Moderna says its COVID-19 vaccine generated robust immune response in children ages 6 to 11 – Pittsburgh, Pennsylvania

Date:

Pittsburgh, Pennsylvania 2021-10-25 10:33:00 –

Interim results from the Phase 2/3 trial showed that Moderna’s COVID-19 vaccine was well tolerated and produced a strong immune response in children aged 6 to 11 years. Two 50 microgram doses of Moderna vaccine given at 11 and 28 day intervals were examined. This is less than the 100 microgram dose given to adults. In its Phase 3 trial, the company compared the antibody response of infants to that of young adults and found “a strong immune response in this cohort of children one month after the second vaccination.” .. The data has not been peered yet. The company said the vaccine’s safety and tolerability were in line with Phase 3 vaccine trials in adolescents and adults. “Most of the adverse events were mild or moderately severe,” the company said in a news release. “The most common requested adverse events were fatigue, headache, fever, and pain at the injection site.” Moderna sent these data to the Food and Drug Administration, the European Pharmaceutical Agency, and other global regulatory agencies. He said he would submit it “in the near future.” Currently, it is allowed for people over the age of 18. The company requested an emergency use authorization for vaccines between the ages of 12 and 17 in June, but the FDA’s authorization has not yet been extended to that age group. The company continues to monitor research participants and is part of the trial. The Next Steps for Infant Vaccination Infants may be eligible for COVID-19 vaccination within a few weeks. Another vaccine company, Pfizer, is already seeking an emergency use authorization for vaccines between the ages of 5 and 11. The FDA’s independent vaccine advisory board will meet on Tuesday to discuss with Pfizer whether to allow infants to receive BioNTech’s COVID-19 vaccine. If approved, it will be the first vaccine available to infants. The Pfizer vaccine has already been approved for children aged 12 to 15 years and for people over the age of 16. If the FDA Committee votes in favor, the FDA will make the final decision. The Centers for Disease Control and Prevention’s Independent Advisory Board will then meet on November 2nd and 3rd to vote on whether to recommend it. Finally, CDC Director Dr. Rochelle Walensky decides whether to accept or amend the Commission’s recommendations.

Interim results from the Phase 2/3 trial showed that Moderna’s COVID-19 vaccine was well tolerated and produced a strong immune response in children aged 6 to 11 years.

The study enrolled more than 4,700 participants aged 6 to 11 years and examined two 50 microgram doses of the Moderna vaccine at 28-day intervals. This is less than the 100 microgram dose given to adults. In its Phase 3 trial, the company compared the antibody response of infants to that of young adults and found “a strong immune response in this cohort of children one month after the second dose.” ..

The data has not yet been peer-reviewed or published.

The company said the vaccine’s safety and tolerability were in line with Phase 3 vaccine trials in adolescents and adults. “Most of the adverse events were mild or moderately severe,” the company said in a news release. “The most common requested adverse events were fatigue, headache, fever, and pain at the injection site.”

Moderna said it will submit these data “in the near future” to the Food and Drug Administration, the European Medicines Agency, and other global regulators.

The Moderna vaccine is currently approved for people over the age of 18. The company requested an emergency use authorization for vaccines between the ages of 12 and 17 in June, but the FDA’s authorization has not yet been extended to that age group.

The company said it continues to monitor study participants and is studying the younger age group that is part of the study.

What’s Next for Infant Vaccines

Younger children may be eligible for COVID-19 vaccination within a few weeks. Another vaccine company, Pfizer, is already seeking an emergency use authorization for vaccines between the ages of 5 and 11.

The FDA’s independent vaccine advisory board will meet on Tuesday to discuss whether Pfizer and BioNTech’s COVID-19 vaccine should be approved for infants. Once approved, it will be the first vaccine available to infants.

The Pfizer vaccine has already been approved for children aged 12 to 15 years and for people over the age of 16.

If the FDA Committee votes in favor, the FDA will make the final decision on whether to approve it.

The Centers for Disease Control and Prevention’s Independent Advisory Board will then meet on November 2nd and 3rd to vote on whether to recommend it. Finally, CDC Director Dr. Rochelle Walensky decides whether to accept or amend the Commission’s recommendations.

Moderna says its COVID-19 vaccine generated robust immune response in children ages 6 to 11 Source link Moderna says its COVID-19 vaccine generated robust immune response in children ages 6 to 11

The post Moderna says its COVID-19 vaccine generated robust immune response in children ages 6 to 11 – Pittsburgh, Pennsylvania appeared first on Eminetra.

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