The Pfizer Covid vaccine seems to be extremely effective for young children

Aiden Arthurs received the Pfizer-BioNTech Covid-19 vaccine from pharmacist Andrew Mack on May 13, 2021 at the office of the Jewish Federation / JARC in Bloomfield Hills, Michigan.

Jeff Kowalski | AFP | Getty Images

Federal health regulators said late Friday that the Kidsize dose of Pfizer’s Covid-19 vaccine appears to be highly effective in preventing significant infections in primary school children and does not cause any unexpected safety issues, as vaccinations have begun among young people in the United States.

The Food and Drug Administration posted an analysis of Pfizer’s data ahead of a public meeting next week to debate whether the shots were ready for the country’s nearly 28 million children aged 5 to 11. The agency will ask a panel of outside vaccine experts to vote on the question.

In their analysis, FDA scientists concluded that the benefits of the vaccine to prevent hospitalization and death from Covid-19 in almost every situation would outweigh any serious potential side effects in children. But agency reviewers stopped calling for Pfizer’s shot to be approved.

The agency will put that question to a panel of independent advisers next Tuesday and weigh their advice before making its own decision.

If the FDA approves the shots, the Centers for Disease Control and Prevention will make additional recommendations about who should receive them in the first week of November. Babies can start getting vaccinated early next month – the first youngsters to be on the fully protected line by Christmas.

Full-strength Pfizer shots are already recommended for anyone 12 or older, but pediatricians and many parents are anxiously awaiting the protection of young children to prevent infection from the extra-contagious Delta variant and to help keep children in school.

The FDA review confirmed the results posted the day before Pfizer showed that the two-dose shot was about 91% effective in preventing significant infections in young children. The researchers calculated the figure based on 16 Covid-19 cases in three of the youngsters given dummy shots versus vaccinated children. No serious illness was reported in any of the young people, but vaccinated individuals had much milder symptoms than their unwanted counterparts.

Most of the data from the study were collected in the United States in August and September, when the Delta variant became the dominant COVID-19 strain.

The FDA review found no new or unexpected side effects, most of which are pain, fever, or pain in the arm that adolescents experience.

However, FDA scientists noted that the study was not large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that sometimes occurs after the second dose.

The agency tried to use statistical modeling to predict how many people would be hospitalized from COVID-19 and the number of possible heart side effects compared to the death vaccine. In four epidemic situations, the vaccine has clearly prevented more hospital admissions than expected from heart side effects.

Only when the incidence of the virus was extremely low could more people be hospitalized than to prevent the vaccine. But overall, regulators have concluded that the vaccine’s protective advantages will “clearly outweigh” its risks.

Although children are at lower risk of serious illness or death than the elderly, according to the CDC, Covid-19 killed more than 630 Americans 18 or younger. The American Academy of Pediatrics says about 6.2 million children have been infected with the coronavirus due to Delta variant growth, up from 1.1 million in the past six weeks.

The Biden administration has purchased child-sized doses in special orange-cloth vials to differentiate them from the adult vaccine for children aged 5 to 11 in the country. If the vaccine is cleared, millions of doses will be sent across the country immediately, along with baby-sized needles.

More than 25,000 pediatricians and primary care providers have already signed up to receive small arms shots.

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