Portland, Oregon 2021-10-26 17:01:12 –
Washington (AP) — Tuesday’s Commission of U.S. Health Advisors approved Pfizer’s child-sized dose of COVID-19 vaccine, bringing the United States closer to the start of vaccination for children aged 5 to 11 years. ..
The Food and Drug Administration’s advisory board unanimously voted to abstain from the benefits of vaccines that prevent COVID-19 in that age group outweighing the potential risks. Higher dose.
The FDA is not bound by the panel’s recommendations and is expected to make its own decisions within a few days.
If the FDA approves a child-sized dose, there are yet another steps. Next week, the Centers for Disease Control and Prevention will need to decide whether to recommend shots and which young people will get them.
Infant doses are only one-third of the Pfizer shots already recommended for everyone over the age of 12. Moderna is also researching vaccines for infants.
According to a survey of elementary school students, Pfizer injections are nearly 91% effective in preventing sexually transmitted infections, even though young people receive only one-third of the dose given to teens and adults. It turned out to be.
In a preliminary analysis last week, a Food and Drug Administration reviewer said that in almost all pandemic scenarios, protection “clearly outweighs” the risk of very rare side effects.
Children are at lower risk of severe COVID-19 than older people, but ages 5-11 still face significant illness. It reported more than 8,300 hospitalizations, about one-third required intensive care, and nearly 100 died.
“Infectious diseases have caused many school closures and disrupted children’s education and socialization,” he said.
Marks added, “I want to admit the fact that there is a strong sentiment among the public about vaccination of children,” adding that “scientific data, not about vaccine obligations entrusted to other bodies than the FDA.” I will discuss it. ” “
Full-strength shots by Pfizer and its partner BioNTech are already recommended for everyone over the age of 12, but pediatricians and many parents want to protect their infants. The highly contagious delta mutant caused a surprising increase in pediatric infections. Family members are dissatisfied with school quarantine and have to say no to oversleeping and other childhood rituals to keep the virus away.
The state is preparing to deploy a small arm shot as soon as the government gives OK — in a vial with a special orange cap to distinguish it from the adult vaccine. To date, more than 25,000 pediatricians and other primary care providers have signed up to provide vaccinations.
The Pfizer study followed 2,268 children aged 5 to 11 years who received either placebo or a child’s dose twice at 3-week intervals. Vaccinated adolescents have developed antibodies that fight the virus at levels as strong as teens and young adults who have taken full-strength shots.
And so far, 16 children given dummy shots developed symptomatic COVID-19 compared to 3 vaccinated adolescents. This means that the vaccine was almost 91% effective. Due to the surge in delta variants, most of the survey data was collected in the United States in August and September.
Dosages for children have also proven to be safe, with the same or less temporary side effects experienced by teens, such as arm pain, fever, and pain. At the request of the FDA, Pfizer recently enrolled an additional 2,300 adolescents in the study, but preliminary safety data do not indicate a danger signal.
This study is not large enough to detect very rare side effects, such as occasional heart inflammation after the second dose, mainly in young men and teenage boys.
According to FDA analysis, in most scenarios where the pandemic continues, the vaccine prevents about 200 to 250 COVID-19 hospitalizations for every 1 million vaccinated adolescents and about 58 hospitalizations for carditis. To prevent. The risk of side effects is based on teenage levels, and Pfizer expects young people taking child-sized doses to be much lower.
FDA advisers back Pfizer’s COVID-19 vaccine for young kids Source link FDA advisers back Pfizer’s COVID-19 vaccine for young kids