The European Medicines Agency (Ema) has begun to examine the data accompanying the authorization requested by Pfizer-BioNTech for the administration of its coronavirus vaccine to under 16s. Not only that: Pfizer plans to ask in September in the States United the authorization of its Covid-19 vaccine for children between 3 and 12 years of age.
The countdown to the Pfizer vaccine for under 16s
And so, while the same company expects the go-ahead from the Food and Drug Administration (Fda) to the vaccine for the 12 to 16 year old group in the United States for next week, the countdown to the start of vaccination begins. of under 16 in Italy. Which could start in June for that age group and in September for the little ones. Meanwhile, data on the efficacy and safety of the vaccine for pregnant women are expected between July and August.
Yesterday the blessing of US President Joe Biden arrived in America: “As soon as the Drug and Administration (Fda, ed) gives its authorization to Pfizer vaccine for adolescents between 12 and 15 years, we are ready to move” . Pfizer, which expects revenues of $ 26 billion in 2021 after closing the first quarter with a boom of $ 14.58 billion, is waiting for the go-ahead to counter the drop of more than 25% in the vaccination rate in the USA compared to at the peak of mid-April. But it is not the only one, given that Moderna is also carrying out tests on the little ones to present the results as soon as possible and ask for authorization. As well as Novavax, while AstraZeneca and Johnson & Johnson stopped their studies after thrombosis cases.
The results of the phase 3 study of two thousand children between 12 and 16 years presented by Pfizer are encouraging, given that the vaccine generated more antibodies than the age group between 16 and 25. The efficacy, according to the data presented from the German company, it reached 100% (in adults it is 95%) but the possibility of asymptomatic infections has not been investigated. And this is a problem, since children can become vectors of the infection and infect adults, even the frail ones.
Massimo Ciccozzi, director of the Epidemiological Unit of the Campus Biomedico University of Rome, yesterday called for a quick ok from Ema: “I hope he will do things very quickly, because we also need to vaccinate those children, who become infected in asymptomatically and carry the virus in the family “. “After completing the vaccination with the over 60s – he stressed – I would immediately start with the 14-28 year old category.” The vaccination plan is accelerating in an incredible way – observed Ciccozzi – I think also thanks to Draghi who was able to put his feet in Europe for the delivery of the doses we had purchased “.
Vaccination for children and young people on the way
Republic writes today that extending the authorization to administer the vaccine also to children takes time, however, because it is not possible to skip the phases of the experimentation and it is necessary to standardize the rules of informed consent to those of adults. Then there is the problem of dosage, since children tend to respond more intensely to immunization. It is therefore necessary to calibrate the concentration of the vaccine to allow the production of the necessary antibodies, but without exceeding the limits.
For example, Moderna, which is expected to finish testing at the end of the summer, uses 100 micrograms for adults. For children between 6 months and 2 years he is trying three dosages: 25, 50 and 100 micrograms. For those over the age of two, experiment with 50 or 100 micrograms.
For the rest there were no side effects other than adults: possibly a little fever and arm pain. Even Israel, which immunized 600 frail children at risk of severe Covid, did not notice any adverse reactions. As a precaution, the Association of American Pediatricians recommends allowing two weeks to pass between the vaccine for Covid and the others provided for children.
In recent days, General Francesco Paolo Figliuolo spoke about the vaccination of children in schools: “We are thinking about it, it would work as it once did in the seventies”. Both vaccines that are being tested in children and adolescents are based on the messenger RNA technique and the companies Moderna and Pfizer / BioNTech are conducting the studies.
The first trial in phase 2/3, conducted by Moderna, began in the United States in December 2020 on 3,000 children between 12 and 17 years and the same company has just launched a second study, called KidCove, also in phase 2/3 on 6,750 children from six months to 11 years. According to the plans, the first to receive the vaccine will be the older ones and gradually it will move to the smallest ones.
In the United States and Germany, the experiment conducted by Pfizer / BioNTech on 2,260 children between the ages of 12 and 15 has reached phase 3. In light of the positive results obtained, the company is preparing to submit the application for authorization to the regulatory authorities of the United States (Fda) and Europe (Ema) and expects its vaccine to be available as early as June.
Sergio Abrignani, professor at the State University of Milan and member of the Scientific Technical Committee, in recent days spoke with Ansa about vaccinating children and young people: “It is likely that in both cases the approval by the regulatory authorities is fast enough “and” in time for schools to reopen “. If all goes as planned, “at the beginning of the school year children and teenagers could be vaccinated. This could mean having vaccinated all adults and all children who want to be vaccinated much earlier than Christmas holidays: a great result”.