Walgreens pharmacist Jessica Sahni has the Pfizer-BioNTech (COVID-19) coronavirus disease vaccine at The New Jewish Home in New York on December 21, 2020.
Yuki Iwamura | Reuters
Pfizer said it had fully enrolled its trial of the Covid-19 vaccine in children between the ages of 12 and 15, a key step before the vaccine could be used in that age group.
The study, an extension of the one used to support the company’s emergency use of the vaccine in people 16 and older, enrolled 2,259 children between the ages of 12 and 15 said Pfizer on CNBC on Friday. His entry on a government website for clinical trials was updated to keep in mind that he no longer recruits subjects.
The vaccine, developed with German partner BioNTech, was licensed for people over 16 in December. Trials in younger age groups are needed to ensure the right dose, as well as safety and efficacy in these different groups, said Dr. Evan Anderson, a pediatrician at Emory University School of Medicine.
“I am very uncomfortable returning my children to school, where, despite the best efforts of the school, there is a real risk of hiring Covid-19,” Anderson told CNBC in October.
Although children are less affected by Covid-19 than adults, they still catch the virus and get sick. Some have even died. According to a report by the American Academy of Pediatrics and the Children’s Hospital Association, more than 2.5 million cases of Covid-19 were reported in children as of January 14, approximately 13% of all cases.
“Children can still get sick and die from Covid-19,” said Dr. Paul Offit, director of the Vaccine Education Center and infectious disease physician at Philadelphia Children’s Hospital. “So many children last year died of Covid-19 as they died from the flu. And we recommend a flu shot for the kids.”
Offit also noted that children may suffer from a disease called Covid-19-associated multisystem inflammatory syndrome, “which can be debilitating.”
There have been 1,659 cases of syndrome in children, known as MIS-C, and 26 associated deaths as of Jan. 8, according to data from the Centers for Disease Control and Prevention. There have been a total of 78 deaths from Covid-19 in children 4 years of age and younger and 178 in children 5 to 17 years old, according to CDC data, although these figures do not account for all deaths reported in the U.S.
Children line up to attend class at PS 361 on the first day of return to class during the coronavirus disease pandemic (COVID-19) in the Manhattan district of New York City, New York, USA, on 7 December 2020.
Carlo Allegri | Reuters
Pfizer declined to say when to wait for the results of the trial, which depend on the rate of infections observed in order to compare the rates of the placebo group with those received by the vaccine. With higher infection rates in the United States since the fall (the seven-day average of daily cases is now about 187,500, according to a CNBC analysis of Johns Hopkins University data), efficacy trials of the vaccine have seen their readings accelerate.
But recruitment for rehearsals in teens had been slower than expected, at least for the study of Moderna in children ages 12 to 17, said Moncef Slaoui, chief adviser to Operation Warp Speed, l the Trump Administration’s vaccination effort, at its last briefing on Jan. 12.
By then, about a thousand children had been registered for trial for a month, he said, of the nearly 3,000 needed. The Moderna vaccine was licensed for people over the age of 18 in December, weeks after it began its trial in adolescents. Pfizer reduced the age of his trial to 12 in October.
“While enrollment was lower during the holiday season, we expect the new year to increase as planned,” Moderna spokeswoman Colleen Hussey said Friday. “We are on track to provide updated data by mid-2021.”
AstraZeneca, the vaccine developed by Oxford University is in final-stage trials in the US and authorized in the UK, told CNBC on Friday that it plans to continue British trials in a new protocol for children aged 5 to 18 years from the coming months. “
Johnson & Johnson, who is expected to see phase three results in adults imminently expected, said he is in discussions with regulators about including pediatric populations in their development plan. He noted that the same technology he uses for the Covid-19 vaccine has been used in vaccines administered to more than 200,000 people, including people over 65, infants, children, HIV-positive adults and pregnant women.
Vaccine trials typically pass to younger age groups after they have been shown to be safe and effective in larger groups, and Covid-19 vaccine manufacturers have indicated that they will follow this plan as well.
Moderna chief executive Stephane Bancel said this month that the company is unlikely to have data on children aged 11 and under, which would imply a lower dose, before next year. He said he expects data for children 12 and older to be available before September.
U.S. public health officials, such as the White House chief medical adviser, Dr. Anthony Fauci, have said they hope that between 75% and 80% of the American population can be vaccinated by the fall to allow life to return to some form of normalcy.
About 78 percent of the U.S. population, or 255 million people, are over the age of 18, according to a CNBC census data analysis. Another 25 million people are between 12 and 17 years old.
Fauci did not immediately respond to an investigation into whether children should be included in vaccines to reach their 75% to 80% coverage goal.
“It’s important that all children get vaccinated and manufacturers can’t do these tests fast enough,” Angela Rasmussen, a virologist and affiliate of the Georgetown Center for Global Health Science and Security, told CNBC on Friday. “The more people of any age are vaccinated, the better.”