Two 10-microgram doses, one-third the approved dosage for older adults, of Pfizer-BioNTech’s Covid vaccine, have been shown to be effective in children between the ages of 5 and 11. The news – which the American Pfizer announced via Twitter – comes from the results of a phase 2/3 study just published in the ‘New England Journal of Medicine’.
Studies on children
A phase 1 study to determine the appropriate dose based on age groups and a randomized phase 2-3 study to investigate the safety, immunogenicity and efficacy of two doses of the BNT162b2 vaccine are currently underway. 21 days apart in children aged 6 months to 11 years. On the New England Journal of Medicine The results for children aged 5 to 11 have been published. After phase 1, it was decided to opt for 10 micrograms doses. In the subsequent phases, 2,268 children were involved, of which 1,517 received the vaccine and 751 received placebo. Then, they were followed up for 2-3 months. Thus it was found that the Pfizer vaccine has a favorable safety profile. In particular, the two 10 microgram doses of the BNT162b2 vaccine, administered 21 days apart, were found to be safe, immunogenic and 90.7% effective against Covid-19 in children between the ages of 5 and 11.
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Adverse events
The coronavirus neutralization response seen in children aged 5 to 11 years was similar to that seen in adolescents aged 16 to 25 in the pilot study, which demonstrated 95% efficacy of the vaccine among people aged 16 years or older. 7 days to approximately 2 months after the second dose. In addition – we read in the study on New England Journal of Medicine no serious adverse events related to the vaccine were noted. As for the adverse events, they were recorded of short duration (1-2 days). Compared to adults and adolescents in the pilot study, children aged 5 to 11 years reported a higher incidence of injection site redness (15 to 19%, versus 5-7%) and swelling (10 to 15%, versus 5-8%), but a generally lower incidence of systemic events, including fever (3 to 7%, versus 1-20%) and chills (5 to 10%, versus 6-42%). Lymphadenopathy was reported in 0.9% of recipients, an incidence similar to that in 12-15 years (0.8%) but higher than that seen in adults (0.3%). Four potentially vaccine-related rashes have been reported, too few to determine if the pattern was similar to that seen in adult Pfizer recipients. However, no cases of MIS-C have been reported, although surveillance continues. Neither myocarditis nor pericarditis were observed, a finding consistent with the low frequency of these adverse events with Pfizer use in other age groups.
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The opinion of the experts
Among the first to comment on the news Sarah Palmer, co-director of the Center for Virus Research at the Westmead Institute for Medical Research and lecturer at the University of Sydney School of Medicine. “These are exciting results. This research further underscores the safety and efficacy of the Pfizer Covid-19 vaccine for children, which is one-third the adult dose. vaccinations for children between the ages of 5 and 11. We should extend the same protections to children under the age of 12 in Australia as well. “
Invites Professor to be cautious Robert Booy, infectious disease and vaccine expert with an honorary chair at the University of Sydney: “Importantly, as only 1,500 children have received the Pfizer vaccine, the safety data regarding rare side effects is inadequate. We need of information on 1000 times more children (from one to 2 million) to be adequately reassured that young children do not suffer from serious but important side effects such as myocarditis and pericarditis “. The expert recalls that “We know that the incidence of myocarditis after mRNA vaccines is higher after the second dose than the first, higher in boys than in girls and higher in adolescents than in young adults. The real possibility remains that children between the ages of 5 and 11 may have an even greater risk of myocarditis, despite the fact that only a 1/3 “dose was used in this study.
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