The Pfizer / BioNTech Covid-19 vaccine has been approved for use in ages 12 to 15, the Medicines and Health Products Regulatory Agency said.
The Medicines and Health Products Regulatory Agency (MHRA) has approved the Pfizer Covid-19 vaccine for use in 12 to 15 year olds.
The MHRA said the decision followed a “rigorous review” of safety and effectiveness in this age group.
Dr June Raine, Managing Director of the MHRA, said: “We have carefully reviewed the data from clinical trials in children aged 12 to 15 years and concluded that the Pfizer / BioNTech Covid-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk.
“We have a comprehensive safety oversight strategy in place to monitor the safety of all approved Covid-19 vaccines in the UK and this oversight will include the 12-15 age group.
“No license extension would be approved unless expected standards of safety, quality and efficacy have been met.
“It will now be up to the Joint Committee on Immunization and Immunization (JCVI) to indicate whether this age group will be vaccinated as part of the deployment program. ”
More than 2,000 children have participated in the clinical trial to determine the safety of the Pfizer / BioNTech vaccine, said the chairman of the Commission on Human Medicines.
Professor Sir Munir Pirmohamed said: “We have been very careful to consider the younger age group and the benefits of vaccinating this population against any potential risk of side effects.
“There has been an extensive evaluation and review of this data which has also been reviewed specifically by the CHM’s Pediatric Medicines Expert Advisory Group, who are scientific experts in this age group, as well as the group expert work on the risks and benefits of CHM’s Covid-19 vaccines.
“We concluded that based on the data we saw on the quality, efficacy and safety of the vaccine, its benefits outweigh any risk. The MHRA will continue to review all data on suspected side effects received under the rigorous surveillance program in place through the yellow card program and other safety surveillance measures for all Covid-19 vaccines used in the country. UK.
“More than 2,000 children between the ages of 12 and 15 have been studied in randomized, placebo-controlled clinical trials. There were no cases of Covid-19 from seven days after the second dose in the vaccinated group, compared to 16 cases in the placebo group.
“In addition, the data on the neutralizing antibodies showed that the vaccine worked at the same level as seen in adults aged 16 to 25 years. These are extremely positive results.”
The UK has taken longer than other countries to approve the vaccine for children.
Appearing on Sky New last week, Vaccines Minister Nadhim Zahawi was asked why the UK had not followed in the footsteps of the European Medicines Agency, which recommended that the Pfizer / BioNTech vaccine be extended to children ages 12 to 15.
Mr. Zahawi replied, “Our own regulatory body has yet to approve the administration of vaccines to children.
“You have to make sure the vaccines are incredibly safe before you give them to children. ”
Mr Zahawi explained that while some children may be infected or develop a long Covid, “overall you are vaccinating to protect their families and their communities and the country”.
He added, “So vaccines… have to be incredibly safe before they are given to children.”
He said the “infrastructure” is in place to prick children in the UK if necessary, but “clinicians need to make that final decision”.
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Source: www.times-series.co.uk
This notice was published: 2021-06-04 13:10:49
