Pfizer vaccine for children aged 5 to 11, approval by Ema- time.news

by time news
from Cristina Marrone

With the approval of the preparation by Ema and the forthcoming green light from Aifa, about 3 million children between 5 and 11 years old will be able to access the vaccination campaign in Italy

On November 25, Ema, the European Medicines Agency, approved the vaccine for children aged 5-11. The vaccine is already approved for use in adults and children aged 12 and over. For the actual administration to children in Italy, Aifa’s ok remains necessary, which should closely follow Ema’s decision. Giorgio Pal himself, president of the Italian drug agency, had anticipated that, in case the green light from Ema had arrived by 25 November, Aifa could probably have given the ok at the beginning of the administration on Monday 29 November. .


With the approval by the Ema (European Medicines Agency) of the Pfizer-BioNTech vaccine for the age group 5-11 years and the ratification by the Aifa (Italian Medicines Agency), they will be approximately 4 million children who will be able to access the vaccination campaign in Italy. The reservation will take place through the usual channels and each region will be able to organize itself on how to proceed with the administration.

What do studies say about Pfizer vaccine efficacy on children?

The Pfizer-BioNTech vaccine safe, well tolerated and produced a robust immune response in children between the ages of 5 and 11, according to studies conducted by the same pharmaceutical company and released in late September. The vaccine triggers a strong immune response in children of this age group, comparable to that of boys between 16 and 25 years. The effectiveness in preventing the disease stood at 90.7%. Pfizer and BioNTech have initiated studies on children aged 6 months to 2 years and 2 to 5 years. Results are expected within the year.

How was the experimentation carried out?

Pfizer’s experimentation included 2,268 children aged 5 to 11: two thirds received the double dose of the vaccine three weeks apart; the others were injected with two doses of placebo. The study was not large enough to draw conclusions about the vaccine’s ability to prevent disease or hospitalization (given the low frequency of such events in children), so the researchers measured the immune response, assuming that the protective levels of antibodies observed in adults are equally effective in children.

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Does the dosage change for children?

In children between 5 and 11 years old they were found 10 micrograms sufficient, one third of the quantity currently offered to over 12s and adults, always with a double dose three weeks apart. At higher doses, the researchers observed a greater frequency of side effects (albeit mild): fever, headache and fatigue. In children under 5, from the first studies, it seems that 3 micrograms, one-tenth of the standard dose, are enough. The vial of the preparation for children will have a orange hood (for adults purple) to avoid administration errors. Additionally, the vials will be labeled for children only.

Who is vaccinating the children?

After the FDA’s approval of the Pfizer vaccine in the 5-11 age group, on November 8, vaccinations for children started in the United States and reached 2 million and 600 thousand children immunized in this age group. According to forecasts by the CDC, every million doses given to children between the ages of 5 and 11 would avoid approximately 58,000 cases and 226 hospitalizations in that age group. Two days ago the immunization campaign in Israel began where almost half of the new cases of infection concern this age group. In Europe, Austria has already begun to vaccinate children without waiting for the opinion of the EMA (European Medicines Agency) given the dramatic pandemic situation that the country is experiencing, returned to lockdown. Here the vaccination coverage stops at 65%, among the lowest in Europe. In China, Sinovac also proceeds for the 3-17 range, authorized in June. Cuba instead began administering its Abdala and Soberana to young people aged 2 to 18 in September, while at the beginning of August the United Arab Emirates also began administering the Chinese Sinopharm vaccine to children aged 3 to 17.

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What are the side effects?

Side effects in children are similar to those seen among adults: discomfort at the site of infection, fatigue, a little fever. Many have not experienced any side effects. In the phase 3 study, no p was recorded
ericarditi or myocarditis post vaccine, but the number of trials was limited. However, the White House as of November 10 estimated that nearly one million children had been vaccinated (at the time) and no major side effects occurred.

How were they evaluated?

During the trial, parents were given a diary to report any post-vaccine symptoms every day for seven days. Whether a child complained of chest pain or shortness of breath (myocarditis symptoms) was carefully evaluated.

Why should children be vaccinated?

As is known, children have a low risk of becoming seriously ill with Covid, but a small percentage develop the potentially dangerous multisystem inflammatory syndrome (MIS-C). In Italy, since the beginning of the pandemic, 239 cases have occurred. Even children can still end up in hospital attached to oxygen due to Covid pneumonia. Other kids suffer from long Covid and have persistent symptoms for months. The vaccine has a preventive function: if the virus mutates it could become dangerous even for the little ones. If we leave Sars-CoV-2 free to replicate, the ability to give rise to new variants will increase. According to Giorgio Pal, virologist, president of AIFA, the picture of the epidemic is changing in Italy and the risk of infection is becoming much higher than the risk of the vaccine. If before 2% of children contracted the infection with the Alpha variant – he underlines – today we are reaching 25-30%. The data from the epidemic are telling us that the 4 to 11 year old category is the one with the highest number of incident cases. There are hospitalized children who do not have concomitant pathologies, there are children who develop a multisystem inflammatory syndrome (MIS-C), ie on various organs.

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In addition, children, even if they often become infected asymptomatically, can infect teachers, parents, grandparents and especially immunosuppressed people who (despite the vaccine) risk death from Sars-CoV-2. The significant increase in infections in the pediatric age group that is occurring in recent weeks is worrying: in the last two months alone, over 24 thousand cases between 6-10 years have been recorded (over 240 thousand cases since the beginning of the pandemic with 1400 hospitalizations and 9 deaths in this age group) according to the latest bulletin Iss.

Another important reason why even the smallest ones should be vaccinated to allow them to have a more normal life. It is true that with the vaccine infection is not excluded, but the decline in infections would allow them to practice sports, go to school in the presence and be freer than they are now.

Is it true that the tests were carried out too quickly?

The safety protocols were respected however with a global health emergency it was necessary to collect data more quickly so the enrollment, the data collection, the review were all faster stages because they were continuous.

If a child is 11 and a half years old, should he be vaccinated immediately or should he wait 12 years for the full dose?

The virus is still circulating a lot, so don’t waste time. A 5-year-old will be smaller and lighter than an 11-year-old, which begs the question of whether older children will actually be protected with a lower dose of the drug. However, the clinical study enrolled 11-year-old children of different weights to investigate this aspect. While there are differences in size, in terms of immune response even the largest should have a good and robust response to the vaccine.

November 25, 2021 (change November 25, 2021 | 14:33)

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