The UK Medicines and Healthcare products Regulatory Agency (MHRA) have approved Pfizer’s COVID-19 vaccine for 12-15-year-olds.
“We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded the Pfizer/BioNTech COVID-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk,” a statement from the UK medicines regulator confirmed.
“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance will include the 12-to-15-year age group.”
Side effects risk closely watched
Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicines, said the benefits of being vaccinated outweighed potential risk of side effects.
“We have concluded that based on the data we have seen on the quality, effectiveness and safety of the vaccine, its benefits do outweigh any risk.”
More than 2000 children aged 12-15 years were studied as part of the clinical trials. There were no cases of COVID-19 from seven days after the second dose in the vaccinated group, compared with 16 cases in the placebo group, the MHRA said.
Antibody young adult parity claimed
“In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16-25 years. These are extremely positive results.”
Italy approved the Pfizer vaccine on Monday. On Wednesday President Macron confirmed French teenagers 12-18 would be eligible for vaccine from 15 June.
New York City-based Pfizer has a dividend yield of 3.84 and reported $0.93 in earnings per share in the first quarter. Its share price is up more than 13.5% in the last 12 months.