Pfizer and BioNTech today announced the results of a phase 2/3 study showing for their Covid vaccine “a favorable safety profile and robust response” in terms of neutralizing antibodies in children aged 5 to 11 years, using a two-dose regimen of 10 micrograms (µg) 21 days apart. This is a lower dose than that (30 µg) used for people aged 12 years and over.
The antibody responses in the participants who were given these quantities “were comparable to those recorded in a previous Pfizer-BioNTech study in people aged 16-25 years immunized with doses of 30 µg,” the two companies explain in a note. . “The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children aged 5 to 11 years.”
Pfizer and BioNTech they intend to present data on their Covid vaccine “as soon as possible” in the 5-11 year range the US Food and Drug Administration (Fda) and the European Medicines Agency Ema, but also to other regulatory bodies. On the one hand, they explain, “a request to the EMA is expected to update the EU conditional marketing authorization”. On the other hand, for the United States, companies plan to include the data in a short-term submission for Emergency Use Authorization (Eua), while they continue to accumulate safety and efficacy data needed to submit the request for full approval in this age group.
“Over the past 9 months, hundreds of millions of people 12 years of age and older from around the world have received our Covid vaccine. We look forward to extending the vaccine protection to this younger, affected population. ‘regulatory clearance, as we follow the spread of the Delta variant and the substantial threat it poses to children, ”said Albert Bourla, Pfizer president and CEO. “Since July, pediatric cases of Covid have increased by about 240% in the United States, highlighting the need for vaccination” from a public health point of view, he adds. “These results of the trial – he concludes – provide a solid basis for requesting the authorization of our vaccine for children aged 5 to 11 and we plan to urgently present them to the FDA and other regulators”.