Photo: ANGELIKA WARMUTH/DPA/PICTURE ALLIANCE / Deutsche Welle
The pharmaceutical companies BioNTech and Pfizer assured this Monday (23.05.2022) what ” three doses” of its SARS-CoV-2 vaccine offer “a strong immune response, high efficacy and favorable safety” in children between 6 months and 5 years. The companies highlighted that, according to the information collected in their clinical trials, the three doses meet the criteria required for emergency approval by the health authorities.
The document states that during the trials an efficacy of 80 was observed, 3 percent after the third dose, at a time when the omicron variant of SARS-CoV-2 was predominant. Likewise, it points out that the third dose of 3 micrograms was well tolerated by 1, 678 children under five years of age “with a safety profile similar to that of placebo”.
“Most of the adverse events were mild or moderate” both among those who received the doses of the preparation and those who received the placebo, states the note, adding that “the 3 µg (microgram) dose level, which represents one-tenth of the adult dose, was selected for children under 5 years of age based on safety, tolerability, and immunogenicity.” .
Presentation to regulators
“We hope to soon complete our presentations to regulators around the world hoping to make this vaccine available to the youngest children as soon as possible,” said the CEO of Pfizer, the company that distributes the developed inoculant worldwide. by the German BioNTech, Albert Bourla.
The announcement comes at a time when the US Food and Drug Administration (FDA) has Several meetings are planned to analyze the authorization of the coronavirus vaccine for the segment of younger children, who are not eligible for vaccination in most countries. The agency originally planned to test BioNTech’s vaccine given in two doses in February, but data showed it did not elicit a strong enough immune response in children ages two to four.
“Pfizer reports follow-up data only up to seven days after the third dose of the vaccine. It’s too early to say how three doses would work after several months or a year,” said Celine Gounder, chief public health editor for Kaiser Health News.