The strange syndrome that strikes some children a month after
coronavirus infection Vaccines against the coronavirus already have their children's version. Pharmaceuticals with inoculated for adults are now recruiting and pricking thousands of children under 18 years of age in various countries, including Spain. They want to test both its safety and effectiveness with different dosages and regimens. Although SARS-CoV-2 has not been especially primed with children, experts consider it a risk to leave them out, both for their personal health and for everyone's: they could become reservoirs from which the virus can attack again.
Young people make up around 20% of the population in the most advanced countries. The percentage rises to almost 50% in continents such as Africa. But, except for adolescents aged 16 to 18 in Israel, they have been excluded from vaccination plans for reasons of urgency, scientific and even prudence.Since the beginning of the pandemic, it has been proven that the coronavirus attacks the elderly more than to young people. Science is also very clear that children are less contagious, have a milder COVID and are less contagious . Hence, the reduction of mortality among the elderly was prioritized.
In addition, scientific practice when testing new vaccines is based on prudence. Dr. Alberto Borobia, coordinator of the clinical trials unit at the La Paz hospital in Madrid, says: “We always start with a population between 18 and 65 years old. Then it continues with adults with pathologies and those over 65 years of age. And when you confirm safety and efficacy, you expand to adolescents, to children and you end up with pregnant women ”.
Janssen tests his vaccine with hundreds of young people between 12 and 17 years old in Madrid and Santander
Borobia is responsible for one of the two trials of the Janssen vaccine (a Johnson & Johnson subsidiary) that are being carried out in Spain. "We have added a cohort between 12 and 17 years of age to the study that we started in September," he says. Plans are to recruit 660 young people between the UK and Spain, although two more countries will join. In addition to La Paz, the Marqués de Valdecilla University Hospital in Santander also participates. The trial design will test two dosages of the same vaccine already approved for adults and in different regimens, one or two pricks. This week they have already vaccinated a dozen boys and girls.
"In any trial with minors, the informed consent of the parents is required," recalls Borobia. It also needs the consent of the minor to whom they give information adapted to their age. In La Paz, where they usually do three clinical trials with a pediatric population a year, this time they didn't even have to announce it to get volunteers. “This pandemic is different, perhaps because of the altruism factor. Many are children of parents who have participated in the trial of the elderly, "says Dr.
In addition to Janssen, the other three vaccines already approved in Western countries have their own trials with minors. Moderna announced last week that it was beginning to inject its serum into the 6,750 children in Canada and the US participating in KidCOVE, the children's version of its vaccine study. They will puncture children between 6 months and 12 years old, testing different amounts of the drug.
Dr. Alberto Borobia directs a trial with Janssen's vaccine in boys between 12 and 17 years old at the Hospital La Paz, Madrid.Olmo Calvo
Also la American Pfizer is already inoculating its RNA vaccine to minors. In fact, they included nearly 300 young people ages 16 to 18 in their adult trial last year for emergency use authorization from the US drug agency, then extended it to 2,259 teens ages 12 to 15. years. But this week, without waiting for the results of this second group, they have started the vaccination of 144 children aged 11 years or less. After this phase I (safety) trial, they will extend it to another 4,500 children. Sharon Castillo, a Pfizer spokeswoman, says they will expand the trials to Europe. "We hope to have results during the second half of 2021," he says in an email.
Some British media, such as The Telegraph , dare to write that in the United Kingdom they will begin to vaccinate already this summer. The British University of Oxford and AstraZeneca have already closed the recruitment for the first part of their COV006. There are 300 children and adolescents from 6 to 17 years old. They have already begun to vaccinate the subgroup of 12 to 17 and later they will do it with the little ones. Most will be given the same dose that older people are already receiving. The rest will be injected with a meningitis vaccine. The idea is to take advantage of the fact that the latter causes similar reactions, such as swelling and pain in the area of the puncture, to validate the study. In this phase, which requires at least four months, they seek to know the tolerability, ability to activate the immune system and safety of the formulation. They will then have to recruit a few thousand more to determine actual effectiveness. So the date given by the English newspaper seems unrealistic.
As for vaccines coming from the east , Russia plans to start clinical trials of its main coronavirus vaccine, Sputnik V, developed by the Gamaleya Institute in Moscow, at the beginning of summer, after finishing the studies with cancer patients, explain sources from this state center. In minors it will be tested first in the group of 17 to 14 years, after 13 to eight and last in the youngest, according to Alexander Gintsburg, director of the state institute, who pointed out that the dose will be regulated not only based on age, but also weight, reports María R. Sahuquillo from Moscow.
More advanced are in China . This week, Sinovac's medical director, Gang Zeng, announced at a press conference that his serum is safe for use in children, and that the pharmaceutical company has submitted the documentation to the Chinese health authorities. The study, started in September, included about 550 children between the ages of 3 and 17 in Hebei province. The early stages of the trial show that most of the minors developed antibodies and no serious adverse effects were recorded. For its part, Sinopharm is also investigating whether its vaccines are effective among children. The president of this state pharmaceutical company, Zhang Yuntao, told Radio China International in early January that the results of the tests had been "excellent" in terms of the safety of using its vaccine in minors, and the company hoped to be able to use it in children between the ages of three and 17, reports Macarena Vidal Liy from Beijing.
"The little ones could become reservoirs of the virus" María Garcés, of the vaccine advisory committee of the Spanish Association of Pediatrics
Why did the trials start now and were they not done before? In addition to what Dr. Borobia pointed out about the times of the trials, the epidemiologist Ángela Domínguez points to the novelty of the virus, which advised prudence. “Children have a different role in each disease. For example, in influenza they play a very important role as transmitters, says Domínguez, coordinator of the vaccination working group of the Spanish Epidemiology Society. It was necessary to determine the prominence of the little ones in such a new pandemic and "prioritize those most at risk," he adds.
Pediatrician Ángel Hernández Merino believes that, as soon as possible, "the first vaccines will arrive after the summer and for the fringe from 12 to 18 years old ”. You think this is a real need. “Although the risk of serious illness or death is incomparably lower than that of your grandparents, it is still real. Furthermore, children do not live in isolation. "It is not reasonable to think that we will reduce transmission if we leave out 20% of the population," says this vaccine specialist from the Spanish Association of Primary Care Pediatrics.
Vaccination plans around the world have created a final argument in favor of vaccinating children. There is a final aspect that reinforces the need to vaccinate children. Dr. María Garcés, from the vaccine advisory committee of the Spanish Association of Pediatrics, says in this regard that "everything will depend on how the pandemic evolves as we vaccinate." As Garcés recalls, "the viral replication in children is much lower, but we don't really know how much they infect and the little ones could become reservoirs of the virus."
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