By Tara Rippin • 31 March 2021 • 16:34
Pfizer/BioNTech claims its Covid jab is 100 per cent effective among young teenagers.
The results of clinical trials of Pfizer/BioNTech’s Covid-19 vaccine showed its efficacy is 100 per cent and it is well tolerated in youths ages 12 to 15, the firms announced today, Wednesday, March 31.
The companies plan to submit these data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as soon as possible.
“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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“We plan to submit these data to 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.”
Ugur Sahin, CEO and Co-founder of BioNTech said the initial results 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”.
“Across the globe, we are longing for a normal life. This is especially true for our children. . 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.”
Both companies stressed that in a Phase 3 trial of 2,260 adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech Covid-19 vaccine BNT162b2 demonstrated 100 per cent efficacy and robust antibody responses.
This, they said, exceeds those recorded earlier in vaccinated participants aged 16 to 25 years old, “and was well tolerated”.
Researchers observed 18 Covid-19 cases among the 1,129 participants who were given a placebo, and none among the 1,131 volunteers who got the vaccine. The data has yet to be peer reviewed.
Pfizer/BioNTech added that the side effects seen in the young teens were similar to those seen among 16 to 25-year-olds. Common side effects include pain at the injection site, fatigue and fever. The participants will be monitored for protection and safety for two years after their second dose.
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Tara Rippin is a reporter for Spain’s largest English-speaking newspaper, Euro Weekly News, and is responsible for the Costa Blanca region.
She has been in journalism for more than 20 years, having worked for local newspapers in the Midlands, UK, before relocating to Spain in 1990.
Since arriving, the mother-of-one has made her home on the Costa Blanca, while spending 18 months at the EWN head office in Fuengirola on the Costa del Sol.
She loves being part of a community that has a wonderful expat and Spanish mix, and strives to bring the latest and most relevant news to EWN’s loyal and valued readers.
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