Pfizer/BioNTech applies for a license to give booster shots for children 5-11 years old

On April 26, US pharmaceutical company Pfizer and German biotech company BioNTech announced that they had submitted to the US Food and Drug Administration (FDA) an application for an emergency use authorization of the vaccine Comirnaty against COVID-19. -19 co-developed by these two firms as a booster nose for children aged 5-11.

The move comes after a new study showed that a booster shot with the Comirnaty vaccine induces a strong immune response in healthy children in this age group.

If approved, Comirnaty will be used as a booster for children aged 5 to 11 years who have had the full primary dose and 6 months after the last dose of vaccine. Children in this age group were given a dose of 10 micrograms, one-third of the adult dose.

Earlier, on April 14, Pfizer and BioNTech confirmed that the third dose of Comirnaty vaccine could provide significant protection against the Omicron variant in healthy children aged 5 to 11 years.

According to Pfizer and BioNTech, the serological test results of 30 children who received a booster shot of the COVID-19 vaccine showed a 36-fold increase in the concentration of neutralizing antibodies against Omicron. Neutralizing antibodies against the original strain of the virus SARS-CoV-2, the target the vaccine was developed for, increased sixfold after a booster shot.

The study was performed to test the safety and immunogenicity in 140 healthy children aged 5-11 years after a booster dose of 10 micrograms.

Earlier this year, the FDA approved the use of Pfizer and BioNTech vaccines as booster shots for children 12-15 years old and children 5-11 years old who are immunocompromised.

According to the US Centers for Disease Control and Prevention (CDC), only 28% of children aged 5-11 in the US – or more than 8 million children – have completed basic doses of the COVID-19 vaccine. 19.

There is currently no approved vaccine for COVID-19 for children under 5 years of age.