Study: Pfizer jab ‘100% effective’ in kids aged 12 to 15
THE Pfizer Covid-19 jab, pictured, is “100% effective and well tolerated” among children aged 12 to 15, a new study suggests.
Pfizer said it now plans to seek approval for use of the vaccine in this age group from regulators around the world and hopes youngsters will start to receive the jab before the next school year.
The pharmaceutical company said it plans to submit the data to the UK regulator – the Medicines and Healthcare products Regulatory Agency – within the next couple of months.
Researchers examined the use of the Pfizer/ Biontech vaccine in a trial of 2,260 teenagers in the US.
Half were given the jab and the other half were given a placebo drug. There were no Covid-19 cases seen in the group who received the vaccine and 18 infections among those who did not.
Albert Bourla, chief executive of Pfizer, said: “We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15.
“We plan to submit these data to FDA (the US Food and Drug Administration) 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.”
Ugur Sahin, chief executive and co-founder of Biontech, said: “Across the globe, we are longing for a normal life. This is especially true for our children.
“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.”
Pfizer said the jab “demonstrated 100% efficacy and robust antibody responses exceeding those reported in trial of vaccinated 16-25-year-old participants in an earlier analysis”.
Participants in the Phase 3 trial, conducted in the US, showed “strong immunogenicity” a month after the second dose of the jab.
It added that “administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age”.
All participants in the trial will be monitored for two years after their second dose. Pfizer and Biontech said they plan to submit the data for scientific peer review for potential publication.
Commenting on the news, Dr Stephen Griffin, associate professor at the University of Leeds, said: “In short, this is fantastic news. Demonstrating efficacy and safety in younger patients is an important step forwards in terms of enabling eventual population immunity against Sars-cov2.
“It will enable a long term programme of school-based vaccination to be implemented following the initial rollout, ensuring that our population is well protected from the virus in the future.”
Dr Peter English, retired consultant in communicable disease control, added: “When the full, peer-reviewed papers appear – or when regulators receive the data directly from the companies – it will open up the way to extending vaccination to this age group (and likely to the younger age group referred to).
“It will be important to do this to achieve herd immunity.”
Meanwhile, the companies also announced they have dosed the first children in a trial assessing the safety and effectiveness of the jab in youngsters aged six months to 11 years.