Kansas City, Missouri 2021-09-20 06:45:00 –
Pfizer said in a long-awaited announcement Monday that Phase 2/3 trials showed that the Covid-19 vaccine was safe and showed a “strong” antibody response in children aged 5-11 years. ..
These are the first such results published in this age group for the US Covid-19 vaccine, and the data have not yet been peer-reviewed or published. Pfizer said it will soon be filed with the US Food and Drug Administration for an emergency use authorization.
The study enrolled 2,268 participants aged 5 to 11 years and used a two-dose regimen of the vaccine given at 21-day intervals. This study used a dose of 10 micrograms. This is less than the 30 microgram dose used for people over the age of 12.
“The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability, and immunogenicity in children aged 5 to 11 years,” Pfizer said.
Participant’s immune response was determined by examining the levels of neutralizing antibodies in the blood and comparing those levels with controls aged 16-25 years who were given a double dose regimen at a higher dose of 30 micrograms. It was measured. Pfizer said levels were often compared to older people who received higher doses and showed “a strong immune response in this cohort of children one month after the second dose.”
“In addition, the COVID-19 vaccine was well tolerated and side effects were generally similar to those observed in participants aged 16 to 25 years,” the company said.
A Pfizer spokesperson also confirmed that there were no cases of myocarditis, a type of heart inflammation associated with the mRNA vaccine.
Pfizer said these data are included in the EUA’s “short-term submission” and companies will continue to accumulate the data needed to apply for FDA approval for people aged 5-11.
The Pfizer / BioNTech vaccine is currently approved for people over the age of 16 and for use in people between the ages of 12 and 15.
Pfizer said it expects test data for six-month-old young children “in the fourth quarter of this year.”
“Since July, pediatric cases of COVID-19 have increased by about 240% in the United States, highlighting the public health needs of vaccination. These study results show children aged 5 to 11 years. It provides a strong foundation for seeking vaccine approval. Pfizer Chairman and Chief Executive Officer Albert Bula will urgently submit these to the FDA and other regulators in a statement. “.
In a statement this month, Dr. Janet Woodcock, Deputy FDA Commissioner, and Dr. Peter Marks, Director of the FDA’s Center for Biologics Research and Evaluation, officials submitted data on vaccines for infants “as soon as possible, perhaps for approval.” The rest is a matter of weeks, not months.
“But the institution’s ability to quickly review these submissions will depend in part on the quality and timeliness of the submissions by the manufacturer,” they wrote.
The demand for Covid-19 vaccines for young children has grown in recent months as the number of cases has skyrocketed among children.
Coronavirus infections have increased “exponentially” among children across the United States, accounting for almost 29% of all reported cases nationwide, according to a report last week by the American Academy of Pediatrics. I am.
Still, US health officials emphasize that children are not just small adults, and even children approaching the age of 12 should not be given more vaccines available to the elderly.
“I don’t want to hurt my kids, I want to get them vaccinated as soon as possible, but I’ll do it right,” FDA Marks said in a chat by the Fireplace hosted by the Research America Alliance last week. Said.
“There is a difference here because we are not just taking the same age and the same age dose as people over 12 years old. We need to lose weight. Therefore, it is not a good idea for doctors to take it. What is in their hands at this point. “
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Covid-19 vaccine for 5 to 11-year-olds is safe and shows ‘robust’ antibody response, Pfizer says | Coronavirus Source link Covid-19 vaccine for 5 to 11-year-olds is safe and shows ‘robust’ antibody response, Pfizer says | Coronavirus