The US Food and Drug Administration (FDA) has issued emergency approval for the COVID-19 vaccine for children five years of age and younger. Considering that the Centers for Disease Control and Prevention (CDC) is also signing, more than 18 million people in the United States will be eligible for immunization – the last major group to be granted access. to the FDA advisory panel on 15 June, which shows that their mRNA-based vaccines are safe for children, and initiates antibody levels similar to those that provide protection for adults. But researchers and parents still have questions about the real-world benefits of vaccines and what will work best.
Young children are at very low risk of getting very sick with COVID-19. But that does not mean that the disease is dangerous. Since the outbreak began, 442 children four years of age and younger have died of the disease in the United States, and thousands have been hospitalized. The variant of the coronavirus Omicron has greatly affected children especially this year. After its emergence, the hospitalization rate for children under five years was five times higher than it was at the time of previous surgery, which is due to Delta differences. These numbers may seem small, said Yvonne Maldonado, a pediatrician and infectious disease specialist at Stanford University in California, but children “should not die of anything”. “If we have a way to prevent death, we must protect it.”
If the CDC gives green light vaccines – which is likely – parents will be curious about the information they can give their children. The most notable difference is the number and duration of the doses. The Modern vaccine will be given as two doses per month, one-fourth of the total amount given to adults. Pfizer will be given as three doses, three weeks between the first two, and eight weeks between the second and third. Each shot is one-tenth of the value given to adults. Safety was a major concern for FDA panel members, and both vaccines met the mark (the panel recommended that they authorize them with 21–0 votes). Many side effects were mild, such as pain in the injection site and fatigue, and were quickly resolved.
Effective anti-coronavirus infection SARS-CoV-2 was difficult to determine for each vaccine. Regulators have allowed vaccine makers to reduce their effectiveness by demonstrating that vaccines can have antibody levels similar to those that protect adolescents and young adults, a concept known as immunobridging. That helped speed up the tests.But the companies were able to collect some performance data successfully. In the case of Moderna, 265 of the 5,476 19 children with a COVID-19 contract, and efficacy ranged from about 50% in infants and children to less than 40% in children aged 2-5. The Pfizer vaccine has been shown to do better, with an average effectiveness of about 80% in children aged 6 to 4 months. But these figures are based on a small number of cases – only seven infections in the placebo group and three in the vaccine group. Doran Fink, deputy director of policy and applications for FDA-related products in Silver Spring, Maryland, said at a panel meeting he considered the ratings to be “original” and “indirect”.
Despite the broad consensus among conference organizers that the benefits of both goals outweigh the risks, some concerns arose. Paul Offit, a vaccine and infectious disease specialist at Philadelphia Children’s Hospital in Pennsylvania, is concerned about the inefficiency shown in the first two doses of the Pfizer vaccine, developed in partnership with biotechnology company BioNTech, based in Mainz, Germany. Offit told Mvelo after the meeting: “You have not seen any evidence of security.” In other age groups, he added, the principles of Moderna and Pfizer “are in line with their performance”. This age group is “the first time you see them apart”.That leaves young children who get the Pfizer vaccine at risk for a long time. It also means that children should receive three doses for protection, which may present a planning challenge. “I am deeply concerned that many of these children will not get a third dose, as we know the struggle to get two people,” said Jeannette Lee, a biostatistician at the University of Arkansas for Medical Sciences in Little Rock. a member of the advisory team, during the meeting. “We’ve seen it in adult boosters, a lot of people don’t take it.”WayneMarasco, an orthopedic surgeon at the Dana-Farber Cancer Institute in Boston, Massachusetts, has raised some important concerns in both cases. He said the first type of virus a person is exposed to can determine their immune response to new strains of the virus for life – something known as immune imprinting. That can be a problem for children and adults alike. When young children are given a vaccine for the first version of SARS-CoV-2, the question is whether their immune system will protect them from a highly mutated mutant like Omicron.
In the study three vaccinated health workers infected with Omicron showed improvement in their response to T-cell, B-cell and antibody, but only against a variety of concerns that emerged prior to Omicron. Despite these problems, says Andy Pekosz, an orthopedic surgeon at Johns Hopkins University in Baltimore, Maryland, “you still have a better chance of getting a vaccine and getting that immune system, than risking it and getting that protection against infection”. The decision comes more than seven months after the first vaccination was approved by US children five years and older, and after a series of delays. The wait was painful for some parents, and their frustration was felt during public comment at a panel meeting. “I do not know the internal workings of the FDA, but I can honestly say why the review of Modernaunder fives took longer than any other age group made me feel that vaccinating my children was not a priority for the FDA,” said Lauren Dunington, a public health worker. worldwide and has two children under the age of five.
These two vaccines are likely to be approved by the FDA in the coming days. But it is up to the CDC to decide how they should be used. The organisation’s Immunization Advisory Committee is expected to make its recommendations within days, with the director of the organization, Rochelle Walensky, signing it. Offit predicts that vaccines will receive full recommendations from the committee, but notes that there is an example of recommending a vaccine over another. senior White House officials. If that happens, the United States will join a number of countries that vaccinate children under the age of five, including Argentina, Bahrain, China, Cuba and Venezuela. It is not yet clear whether other countries will comply with the US decision to make vaccines available to young children.
For more read and publication link: https://www.nature.com/articles/d41586-022-01689-w
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