#childsafety | FDA advisers discuss the urgency of vaccination of children


The Food and Drug Administration’s vaccine adviser discussed on Thursday the types of detailed information that authorities need to consider permitting children under the age of 12 to use the coronavirus vaccine. Most people argued that children are at very low risk of the virus, so it is important to have permission at hand in case the virus recurs in the fall and winter. Kill the child Members of the FDA’s Vaccine and Related Biological Products Advisory Board were not asked to provide specific advice or votes. The FDA advises companies on the types of clinical trials and data they would like to consider extending the use of licensed vaccines to children. It is the company’s responsibility to ask the FDA to approve or extend full approval to the new age group. The Pfizer / BioNTech vaccine is approved for use by people up to the age of 12. The Moderna vaccine is approved for people over the age of 18, but the company is asking the FDA to allow it for children up to the age of 12. Johnson & Johnson vaccines have been shown to be very safe and effective in the elderly group for people over the age of 18, but VRBPAC members have an inflammatory heart called myocarditis that may be associated with the vaccine. He expressed concern about a fresh and preliminary report of the disease. 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 the younger age group. It is important to point out that children have low COVID-19 hospitalization rates and to know what the consequences will be. ” “I don’t think the EUA can be justified. The burden of illness is very small and the risks are unclear,” he said. However, other members of the committee strongly opposed it. “I think we need these. Vaccination of children sooner or later,” he said. Dr. Mark Sawyer, a professor of pediatrics at the University of California, San Diego Medical College, said. 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 looks good, but it could change. “I don’t know what will happen. I think that’s why we want to put them in the arsenal. Just because we give the vaccine EUA doesn’t mean we have to use it. Given that, I think we have to think hard about how to use it, “Rubin added. Marion Gruber, director of the FDA’s vaccine lab, also expressed dissatisfaction. Vaccines are needed soon, they don’t know what the virus will do in the fall, and children are back in school or indoors, so they will need them soon, “she said. For pediatric subjects, these tools may not be ready to be available when needed. “I think we need to be ready for the EUA if the number of cases begins to surge in the fall,” said Dr. Stanley Perlman, a professor of pediatrics at the University of Iowa. Dr. Peter Marks, who heads the FDA’s department for evaluating vaccines, said. Risk of Heart Inflammation Meissner and colleagues said they were worried about reports of heart inflammation. Dr. Tom Shimabukuro, Deputy Director of the Vaccination Safety Department of the US Food and Drug Administration, spoke at a conference about myocarditis or myocarditis aged 12 to 15 years vaccinated with coronavirus vaccine. -Expected number of cases of carditis in young people who recently received a second dose of Pfizer / BioNTech and Moderna coronavirus vaccine-But most of them are among older people. Between 16 and 17 years old, May 31st. By now, nearly 2.3 mi millions of vaccines have been administered and 79 cases of myocarditis and pericarditis have been reported. In his presentation, Shimabukuro showed that the expected rate (typical for people of this age) is 2 to 19 cases. CDC data also show that approximately 9.8 million doses were given between the ages of 18 and 24. There were 196 reports of myocarditis and pericarditis. The CDC Immunization Implementation Advisory Board has scheduled an emergency meeting next week to update the data and further evaluate post-vaccination myocarditis with Pfizer / BioNTech or Moderna vaccines. VRBPAC members should consider the risks and benefits to their children as individuals, or the benefits to society as a whole of vaccination of groups that may be a vector of dissemination. “I also want to remember all the children who died in COVID-19 in this pandemic, because we must not forget here,” Marks told the meeting in his closing remarks. This is a life-threatening illness for children. We know that more than 300 children have died in pandemics so far, “said Marks, director of the FDA’s Center for Biologics Evaluation and Research. The CDC says there are reports of 314 deaths. Children under the age of 17 in the United States by COVID-19. And looking at the mortality rate of 11-17 years old who had COVID-19, it was about 1 in 3,600 of those individuals. And since there were more than a million cases in that age group, we know there are deaths from this, “Marks added. .. ”

The Food and Drug Administration’s vaccine adviser discussed on Thursday the types of detailed information that authorities need to consider permitting children under the age of 12 to use the coronavirus vaccine.

Some advisers said it was premature to rush vaccines to children because children are at very low risk of the virus, but most people have a recurrence of the virus in the fall and winter. He argued that it was important to get permission in preparation for the virus.

And the FDA’s chief executive reminded members of the committee that COVID-19 can and does kill children.

Members of the FDA’s Vaccine and Related Biopharmaceutical Advisory Board were not asked to provide specific advice or voting. The FDA advises companies on the types of clinical trials and data they would like to consider extending the use of licensed vaccines to children. It is the company’s responsibility to ask the FDA to approve or extend full approval to the new age group.

The Pfizer / BioNTech vaccine is approved for use by people up to the age of 12. The Moderna vaccine is approved for people over the age of 18, but the company is asking the FDA to allow it for children up to the age of 12. Johnson & Johnson vaccine is for people over 18 years old.

Although the vaccine has been shown to be very safe and effective in the elderly group, VRBPAC members commented on a fresh and preliminary report of an inflammatory heart disease called myocarditis that may be associated with the vaccine. Expressed concern.

Dr. Cody Meissner, director 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 the younger age group.

“It’s important to know what the consequences will be before we start vaccination of millions of adolescents and children,” said Meissner, who has a low COVID-19 hospitalization rate for children. Pointed out.

“As more people are vaccinated and immunized from the infection, I think we are likely to be able to control this pandemic fairly well,” he said.

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

However, other members of the committee strongly opposed it.

Dr. Mark Sawyer, a professor of pediatrics at the University of California, San Diego School of Medicine, said:

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 current situation does not seem to be bad, but it may change.

“I’m not sick so far,” he said.

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

And Marion Gruber, director of the FDA’s vaccine lab, expressed some dissatisfaction.

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

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

Dr. Stanley Perlman, a professor of pediatrics at the University of Iowa, said:

“As people can see, achieving consensus can be a bit difficult,” said Dr. Peter Marks, who heads the FDA’s department for evaluating vaccines.

Risk of heart inflammation

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

There are “very few” reports of myocarditis or pericarditis between the ages of 12 and 15 who have been vaccinated with the coronavirus vaccine, Dr. Tom Shimabukuro, deputy director of the Centers for Disease Control and Prevention’s Immunization Safety Department, told the meeting. Told.

Data show that there are more cases of carditis than expected among adolescents who received a second dose of Pfizer / BioNTech and Moderna coronavirus vaccine, but most are among older adolescents.

By May 31, between the ages of 16 and 17, about 2.3 million vaccines had been administered and 79 cases of myocarditis and pericarditis were reported. The expected rate (typical rate among people of this age) is between 2 and 19 cases, Shimabukuro showed in his presentation.

CDC data also show that between the ages of 18 and 24, there were nearly 9.8 million doses and 196 reports of myocarditis and pericarditis. Expected rates are between 8 and 83 cases.

The CDC Immunization Implementation Advisory Board has scheduled an emergency meeting next week to update the data and further assess post-vaccination myocarditis with Pfizer / BioNTech or Moderna vaccines.

It is more important for VRBPAC members to consider the risks and benefits to their children as individuals, or to immunize groups that may be a vector of dissemination for the benefit of society as a whole. We talked about whether it is more important to consider.

Mark accused the members of the committee. “I also want to remember all the children who died in COVID-19 in this pandemic, because we must not forget here,” Marks told the meeting in his closing remarks.

“I would like to reiterate here that this is a life-threatening disease for children. I know that more than 300 children have died in a pandemic so far,” said the FDA’s Center for Biologics Evaluation and Research. Marks, the director, said.

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

“And looking at the mortality rate of 11-17 years old who had COVID-19, it was about 1 in 3,600 of those individuals, and because there were more than 1 million cases in that age range. , You can make sure you’re dead because of this, “Marks added.

“All of us have the goal of eliminating vaccine-preventable deaths at a reasonable risk of benefit.”



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