Friday, December 3

EMA approves Pfizer’s vaccine in children ages 5 to 11


The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has decided, in an extraordinary meeting held this Thursday, to approve Pfizer’s vaccine against COVID-19 in children from 5 to 11 years old.

As just reported in a statement, the dose will be lower than that used in people 12 years of age or older (10 ug versus 30 ug), and as in the older group, it is administered in two injections into the muscles. upper arm, three weeks apart.

After reviewing the studies provided by the company, the CHMP concludes that the benefits of the vaccine ‘Comirnaty‘from Pfizer in children 5 to 11 outweigh the risks, “particularly in those with conditions that increase the risk of severe COVID-19.”

Therefore, the CHMP will now forward its recommendation to the European Comission, which will issue a final decision.

This decision comes amid a large increase in COVID-19 cases throughout Europe, mainly due to poor vaccination coverage in some countries and because the group of children under 11 years of age has not yet been able to receive the vaccine.

In Spain, in fact, children under 11 years of age are the ones with the highest cumulative incidence 14 days per 100,000 inhabitants, with 203,57, according to data from Ministry of Health published yesterday, well ahead of the next group, people between 40 and 49 years old, which stands at 155.91.

The Pfizer vaccine, ‘Comirnaty‘, is authorized in children of 5 to 11 years in the United States for almost a month.

According to the data published by the US Food and Drug Administration (FDA), the vaccine was 90.7 percent effective in preventing COVID-19 in this age group.

What the approval is based on

The committee has based its approval on a study in children aged 5 to 11 years that showed that the immune response to ‘Comirnaty‘administered at a lower dose (10 ug) in this age group was comparable to that observed with the highest dose (30 ug) in 16 to 25 years.

The effectiveness of ‘Comirnaty‘was calculated at almost 2,000 children from 5 to 11 years old who did not show signs of previous infection.

These children received either the vaccine or a placebo (a dummy injection).

Of the 1,305 children who received the vaccine, three developed COVID-19 compared to 16 of the 663 children who received placebo.

This means that, in this study, the vaccine was 90.7% effective in preventing symptomatic COVID-19 (although the actual rate could be between 67.7% and 98.3%).

The most common side effects in children ages 5 to 11 are similar to those in people 12 and older.

They 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.

Regarding the safety and efficacy of the vaccine, both in children and in adults, the EMA body indicates that it will continue to be closely monitored, since it is used in vaccination campaigns in the EU Member States through the EU pharmacovigilance system and ongoing and additional studies carried out by the company and the European authorities.



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