other vaccines, however, remain unchanged. Recipients of the initial two-shot Moderna series are supposed to wait at least six months to get a booster, and those who received the Johnson & Johnson vaccine are supposed to wait two months.
The FDA said it would consider shortening the Moderna interval if provided with the appropriate data.