Covid vaccine for children, the FDA committee gives the green light between 5 and 11 years

The request for Pfizer has been approved by a committee of the Food and Drug Administration: green light for the Covid vaccine for children aged 5 and over, therefore up to 11 as the product, together with Moderna, is already approved for the over 12s. This is a crucial vote, even if it does not put the final word on the emergency approval process. If the FDA, as expected, decides to authorize the vaccine for children, even i Centers for Disease Control and Prevention they will have to have their say and prepare recommendations before the vaccination campaign can include this new audience of 28 million individuals. A CDC meeting is already scheduled for early next week, so the inoculations could start very quickly. already from the end of the next one, assuming that the FDA expresses itself within the current one.

“I think we need it as a tool in our armory for high-risk children, for reasons of fairness, for parents who really want to protect their children, and because of the long-term and very serious implications of stopping face-to-face lessons, ”he explained Mark Sawyer, one of the members of the advisory board of the FDA (to be precise the Vaccines and Related Biological Products Advisory Committee) which has just expressed itself with 17 votes in favor and one abstention after seven hours of confrontation. For some members of the committee, more than a green light for the whole range of 5-11 year olds, it is the possibility of having parents and doctors choose according to the case. And also as a matter of fairness: although they are less likely to develop severe forms of Covid-19, children can become infected and spread the infection just like adults.

The picture in the United States: over 100 deaths in that age group

“Far from being spared from the Covid-19 threat, in the age group from 5 to 11 there have been over 1.9 million infections, over 8,300 hospitalizations, of which about a third required hospitalization in intensive care, and over 2,500 cases of multisystem inflammatory disorder from Covid-19 “he explained Peter Marks, the FDA’s chief vaccine officer, at the start of the meeting. The counselors were also presented with worrying data on the worsening of the disease in children, in a dynamic that is partly different from the first months of the emergency: there were nearly 100 deaths from Covid-19, and the syndrome is listed among the top ten causes of death in that age group in the United States. All elements that convinced the experts to give the green light to childhood vaccination, considered by many to be an essential key to containing the infection even more strongly.

Excellent efficacy for the severe syndrome, only hopes for the reduction of the infection

Coming to Pfizer’s Covid vaccine for children, clinical trials suggest that a lower dose compared to that used for adults, in any case more than 90% effective in producing an adequate immune response and therefore in blocking the symptomatic forms of Covid-19. It is not known if the transmission will be reduced, but the experts of the pharmaceutical group expect that – similar to what happens with adults – vaccines for children will also help us in that direction, with good protection rates even from asymptomatic contagion. And therefore in the attainment if not of a herd immunity, moreover very distant in places like the United States where the countryside has become bogged down, at least of an ever greater mass protection.

Vaccines: green light for the third dose for the over 60s

Read the article

Side effects: myocarditis and pericarditis

As for the evaluation of possible side effects, much of the committee’s discussion centered around the rare cases of heart inflammation known as myocarditis or pericarditis, identified above all in young males who were given an mRna vaccine during the campaign, therefore in the largest, but not in childhood clinical trials, which are obviously too small. Other effects were similar to those seen in adolescents and young adults. As for myocarditis and pericarditis among teenagers and young adults, in the vast majority of cases they resolved with mild symptoms and within a day, although they still required hospitalization. In some rare cases, reported by the CDC, some teens continue to experience symptoms for up to three months after diagnosis. However, there is talk of 877 cases of these diseases in children under thirty on over 400 million inoculated vaccines. More or less, after the second dose of Pfizer, 21.5 cases per million doses administered. Among other things, these myocarditis can also develop as a symptom of Covid-19.

The point, the experts explain, is that the benefits of the vaccine largely depend – for that age group and for that specific side effect – on the virus incidence rate. In essence, in its review of Pfizer’s request, the FDA panel made it clear that if cases of infection were to drop to low levels, such as those recorded last June, the product could prevent fewer severe Covid-19 cases and trigger more myocarditis related to vaccination. But the picture is no longer that of last June and the war on Covid changes from season to season. The estimate made on the current scenario of contagion in the United States, in fact, confirms that severe cases of Covid-19 prevented by a vaccine for children would “clearly outweigh” the risks of myocarditis from vaccines. In all of this, however, it must be considered that according to the CDC a good 40% of American children may have some form of natural immunity due to a previous Sars-CoV-2 infection. So those benefits estimated by the FDA could be greatly reduced. The central point, in short, touches in particular the need to contain the dynamics of contagion. Also because even the risks could be overestimated, for example considering the reduced dose of the vaccine for children.

The timing of the campaign for 5-11 year olds

What will the times be? After the formal clearance of the FDA, the Biden administration explained that it could immediately make it available up to 15 million reformulated doses for children. According to the federal government, it should leave next week, barring twists and turns at the drug agency and the CDC. Vaccine packs for children will be other than those for adults, some new components will lengthen their expiration always if properly stored in refrigerators and will make it easier to extract lower doses from the vials, which will contain 10 micrograms of mRna instead of 30 as in the standard posology. Two injections, three weeks apart. Among other things, lower doses could be reserved in the future (for example for the third dose) also for adolescents, Pfizer concluded.