Coronavirus, when are vaccines also for children and adolescents?

Don't be in a hurry, experts explain. The Moderna company is "enlisting", that is, now involving adolescents aged 12 to 17 in a clinical trial which is expected to end at the end of June 2022. But this is normal: the times of pediatric trials are longer

photo: Luisella Planeta Leoni from Pixabay) Currently, vaccines against Covid-19 cannot be administered under a certain age, as explained by the World Health Organization, equal to 18 years for the Moderna vaccine and for that of Oxford and Astrazeneca , and equal to 16 years for the Pfizer-Biontech vaccine, already in use in Italy. This is simply because vaccination has not been tested in the age groups in children and young people up to 16 or 18 years. But pharmaceutical companies are gearing up to carry out new clinical trials, which obviously will have different characteristics (dosage, duration), with children and adolescents.

We currently have news of a clinical study with children aged 12 to 17 years, started on 9 December 2020, by the Moderna company - one of the manufacturers of the vaccine approved both in the US and in Europe (here the ongoing trial). The study in question, as stated on the official clinicaltrials.gov page (the US database of ongoing trials) updated to January 14, 2021, is still in the phase of enrolling volunteers. Which, as the company has just reported, are not yet in sufficient numbers and this could slow down the experimentation. Another trial, then, will involve children up to 11 should start later and will take a long time. Here are some hypotheses about when maybe we could have a vaccine even for the very young.

Pfizer-Biontech and Moderna vaccines

The pandemic is underway, but the hope is that with the new vaccines against Covid-19 it can begin to rise again, albeit, as we know, it will be long and complex. Vaccines - more than one - are already in use in healthcare personnel and to date almost a million people have received them in Italy. Pfizer-Biontech's vaccine, approved in Europe and already administered in various countries, including Italy, can be used from the age of 16 (inclusive) up, while that of Moderna, already authorized in Europe but actually not yet administered in our country, is indicated from 18 years upwards, as well as that of Oxford-Astrazeneca.

The new trial of Moderna: adolescents from 12 to 18 years

The study foresees the involvement of 3 thousand children aged 12 to 17. Participants will be divided into two unequal groups: two thirds of the children will be given the vaccine in two doses (28 days apart) while one third of the children will receive a placebo. This means, explains Moderna, that the probability of re-entering the vaccine-treated group is 67%. The start date indicates 9 December 2020, while the conclusion of phase 3, the last stage of the experimentation, is scheduled for the end of June 2022 (therefore in more than a year). So it is likely that, if everything goes as planned, the data could arrive after the end of June 2022. Then there are the times for the evaluation by the regulatory authorities (Fda in the USA and Ema in Europe) and, once the vaccine is approved, the times for distribution (even if a comparison cannot be made, in the case of the formulation for adults from the first announcement of Moderna to the approval in the USA by the FDA it has been about a month and the approval in Europe almost two months). In short, it is still not possible to predict when there will be a vaccine for adolescents but certainly not before the summer of 2022.

Still in the recruitment phase: but it is normal

But currently, according to According to an article on USA Today by Moncef Slaoui, scientific head of the Warp Speed ​​operation, a partnership between the public and the private sector to accelerate the development, production and distribution of vaccines, recruitment is going slowly. To date, about 800 volunteers are being involved in a month - against 800 per day for experiments on adults - and we have not yet reached 3,000. But it's no wonder that the lead time for a clinical trial involving boys is longer, according to Barbara Pahud, director of research for the Division of Infectious Diseases at Children’s Mercy Hospital in Kansas City. The fact that Moderna is taking longer, in fact, does not surprise her, given that pediatric studies always have longer average times.

And then the trial for children up to 11 years

Another category, which will be considered in a separate trial, is that of toddlers, children and teenagers up to 11 years of age. Also in this case the times will be long, perhaps longer than those foreseen for the study on adolescents. Studies with children "will take a lot longer, because we have to scale according to age and start with a lower dosage," said Stephan Bancel, CEO of Moderna on January 11, 2021 at the JPMorgan Virtual Healthcare Conference, as reported by Business Insider. "So we shouldn't expect clinical data in 2021 but more likely in 2022". In short, we still have to wait for them, and we must not be in a hurry.

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Coronavirus Coronavirus Vaccine Modern Vaccine Oxford Vaccine Pfizer BioNTech globalData.fldTopic = "Coronavirus, Coronavirus Vaccine, Modern Vaccine, Oxford Vaccine, Pfizer BioNTech Vaccine "

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