WASHINGTON: A medical panel of U.S. government advisers on Tuesday approved the Pfizer Covid 19 vaccine in children between the ages of five and 11, paving the way for young children to be shot within weeks.
Independent experts conclude that the known benefits – both directly for children’s health but also for school dropouts and other obstacles – far outweigh the known risks.
After a day of presentations and debates, the final vote was 17 in favor and one abstained.
The Food and Drug Administration, which convened the meeting, is expected to give its official green light soon, enabling 28 million young Americans to be shot by mid-November.
“It’s very clear to me that the benefits outweigh the risks when I hear about children being kept in the ICU, having long-term results after COVID, and children dying. ۔ ” Disease Control and Prevention (CDC), who voted yes.
“It never happens when you know everything – the question is when you know enough,” said Paul Affit, a pediatrician at Children’s Hospital of Philadelphia, who also voted yes but considered the fact. Over time, more complete security data will become available. .
He added that many children who are at high risk stand to benefit, and that the theoretical risk of myocarditis, which is the most worrying side effect, is likely to be very low, at 10 micrograms. Given the low dose, older than 30 micrograms. .
Nevertheless, many experts partially rejected their votes, saying they would not be in favor of a broader vaccine mandate in schools and that the decision should be made by the families themselves.
Earlier, Peter Marks, a leading FDA vaccine scientist, said young children were “far from being harmed by Covid 19”, adding that the group had 1.9 million infections and 8,300 hospitalizations. About a third of them need intensive care.
He added that there have been about 100 deaths, making it the top 10 cause of death.
– Rare side effects –
An analysis of Pfizer, posted by the FDA prior to the meeting, found that the vaccine was 90.7% effective in preventing symptomatic colic 19.
FDA scientist Hong Yang presented a risk-taking model that shows the current rates of infection, which would prevent the vaccine from being admitted to more hospitals than it could be due to myocarditis. Is.
He added that this could change if community transmission was reduced to a very low level – but that vaccination could still be beneficial because of the long-term risks associated with non-hospitalization cases.
These include Multi-System Inflammatory Syndrome (MIS-C) in children, a rare but extremely serious post-viral complication that has affected more than 5,000 children of all ages and claimed 46 lives.
In its clinical trial, Pfizer reviewed safety data from a total of 3,000 vaccinated participants, with the most common side effects being mild or moderate, including injection site pain, fatigue, headache, muscle aches and colds. لگنا۔
There were no cases of myocarditis or pericarditis (inflammation of the heart), but experts agreed that the researchers did not have enough volunteers to detect the rare side effects.
Matthew Oyster, a CDC researcher, gave a presentation on how these side effects are already known among vaccine-eligible groups.
Of the 877 vaccine-infected myocarditis cases under the age of 29, 829 were hospitalized, according to official figures. The majority have been fired but five are in intensive care.
In the age group of five to 11 years, the rate may be lower than in teenage men, as it is thought to be linked to testosterone.
The panel weighed in on the ideological risk against cod prevention, which could lead to more recurrent and severe myocarditis.
The meeting comes as the United States is emerging from its latest wave of Delta variants.
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 country in the percentage of fully vaccinated population.