A committee of US experts ruled on Tuesday in favor of authorizing the application of the Pfizer-BioNTech anticovid vaccine to children between 5 and 11 years old.
The committee’s recommendation is advisory in nature, but it is unusual for the Food and Drug Administration (FDA) do not follow. If this agency finally authorizes the use of the vaccine for this age group, some 28 million girls and boys would be eligible to receive the doses in USA.
A medical panel of experts made up of advisers to the United States government met on Tuesday to decide whether to authorize the vaccine against the SARS-CoV-2 disease for minors.
Thus, the 28 million children in this age group would begin to be vaccinated in November.
Before the meeting, the FDA shared a study of Pfizer which showed that the vaccine, with doses of 10 micrograms instead of the 30 inoculated to the older groups, was 90.7% effective in preventing symptomatic Covid-19 and did not present serious safety problems.
The FDA also released its own information document with a risk-benefit analysis. Agency scientists indicated that the benefits outweigh the eventual worst side effect for this age group: myocarditis, or inflammation of the heart.
“My initial opinion is that the benefits of vaccinating children ages five to eleven outweigh the risks 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. York.
In total, 160 children between the ages of 5 and 11 died of COVID-19 in the United States, according to official data.
There were also more than 5,000 cases of multi-system inflammatory syndrome in children (MIS-C), a rare but very serious post-viral complication, which claimed 46 lives.
“Of course, we (want) to protect children, but we also want them not to transmit the SARS-CoV-2 virus to their family members and other people in the community,” Bernstein said.
Low probability of myocarditis
Pfizer evaluated safety data among 3,000 volunteers, and the most common side effects of the vaccine were mild or moderate, such as injection site pain, fatigue, headache, muscle pain and chills.
There were no cases of myocarditis or pericarditis (inflammation around the heart). The company clarified, however, that there were not enough volunteers to be able to detect very rare side effects.
Very rare cases of myocarditis were only detected in adolescents after the vaccine was licensed in June and administered to millions of people in that age group.
Scientists predict it will be even rarer in younger children, but it won’t be known for sure until it’s cleared.
The FDA acknowledged that, hypothetically speaking, if Covid-19 transmission falls dramatically, the number of myocarditis cases caused by the vaccine will be greater than the number of COVID-19 hospitalizations averted.
Still, he added, the benefits will continue to outweigh the risks, as Covid-19 cases that do not require hospitalization can have more serious long-term consequences than vaccine side effects, which are usually temporary.
The United States is emerging from its latest wave, generated by the Delta variant.
But the pandemic continues to spread rapidly in northern states, such as Alaska, Montana, Wyoming and Idaho, with colder climates and low vaccination rates.
In the United States, 57% of the population is fully vaccinated.
Confidence in vaccines has increased in recent months, but the United States continues to lag behind the other G7 countries in terms of the percentage of the population vaccinated.