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FDA approves updated COVID-19 boosters for children aged from six months

The Moderna and Pfizer/BioNTech boosters both target the BA.4/BA.5 omicron subvariants


The US Food and Drug Administration (FDA) has authorised the use of the BA.4/BA.5 Omicron-adapted bivalent Moderna and Pfizer/BioNTech COVID-19 boosters to include the use in children aged from six months.

The Pfizer/ BioNTech vaccine is now indicated for children aged six months to four years who have not yet received the third dose of the three-dose primary series with the monovalent Pfizer/BioNTech COVID-19 vaccine.

Meanwhile, Moderna’s bivalent vaccine is now authorised for children aged six months to five years as a single booster dose after completion of primary vaccination with the company’s monovalent vaccine.

“As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalisations, and deaths,” said FDA commissioner Robert Califf.

The Moderna and Pfizer/BioNTech bivalent COVID-19 vaccines both include an mRNA component targeting the original strain to provide an immune response that is broadly protective against COVID-19, as well as an mRNA component corresponding to BA.4/BA.5 subvariants.

The authorisation of the Pfizer/BioNTech bivalent vaccine was supported by the FDA’s previous analyses of the effectiveness of primary vaccination with the monovalent Pfizer/BioNTech vaccine in individuals aged 16 years and older and in children aged six months to four years.

Previous analyses of immune response data in adults aged over 55 years who had received a two-dose primary series and one booster dose with the monovalent Pfizer/BioNTech vaccine and a second booster dose with the investigational bivalent COVID-19 vaccine – original and omicron BA.1 – also supported the FDA’s decision.

For the authorisation of Moderna’s bivalent vaccine, the FDA relied on immune response data that it had previously evaluated from a clinical study in adults of a booster dose of the company’s investigational bivalent COVID-19 vaccine targeting both the original strain of SARS-CoV-2 and BA.1.

Also supporting Moderna’s application was data from a clinical study which showed the immune response to a booster dose of the monovalent Moderna COVID-19 vaccine in children aged 17 months to five years was comparable to the immune response to the two-dose primary series in adult participants aged 18 to 25 years.

“Vaccines remain the best defence against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalisation and death. Based on the available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Article by
Emily Kimber

9th December 2022

From: Research, Regulatory



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