FDA Vaccine Advisors Discuss the Urgency of Children’s Vaccination Against Coronavirus

On Thursday, a U.S. Food and Drug Administration vaccine advisor discussed what details authorities need to consider to allow children under the age of 12 to use the coronavirus vaccine.

Some advisors said it was premature to consider using the vaccine in children because children are at very low risk of the virus, but most advisors said the virus re-emerged in the fall and winter. He argued that it was important to have the approval handy in case it happened.

And the FDA’s top executives reminded members of the committee that COVID-19 could kill children and actually kill them.

Members of the FDA’s Vaccine and Related Biopharmaceutical Advisory Board (VRBPAC) were not required to provide specific advice or voting. The FDA advises companies on what types of clinical trials and data they would like to see to consider extending the use of licensed vaccines to children. Group.

The Pfizer / BioNTech vaccine is licensed for use in adolescents aged 12 years. The Moderna vaccine is licensed for people over the age of 18, but the company is asking the FDA to license it for use in children aged 12 years. People over 18 years old.

Although the vaccine has been shown to be very safe and effective in older age groups, members of VRBPAC have the latest preliminary report of an inflammatory heart disease called myocarditis that may be associated with the vaccine. Expressed concern about.

Dr. Cody Meissner, Head of Pediatric Infectious Diseases at Tufts University School of Medicine, said children are at low risk of serious viral illness and need further research into the safety of younger age groups. ..

“Before we start vaccination of millions of young people and children, it’s important to know what the consequences are,” said Meissner, who said the COVID-19 hospitalization rate for children Note that it is low.

“As more people get immunized and get immunized from infection, I think it’s likely that they will be able to control this pandemic fairly well.”

“I don’t think the EUA can be justified. The burden of illness is very small and the risks are unclear.”

However, other members of the committee strongly opposed it.

“I think these vaccines are needed sooner than delaying them,” said Dr. Mark Sawyer, a pediatric professor at the University of California, San Diego School of Medicine.

Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine and adjunct professor at Harvard TH Chan School of Public Health, said the situation is not bad, but it is subject to change.

“For now, there are few illnesses,” he said.

“I don’t know what will happen. I think that’s exactly why we want to put them in the arsenal. Just because we gave the vaccine EUA doesn’t mean we have to use it. Given all the concerns raised, we need to think seriously about how to use it, “Rubin added.

And Marion Gruber, director of the FDA Vaccine Lab, expressed dissatisfaction.

“We’ve heard that we don’t know what the virus will do in the fall and children are returning to school or indoors, so they need a vaccine right away, and they need a vaccine right away. “She said.

“If you wait too long and perform these clinical trials in a large number of pediatric patients, you may not be ready to use these tools when you need them.”

Dr. Stanley Perlman, a professor of pediatrics at the University of Iowa, said, “I think we need to prepare for the EUA if we see a surge in cases in the fall.

“It can be a little difficult to reach a consensus, as people can understand,” said Dr. Peter Marks, who heads the FDA’s Vaccine Evaluation Division.

Risk of heart inflammation

Meissner and colleagues said they were concerned about reports of heart inflammation.

There are “very few” reports of myocarditis or pericarditis between the ages of 12 and 15 who received the coronavirus vaccine, Dr. Tom Shimabukuro, deputy director of the Centers for Disease Control and Prevention’s Vaccination Safety Department, said at a meeting. Told.

Data show that there were more cases of heart inflammation than expected among adolescents who received a second dose of Pfizer / Bio-N Tech and Moderna’s coronavirus vaccine, most of which are older. Among the young people.

By May 31, at ages 16 and 17, approximately 2.3 million vaccines had been administered and 79 cases of myocarditis and pericarditis were reported. The expected incidence is typical of people of this age, between 2 and 19 cases, Shimabukuro said in a presentation.

According to CDC data, the age group from 18 to 24 was given nearly 9.8 million doses, with 196 reports of myocarditis. Expected incidence is 8 to 83.

The CDC Vaccination Advisory Committee has scheduled an emergency meeting next week to update the data and further assess myocarditis after vaccination with the Pfizer / BioNTech or Moderna vaccine.

It is important for members to consider the risks and benefits to their children as individuals, or to consider the benefits to society as a whole of vaccination of groups that may be vectors of spread. Discussed whether it is more important.

Marks told the committee members, “I want to remember all the children who died in COVID-19 in this pandemic.

“I want to repeat it again here. It’s a life-threatening illness. We know that more than 300 children have died in pandemics so far,” said the FDA’s biologics. Marks, director of the Evaluation Research Center, said. ..

The CDC states that COVID-19 has reported 314 deaths in US children under the age of 17.

“And looking at the mortality rate of COVID-19-infected people aged 11 to 17 years, it was about 1 in 3,600. Since the number of cases in this age group exceeds 1 million, this caused death. Make sure there are people out there, “Marks added.

“All of us have the goal of eliminating preventable deaths with vaccines that are possible with reasonable benefit risks.”

The-CNN-Wire
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