The go-ahead for the administration of the monovalent vaccine against Sars-CoV-2 developed by Pfizer-Biontech for children aged between 6 months and 4 years was obtained before Christmas, another gap remains to be filled in the prophylaxis initiatives aimed at the youngest to contain the extent of the Covid-19 pandemic: the green light for recalls for those between the ages of 5 and 11. Children who were vaccinated with the first two doses between December 2021 and February 2022. And who as such, with the exception of those who have contracted the Sars-CoV-2 infection in recent weeks, would need a booster. A procedure authorized in two different moments by the European Medicines Agency: first with standard mRna vaccines (in September) and then with bivalent versions (in November). But not yet implemented in our country, in the authorization process that first calls into question the Italian Medicines Agency (which following the approval of EMA updated the drug leaflet) and then the Ministry of Health.
Covid, green light for the vaccine for the little ones: how much and why it is administered
by Elena Bozzola
Sars-CoV-2: the boosters that are missing for children between 5 and 11 years old
The more than 1.2 million children therefore remain in limbo who, just as the Omicron variant was beginning to spread in Europe too, with the support of their families had decided to undergo vaccination prophylaxis against Sars-CoV-2. Just over a third of the entire audience of possible beneficiaries who, although little listened to, have been asking their respective paediatricians and institutions for months when it will be possible to update the vaccination cycle. “We are working on it: we will decide shortly”, is the only information filtered by the ministry now led by Orazio Schillaci. Yet more than ninety days have passed since the first go-ahead from Amsterdam, immediately updated with the possibility of protecting even the little ones with the bivalent vaccine. Not to mention the nine months of recalls already put behind us by the United States: the first to approve the booster for the 5-11 age group. The recommendation to carry out the booster will be intended only for fragile children. “We are defining the list of diseases that define frailty for that age group”, is the only information left to filter by the ministry. One more indication, which will expand the indication to administer the booster to all the immunosuppressed: who are less than the total of the frail. Even all the other parents, if they wish, can still ask to administer the booster to their own children (according to the organizational procedures which will then be defined at the regional level). Pending ministerial indications, as indicated in the latest leaflet updated by AIFA, in children aged between 5 and 11 it will be “possible to administer a booster dose at least six months after completing the primary cycle”. Unlike the 120 days set instead as a minimum limit for adults.
For pediatricians, the recall remains necessary
In Italy, the change of government has probably slowed down the authorization process. But in reality, also due to the spread of other respiratory viruses with the arrival of winter, the topic seems to have ended up outside the discussion tables between the scientific world and the institutions. Although today it is clear that Covid-19 almost always has a benevolent course among the little ones, the position of Italian pediatricians and public health experts remains carved in stone: when a safe and effective vaccine is also available for children, the benefits of receiving it outweigh the risks. This applies to everyone, but even more so to those who are fragile. The recall would serve as an element of personal protection. But not only. Vaccination is also important as a tool to protect public health, when a child risks coming into contact with older people or people suffering from one or more diseases. To this we must add that what has been observed in almost two years of vaccination campaign conducted in adults is also valid for the little ones. And that is, as also confirmed by a meta-analysis just published in “Frontiers in Immunology”: whether you entered it with one of the variants that preceded Omicron or that you are vaccinated with two doses, antibody immunity tends to decrease after 10-12 months. Reason why “it could be reasonable to offer a booster vaccination to the families of children infected before Omicron and for those who, despite having come into contact with this variant, are exposed to a greater risk of complications related to Covid-19”, is what put on paper by researchers led by Susanna Esposito, director of the pediatric clinic of the University of Parma. “The ministerial indications are necessary to be able to administer the boosters to children aged between 5 and 11, but we must not forget that just over two thirds of them have not even received the first dose”, recalls Rocco Russo, pediatrician of the mother-child operating unit of the Asl of Benevento and head of the vaccination technical table of the Italian Society of Pediatrics. “We would expect a commitment in terms of communication and organization also to promote the recovery of at least a part of this segment of the pediatric population”.
To remedy this, there are those who bring their children to be vaccinated in Germany and Austria
Considering the mess described, some families in the meantime have organized themselves. How? Taking the children to get vaccinated in Germany, where the administration of the bivalent drug to children aged between 5 and 11 (as a booster) already took place off-label before the ok from the European Medicines Agency. The first to discover this opportunity – offered free of charge to families from other countries, over time also from Austria – were above all parents and grandparents who work or used to work in the health sector. Then the rumor started circulating, thanks also to a Twitter profile run by a group of German volunteers to help foreign families make appointments with the most convenient vaccination centers to reach. Stefania, a mother from Rome, recounts her experience to Salute. “We left in October to first vaccinate my youngest son: he is 2 years old and at that time prophylaxis against Sars-CoV-2 for such young children was not authorized. We did this because our other 11-year-old son suffers from asthmatic bronchitis and during the winter undergoes several cycles of cortisone treatment which lead to a state of clinical immunosuppression. For this reason, he always continued to wear the Ffp2 mask at school, even undergoing some acts bordering on bullying. Once in Baiersbronn, precisely because of his high frailty, the doctors suggested we do a booster with the bivalent vaccine. Thanks also to the advice received in Italy from various health professionals, we have opted for this choice. And like us many families we met there from Switzerland, France, Belgium, Spain and the United Kingdom”. Other countries in which, at that time, the green light for the booster for children aged between 5 and 11 had not been granted (and in many cases still is not).
Covid, still no decision in Italy on recalls for children between 5 and 11