Pfizer: «Safe and effective vaccine between 5 and 11 years». Soon the authorization request

The Pfizer-Biontech vaccine has proven to be Safe ed extremely effective in the children between 5 and 11 years old. This was announced by the two groups that produce it. Having an authorization early for that age group would be important to further contain the circulation of the infection: in the United States, for example, more than one in five cases occur in children and the Delta variant sent more of them to hospital and ICU than there ever were in other phases of the pandemic.

Pfizer and Biontech, explains the New York Times, they will seek FDA clearance by the end of the month. Estimates are that if assessments are as quick as adults and teens have, millions of elementary school-age children will be able to get their first dose before Halloween or in any case during autumn and winter. For even younger children, under 5, the results will come instead not before the end of the year divided into two sub-bands: from 6 months to 2 years and from 2 to 5 years. Moderna is also about to present the results of its tests on children thus following Pfizer’s path.

As usual, it is a announcement of the pharmaceutical company. The data will be delivered to the competent authorities and soon published but at the moment they have not been communicated or published in a peer-reviewed scientific journal. But for the experts there was basically nothing to expect different from what happened with the older brothers and sisters. While it is true that children have a much lower risk of developing severe forms of Covid-19, even in the presence of Delta variant infection, a small number still have a very risky condition called Mis-C, multisystem inflammatory syndrome in children, apparently related to Sars-CoV-2 infection in which different parts of the body can become inflamed: heart, lungs, kidneys, brain, skin, eyes or organs of the gastrointestinal system. Still others, like adults, can experiencing symptoms of various kinds for months.

In the United States, the territories with lower vaccination rates, where therefore the circulation of the virus is more sustained, have not surprisingly recorded the highest levels of hospitalization for children, who are not protected and even if they do not get sick they can lead to the infection in the family, for example in the most vulnerable grandparents, teachers, educators of other activities. There reopening of schools was among the causes that fueled this surge: from Mississippi to North Carolina, the NY Times is fighting against thousands and thousands of infected and other children in quarantine.

Pfizer’s clinical trial conducted with Stanford University under the leadership of Yvonne Maldonado, a member of the American Academy of Pediatrics Infectious Diseases Committee, included 2,268 children between 5 and 11 years old, two thirds of whom received the two doses of the vaccine three weeks apart and one third a placebo solution. Given that the study is of limited proportions, the conclusions of the colossus are based on measurement of the immune response, assuming that it protects on thresholds similar to those that occurred in the largest, and not on the practical observation of hospitalizations avoided. The vaccinated produced one strong antibody response, comparable to that measured between 16 and 25 years, but with a vaccine dose of only 10 micrograms, just a third of that recommended for teenagers and adults. Higher doses would have produced more side effects in children including fever, headache and fatigue, in any case none severe. A dose of only three micrograms, a tenth of that of adults, which from the first statements seems to be sufficient.

The two companies will therefore ask for the authorization for emergency use, as is still the case for 12-15 year olds, while for the over 16s the FDA provided full and complete authorization to the product last August. In very rare cases, the vaccine has produced myocarditis in young people (although an Israeli study has shown that Covid produces heart problems with a much higher frequency than vaccination), in the over 12s, 60-70 of every million injections were observed, all resolved in little time and without complications. Therefore, the experts of the federal agency will have to evaluate the relationship between risks and benefits also in light of how the Delta variant has changed the situation.