Pfizer/BioNTech says its coronavirus vaccine is 100% effective in 12 to 15 year olds

Pfizer/BioNTech on March 31 said that their vaccine showed 100 per cent efficacy against COVID-19 in 12-15 years old. 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. While the vaccine has already been authorised in the US for emergency use in people 16 and older, the company now plans to submit the data to the US FDA as soon as possible for expanded EUA of the two-dose vaccine. 

"We plan to submit these data to (US regulator) FDA as a proposed amendment to our Emergency Use Authorisation in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year," said Pfizer CEO Albert Bourla.

‘Children well protected by vaccination’ 

According to the press note, researchers observed 18 COVID-19 among the 1,129 participants who were given a placebo, and none among the 1,131 volunteers who got the vaccine. Pfizer/BioNTech said that the side effects seen in the young teens were similar to those seen among 16 to 25-year-olds. The company added that the side effects included pain at the injection site, fatigue and fever.  

Ugur Sahin, CEO and Co-founder of BioNTech, said, “The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant. It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones”. 

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. While the recent data is yet to be peer-reviewed, it is worth noting that a separate Phase 1/2/3 study of the Pfizer/BioNTech vaccine in children ages 6 months to 11 years launched last week, 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 next week 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/Pixabay)