MHRA approves new formulation of Pfizer BioNTech COVID-19 vaccine for 5-11 yr olds

A brand new age-appropriate formulation of the Pfizer BioNTech COVID-19 vaccine (Comirnaty) to be used in youngsters aged 5 to 11 years previous has been accepted at the moment by the Medicines and Healthcare merchandise Regulatory Company (MHRA) after discovering that it’s protected and efficient. This approval was given following a sturdy overview of security knowledge that exhibits a constructive benefit-risk profile for this vaccine for use on this age group.

Dad and mom and carers may be reassured that no new vaccine for youngsters would have been accepted until the anticipated requirements of security, high quality and effectiveness have been met.


Now we have concluded that the Pfizer/BioNTech COVID-19 vaccine is protected and efficient for five to 11-year olds, with no new security issues recognized. Now we have rigorously thought of all of the accessible knowledge and reached the choice that there’s sturdy proof to assist a constructive profit danger for youngsters on this age group.


Our detailed overview of all side-effect stories up to now has discovered that the overwhelming majority relate to delicate signs, reminiscent of a sore arm or a flu-like sickness. Now we have in place a complete security surveillance technique for monitoring the security of all UK-approved COVID-19 vaccines and this consists of youngsters aged 5 to 11 years previous.”


Dr June Raine, MHRA Chief Govt

At the moment’s approval is for a formulation specifically designed for 5-11 yr olds and given at a decrease dose in comparison with that utilized in people aged 12 and above (10 micrograms in contrast with 30 micrograms).

As with different age teams, it’s given as two injections within the higher arm. Will probably be for the Joint Committee on Vaccination and Immunisation (JCVI) to make the ultimate suggestion on the dosing interval.

In coming to this determination, the MHRA has liaised carefully with different worldwide regulators and public well being our bodies and punctiliously thought of world knowledge on use in 5-11-year olds. These knowledge reveal a beneficial security profile in contrast with that seen in different age teams. Over 5.5 million dosages of the vaccine in 5-11s have now been administered within the US alone.

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