The EMA approves the use of Pfizer’s covid-19 vaccine in children aged 5 to 11 years

The European Medicines Agency (EMA) supported today use of the Pfizer vaccine in children 5 to 11 years old, while warning in a public document against misinformation that the pandemic “is not over yet”, although Europe has “more tools to fight” against covid-19 than last winter.

The EMA completed its evaluation of Pfizer’s request to increase the use of its vaccine in children aged 5 to 11: considered this option safe and effective, and recommended that two injections be administered, at an interval of three weeks, and a dose of 10 milligrams, instead of 30 milligrams of the recommended guideline for people over 12 years of age.

The Committee for Medicinal Products for Human Use (CHMP) concluded today that the benefits of vaccinating this age group with Pfizeroutweigh the risks“That there may be and detailed that the adverse effects detected in clinical trials were”mild or moderate“And improved within a few days after vaccination.

Common side effects are similar to those 12 years and older, such as fatigue, muscle and headaches, chills and redness at the injection site..

The main study involved almost 2,000 children with no evidence of previous infection. “The vaccine was 90.7% effective in preventing symptomatic covid-19 (although the actual frequency could be between 67.7% and 98.3%)“, he emphasized.

Pfizer is the first to achieve EMA approval for this age groupAlthough the authority is also evaluating the data presented by Moderna to extend its current European license to children from 6 to 11 years of age.

Second, The EMA reiterated the urgency of extending vaccination protection because “it is still very low” in some countries, during a virtual act to interact with the European public who have “needs, expectations and possible concerns” about the safety, quality and effectiveness of vaccines, in an attempt to combat misinformation.

The agency urged citizens to report suspected side effects as “helps everyone identify risks and find the best measures to reduce them“And remember that”Incorrect information about covid-19 has serious consequences that we all have to fight“, For which he called to ask the public health authorities.

There is no doubt that vaccines have reduced the effects of the virus and saved people from the burden of serious illness and death, but much remains to be done.“, Alerted the EMA’s Executive Director, Emer Cooke, who acknowledged that”these are difficult times for everyone and the pandemic is obviously not over yet”.

He lamented that infections and hospital stays were on the rise in many European countries. “mainly with unvaccinated patients, but also some vaccinated“And reminded that thanks to vaccines European health systems”can provide routine care without the overwhelming number of covid-19 patients we have seen before”.

Cooke acknowledged that “as we gather more evidence on how vaccines protect against delta variant“, Dominant in Europe, it is more obvious that protection is reduced, especially in the elderly and more vulnerable to the virus.

This means that booster doses are needed after the second dose to prolong the vaccine’s effectiveness. It is also very clear that vaccines alone are not enough when temperatures drop in Europe. As long as the virus continues to circulate, public health measures such as social distancing, masks, good ventilation and hand washing will remain pillars in the fight against the pandemic.He urged.

The approved vaccines – Pfizer, Moderna, AstraZeneca and Janssen – “remain effective” in preventing serious covid-19 and death, and are the “cornerstone” in the response to the coronavirus, he added.

On a “more positive note,” Cooke noted, the current epidemiological situation is occurring in a “better” context than last winter, as “we have tools like vaccines and additional treatments available to help fight the pandemic, and it really makes a difference”.

However, he stressed that treatments such as oral antiviral molperperavir (approved for possible acute use at national level) or approved monoclonal antibodies will “supplement but not replace” vaccines.

Vaccines remain a key instrument against covid-19, so it is of utmost importance that people are vaccinated and given the initial cure, as well as any booster doses as soon as they are advised to do so.“Added the director.


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