U.S. Food and Drug Administration scientists said Friday that the risks of inoculating children 5 to 11 years old against COVID-19 are far less than the risk of rare cases of heart inflammation, called myocarditis.
The announcement comes as a panel of outside experts is expected to vote on Tuesday whether to recommend FDA approval of the vaccine for the young age group.
If the agency authorizes emergency immunization, the shots could be available in the United States in early November.
The Centers for Disease Control and Prevention’s independent advisory committee takes up the issue on November 2 and 3.
U.S. pharmaceutical company Pfizer and its German partner, BioNTech, on Friday released data showing their COVID-19 vaccine is safe and 90.7% effective at preventing symptomatic infections in children 5 to 11 years old.
Pfizer said the trial was conducted among 2,268 children between the ages of 5 and 11 who were given two shots of a 10-microgram dose of the vaccine, a third of the dose given to those 12 and older.
In anticipation of the emergency approval, the White House this week announced plans to deliver enough of the children’s doses of the vaccine to all 28 million children between the ages of 5 and 11 currently living in the U.S.
Meanwhile in Britain, Prime Minister Boris Johnson on Friday continued to dismiss calls for renewed COVID-19 restrictions, saying there is nothing to indicate those moves will be necessary in the coming months, despite the fact Britain is currently seeing a dramatic surge in COVID-19 infections.
Speaking to reporters while touring a London vaccination facility, Johnson said the current surge in infections is high, but still within the parameters experts predicted.
Johnson encouraged people to get vaccinated if they had not already done so, and for those eligible to get a booster vaccination. The British government has approved booster shots for everyone over 50.
With an average of more than 45,000 infection a day, up 17% from the previous week, the World Health Organization reported this week that Britain has among the highest number of daily new infections in Europe, the only part of the world that saw an increase in new cases last week.
Late Thursday, the U.S. Centers for Disease Control and Prevention Thursday recommended booster shots for millions who received the Moderna or Johnson & Johnson coronavirus vaccines, saying that the booster does not necessarily have to match the original shot.
Rochelle Walensky, the head of the government agency, endorsed the recommendations by an advisory panel Thursday, putting the CDC on the same page as the FDA.
The booster shot for Pfizer’s vaccine was approved in September.
The CDC committee has recommended that people age 18 and older and who were vaccinated two months or more ago with the single-dose Johnson & Johnson vaccine are eligible for a booster shot.
Those 65 or older inoculated with two-dose Pfizer or Moderna vaccines are recommended for a booster six months or more after the second dose.
The CDC also recommended a booster for those 18 or older in long-term care facilities, have preexisting medical conditions, as well as those who live or work in high-risk settings.
Some information for this report was provided by the Associated Press, Reuters and Agence France-Presse.
