Europe Authorizes Pfizer Vaccine in Children 5-11 Years

• The European Medicines Agency considers that the benefits of its emergency use exceed the risks

• The EU is thus following in the footsteps of the US and that of Pfizer will be the first approved serum for children

–

The European Medicines Agency (EMA) has authorized this Thursday to emergency use from vaccine against him covid-19 developed by laboratories Pfizer/BioNTech in the children between 5 and 11 years old, with what will become the first that can be used in this age group in the European Union (EU). The Twenty-seven thus follow in the wake of USA who already authorized the use of this serum for the little ones at the end of October. According to the conclusion of the EMA, the vaccine is safe and effective and will be administered in two injections of 10 micrograms in the arm, a third of that administered to those older than 12 years (30 mcg), with an interval between both of three weeks.

As explained by the EMA, the main study carried out in almost 2,000 children among children aged 5 to 11 years has shown that the immune response with a dose The lowest rate in this age group is comparable to that observed with the dose administered to people aged 16 to 25 years and as in this group the “benefits outweigh the risks, especially in those with conditions that increase the risk of severe covid19” although the EMA will continue to monitor closely as they are used in vaccination campaigns.

The side effects They are also similar to those seen in those over 12 years of age and include injection site pain, tiredness, headache, redness and swelling at the injection site, muscle pain, and chills. These effects are usually mild or moderate and improve within a few days of vaccination. According to the recommendation of the EMA, which continues to evaluate the use of Moderna serum (spikevax) for children 6 to 11 years old, the vaccine has a 90.7% effectiveness in preventing symptomatic covid19 although the real rate could range between 67.7 and 98.3%.

In the footsteps of the USA

The first country to authorize the use of Pfizer serum in children between the ages of 5 and 11 was the United States on October 29. According to the Food and Drug Administration (FDA), the immune response of children in this age group is comparable to that of young people between 16 and 25 years old and was 90.7% effective in the covid prevention 19.

Regarding the safety of the vaccine, it was tested in 3,100 children and serious side effects are ruled out. However, clinical studies continue on a population of 4,700 children in the United States, Finland, Poland and Spain. Until the end of October, 39% of the cases of coronavirus of those under 18 years old corresponded to the age group between 5 and 11 years old. In addition, 8,300 children corresponding to this age group would have had to be hospitalized and as of October 17, 146 had died.

Booster dose

The expansion of Pfizer’s vaccine coverage adds to the campaign launched in recent days by the European regulator, the European Center for Disease Prevention and Control (ECDC) and the European Comission to make citizens aware of the need to get vaccinated, in the case of those who have not done so yet, and to receive the booster dose for those who have already completed the regimen. “The current level of vaccination in the EU it will be insufficient to limit the burden of covid19 cases and hospitalizations during the winter months and countries with low vaccination rates are in greater danger, ”the ECDC director warned on Thursday. Andrea Ammon. “

Related news

Until now, the general slogan was to offer the booster dose to the elderly or those with weakened immune systems although the EMA itself already admitted last week that “sooner or later” the booster dose would have to be generalized to “restore” the level of protection obtained after completing the regimen. With the contagion again rampant in much of Europe and one epidemiological situation aggravated by force, the EU is now recommending that governments start injecting the third dose to all adults over 40 years of age.

For now, the European regulator has authorized the use of booster doses from the pharmaceutical companies Pfizer and Modern for those over 18 years of age and assesses the AstraZeneca and Janssen although no date for the conclusion of the study. “The booster doses increase the level of protection even above that of the original vaccination. They prevent many hospitalizations and deaths,” recalled the president of the European Commission, Ursula von der Leyen, warning that almost 25% of adults do not They are vaccinated despite the fact that the delta variant, dominant in Europe, is 60% more transmissible than the original.

– .