Pfizer-BioNTech: three doses protect children under 5 against coronavirus

Hasta la fecha, los mayores de cinco años son quienes generalmente reciben las vacunas contra el SARS-CoV-2.

To date, those over the age of five are the ones who generally receive the SARS-CoV-2 vaccines.


The pharmaceutical companies BioNTech and Pfizer assured this Monday (05.23.2022) that “three doses” of their vaccine against SARS-CoV-2 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 an emergency approval by the health authorities.

The document maintains that during the trials an efficacy of 80.3 percent was observed 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 placebo”.

“Most 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, which adds that “the dose level of 3 µg (micrograms), which represents a 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 complete our presentations to the world’s regulators soon in the hope of making this vaccine available to the youngest children as soon as possible,” said the CEO of Pfizer, the company that distributes the inoculant worldwide. developed by the German BioNTech, Albert Bourla.

The announcement comes at a time when the United States Food and Drug Administration (FDA) has several meetings scheduled 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 two-dose vaccine in February, but data showed it didn’t elicit a strong enough immune response in children two to four years old.

“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.

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