At the end of April, it was the Moderna company that applied for permission for the Covid vaccine for the youngest part of the population (6 months – 5 years). Now, Pfizer is getting closer to this step with the announcement of Phases 2 and 3 of the connection. With three doses of Pfizer-BioNTech vaccine, an effect of 80.3% was observed during a period in which Omicron variant of Sars CoV 2 was already prevalent. It is one of the “positive” data from the experiment, which today is shared by the two American and German companies. Data, which we read in a note, “showed that three doses of the vaccine” make it possible to obtain “a strong immune response, high efficiency“With” a favorable safety profile in this age group “.
The experiment, the main data of which is shared today, was performed to evaluate a third dose of 3 micrograms. After this third dose, the companies explain, a strong immune response was found, “with a favorable safety profile similar to placebo”. Vaccine efficacy was the secondary measure of this trial and was found to be 80.3%. This descriptive analysis was based on 10 symptomatic cases identified, starting 7 days after the third dose and accumulating from 29 April. The trial protocol specifies that a formal analysis will be performed when at least 21 cases have been collected. And final power data will be shared as soon as they become available.
“Our Covid vaccine has been tested in thousands of children and adolescents, and we are pleased that our formulation for the little ones, which we have carefully selected to be one tenth of the adult dosewas well tolerated and produced a strong immune response, ”he said Albert Bourla, President and CEO of Pfizer. These key data on safety, immunogenicity and efficacy are encouraging and we look forward to implementing our ‘approval’ requests to regulators globally soon with the hope of making this vaccine available to younger children as soon as possible, with prior permission. The study – he added Ugur SahinCEO and co-founder of BioNTech – suggests that a low dose of 3 micrograms of our vaccine, carefully selected based on tolerability data, gives children a high level of protection against recent strains of Covid“” We are preparing the necessary documents, “he continued,” and we plan to complete the submission process to the FDA this week. Requests to EMA and other agencies will follow in the coming weeks “.
In the Phase 2-3 study, 1,678 infants received a third dose of 3 µg at least 2 months after the second, at a time when Omicron was the predominant variant. The immunogenicity analysis of the geometric mean of neutralizing titers (Gmt) and of the sero-response rate was performed on a subset of participants under 5 years one month after the third dose and compared to the second dose in patients aged 16-25 years. . The non-inferiority of this third dose in children was found both for the population aged 6-24 months and for those between 2 years and under 5. No new safety signals were identified. Most side effects were mild or moderate. “Studies in adults, adolescents and children over 5 years of age – the two companies highlight in the note – continue to indicate that three doses of Pfizer-BioNTech’s anti-Covid vaccine improve protection compared to two doses.”