Pfizer says its Covid vaccine trial for children ages 12-15 is fully enrolled

Pfizer said it has fully enrolled its trial of the Covid-19 vaccine in children aged 12 to 15, a key step before the vaccine can be used in this age group.

The study, an extension of one used to support the company’s authorization for emergency use of the vaccine in people 16 and older, enrolled 2,259 children between the ages of 12 and 15, Pfizer told CNBC on Friday. . Its entry on a government website for clinical trials has been updated to note that it is no longer recruiting subjects.

The vaccine, developed with German partner BioNTech, was approved 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’m very uncomfortable sending my kids back to school, where – despite the school’s best efforts – there’s a real risk of contracting 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 even died. More than 2.5 million cases of Covid-19 had been reported in children as of Jan. 14, or about 13% of all cases, according to a report from 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 infectious disease physician at Children’s Hospital in Philadelphia. “Last year, as many children died from Covid-19 as from the flu. And we recommend a flu shot for children.”

Offit also pointed out that children can suffer from a condition called multisystem inflammatory syndrome associated with Covid-19, “which can be debilitating.”

According to data from the Centers for Disease Control and Prevention, there have been 1,659 cases of the syndrome in children, called MIS-C, and 26 deaths associated with it as of January 8. There have been 78 total deaths from Covid-19 in children 4 and under and 178 in children 5 to 17, according to CDC data, although these figures do not take into account all deaths reported in the United States.

Pfizer declined to say when it expected the results of the trial, which depend on the rate of infections observed to be able to compare the rates in the placebo group to those receiving the vaccine. With higher infection rates in the United States since the fall – the seven-day average of daily cases is now around 187,500, according to CNBC analysis of data from Johns Hopkins University – the trials of vaccine effectiveness has seen their readings accelerate.

But recruitment for the adolescent trials had been slower than expected, at least for Moderna’s study in children aged 12 to 17, said Moncef Slaoui, chief advisor to Operation Warp Speed, the The Trump administration’s vaccine effort, during its last briefing on Jan.12.

By that time, around 800 children had been enrolled in the one-month trial, he said, out of around 3,000 needed. Moderna’s vaccine was cleared for people 18 and older in December, weeks after it started its trial in adolescents. Pfizer lowered the age of its trial to 12 in October.

“While registrations were lower during the holiday season, we expect to see an increase in the New Year as expected,” Moderna spokesperson Colleen Hussey said on Friday. “We are on track to provide updated data by mid-2021.”

AstraZeneca, whose vaccine developed by the University of Oxford is in late testing in the US and cleared in the UK, told CNBC on Friday that it plans to continue trials in the UK in a new protocol for children aged 5 to 18 from the next few months. “

Johnson & Johnson, whose results from phase three in adults are expected shortly, said it was in discussions with regulators to include pediatric populations in its development plan. He noted that the same technology it uses for the Covid-19 vaccine has been used in vaccines given to over 200,000 people, including people over 65, infants, children, and adults with HIV. and pregnant women.

Typically, vaccine trials take place in younger age groups after being proven to be safe and effective in older groups, and the makers of the Covid-19 vaccine have indicated that they will also follow this plan here. .

Moderna chief executive Stephane Bancel said this month that the company was unlikely to have data on children 11 and under, which would imply a lower dose, until next year. He said he expects data for children 12 and older to be available before September.

Public health officials in the United States, like White House Chief Medical Advisor Dr Anthony Fauci, have said they hope 75% to 80% of the American population could be vaccinated by the time fall to allow life to return to a form of normalcy. .

About 78% of the U.S. population, or 255 million people, are over 18, according to CNBC analysis of census data. 25 million more people are between the ages of 12 and 17.

Fauci did not immediately respond to a survey on the need to include children in vaccinations to meet his target of 75% to 80% coverage.

“Getting vaccinated is important for all children and manufacturers cannot do these tests quickly enough,” Angela Rasmussen, a virologist and affiliate of the Georgetown Center for Global Health Science and Security, told CNBC Friday. “The more people of all ages vaccinated, the better.”