British regulators on Wednesday approved the use of a COVID-19 vaccine for children aged 5 to 11 years old, paving the way for kids in that age group in Cayman to be vaccinated.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the new paediatric formulation of the Pfizer BioNTech COVID-19 vaccine, called Comirnaty, after finding that it is “safe and effective”, according to a statement issued by the agency.
MHRA Chief Executive Dr. June Raine assured parents and carers “that no new vaccine for children would have been approved unless the expected standards of safety, quality and effectiveness have been met”.
She added, “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.”
COVID pill approved in US
Meanwhile, in the United States, the Food and Drug Administration has authorised a Pfizer pill for COVID-19 in adults and children over the age of 12. The pill, known as Paxlovid, has been approved for treatment of mild-to-moderate coronavirus disease in COVID-positive people who are at high risk for progression to severe COVID-19, including hospitalisation or death, the FDA said in a statement.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally – a major step forward in the fight against this global pandemic,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”
The FDA noted that Paxlovid is not authorised for preventative use or for use in hospitalised patients who already have severe or critical COVID-19. The agency also pointed out that the drug is not a substitute for vaccinations and boosters.
Children’s vaccine ‘safe and effective’
The UK regulatory approval of the vaccine for ages 5-11 comes almost two months after the US authorised the use of vaccines for children in that age group. So far, 5.5 million doses of the vaccine have been administered to 5-11 year olds in the US.
Because the Cayman Islands receives its vaccines from the UK government, Cayman has to wait for authorisation from the UK before they can be administered here.
Children ages 5 through 11 years old will receive a separate vaccine formulation of the Pfizer-BioNTech COVID-19 vaccine, which contains one-third of the dose given to adolescents and adults, and children will receive the vaccine with a smaller needle.
The children will receive 10 micrograms of the vaccine, compared with 30 micrograms given to older individuals.
The Compass reached out to Public Health and the Governor’s Office to request information on when the paediatric doses will be available here. A spokesperson at the Governor’s Office said it has asked Chief Medical Officer Autilia Newton for eligible numbers “so that we can place an order with [the Foreign and Commonwealth Development Office]”.
Vaccines for children over the age of 12 became available here in June, after being approved by the MHRA.
Raine said the MHRA’s detailed review of side-effect reports on children who were vaccinated had 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 MHRA, in its statement, said it had liaised closely with other international regulators and public health bodies and had considered global data on use of the vaccine in 5-11 year olds.
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