Oliver Ortega (13 years old) and his twin brother received 2 doses of Pfizer vaccine during a series of vaccinations for children aged 13 to 17 years old in Spain on September 1. Each country has its own regulations on vaccines given to age groups – Photo: REUTERS
Reuters news agency cited two sources with knowledge of the matter, revealing that a COVID-19 vaccine manufactured by Pfizer could be approved by the FDA for children aged 5-11 in October. Pfizer is said to have the data ready and ready to apply for an emergency use authorization (EUA) for the 5-11 year old group later this month.
The FDA will conclude whether the vaccine is safe and effective for this age group within three weeks of Pfizer’s EUA application, the source told Reuters.
According to Reuters, such a process is quick in the context of many American parents concerned about the health of their children because of the spread of the Delta variant. Rising infections among children disrupted teaching and learning in several US school districts earlier this month.
A Reuters source revealed that Moderna could file an EUA application a few weeks later than Pfizer, and it is expected that as early as November, the Moderna vaccine will be urgently licensed for injection to the 5-11 year old group in the US.
Last month, the FDA fully authorized the use of the Pfizer vaccine for people over 16 years old based on the results of a six-month trial. The vaccine is also approved for emergency use in 12 to 15 year olds in the United States.
In December last year, the FDA took only two months to urgently approve the Pfizer vaccine for the vaccination campaign, according to Reuters.
In addition to clinical trial data on 5-11 year olds, Pfizer also said data on 2-5 year olds is being prepared and will be reported to the FDA soon.
For children 6 months to under 2 years, Pfizer expects safety and immunogenicity data to be available as early as October or November of this year.
In Europe, Pfizer’s partner BioNTech has also announced its intention to apply for a global license to vaccinate 5-11 year olds. Currently BioNTech is in the process of preparation and could be done in “a few weeks”.