Walgreens drugmaker Jessica Sahni owns the Pfizer-BioNTech coronavirus vaccine (COVID-19) at The New Jewish Home in New York, December 21, 2020.
Yuki Iwamura | Reuters
Pfizer said it had fully enrolled the Covid-19 vaccine test in children aged 12 to 15 years, a critical step before the vaccine could be used in this age group.
The study, an extension of the one used to support the Emergency Use Authorization for the vaccine in people aged 16 and over, enrolled 2,259 children aged 12 to 15, Pfizer told CNBC on Friday. His entry on a government website for clinical trials has been updated to note that he is no longer recruiting volunteers.
The vaccine, developed with the German partner BioNTech, was authorized for people aged 16 and over in December. Trials in younger age groups are needed to ensure the correct dose, as well as safety and efficacy in these different groups, said Dr. Evan Anderson, a pediatrician at Emory University School of Medicine.
“I feel very uncomfortable sending my kids back to school, where – despite the school’s best efforts – there is a real risk of contracting Covid-19,” Anderson told CNBC in October.
Although 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 have been reported in children as of 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 Vaccine Education Center and an infectious physician at Children’s Hospital of Philadelphia. “Last year, as many children died from Covid-19 as from the flu. And we recommend a flu vaccine for children ”.
Offit also pointed out that children can suffer from a disease called multisystemic inflammatory syndrome associated with Covid-19, “which can be debilitating”.
There have been 1,659 cases of the syndrome in children, known as MIS-C, and 26 deaths associated with it by January 8, according to data from the Centers for Disease Control and Prevention. There were 78 deaths in total Covid-19 among children aged 4 years and under and 178 in children aged 5 to 17 years, CDC data show, although these numbers do not represent all reported deaths in the United States
Children line up to attend classes at PS 361 on the first day of return to school during the coronavirus disease pandemic (COVID-19) in the Manhattan neighborhood of New York City, New York, USA, December 7, 2020.
Carlo Allegri | Reuters
Pfizer declined to say when it expects trial results, which depend on the rate of infections observed in order to be able to compare the rates of the placebo group with those who received the vaccine. With the highest infection rates in the United States since the fall – the seven-day average of daily cases is now 187,500, according to a CNBC analysis of data from Johns Hopkins University – vaccine effectiveness tests have seen their readings increase.
But recruiting for tests on teenagers was slower than expected, at least for the study of Moderna in children 12 to 17, said Moncef Slaoui, chief adviser to Operation Warp Speed, the Trump Administration’s vaccine effort, at its last meeting on January 12.
So far, about 800 children have been enrolled in the test over the course of a month, he said, out of the nearly 3,000 needed. Moderna’s vaccine was authorized for people aged 18 or over in December, weeks after starting its test in adolescents. Pfizer reduced the age of its trial to 12 in October.
“Although the number of enrollments decreased during the holiday season, we expect to see an increase in the new year as planned,” Moderna spokeswoman Colleen Hussey said on Friday. “We are on track to provide updated data in mid-2021.”
AstraZeneca, whose vaccine developed by the University of Oxford is in the final stages of testing in the United States and authorized in the United Kingdom, told CNBC on Friday that it plans to continue testing in the UK on a new protocol for children aged 5 to 18. years old “starting in the next few months.”
Johnson & Johnson, whose phase three results in adults are expected soon, said it is in discussions with regulators about including the pediatric population in its development plan. He noted that the same technology he is using for the Covid-19 vaccine has been used in vaccines administered to more than 200,000 people, including people over 65, babies, children, HIV-positive adults and pregnant women.
Typically, vaccine testing continues in younger age groups after it has been proven safe and effective in older groups, and vaccine manufacturers Covid-19 have indicated that they will also follow that plan here.
Moderna’s chief executive, Stephane Bancel, said this month that the company is unlikely to have data on children age 11 and under, which would involve a smaller dose before next year. He said he expects data for children 12 and older to be available before September.
US public health officials, like the White House chief medical advisor, Dr. Anthony Fauci, said they expected 75% to 80% of the US population to be vaccinated with the fall to allow life to return to some form of normality.
About 78% of the population in the United States, or 255 million people, are over 18, according to a CNBC analysis of the Census data. Another 25 million people are between 12 and 17 years old.
Fauci did not immediately answer a question about whether including children in vaccines is necessary to achieve his goal of 75% to 80% coverage.
“It is important that all children are vaccinated and manufacturers cannot do these tests quickly enough,” Angela Rasmussen, virologist and affiliate at the Georgetown Center for Global Health Science and Safety, told CNBC on Friday. “The more people of any age are vaccinated, the better.”