(CMR) Children five to eleven years old here in the Cayman Islands could soon be able to get vaccinated against the coronavirus as the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Pfizer vaccine for that age group. The new pediatric formulation of the Pfizer BioNTech COVID-19 vaccine was approved after meeting the required safety, quality, and effectiveness standards.
Dr. June Raine, MHRA Chief Executive, said, “Parents and carers can be reassured that no new vaccine for children would have been approved unless the expected standards of safety, quality, and effectiveness have been met.
“We have concluded that the Pfizer/BioNTech COVID-19 vaccine is safe and effective for 5 to 11-year olds, with no new safety concerns identified. We have carefully considered all the available data and reached the decision that there is robust evidence to support a positive benefit-risk for children in this age group,” Dr. Raine added.
“Our detailed review of all side-effect reports to date has found that the overwhelming majority relate to mild symptoms, such as a sore arm or a flu-like illness. We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines, and this includes children aged 5 to 11 years old.”
The vaccine will be given at a lower dose than used in individuals aged 12 and above (10 micrograms compared with 30 micrograms). As with other age groups, it will be given as two injections in the upper arm. It will be for the Joint Committee on Vaccination and Immunisation (JCVI) to make the final recommendation on the dosing interval.