Pfizer and BioNTech have asked the US Food and Drug Administration (Fda) to authorize the emergency use of their Covid mRNA vaccine for children between 5 and 11 years old. Administration in this age group can help protect 28 million children in the United States alone. Last month Pfizer released new data that a double dose of 10 micrograms – a third of that used for adolescents and adults – is safe and generates a “solid” immune response. This double dose, Pfizer argues, was well tolerated in clinical trials and produced an immune response and side effects comparable to those seen in the 16-25 year old age group.
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The FDA has promised that it will quickly examine the request and has already scheduled a session at the end of the month to examine data and the request of the two companies: a decision is expected between Halloween and Thanksgiving, which falls on November 25. “With new cases among children continuing to be very numerous in the US, this authorization is an important step in the efforts against Covid-19,” Pfizer pointed out. And parents are anxiously awaiting the decision of the regulatory body, which can affect school attendance and family life itself. Authorization depends not only on the robustness of the study data but also on whether the company is able to implement the new pediatric formulation.
Janet Woodcock, Commissioner Fda, last week precisely specified that children may require “a dosage or a different formulation from that used in the over 12 age group or in adults”. And Pfizer has in fact proposed a dose that is one third of that of adults, which may require using more diluent in each injection or using different vials or syringes. The company will describe the method it intends to use in submitting data to the FDA.
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The regulatory body will also have to examine the purity and stability of the vaccine doses, determine whether the quality and quantity of the dosage correspond to those used on children in clinical trials. The pediatric dose will probably also require different labeling, with special codes to allow American CDCs, the Centers for Disease Control and Prevention, to be able to track specific batches in case serious side effects are reported.
Children rarely get seriously ill with Covid, but the Delta variant brought nearly 30,000 to the hospital in August alone. According to the American Academy of Pediatrics, nearly 5.9 million Americans under the age of 18 have been infected with the coronavirus. Of the nearly 500 who died under the age of 18, about 125 were between 5 and 11 years old.
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“It really baffles me when I hear that children don’t die from Covid – he says Grace Lee, of Stanford Children’s Health, which led a committee to the CDC – instead they die. And it breaks your heart. “
In May, the FDA was authorized for the Pfizer vaccine between 12 and 15 years and now in the United States it is feared that the arrival of the cold season could increase the transmission of the virus. Vaccination for children is not eagerly awaited by everyone: according to research conducted by the Kaiser Family Foundation, about a third of parents of 5-11 year olds would prefer to wait a little longer.
According to Walt A. Orenstein, an epidemiologist at Emory University and former director of the American immunization program, it is right to press the FDA to decide quickly, but with great care, and public discussion is essential. In fact, many parents – according to the scientist – oscillate between fear of Covid and that of the effects of the pediatric vaccine. And in this case the role of the pediatrician is fundamental to allay anxieties and answer doubts.
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Pfizer’s trial involved 2,268 children, two-thirds of whom received two doses of the vaccine three weeks apart. The remainder (all were obviously volunteers) received two doses of placebo. The regulatory body asked to expand the study to 3,000 children. But it is important to point out that the study was not designed to draw conclusions about the vaccine‘s ability to prevent illness or hospitalization. Instead, the researchers focused on the levels of antibodies, comparing them with the levels that conferred high protection in adults.
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