Pfizer asks for the green light in the United States for an anticovid vaccine in children under five

Through a statement, the pharmaceutical Pfizer revealed this Monday -May 23- the results of its most recent clinical trial on the effectiveness of the anticovid vaccine, on this occasion, focused on the age group between six months of age and five years.

According to the results revealed by this pharmaceutical company, its vaccine, developed by Biontech, it is effective in this population, noting the high level of immunity achieved with the application of three doses of said vaccine in minors.

The statement, revealed this Monday, is known, at a time when the FDA, the main health certification authority for food and drugs in the United States, will begin expert meetings, in order to analyze the feasibility or approval for the use of this medicine in children under five years of age; population that has not yet been considered in the objectives of the anticovid immunization programs of most countries in the world.

Regarding the immune response revealed by Pfizer/ Biontech, it is ensured that with the application of three doses of three micrograms, a praiseworthy immune response close to 80.3% is achieved, according to the preliminary results achieved.

In that same sense, heThe pharmacist stated that the observed side effects “were similar between those who received the vaccine and the placebo”

In its statement, the company expressed its satisfaction with the results achieved by the vaccine in children, explaining that the dose supplied in the clinical trial corresponds to a tenth of that used in adults, noting that the objective was to achieve tolerance in the body of minors, as well as satisfactory responses to the virus.

“We hope to soon complete our submissions to regulators around the world in hopes of putting this vaccine available to younger children as soon as possible”the company added in its statement.

Expectation regarding the FDA decision

In light of the studies carried out by the health regulation authority, according to international media, it is expected that in the next month, June, the FDA will meet at least 3 times, in which its members will discuss the feasibility of authorizing the application of anticovid vaccines in the age group under 5 years.

In addition to Pfizer, the Moderna pharmaceutical company is also currently applying to the FDA for permission to apply the vaccine to children under 6 years of age. In the case of Moderna, the vaccine corresponds to injections of 25 grams.

Within the framework of the current process that is being carried out for the approval of the inoculation of children under five years of age with Pfizer vaccines, it is important to remember that in the past, the FDA had already denied said permission to the aforementioned pharmaceutical company, while had shown that the doses proposed by the company “did not achieve the required immune response”, so it was suggested that the test contemplate an additional dose.

clinical trial

Regarding the clinical trial of the aforementioned immunization process, the pharmaceutical company stated that it included about 1,678 children, who received the application of the vaccine, in a trial that was developed when the omicron variant was already active and predominant.

Regarding the level of immunity, it is clarified that the level of antibodies reached by children under 6 years of age, with three doses, is close to that reached by population between 16 and 25 years who at the time received 2 doses.

“All three doses of their covid vaccine appear to be very safe and highly effective in preventing not only severe illness, hospitalization, and death from covid, but also symptomatic covid at a time when omicron was the dominant variant,” Celine Gounder, editor-in-chief of public health at Kaiser Health News, pointed out in a statement delivered to the AFP Agency, warning that, from experience, although significant levels of immunity are achievedthis began to decrease with the passage of time.

Although the age group of children under five is not considered to be at high risk for covid, so far this emergency has left a total of 477 deaths, according to official records.

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