Pfizer to seek FDA approval of Covid vaccine for children aged 5 to 11
Pfizer plans to seek approval of its coronavirus vaccine for use on children five to 11 years old from the US Food and Drug Administration (FDA), a chief physician has said.
Dr Özlem Türeci, who works for BioNTech, Pfizer’s partner in the vaccine, said the companies will soon release findings from a study of children under 12 years old and will seek emergency use authorization for the jab from the FDA.
‘In the coming weeks, we will present the results of our study on the five-to-11-year-olds worldwide to the authorities and apply for approval of the vaccine for this age group,’ Türeci told the German news site Der Spiegel, according to the Daily Mail.
Pfizer’s vaccine received authorization from the FDA for usage on youth ages 12 to 15 in May. It was authorized for people 16 years and older in December.
The formula for the jab that Pfizer is seeking a sign-off to administer on children five to 11 years old is the same as the one for the older age groups, Türeci said.
Shortly after the latest news on Pfizer, the FDA said that clinical trial data had to include a monitoring period of two months minimum after the last dose, for safety reasons.
‘Children are not small adults – and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults,’ FDA Acting Commissioner Dr Janet Woodcock said in a statement.
Pfizer’s push to get its jab approved for a younger age group comes as the Biden administration takes significant strides to push the US’s unvaccinated population to get inoculated.
On Thursday, President Joe Biden announced he would order all employers with 100 or more workers to make sure they are vaccinated or provide Covid test results at least once a week. He also signed executive orders mandating all federal workers in the executive branch and government contractors to get the vaccine.
Biden has said he will not mandate vaccinations for students, in the interest of getting them back to schools as soon as possible.
Get in touch with our news team by emailing us at [email protected].
For more stories like this, check our news page.
Source: Read Full Article