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The US government has purchased 50 million more doses of Pfizer and BioNTech’s COVID-19 vaccine to support preparedness for pediatric vaccinations.
The government has exercised its final purchase option under the existing supply agreement, bringing the total Pfizer-BioNTech vaccine doses secured since the pandemic to 600 million for adults, adolescents, and children.
The companies have also agreed to provide 1 billion doses to the government at a non-for-profit price for donation to low-and lower-middle-income countries.
Pfizer and BioNTech will deliver the doses by April 2022.
“We are extremely proud to provide enough doses of our vaccine to help protect every US child under 12 from COVID-19, if authorized by the FDA,” Albert Bourla, chairman and chief executive officer at Pfizer, said in the announcement.
“We are working with the US government to help ensure communities across the country have access to pediatric doses as soon as possible. The introduction of doses for young children will be another critical milestone in addressing this public health crisis,” Bourla continued.
Last week, FDA authorized Pfizer and BioNTech’s vaccine for children five to 11 years of age based on a trial that found that the vaccine was 90.7 percent effective in preventing COVID-19 in this age group.
Additionally, the companies submitted data to the European Medicines Agency (EMA) to support the vaccine for this age group. And further submissions are underway with other regulatory agencies globally.
FDA Needs More Time to Complete Moderna’s EUA Request for Vaccine
FDA recently stated that it needs additional time to complete the assessment of Moderna’s emergency use authorization (EUA) request for its COVID-19 vaccine in adolescents.
The agency notified Moderna that the review of the EUA for a 100 microgram dose of the vaccine in children 12 to 17 years of age may not be complete before January 2022. But Moderna noted that it is fully committed to working with FDA to support its review.
In May, Moderna announced that its vaccine was 93 percent effective in seronegative adolescents starting 14 days after the first dose using the secondary CDC case definition of COVID-19, which tested for milder disease.
And after two doses, there were no cases of COVID-19 cases in the vaccine group compared to four cases in the placebo group. Therefore, the vaccine was 100 percent effective starting 14 days after the second dose.
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