A brand new age-appropriate formulation of the Pfizer BioNTech COVID-19 vaccine (Comirnaty) to be used in kids aged 5 to 11 years outdated has been accredited at the moment by the Medicines and Healthcare merchandise Regulatory Company (MHRA) after discovering that it’s protected and efficient.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 strong evaluation of security knowledge that reveals a constructive benefit-risk profile for this vaccine for use on this age group.
Dr June Raine, MHRA Chief Government stated: “Dad and mom and carers will be reassured that no new vaccine for kids would have been accredited except the anticipated requirements of security, high quality and effectiveness have been met.
“We’ve got concluded that the Pfizer/BioNTech COVID-19 vaccine is protected and efficient for five to 11-year olds, with no new security considerations recognized. We’ve got rigorously thought of all of the accessible knowledge and reached the choice that there’s sturdy proof to assist a constructive profit threat for kids on this age group.
“Our detailed evaluation of all side-effect studies so far has discovered that the overwhelming majority relate to delicate signs, equivalent to a sore arm or a flu-like sickness. We’ve got in place a complete security surveillance technique for monitoring the protection of all UK-approved COVID-19 vaccines and this contains kids aged 5 to 11 years outdated.”
Right now’s approval is for a formulation specifically designed for 5-11 12 months 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 choice, the MHRA has liaised carefully with different worldwide regulators and public well being our bodies and punctiliously thought of international knowledge on use in 5-11-year olds. These knowledge show 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.