Tue. Dec 7th, 2021

FDA approves Pfizer Covid-19 vaccine for children 5 to 11 years old

Pictures: Cindy Ord (Getty Images)

The US Food and Drug Administration has now approved the first Covid-19 vaccine for children ages 5 to 11. The approval will cover the Pfizer / Biotech mRNA vaccine, although disease control and prevention centers need to bless them. The vaccine will be widely available before next week.

The approval comes after almost unanimous approval from the FDA Advisory Committee, which met earlier this week to discuss the vaccine. During that meeting, data were presented from trials of 3,100 children who had been vaccinated, compared with those who had been given a placebo. The trial showed that the immune system of children was similar to the immune response seen in young people aged 16 to 25 years, and that the vaccine was estimated to be 90.7% effective in preventing Covid-19. In addition, no serious adverse events associated with the vaccine were reported, although one child was reported to have eaten a penny. Unrelated events.

“As a mother and a physician, I know that parents, caregivers, school staff and children are waiting for approval today. Vaccinating young children against Cavid-19 will bring us closer to normalcy, “said Janet Woodcock, acting FDA commissioner. Statement From the FDA. “Our comprehensive and rigorous assessment of vaccine safety and efficacy data will help reassure parents and guardians that this vaccine meets our high standards.”

The infant version of the vaccine will come in a smaller dose than the adult version. However it will similarly be given as a two-dose shot given over a three-week period.

Although no serious adverse events were detected during the trial, common side effects include pain at the injection site, redness and swelling, fatigue and headache. Health officials also noted that rarely reported side effects in young recipients, especially myocarditis (inflammation of the heart), can occur once the vaccine is widely administered. But in modeling various scenarios for the near future of the epidemic, FDA researchers concluded that the benefits of vaccinating against Covid-19 would still outweigh the risks. Significantly, several studies have speculated that Covid-19 is present High risk Causes myocarditis more than vaccines. And although young children have rarely died from Covid-19, it is still a leader The cause of death In that age.

FDA approval is the first step required for children to receive the vaccine. Early next week, the CDC’s advisory committee will meet to discuss proper guidelines for administration, after which the CDC is expected to give them the green light. Earlier this week, Moderna Release Young children are expected to get promising results from their own trials and file for approval soon.

Source link

By admin

Leave a Reply

Your email address will not be published. Required fields are marked *