Pfizer-BioNTech soon will be asking regulators to approve the use of its COVID-19 vaccine in children aged 5 and up, according to reports Friday.
Pfizer-BioNTech is preparing to make smaller doses of the vaccine for the younger children. The European Union and the United States approved the Pfizer vaccine for use in children 12 and older in May. They have not approved any COVID-19 vaccines for children younger than 12.
“We will be presenting the results from our study on five- to 11-year-olds to authorities around the world in the coming weeks,” Ozlem Tureci, the co-founder of BioNTech and its chief medical officer, told Der Spiegel, a German news site, in an interview published on Friday.
Meanwhile, some children in Metro Detroit are participating in a trial of Moderna’s COVID vaccine on those younger than 12. In May, Moderna asked the federal government to start the process so it could test its vaccine on children between the ages of 6 months and 11 years old. Henry Ford Hospital has been Michigan’s test site.
The process has been expected to take several months before we know when such a vaccine could be available for young children. Friday’s report on Tureci’s statement is moving up that timeline.
Over the summer Pfizer said it was planning to enroll 4,600 children age 5 to 11 in the United States, Finland, Poland and Spain for vaccine trials.
Comirnaty and Pfizer-BioNTech COVID-19 Vaccine -- per the FDA:
On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Moderna COVID-19 Vaccine -- per the FDA:
On December 18, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On June 25, 2021, the FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. On August 12, 2021, the FDA amended the Moderna COVID-19 Vaccine EUA to allow for an additional dose to be given to certain immunocompromised individuals. The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
Janssen COVID-19 Vaccine -- per the FDA:
On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On April 23, 2021, the FDA amended the EUA to include information about a very rare and serious type of blood clot in people who receive the vaccine. The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
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