The three main issues that the FDA Panel considered at the meeting are:
The Commission will primarily assess whether the vaccine is safe for children and, ultimately, has potential protective effects on children and society as a whole when used by the youngest Americans. I focused on it.
One of the major considerations for regulators: The child’s developing immune system appears to respond to Covid-19 in a different way than the adult’s immune system. Children are generally less likely to develop more severe Covid-19 than adults, but only a few develop a serious inflammatory syndrome called MIS-C, but adults do not.
More than 300 children are hospitalized for the disease in the United States, and recent data from the US Centers for Disease Control and Prevention show that hospitalizations are on the rise. According to federal data, children under the age of 5 and teens have higher hospitalization rates than children between the ages of 5 and 11.
“You will need a highly vaccinated or immune population for years, if not decades. You don’t have to include children as part of it. It seems ridiculous to think, “says Paul Offit. Pediatrician at Philadelphia Children’s Hospital.
Others were more cautious. Cody Meissner, a pediatric professor at Tufts University School of Medicine, said children need safe and effective Covid shots — However, he objected to allowing people under the age of 18 to use it urgently, citing insufficient safety data currently available.
“The burden of illness is very small and the risks are not clear,” he said.
Although clinical trials are designed to sniff out common side effects, some rare conditions associated with vaccination can only occur if the shot is widely used. The Federal Health Organization is currently investigating reports of heart inflammation in some people under the age of 30 who received the mRNA vaccine from Moderna and Pfizer.
Although the condition is rare, CDC often occurs after the second inoculation of the mRNA vaccine, with initial data showing about 16 cases per million seconds of administration.
The panel discussed whether it was more important to test a large cohort of children, or to track their immune response over a long period of time. “There are no more adverse events going forward,” said Haley Guns, a pediatrician at Stanford University, about the Covid vaccine trial. She is looking at larger studies in a shorter period of time to rule out even the rarest adverse events such as heart inflammation.
Other committee members acknowledge the uncertainty about how Covid spreads in the fall and winter, and a wide range of people in the country begin to spend more time indoors. Panel experts have expressed concern that younger populations have no vaccination options by then. It has also been pointed out that children are still vaccinated against diseases that are rare or nonexistent in the country, such as measles and polio.
Vaccine efficacy is usually calculated in clinical trials by comparing the number of infections in study participants who received injections with those who received placebo. The exam is designed so that the data is analyzed at a given point in time. If the number of cases indicates that the injection is ineffective, you can either stop it or continue to determine the effectiveness of the vaccine more accurately.
However, children are less susceptible to symptomatic Covid-19 infections than adults, so it can take much longer for pediatric vaccine trials to meet the statistical criteria set by the FDA for adult vaccine research. ..
FDA authorities are considering other approaches to measuring vaccine efficacy. monitor The type of antibody developed by the vaccinated person. Children inoculated against Covid develop the same amount of protective antibody as adults, especially if adults are as highly protected from the disease as in clinical trials of the Covid vaccine. So far, which real-world data is supported — scientists can think of vaccines as effective.
Measuring antibody levels in vaccinated children Doran Fink, pediatrician and deputy director of the Center for Biologics Evaluation and Research, states that this is an established approach to demonstrate efficacy in pediatric age groups. If these antibody levels are equal to or higher than those measured in adults, researchers believe the vaccine is effective in children.
How the Covid vaccine mixes with regular childhood injections
People receive most vaccinations as a child and often receive multiple injections at the same time. The FDA has asked its advisory board to think about whether children should be vaccinated with the Covid vaccine along with regular childhood vaccinations.
The CDC recently updated the vaccine guidance for teens and adults to recommend taking the Covid vaccine with other shots. Tetanus-Diphtheria-Whooping cough and human papillomavirus orders decreased by about 18% compared to 2019, and many teens lag behind regular shots after a year or more of pandemic restrictions The data may indicate
One of the small concerns is whether co-administered vaccines can interact in ways that lead to more serious side effects and reduced efficacy. “We need to look for interference not only in safety, but also in the immune response,” Guns said.
Kidcovid-19 Vaccine: Three Points from the FDA Conference
Source link Kidcovid-19 Vaccine: Three Points from the FDA Conference