A group of expert consultants from the US government has come out in favor of administering Pfizer’s anti-Covid vaccine to children between the ages of 5 and 11; if the definitive authorization arrives (the opinion of this committee is rarely accepted by the Food and Drug Administration, the FDA), the US would be the first Western country to vaccinate children against Covid-19.
After more than seven hours of meetings, the FDA experts gave the ‘green light’ to the recommendation, with 17 votes in favor and one abstention. The committee determined that the benefits of administering the Pfizer / BioNTech vaccine (2 doses 3 weeks apart, 10 micrograms each, one-third that of adults) outweigh the risks for that age group as well.
Covid Pfizer vaccine: more than 90 percent efficacy in children
While it is true that very young people who become seriously ill or die from Covid-19 are relatively rare compared to adults, some develop complications; and infections in unvaccinated children have increased due to the Delta variant of the coronavirus, which is more easily transmitted. In the US, in particular, nearly 100 children died during the pandemic, nearly two million were infected and 8,300 were hospitalized.
Pfizer released its data on children between 5 and 11 years ago four days ago, after a trial conducted on 2,000 minors. According to the pharmaceutical company, its vaccine is 90.7 percent effective in children of that age. During clinical trials, a strong immune response was found in children, comparable to antibody levels seen in previous studies involving participants aged 16 to 25 years. But the little ones in the 5 to 11-year-old age group achieved this response with 10 micrograms of the vaccine, a third of the dose given to older adults and adults.
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Side effects tend to be mild and similar to those seen in young people; at higher doses, however, the researchers observed more side effects in younger children, including fever, headache and fatigue, although no severe symptoms.
Pfizer and BioNTech applied to the FDA on October 7 for authorization for the emergency use of their vaccine in children. So far, the FDA only authorizes its use from the age of 12. Authorization from the FDA is expected on November 1 (the FDA is not obligated to follow the advice of its external consultants, but it usually does). If confirmed, the Centers for Disease Control and Prevention (the famous CDCs of Atlanta) will eventually confirm the authorization for immunization in this age group, which has 28 million people in the USA, most of them in school age.
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It is expected that the committee of consultants of the CDC will meet between 2 and 3 November to review the data and then it will be the director of the agency, Rochelle Wallensky, to have the last word.
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