F.D.A. Panel Recommends Vaccine for Children 5 to 11

Washington – A group of Food and Drug Administration advisers on Tuesday recommended that regulators approve Pfizer BioNTech’s coronavirus vaccine for 5 to 11 years.

As expected, if the FDA follows the commission’s advice in the coming days, the Biden administration will expand access to the vaccine to everyone but the youngest Americans while providing booster vaccines for many.

Biden officials say it’s an important dose for children to keep schools open and restore a sense of family and normal work life if the pandemic escalates at the end of their second year. think about. As the Delta variance decreases and the daily pulse of infections and deaths declines, the government wants to be seen as fighting the virus and doing its best based on positive trends.

Younger children are being vaccinated as the number of coronavirus cases is falling rapidly. However, public demand for vaccines for children is high, and while some committee members are unlikely to become seriously ill from Covid-19, parents and doctors also want to protect them. On the phone.

dr. Japort New, medical director of Children’s Mercy Hospital in Kansas City, Missouri, said he saw critically ill children and “scared” parents in intensive care units. “I’m really looking forward to doing something to prevent this from happening,” he said.

The vote was 17-0 with one abstention. Federal regulators and scientists have made a strong push, claiming 8,300 children between the ages of 5 and 11 were hospitalized with Covid-19 and nearly 100 died during the pandemic.

Covid-19 is “the eighth biggest child killer in this age group in the past year,” said Dr. Amanda Korn, CDC’s director of vaccines. “Using this vaccine prevents death, prevents admission to the intensive care unit, and prevents serious long-term side effects for children.

In clinical trials aged 5 to 11 years, the vaccine showed 90.7% effectiveness in preventing Covid-19 symptoms, according to Pfizer. However, many Advisory Panel members have repeatedly discussed the risk of myocarditis in vaccinated young people and raised concerns about limited safety data. Myocarditis and pericarditis, inflammation of the lining of the heart, have been associated with Pfizer-BioNTech and Moderna vaccines, especially in young men.

The Pfizer dose for toddlers is one-third the strength given to people over the age of 12, with two injections given every three weeks. Experts say it could reduce the risk of heart-related side effects.

Approval could be granted in a matter of days if FDA regulators follow the commission’s recommendations as usual. A unique panel of external experts from the Centers for Disease Control and Prevention will meet on Tuesday and Wednesday and are expected to agree on a pediatric dose. The CDC, which sets the vaccination policy, may immediately recommend vaccination.

In a lengthy debate before the vote, several committee members asked whether all children in that age group really need the vaccine or should it be limited to children who are at high risk of severe COVID-19. I asked a question. Obesity or other risk factors.

dr. James EK Hildress, President and CEO of Mehary Medical College, said that many children between the ages of 5 and 11 may already have immunity after being infected with the virus. He said the need for widespread vaccination of all strata may not be so urgent.

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“On the one hand, we seem to be vaccinating children to protect adults, but the opposite has to happen,” he said. “I believe that the most vulnerable children should be vaccinated, but vaccinating all children to achieve this seems small to me.”

dr. Hildres also lamented that Pfizer’s pediatric studies rarely included minority children, particularly those at risk for poor Covid-19 outcomes.

Several committee members said they would like to recommend the vaccine to a smaller group of children, but were asked to determine whether the benefits of pediatric injections outweigh the risks. dr. Eric Rubin, an infectious disease expert at the Harvard TH Chan School of Public Health, said:

dr. Paul Ofit, a panelist who heads the Vaccine Training Center at Children’s Hospital of Philadelphia, makes public health decisions that affect millions of children based on surveys of just thousands of participants. He said he was “draining his nerves”.

But he said: And we certainly know that there are many children between the ages of 5 and 11 who are susceptible to this disease and who may get sick, be hospitalized, or even die from it. ”

dr. Peter Marx, who heads the vaccine approval monitoring department, told the commission that nearly two million people in this age group were infected and a third of hospital patients needed intensive care. Which says.

The commissioners said they hoped the pediatric dose would not only keep elementary school children away from hospitals, but would also reduce the incidence of prolonged viral and covid infections.

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The CDC’s expert on viral diseases, Dr. Fiona Havers said the epidemic forced more than 2,000 schools to close between early August and October, affecting more than a million students. I said on the panel.

He said levels of neutralizing antibodies, which are important for preventing infection, were higher than in children, but at least the same as in adults. He said there appeared to be more cases of infection in children than publicly reported.

dr. Havers added that the Covid-19 hospitalization rate for the 5-11 age group was three times higher for blacks, Spaniards and Indians than for white children.

The CDC also presented data from blood tests showing that 42% of infants had antibodies to the coronavirus, raising the question of whether many of them are asymptomatically infected and develop innate immunity. dr. Havers warned that the children being tested were already in clinical care and may not be representative of the general public.

It is unclear how many parents would immediately vaccinate elementary school students if given the opportunity. Studies show that about a third want to do this right away and a third prefer to wait and see. Since federal agencies approved Pfizer vaccination for youth ages 12-15 in May, 46% have been fully vaccinated, compared with about 69% for adults.

Many panelists said the safety and efficacy data were convincing enough for the government to provide a vaccine and give parents options.

What you need to know about Covid-19 booster photos
What is the purpose of amplifying the shot?
The FDA has approved a booster vaccine for millions of Pfizer BioNTech, Moderna, Johnson & Johnson vaccine recipients. Pfizer and Moderna’s increasing recipients include people over the age of 65 and young adults who are at high risk of developing severe COVID-19 because of their illness or occupation.

Eligible Pfizer and Moderna recipients may receive a booster vaccination for at least 6 months after the second dose. All Johnson & Johnson recipients are entitled to a second vaccination at least two months after the first vaccination.

Is it possible to replace the Covid vaccine with a booster?
Yes, Sir. The FDA has updated its approval to allow health care providers to push people with a different vaccine than the one originally given. This is a strategy known as “mix and match”. Whether you receive Moderna, Johnson & Johnson, or Pfizer-BioNTech, you can get booster vaccinations for other vaccines.