This week the FDA has expressed itself in favor of the anti Covid19 vaccines for the pediatric age produced by the companies Pfizer and Moderna, in case of final approval next week in the United States it could start administering it to millions of children. Why did the approval come so late compared to that for adults? Is it necessary to vaccinate children?
Children aged 6 months to 5 years are the last category without yet a vaccine authorized in Europe and the United States (remember that Cuba with Soberana vaccines started pediatric vaccination several months ago). In the early stages of the pandemic, due to the limited number of infections it seemed that children were immune to Covid19, today we know that children can get sick and in some rare cases even die. Today, with the practically uncontrolled spread of Omicron variants, it is obvious that even the smallest range needs a vaccination that can protect them from the more serious effects of Covid19.
The fact that the authorization took so long is in itself a good sign that testifies to the accuracy with which the trial and data review have been carried out.
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Difficulty in retrieving data
As we know, for a vaccine or any drug to be approved, it must demonstrate superior efficacy over the current standard. In the case of vaccines there is no standard against which to compare them so the effectiveness of the vaccine in preventing infection, symptoms, hospitalization or death must be demonstrated.
These parameters are called ‘endpoints’ and a clinical trial must meet them. Vaccines against Covid19 have shown their effectiveness against the various endpoints, for example they have shown good efficacy (about 50%) against infection and symptomatic disease and excellent efficacy (over 90%) against death and hospitalization.
Pediatric trials have similar endpoints to adults but obviously the disease manifests itself differently. The risk of death from Covid19 of an over 85 year old is about 300 times higher than that of a 2 year old child. In the course of a clinical trial it is relatively easy to demonstrate that a vaccine can avoid the death of an 85-year-old since unfortunately it is not such a rare event, it becomes very difficult instead to prove that a pediatric vaccine prevents the death of a child.
This difference explains why much more data had to be collected for children in order to demonstrate incontrovertibly that pediatric vaccines have benefits.
Why, if the risk of death in children is low, should they be vaccinated anyway?
Since the beginning of the pandemic in Italy 15 children between 0 and 5 years have died due to Covid19, this number alone should justify the use of the vaccine but in addition to the deaths, about 7,000 children have fallen ill and needed medical treatment. Furthermore, children in most cases are asymptomatic and therefore silently contribute to the spread of infections.
Although current vaccines do not prevent infections, vaccinated individuals have been shown to release fewer viral particles during infection.
Finally, children so young have less chance of having come into contact with viruses similar to Sars-CoV2 in the past so they are totally naive against the virus and their immune systems are unprepared to handle the infection.
YOUR QUESTIONS Vaccines, the pediatrician responds
TAKE HOME MESSAGES:
- The American FDA has expressed a favorable opinion on the pediatric vaccines offered by Moderna and Pfizer
- the timing has been much longer than with adult vaccines as children experience less severe symptoms
- although children rarely get seriously ill with Covid19, it is essential that they receive a vaccine
REF:
https://time.com/6187674/covid-19-vaccines-kids-under-five-fda/
https://www.epicentro.iss.it/coronavirus/bollettino/Bollettino-sorveglianza-integrata-COVID-19_9-marzo-2022.pdf
Aureliano Stingi, doctor in molecular biology works in the field of precision oncology. He collaborates with the World Health Organization in the battle against Covid19-themed fake news
Instagram: Aureliano _Stingi