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Tuesday, December 7, 2021

Pfizer says Covid-19 vaccine is safe for 5- to 11-year-olds and shows ‘strong’ antibody response

by Amanda Seeley | CNN

In a much-anticipated announcement, Pfizer said on Monday that a phase 2/3 trial showed that its COVID-19 vaccine was safe and produced a “strong” antibody response in children aged 5 to 11.

These are the first such results for a US COVID-19 vaccine released for this age group, and the data have not yet been peer-reviewed or published. Pfizer said it plans to submit the drug to the US Food and Drug Administration for emergency use authorization soon.

The trial involved 2,268 participants aged 5 to 11 years and used two-dose doses of the vaccine administered 21 days apart. This trial used a 10-microgram dose—smaller than the 30-microgram dose that has been used for those 12 and older.

“The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer said in a news release.

The participants’ immune responses were measured by the levels of neutralizing antibodies in their blood and those levels were compared to a control group of 16- to 25-year-olds who were given a two-dose regimen with large doses of 30 micrograms. . Pfizer said the levels demonstrated a “stronger immune response in this group of children one month after the second dose,” compared with levels with older people receiving the larger dose.

“In addition, the COVID-19 vaccine was well tolerated, with side effects most commonly seen in participants aged 16 to 25 years,” the company said.

A Pfizer spokesperson also confirmed that there was no instance of myocarditis, a type of heart inflammation that has been linked to mRNA vaccines.

Pfizer said these data would be included in “near-term submissions” to the EUA and that companies would continue to submit the data needed for people ages 5 to 11 to file for FDA approval.

The Pfizer/BioNTech vaccine is currently approved for people 16 years of age and older, and is authorized for use in people 12 to 15 years of age.

Pfizer said it expects trial data for babies under 6 months of age “in the fourth quarter of this year.”

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“Since July, there has been a nearly 240 percent increase in pediatric cases of COVID-19 in the US – underscoring the public health need for vaccination. These trial results provide a strong basis for seeking authorization of our vaccines for children ages 5 to 11, and we plan to submit them to the FDA and other regulators immediately,” said Pfizer’s president and chief executive. Officer Albert Borla said in the statement.

FDA Acting Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation, said in a statement this month that the agency will review data for a vaccine for young children “as soon as possible, Possibly in a matter of weeks instead of months,” once it was submitted to the authority.

“However, the agency’s ability to rapidly review these submissions will depend on the quality and timeliness of submissions by producers,” they wrote.

The demand for a COVID-19 vaccine for young children has grown strongly in recent months as cases among children have increased.

The American Academy of Pediatrics reported last week that coronavirus infections among children have increased “rapidly” across the United States, and now account for about 29% of all reported cases nationwide.

World Nation News Deskhttps://www.worldnationnews.com
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