Walgreens Pharmacist Jessica Sahni Holds Vaccination Against Pfizer-BioNTech Coronavirus (COVID-19) at The New Jewish Home in New York, December 21, 2020.
Yuki Iwamura | Reuters
Pfizer said it had fully enrolled its Covid-19 vaccine test in children aged 12 to 15, an important 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 vaccinations for the vaccine in people 16 and older, enrolled 2,259 children between the ages of 12 and 15, Pfizer told CNBC. The entry on a government website for clinical trials has been updated to note that it no longer recruits subjects.
The vaccine, developed together with German partner BioNTech, was approved in December for people aged 16 and over. Trials in younger age groups are needed to ensure the right dose, as well as safety and efficacy in the different groups, said dr. Evan Anderson, a pediatrician at Emory University School of Medicine, said.
“I am very uncomfortable sending my children back to school, where – despite the best efforts of the school – there is a real risk of contracting Covid-19,” Anderson told CNBC in October.
While children are less affected by Covid-19 than adults, they still get the virus and get sick. Some even died. More than 2.5 million cases of Covid-19 were reported in children on January 14, about 13% of all cases, according to a report by the American Academy of Pediatrics and the Children’s Hospital Association.
“Children can still get sick and die from Covid-19,” said Dr. Paul Offit, director of the Center for Vaccine Education and a physician for infectious diseases at the Children’s Hospital in Philadelphia, said. “As many children have died from Covid-19 in the past year as from the flu. And we recommend a flu vaccine for children.”
Offit also pointed out that children can suffer from a disease called multisystem inflammatory syndrome associated with Covid-19, “which can be debilitating.”
There were 1,659 cases of the syndrome in children, called MIS-C, and 26 deaths associated with it as of January 8, according to data from the Centers for Disease Control and Prevention. CDC data show 78 total deaths among Covid-19 among children aged 4 and younger, and 178 in children 5 to 17, although the numbers are not responsible for all deaths reported in the US.
Children line up to attend the PS 361 class on the first day of returning to class during coronavirus (COVID-19) in New York City, New York, USA, December 7, 2020.
Carlo Allegri | Reuters
Pfizer would not say when the results of the trial are expected, which depends on the rate of infection observed to be able to compare the dose in the placebo group with those who received the vaccine. With a higher infection rate in the U.S. 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 – vaccine readings have increased.
But recruitment for trials in adolescents has been slower than hoped, at least for the study of Moderna in children aged 12 to 17, said Moncef Slaoui, chief adviser to Operation Warp Speed, the Trump administration’s effort against vaccinations, said on January 12th.
Since then, there have been about a month of about 3,000 children enrolled in the trial for more than a month. Moderna’s vaccine was approved in December for people 18 years and older, weeks after it was started among adolescents. Pfizer lowered the age of his trial in October to 12.
“While enrollment was lower during the holiday season, we expect an increase in the new year as planned,” Moderna spokeswoman Colleen Hussey said Friday. “We are on track to provide updated data around mid-2021.”
AstraZeneca, whose vaccine developed by Oxford University has been authorized in the US and UK in late stages, told CNBC on Friday that it plans to continue the trials in the UK in a new protocol for children between the ages of 5 and 18, starting in the coming months. “
Johnson & Johnson, whose phase three results in adults are expected soon, said it is in talks with regulators about including pediatric populations in its development plan. It noted the same technology it uses for the Covid-19 vaccine has been used in vaccines given to more than 200,000 people, including people over 65, babies, children, HIV-positive adults and pregnant women.
Vaccination trials usually go out in younger age groups after being safe and effective in older groups, and the manufacturers of Covid-19 vaccines have indicated that they will follow the plan here as well.
Stephane Bancel, CEO of Moderna, said it was unlikely the company would include information on children 11 years and younger, which will involve a lower dose, before next year. He said he expects data for children from 12 years to be available before September.
Public health officials in the US, such as dr. Anthony Fauci, White House chief medical adviser, said they hoped up to 75% to 80% of the U.S. population could be vaccinated by the fall to get life back to normal. .
About 78% of the U.S. population, or 255 million people, are older than 18, according to a CNBC analysis of census data. Another 25 million people are between 12 and 17 years old.
Fauci did not immediately respond to a question about whether children needed to be vaccinated to reach his goal of 75% to 80%.
“It is important for all children to be vaccinated and the manufacturers cannot do the trials fast enough,” Angela Rasmussen, a virologist and subsidiary at the Georgetown Center for Global Health Science and Security, told CNBC on Friday. “The more people of any age are vaccinated, the better.”