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FDA vaccination advisers debate vaccinating children under 12

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(CNN) – Vaccination advisers from the U.S. Food and Drug Administration (FDA) debated on Thursday what detailed information the agency should request to consider approval of the Covid-19 vaccination. of those under 12 years of age.
While some advisers said that it is too early to rush the use of vaccines in children because they are at very low risk of contracting the virus, most argued that it is important to have authorizations on hand in case there is a flare-up viruses in autumn and winter.

And a senior FDA official reminded committee members that Covid-19 can and does kill children.

Members of the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) did not discuss specific vaccines or vote on any issue. The FDA committee will issue recommendations to pharmaceutical companies on what type of clinical trials and data it will require to consider the extension of the authorized use of covid vaccines in children, and it will be up to the companies to ask the FDA for the extension of the authorization, or full approval, for new age ranges.

Pfizer’s Covid-19 vaccine is currently licensed for people 12 years of age and older in the United States. Moderna’s covid-19 vaccine is authorized for use by people over 18 years of age, although the company requested authorization from the FDA for the use of its vaccine in young people up to 12 years of age. The Johnson & Johnson vaccine is licensed for people 18 years of age and older.

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Although vaccines have been shown to be very safe and effective in older age groups, members of the VRBPAC expressed concern about recent, albeit preliminary, reports of an inflammatory heart disease called myocarditis that could be related to the vaccine.

Dr. Cody Meissner, director of pediatric infectious diseases at Tufts University School of Medicine, said children are at low risk of serious illness from the virus and more studies are needed on safety in groups. younger age.

“Before we start vaccinating millions of adolescents and children, it is important to find out what the consequences are,” said Meissner, who highlighted the low rate of hospitalization for COVID-19 among children.

“As more people get vaccinated and become immune to infection, I think we are likely to have this pandemic fairly under control,” he said.

‘I don’t think we can justify an emergency use authorization (AUE). The incidence of the disease is so small and the risks are unclear.

But other committee members strongly disagreed.

“I think we need these vaccines as soon as possible in children,” said Dr. Mark Sawyer, a professor of pediatrics at the University of California San Diego School of Medicine.

Dr. Eric Rubin, editor-in-chief of The New England Journal of Medicine and an associate professor at Harvard’s TH Chan School of Public Health, noted that the situation does not look bad at the moment, but that it could change.

“Right now there is not much disease,” he said.

We don’t know what will happen. I think that’s precisely why we want to have them in our arsenal. The fact that we grant an authorization to use the vaccine does not mean that we have to use it, and I think we would have to think very well how to use it, given all the concern that has been raised, “added Rubin.

And Marion Gruber, director of the FDA’s Office of Vaccine Research, expressed some frustration.

“We have heard that we need vaccines soon and that we need them soon in children because we do not know what the virus will do in the fall and the children are back in school and indoors,” he said.

“If we wait too long and do these clinical trials with large numbers of pediatric subjects, we may not be ready to have these tools available when we need them.”

“I think we need to have the AUE ready in case we start to see a spike in cases in the fall,” said Dr. Stanley Perlman, a professor of pediatrics at the University of Iowa.

“Getting consensus, as you can see, can be a bit difficult,” said Dr. Peter Marks, who heads the FDA’s division that evaluates vaccines.

Risks of heart inflammation

Meissner and others were concerned about reports of heart inflammation.

Dr. Tom Shimabukuro, deputy director of the Office of Immunization Safety at the US Centers for Disease Control and Prevention (CDC) told the meeting that there are “very few »Reports of myocarditis or pericarditis in children ages 12-15 who have received coronavirus vaccines.

Data shows that higher than expected number of cases of heart inflammation have occurred among young people who have recently received their second doses of the Pfizer / BioNTech and Moderna coronavirus vaccines, but especially among older youth. .

Among 16-17-year-olds, as of May 31, nearly 2.3 million doses of the vaccines were administered and 79 cases of myocarditis and pericarditis were reported. The expected rate, typical for people of this age, is between two and 19 cases, Shimabukuro showed in his presentation.

CDC data also showed that nearly 9.8 million doses were administered among 18 to 24-year-olds, and 196 cases of myocarditis and pericarditis were recorded. The expected rate is between 8 and 83 cases.

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CDC’s Advisory Committee on Immunization Practices scheduled an emergency meeting for next week to update the data and further evaluate myocarditis after vaccination with the Pfizer / BioNTech or Moderna covid-19 vaccines. .

Members of the VRBPAC debated whether it is more important to consider the risks and benefits for children as individuals, or the benefits for society as a whole, of vaccinating a group that could be a vector of spread.

Marks berated the committee members. “I also want to take a moment to remember all the children who have died from covid-19 in this pandemic, because that should not be forgotten here,” Marks said at the closing meeting.

“I just want to reiterate something here: this is a disease that takes the lives of children. We know that more than 300 children have died in the pandemic so far, “said Marks, who is director of the FDA’s Center for Biological Research and Evaluation.

The CDC says it has a record of 314 deaths of children 17 and under in the United States from COVID-19.

“And if you look at the mortality rate of children aged 11 to 17 who had COVID-19, it was approximately 1 in 3,600 of those individuals. And since we had more than a million cases in that age range, you can see that there are deaths from this, “Marks added.

“All of us have a goal of eliminating as many preventable vaccine deaths that we can with reasonable benefit-risk.”

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