Your new post is loading...
Vaccinated kids aged 5 to 11 showed evidence of protection against the virus, the company said. The data must be reviewed by the F.D.A. before children can be inoculated. The Pfizer-BioNTech coronavirus vaccine has been shown to be safe and highly effective in young children aged 5 to 11 years, the companies announced early Monday morning. The news sets the stage for authorization of the vaccine for younger children, possibly before the end of October. The need is urgent: Children now account for more than one in five new cases, and the highly contagious Delta variant has sent more children into hospitals and intensive care units in the past few weeks than at any other time in the pandemic. Pfizer and BioNTech plan to apply to the Food and Drug Administration by the end of September for authorization to use the vaccine in these children. If the regulatory review goes as smoothly as it did for older children and adults — it took roughly a month — millions of elementary school students could begin to receive shots around Halloween. Trial results for children younger than 5 are not expected till the fourth quarter of this year at the earliest, according to Dr. Bill Gruber, a senior vice president at Pfizer and a pediatrician. Results from Moderna’s vaccine trials in children under 12 are also expected around that time, said Dr. Paul Burton, the company’s chief medical officer. Pfizer and BioNTech announced the results in a statement that did not include detailed data from the trial. The findings have not yet been peer-reviewed nor published in a scientific journal. But the new results dovetail with those seen in older children and in adults, experts said. “There’s going to be a huge number of parents who are going to heave a big sigh of relief when they hear this,” said Dr. Kristin Oliver, a pediatrician and vaccine expert at Mount Sinai Hospital in New York. “We’ve been waiting for these kids to be protected.”
Before the vaccine can be authorized, F.D.A. scientists must carefully sift through the data, looking for side effects the company may have missed, which may slightly delay the process.
Children have a much lower risk of Covid-19 than adults, even when exposed to the Delta variant. Still, some small number of infected children develop a life-threatening condition called multi-system inflammatory syndrome in children, or MIS-C. Still others may have lingering symptoms for months. Nearly 30,000 children were hospitalized for Covid in August; the least vaccinated states reported the highest rates. At Seattle Children’s hospital, about half of the children who are admitted for Covid are older than 12, according to Dr. Danielle Zerr, a pediatric infectious diseases expert at the hospital. “I’ve been dismayed at the fact that the sickest children in our hospital with acute Covid-19 or MIS-C are children who could have been vaccinated,” Dr. Zerr said. As ideological battles over masking and vaccine mandates play out in communities, the reopening of schools has fueled the surge. In Mississippi, among the states without a mask mandate, nearly 6,000 students tested positive for the virus in one week, and more than 30,000 students, teachers and staff had to be quarantined. One county in South Carolina — where mask mandates are banned — had to quarantine more than 2,000 students in one day. Remote learning is not an option in many districts, so the safety of some medically vulnerable children in many parts of the country has become subject to the actions of others. The trial results were greeted enthusiastically by many school administrators and teachers’ organizations, but are unlikely to lead to immediate policy changes. “This is one huge step toward beating Covid and returning to normalcy. I don’t think it changes the conversation around vaccine requirements for kids,” said Randi Weingarten, president of the American Federation of Teachers, a national union. Ms. Weingarten noted that parents and educators were still awaiting full F.D.A. approval of vaccines for children aged 12 to 15, and that mandates for adults did not come until months after the shots first became available....
Pfizer release (Sept. 20, 2021) available at:
