Boston, Massachusetts 2021-09-20 06:45:34 –
NSPfizer and its partner BioNTech announced on Monday that they will apply for approval of the Covid-19 vaccine for children after clinical trial results show volunteer antibody levels and side effects similar to those of teens and young adults. ..
A pediatric study of children aged 5 to 11 years was the first to disclose infant results.
Previous studies have shown that adult doses can cause more side effects, so we used lower doses of the vaccine than are currently given. Adults receive two 30 microgram vaccines every three weeks. In school-aged children, this was reduced to 10 micrograms.
Antibody reactions and common side effects were compared between 2,268 children and another group of volunteers aged 16 to 25 years who received adult doses. To determine safety, children were also compared to a placebo group of similar age. One volunteer for every two vaccinated received a placebo.
The antibody response in children was similar to that of participants aged 16 to 25 years. The two companies said the side effects were also “generally equivalent” between the two groups.
William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said the company hopes to submit the data to the Food and Drug Administration by the end of the month. He said certain side effects, such as fever and chills, were similar to those in the 16-25 year old group.
Pfizer and BioNTech provided only average antibody levels. That can mean lower levels and less protection for some children. However, Gruber said antibody levels were high across the group.
External experts have considered the data positive, but limited.
Kathleen Neuzil, director of the Vaccine Development and Global Health Center at the University of Maryland School of Medicine, said: “Low doses of this vaccine in children appear to be as good as high doses in older children and adults.”
Pfizer’s press release did not contain data on how the vaccine reduced the chances of children getting sick. Gruber said there weren’t enough cases of illness to tell. However, outside experts have said it is reasonable to assume that similar levels of antibodies mean similar protection from disease.
John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, emphasized that the FDA will be able to analyze both safety and efficacy data from vaccines. “Of course it becomes important, so the larger dimension is what they can use for safety assessments,” Moore said.
One concern, which is rare, can be the case of myocarditis, heart inflammation, which is seen in adults. These occur only once for every tens of thousands or hundreds of thousands of vaccinations. However, there are no clinical trials large enough to accurately study such rare risks.
“Children in the age group of 5 to 11 seem to be least likely to have serious consequences for Covid,” Neuzil said, citing recent data from the US Centers for Disease Control and Prevention. “It’s not important and not a disease worth preventing, but if the outcome of the disease is low, the standard of vaccine performance will be high. You need to be very careful about safety issues. . “
But it needs to be balanced with the risks of Covid-19, experts said. Recent data show that more infected children are hospitalized and more are in the intensive care unit. They said that children are no longer the only ones suffering from other illnesses that are becoming ill.
Neusel said she believes it is best to address the risks by making sure that parents understand the risks and make informed choices for their children.
“If this misconception that a child is unaffected continues, one might think that the child does not need to be vaccinated, or that this small risk of side effects is sufficient to not vaccinate the child. “Hmm,” said Flor M. Munoz, an associate professor of pediatrics. Baylor College of Medicine and Exam Researcher. “Currently, there is a pandemic that is different from the 2020 pandemic.”
This means that you have to make decisions about more limited data than regulators want.
Andrew T. Pavia, Head of Pediatric Infectious Diseases at the University of Utah, said: Assuming that safety and efficacy data are retained when scrutinized, Pavia states that keeping track of rare side effects among those who opt for vaccination is the best option. He said he was thinking.
Pfizer executive Gruber emphasized that it must be the public health authorities to determine whether Pfizer’s data are sufficient to approve low-dose vaccines for children.
However, Gruber argued that it was important not only to prevent severe illness, but also to consider the benefits of vaccines.
“Until we actually control the pandemic and the children feel protected, there are still significant restrictions on masking, after-school activities, and everything that allows children to become children. There is, “Gruber said. “As you know, I’m a pediatrician. I see the vaccine being released. I can’t lose that particular aspect of all of these to allow people to return to normal life. “
Pavia said that if the vaccine is approved by the FDA, it will probably be received in the same way as adults.
“There will be a subset of the morning line-ups available, such as doctors and their children, nurses and their children,” Pavia said. “I’m sure there are groups of people who really oppose it because I’m sure the kids aren’t at risk. And a lot of people [will be] Middle: “We need to understand what we know and what we don’t know.” All pediatricians in the country with children aged 5 to 11 are probably already in line is. “
According to the two companies, data reads for children aged 2 to 5 and 6 months to 2 are expected to be as early as the fourth quarter of this year.
Pfizer says its Covid vaccine generates robust antibody response in kids Source link Pfizer says its Covid vaccine generates robust antibody response in kids