May 28, 2021

expert reaction to safety, immunogenicity and efficacy results from the trial of the Pfizer-BioNTech COVID-19 vaccine in adolescents

A study published in the New England Journal of Medicine (NEJM) looks at safety, immunogenicity, and efficacy results from the Pfizer-BioNtech COVID-19 vaccine trial in children aged 12 to 15.

Prof Peter Openshaw, Professor of Experimental Medicine, Imperial College London, said:

“This appears to be a well conducted study, supported by Pfizer and BioNTech.

“Subjects aged 12-15 or 16-25 years of age were given 2 doses of the BNT162b2 vaccine 21 days apart; adverse effects were minor and limited to transient local pain (in about 80% of recipients) and then systemic effects of fatigue, headache, chills and muscle pain in a lower proportion of cases.  Interestingly, the systemic side effects were slightly commoner after the second dose (as previously observed with this vaccine).

“The younger age group developed better immune responses than the older group.  Those given the vaccine appeared fully protected against infection from day 7 after the second dose: there were 16 cases of infection in the placebo group of 1129 individuals, but none in the 1131 who were vaccinated.  This is reassuring, showing that the vaccine is safe and effective down to the age of 12.  There is no information about the efficacy of the vaccine against novel SARS-CoV-2 variants.”

Prof Daniel Altmann, Professor of Immunology, Department of Immunology and Inflammation, Imperial College London, said:

“This is not unexpected news, but important news from an urgently needed study nevertheless.  That is, there was every reason to assume that the vaccine would be safe, immunogenic and efficacious in adolescents, but they had not been eligible for inclusion in the original trials.  It has great local relevance for the UK at present: the disproportionate uptick in cases in the Northwest is especially in teenagers, presumably because they’re unvaccinated and mixing.  Unless we want to make schools the new incubators for spread of variants, it makes sense to keep vaccinating down through the age groups.”

‘Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents’ by Robert W. Frenck, Jr et al. was published in the NEJM on Thursday 27 May 2021.

DOI: 10.1056/NEJMoa2107456

https://www.nejm.org/doi/full/10.1056/NEJMoa2107456

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

Declared interests

Prof Peter Openshaw: “Peter Openshaw has served on scientific advisory boards for Janssen/J&J, Oxford Immunotech, GSK, Nestle and Pfizer in relation to immunity to viruses (fees paid to Imperial College London).”

None others received.