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EU drugs regulator recommends Pfizer/BioNTech vaccine for children 12-15

29th May 2021
EU drugs regulator recommends Pfizer/BioNTech vaccine for children 12-15

By Agnes Szucs

 

BRUSSELS (AA): The European Medicine Agency (EMA) on Friday authorized the Pfizer/BioNTech vaccine for use in children aged 12 and 15.

“The EMA’s Committee for Human Medicine approved today the use of vaccines from Pfizer-BioNTech, called Comirnaty, for adolescents from 12 to 15 years,” Marco Cavaleri, the head of Biological Health Threats and Vaccines Strategy at EMA, announced at a press conference in Brussels.

He explained that clinical trials with the involvement of over 2,000 adolescents proved a similar or even better immune response compared to young adults.

The side effects were also comparably mild to the ones young adults experienced after vaccination.

Upon the recommendation of the EU drugs regulator, the European Commission will modify the marketing license of the jabs, changing the youngest age of recommendation to 12 years from 16 years.

Based on the decision, the EU states will be free to decide whether to extend vaccination programs to young adolescents.

The BioNTech/Pfizer vaccine was the first COVID-19 shot authorized in the EU.

The vaccine uses an innovative mRNA technique based on a messenger molecule with instructions to produce a protein from the virus that causes COVID-19 to prepare the body to fight the disease.

Contrary to traditional vaccines, BioNTech/Pfizer does not contain the virus itself.

Meanwhile, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) approved Friday a fourth Covid vaccine, single dose Janssen Vaccine for Covid-19 manufactured by Johnson and Johnson.

Dr June Raine, MHRA Chief Executive, said: “We have undertaken a thorough review of the conditional marketing authorisation application submitted by Janssen, including the information on quality, safety and effectiveness. I am pleased to confirm today that this authorisation has been granted.”

The Joint Committee on Vaccination and Immunisation (JCVI) will submit ‘updated advice’ for the vaccine before doses become available.

The vaccine can be stored at fridge temperatures of +2-8C and was shown to be 66% effective in phase 3 trials earlier this year, the Department of Health and Social Care (DHSC) said.

It also showed the vaccine is 85% effective in preventing severe disease, with a reduction in hospitalisations from 14 days following the jab, the manufacturer added.

The vaccine is similar to the Oxford/AstraZeneca jab, but delivers a protein from the spike of the coronavirus through a human common cold instead of a chimp adenovirus.

Additional report by The Muslim News

[Image of Covid-19 vaccine and syringe against Biontech and Pfizer logos by Marco Verch /Creative Commmons]

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