A high-level medical panel of advisers to the US government will meet on Tuesday to decide whether to authorize the Pfizer Covid-19 vaccine for children between the ages of five and 11.
If, as is widely expected, independent experts convened by the Food and Drug Administration (FDA) vote in favor, an emergency authorization could follow within weeks. It will make 28 million young American children eligible for shots in November.
Once the FDA approves the move, Israel is widely expected to follow suit following its approval process. health ministry officials said earlier this week That shots for children under the age of 12 in Israel could begin in mid-November.
Question before US panel: Based on available scientific evidence, do the benefits of a two-dose vaccine, given at three-week intervals, outweigh the known risks?
Before the meeting, the FDA uploaded an analysis by Pfizer showing that the vaccine — given at 10 micrograms instead of 30 micrograms in older groups — was 90.7 percent effective in preventing symptomatic COVID-19, and no serious protection. was not the problem.
The FDA also posted its own briefing document that included a risk-benefit analysis, which indicated that agency scientists believe the benefits outweigh the most worrying potential side effects for this age group: myocarditis, or Heart swelling.
An Israeli receives a dose of the COVID-19 vaccine at a Clalit health care maintenance organization in Jerusalem on September 9, 2021. (Olivier Fitoussi/Flash90)
“My initial view is that the benefits of vaccination to children aged five to 11 years outweigh the risk of myocarditis and other safety concerns that people may have,” Henry Bernstein, a pediatrician at Cohen Children’s Medical Center in New York, told AFP. “
Overall, 160 children aged five to 11 have died from COVID-19 in the United States since the start of the pandemic, according to official figures – a tiny fraction of the total of more than 730,000.
But lakhs of people have been infected and thousands are hospitalised. There have also been more than 5,000 cases of multisystem inflammatory syndrome (MIS-C) in children, a rare but extremely serious post-viral complication that has claimed 46 lives.
“Undoubted, [we] We want to protect children, but we also want them not to transmit the SARS-CoV-2 virus to family members and others in the community,” Bernstein said.
Pfizer evaluated safety data from a total of 3,000 vaccination participants, with the most common side effects being mild or moderate, including injection site pain, fatigue, headache, muscle aches and chills.
There were no cases of myocarditis or pericarditis (inflammation around the heart), but the company said there weren’t enough study volunteers to be able to detect extremely rare side effects.
Pedro Montano holds his 3-year-old daughter, Roxana Montano, while she is being vaccinated against COVID-19 with the Cuban vaccine Sobrana Plus, at the Juan Manuel Marquez Hospital in Havana on August 24, 2021, one of the children and adolescents As part of the vaccine study. (Adalberto Roque/AFP)
Very rare instances of myocarditis were found in adolescents only after it was authorized in June and given to millions of people in that age group instead of the thousands tested in the trial.
Scientists think it will be even rarer in young children, but don’t expect to know how rare it is until it turns green.
The FDA acknowledged that, hypothetically, if COVID-19 transmission had been crushed within communities – as it did in June 2021 – the number of cases of vaccine-induced myocarditis would have been more likely to result in preventable COVID-19 hospitalizations. may exceed the number.
But even so, it added that the benefits may still outweigh the risks, as non-hospitalized COVID-19 cases can have more serious consequences than side effects, which are usually temporary.
The United States is emerging from its latest wave powered by Delta Edition. But cases are higher in northern states such as Alaska, Montana, Wyoming and Idaho, which are experiencing cooler weather and lower vaccination rates.
Overall, 57% of the total population is now fully vaccinated. Vaccine confidence has increased in recent months, but the United States lags behind every other G7 nation by percentage of the population fully vaccinated.
