EU approves Pfizer-BioNTech COVID-19 vaccine for children aged 12 years


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The European Commission on May 28, 2021 approved the use of Pfizer and BioNTech SE’s COVID-19 vaccine to vaccinate children as young as 12. 

The decision comes after European Medicines Agency (EMA) approved the use of the vaccine among adolescents aged between 12-15 years.

The move will enable broadening of the vaccination rollout in the European Union covering a larger part of the population. The United States and Canada have already given the clearances for use of the vaccine among adolescents. 

Key Highlights 

• The Pfizer-BioNTech vaccine is already being used in the European Union to vaccinate those aged 16 years and above.

• The European Medicines Agency was evaluating the use of the vaccine in the 12-15 age group as well. 

• The Pfizer-BioNTech vaccine is being sold in the European Union under the brand of Comirnaty. 

• The European Medicines Agency stated that two doses of the vaccine were required in the 12-15 age group and should be administered with an interval of at least three weeks, the same gap as for adults.

• The EMA also added that it was up to individual EU member states to decide if and when to offer the vaccine to the teenagers.

• Pfizer and BioNTech said that the distribution and administration of the vaccine by the EU member states will continue to be determined according to the populations identified in the EU and as per national guidance.

• Germany on May 27, 2021 already announced its plans to vaccinate 12 – 16-year-olds from June 7 after EMA’s approval. 

• Italy has also been preparing to expand its vaccination campaign to over 12-year olds.

Pfizer-BioNTech vaccine efficacy in adolescents 

• As per the trial data unveiled by Pfizer and BioNTech in March, their vaccine offers 100 percent protection against COVID-19 among adolescents. 

• The trial was conducted with around 2,260 adolescents aged between 12 and 15 years. The vaccine also showed less side effects. 

• However, the safety monitoring in trials conducted in the 12-15 age group was done for a shorter duration as compared to the older generation. However, according to EMA, this is not a concern. 

• The health agency noted that based on the experience gathered with many other vaccines throughout the years, what we see with young adults is also seen in adolescents.

Background 

• Japan also joined the countries in giving a go-ahead to Pfizer’s Comirnaty vaccine to innoculate 12-year-olds.

• While young people have been much less likely to suffer severe disease, with many experiencing no symptoms, they play a huge role in transmitting COVID-19 to others.

• Hence, vaccinating children and young people is considered a critical step toward reaching “herd immunity” and taming the pandemic.

• However, the move of giving vaccines to younger people in affluent countries has raised concerns, as the older and more vulnerable population in many parts of the world still has not got their vaccines.



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