Not content with the ‘jabbing’ of children over the age of 12 with their Covid vaccine, Pfizer and BioNTech are now preparing to seek approval from U.S. and European medicines agencies for their vaccine in 5-11 year-olds. MailOnline has the story.
Dr. Özlem Türeci, Chief Physician for BioNTech, told German news site Der Spiegel that the companies are set to shortly release results from their study in kids under age 12 and will ask for the shot to be approved for emergency use authorization by the U.S. Food and Drug Administration (FDA) and other agencies.
“In the coming weeks, we will present the results of our study on the 5-11 year-olds worldwide to the authorities and apply for approval of the vaccine for this age group,'”Türeci said.
She added that the vaccine formula is the same as that approved for adolescents and adults, but that the dose size is smaller.
Currently, the Pfizer vaccine is only approved for children aged 12 and older in both the U.S. and the European Union.
Parents and doctors have been debating about whether or not to inoculate children because they make up 0.1% of all Covid deaths in the U.S.
A few hours after the new from Pfizer and BioNTech, the FDA said that clinical trial data submitted by vaccine manufacturers must include a monitoring period of at least two months after the final dose to ensure safety. …
Around 4,500 younger kids have been enrolled at nearly 100 clinical trial sites in 26 U.S. states, Finland, Poland and Spain. …
If the vaccine is proven to be safe and effective, the trial will be unblinded at the six-month follow-up, meaning those who received [a] placebo will be allowed to get the inoculation.
Trials for kids as young as six months to four years old are still in early stages and will expand once the researchers can determine safety.
Worth reading in full.