Fresno, California 2021-09-20 07:01:00 –
Pfizer Chairman and CEO Albert Bourla said, “Vaccines are subject to regulatory approval, especially as they track the epidemic of delta variants and the significant threat they pose to children. We would like to extend the protection provided by this to this young group. ” statement. “Since July, pediatric cases of COVID-19 have increased by about 240 percent in the United States-emphasizing the need for public health vaccinations.”
The study enrolled 2,268 participants between the ages of 5 and 11 and underwent a two-dose regimen, but due to the “safety, tolerability, and immunogenicity” of younger individuals, ages 12 and older. I used a dose less than the amount given to the person. Children.
“For participants aged 5 to 11, the vaccine was safe, well tolerated, and showed a strong neutralizing antibody response,” the two companies said in a news release.
Pfizer and BioNTech will soon share data with the US Food and Drug Administration, the European Medicines Agency, and other regulatory agencies, and will file a request for an emergency use authorization in the United States.
The FDA approved the Pfizer vaccine, sold as Comirnaty, in August for people over the age of 16. Currently, emergency use is permitted for children aged 12 to 15 years.
“The results of these trials will provide a strong basis for seeking vaccine approval for children ages 5-11 and will be urgently submitted to the FDA and other regulatory agencies,” said Bourla.
According to the two companies, the results of two other ongoing trials, one for children aged 2 to 5 and the other for children aged 6 months to 2 years, are expected later this year.
Pfizer has also received an emergency use authorization from the FDA to give a third dose of the vaccine to people over the age of 12 who have been determined to have a particular type of immunodeficiency.
However, a panel advising the federal government on vaccines recently rejected President Joe Biden’s proposal to deploy booster shots to all Americans, so far, a third dose of COVID over 65 or severe COVID. Recommended to be given only to those at high risk-19.
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Pfizer says COVID-19 vaccine safe, effective for kids ages 5 to 11 Source link Pfizer says COVID-19 vaccine safe, effective for kids ages 5 to 11