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Thursday, December 1, 2022

A panel of the Food and Drug Administration endorses the Pfizer-BioNTech vaccination for young children

In a recommendation released on Tuesday, an expert committee advising the Food and Drug Administration recommended that regulators approve Pfizer-coronavirus BioNTech’s vaccine for children aged 5 to 11 years old. This would bring approximately 28 million children a significant step closer to becoming eligible for vaccinations.

If the Food and Drug Administration (F.D.A.) adopts the panel’s recommendations in the coming days, as is likely, the Biden administration will have increased vaccination availability to all Americans save the very youngest, while also offering booster injections to many more.

Officials in the Biden administration believe that the paediatric dosage is critical to keeping schools open and restoring a feeling of normality to family and work life as the epidemic nears the conclusion of its second year. As the Delta variety ebbs and the daily drumbeat of infections and fatalities fades, the administration wants to be viewed as doing all it can to battle the virus and build on favourable patterns that have already been established.

Younger children would begin receiving their vaccinations at a time when the number of coronavirus illnesses is declining rapidly. However, there has been significant public demand for a paediatric vaccination, and several panel members said that, despite the fact that small children are less likely to get critically sick from Covid-19, parents and physicians alike are desperate to protect them.

Medical director of Children’s Mercy Hospital in Kansas City, Missouri, Dr. Jay Portnoy stated he has seen seriously sick children in the intensive care unit and “terrified” parents. In the meanwhile, he remarked, “I’m looking forward to being able to really do something to avoid it.”

The vote was 17-0 in favour, with one abstention, with one abstention. According to federal authorities and experts, around 8,300 children between the ages of 5 and 11 had been admitted to hospitals with Covid-19, and over 100 children had died as a result of the epidemic.

Dr. Amanda Cohn, a senior official with the Centers for Disease Control and Prevention, stated that Covid-19 is the “eighth-leading cause of death among children in this age range over the last year.” This immunization will prevent deaths and ICU hospitalizations in children. It will also avoid major long-term poor consequences in these youngsters.

The vaccine had a 90.7 percent success rate in avoiding symptomatic Covid-19, according to data from Pfizer, which came from a clinical study including children aged 5 to 11 years. Despite this, several members of the advisory group voiced worry about the lack of safety data, with particular attention drawn to the danger of myocarditis, a rare illness characterised by inflammation of the heart muscle, among young vaccination recipients. A link has been shown between the Pfizer-BioNTech and Moderna vaccines and myocarditis and pericarditis, which are inflammation of the lining of the heart. This has been found to be especially true in younger males.

It is recommended that smaller children have two injections three weeks apart, administered by Pfizer at a concentration one-third that of adults over the age of 12. According to experts, this might reduce the likelihood of heart-related adverse effects.

If FDA authorities follow the committee’s recommendations, as they usually do, an authorization may be issued within a few days. The Centers for Disease Control and Prevention’s own group of outside specialists is slated to convene on Tuesday and Wednesday, and it is likely to recommend a paediatric dosage at the conclusion of the meeting. The Centers for Disease Control and Prevention (C.D.C.), which determines vaccination policy, would almost certainly urge that the injections be implemented as soon as possible.

In an extended discussion before the vote, some committee members questioned whether every child in the age group really needed the vaccine or whether it should be restricted to those at high risk of severe Covid-19 — an easily identifiable group with underlying conditions such as obesity or other risk factors — rather than all children in the age group.

Dr. James E.K. Hildreth, president and chief executive officer of Meharry Medical College, stated that because many children between the ages of 5 and 11 may already have some immunity to the virus as a result of contracting it, the need to vaccinate a large number of children in this age group may be less pressing.

Jonathan James
I serve as a Senior Executive Journalist of The National Era
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