COVID-19: BioNTech hopes to begin vaccination for ages 12-15 years from June in Europe

German biotechnology company BioNTech on April 29 said that it expected its coronavirus vaccine, jointly developed with Pfizer, to be available to 12 to 15-year-olds in Europe from June. While speaking to Der Spiegel weekly BioNTech’s CEO Ugur Sahin said that it was in the “first stretches” of preparing its submission for European regulatory approval. Sahin added that the evaluation of the trial data “takes four to six weeks on average”. 

Amid a surge in coronavirus cases, vaccinating children is believed to a crucial next step toward herd immunity and ending the pandemic. Sahin said that it is “important” to enable children a return to their normal school lives and allow them to meet with family and friends. He further said that he expects to submit a request for an emergency use authorisation for 12-15 year-olds on May 5. 

Back in March, BioNTech and Pfizer had announced that phase 3 clinical trials of the coronavirus vaccine for children aged 12-15 showed it was 100 per cent effective in warding off the disease. Sahin added that in July, the first results for five t 12-year-olds could be available and those for younger children in September. He further continued that the ongoing trials so far are “very encouraging”, suggesting that “children are very well protected by the vaccine”. 

Pfizer seeks authorization for 12-15-yr olds in US

The Pfizer/BioNTech shot is based on novel mRNA technology and it was the first COVID-19 vaccine to be approved in the West last year. Earlier this month, Pfizer-BioNTech also asked the US Food and Drug Administration to allow them to use the vaccine on adolescents between 12 to 15 years of age. The preliminary results showed that the vaccine was safe in blocking infections.

According to a press release, in the Phase 3 trial of 2,260 participants ages 12 to 15 in the US, the vaccines demonstrated strong antibody responses one month after the second dose. A separate Phase 1/2/3 study of the Pfizer/BioNTech vaccine in children ages 6 months to 11 years launched in March, when the first participants’ ages 5 to 11 received a shot. As per the press note, the company plans to begin dosing 2 to 5-year-olds and work its way down to participants ages 6 months and 2 years. The company aims to enrol 4,644 children in the trial and expects results by the end of 2021. 

(Image: AP)