Health FDA says kid-sized Pfizer vaccine doses appear highly effective, safe
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U.S. health regulators said late Friday that kid-size doses of Pfizer's COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues, as the country weighs beginning vaccinations in youngsters.
The Food and Drug Administration posted its analysis of Pfizer's data ahead of a public meeting next week to debate whether the shots are ready for the nation's roughly 28 million children ages 5 to 11. The agency will ask a panel of outside vaccine experts to vote on that question.
FDA Panel Endorses Pfizer COVID-19 Vaccine for Kids 5-11
Here's what happens next.
In their analysis, FDA scientists concluded that in almost every scenario the vaccine's benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children. But agency reviewers stopped short of calling for Pfizer's shot to be authorized.
The agency will put that question to its panel of independent advisers next Tuesday and weigh their advice before making its own decision.
U.S. children could begin vaccinations next month
If the FDA authorizes the shots, the Centers for Disease Control and Prevention will make additional recommendations on who should receive them the first week of November. Children could begin vaccinations early next month — with the first youngsters in line fully protected by Christmas.
FDA Authorizes Pfizer COVID Booster Shot for Some High-Risk Populations
The single booster shot must be administered at least six months after completion of the first two doses . Those eligible to receive the booster include individuals 65 years of age and older, anyone older than 18 who is at high risk of severe COVID-19, and those 18 and over who are at risk of serious complications from COVID-19 due to high exposure at their job. Some of the populations who fall under these categories are "health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons," acting FDA Commissioner Janet Woodcock, M.D., said in a statement Wednesday.
Full-strength Pfizer shots already are recommended for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem infections from the extra-contagious delta variant and help keep kids in school.
Video: U.S. CDC recommends 3rd COVID-19 vaccine doses for millions of Americans (cbc.ca)
The FDA review affirmed results from Pfizer posted earlier in the day showing the two-dose shot was nearly 91 per cent effective at preventing symptomatic infection in young children. Researchers calculated the figure based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.
What You Need to Know About COVID Vaccines for Kids 5-11
Internal medicine physician Dr. Seema Marwaha clears up some of the frequently asked questions and concerns about COVID vaccines for kids. The post Expert Explainer: What You Need to Know About COVID Vaccines for Kids 5-11 appeared first on Best Health Magazine Canada.
Most of the study data was collected in the U.S. during August and September, when the delta variant had become the dominant COVID-19 strain.
No new side effects
The FDA review found no new or unexpected side effects, which mostly consisted of sore arms, fever or achiness that teens experience.
However, FDA scientists noted that the study wasn't large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that occasionally occurs after the second dose.
The agency used statistical modelling to try to predict how many hospitalizations and deaths from COVID-19 the vaccine would prevent versus the number of potential heart side effects it might cause. In four scenarios of the pandemic, the vaccine clearly prevented more hospitalizations than would be expected from the heart side effect. Only when virus cases were extremely low would the vaccine cause more hospitalizations than it would prevent. But overall, regulators concluded that the vaccine's protective benefits "would clearly outweigh" its risks.
While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the last six weeks as the delta variant surged, the American Academy of Pediatrics says.
The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation's 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.
More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.
The FDA Plans to Allow Americans to 'Mix and Match' Boosters .
What health experts are saying about the 'mix and match' approach.FDA officials will not recommend that people get one vaccine over another, according to The New York Times, but the agency may state that sticking with the same vaccine for your booster is ideal.