Comirnaty® authorised for patients six months to four years
Posted: 7 December 2022 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
Comirnaty® has been authorised by the MHRA as a vaccine to protect against Covid-19 for individuals from six months to four years old.
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Comirnaty®, the Pfizer/BioNTech COVID-19 vaccine for infants and children aged six months to four years in Great Britain.
The new line extension approval is for a lower dose of the vaccine compared to the dose used for individuals aged 5 to 11 years (3mcg compared with 10mcg). According to the MHRHA, Comirnaty® is therefore suitable for infants from six month old to children up to four years, given as three injections in the upper arm, with the first two doses given three weeks apart, followed by a third dose given at least eight weeks after the second dose.
Data that facilitated the line extension of Comirnaty® for Covid-19
The MHRA reviewed data from an ongoing clinical trial involving 4,526 participants. The common, expected side effects were within expectations for a vaccine in this age group.
The Joint Committee on Vaccination and Immunisation (JCVI) will determine if the vaccine will be recommended for use in this age group as part of the UK’s COVID-19 vaccination programme. The Commission on Human Medicines (CHM), which endorsed the authorisation, advises ministers on the safety, efficacy and quality of medicinal products.
The line extension was authorised via the European Commission (EC) Decision Reliance Route, which means the marketing authorisation application (MAA) made by the company references the decision made by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Additional authorisations and recommendations of Comirnaty®
In October 2021, The EMA concluded that a booster dose of the Comirnaty® COVID-19 vaccine can be given to people with severely weakened immune systems, at least 28 days after their second dose.
In November 2021, the US Food and Drug Administration (FDA) authorised the emergency use of COVID-19 vaccine Comirnaty® in children aged five to 11 years. The acceptance was based on a randomised, placebo-controlled study that has enrolled approximately 4,700 children five to 11 years of age.
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BioNTech, Commission on Human Medicines (CHM), EMA Committee for Medicinal Products for Human Use (CHMP), European Commission (EC), Joint Committee on Vaccination and Immunisation (JCVI), Medicines and Healthcare Products Regulatory Agency (MHRA), Pfizer