Pfizer says its Covid vaccine study for children ages 12 to 15 is fully enrolled

Pfizer said it had fully enrolled its Covid-19 vaccine trial in children 12 to 15 years old, an important step before the vaccine could be used in that age group.

The study, an extension of the study used to support the company’s Emergency Use Authorization of the vaccine in people 16 and older, enrolled 2,259 children between the ages of 12 and 15, Pfizer told CNBC on Friday. The listing on a government clinical trials website was updated to note that it is no longer recruiting subjects.

The vaccine, developed with German partner BioNTech, was approved in December for people 16 and older. Trials in younger age groups are needed to ensure the correct dose, as well as safety and efficacy in those different groups, said Dr. Evan Anderson, a pediatrician at Emory University School of Medicine.

“I feel 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.

Although children are less affected by Covid-19 than adults, they still contract the virus and become ill. Some have even died. On Jan. 14, more than 2.5 million cases of Covid-19 had been reported in children, 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,” says Dr. Paul Offit, director of the Vaccine Education Center and infectious disease physician at Children’s Hospital in Philadelphia. “As many children have died from Covid-19 as from influenza in the past year. And we recommend a flu vaccine for children.”

Offit also pointed out that children can suffer from a disease called multi-system inflammatory syndrome related to Covid-19, “which can be debilitating.”

According to data from the Centers for Disease Control and Prevention, there were 1,659 cases of the childhood syndrome called MIS-C and 26 deaths associated with it on Jan. 8. There are 78 total deaths from Covid-19 in children ages 4 and under, and 178 in children ages 5 to 17, CDC data shows, although those numbers do not explain all deaths reported from the U.S.

Pfizer declined to say when it expected results from the study, which depend on the number of infections observed in order to compare the percentage in the placebo group with those who received the vaccine. With higher infection rates in the US since the fall – the seven-day average of daily cases is now about 187,500, according to a CNBC analysis of data from Johns Hopkins University – studies of vaccine efficacy have accelerated their readings.

But recruitment for trials in adolescents was slower than hoped, at least for Moderna’s study in children ages 12 to 17, Moncef Slaoui, chief adviser of Operation Warp Speed, the Trump administration’s vaccination effort, said at the latest briefing at 12. January.

At the time, about 800 children had been enrolled in the trial over the course of a month, he said, of the roughly 3,000 needed. Moderna’s vaccine was approved for people 18 and older in December, weeks after it began its trial in adolescents. Pfizer lowered the age of his trial to 12 in October.

“Although enrollments were 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 by mid-2021.”

AstraZeneca, whose Oxford University-developed vaccine is in late-stage testing in the US and authorized in the UK, told CNBC Friday it plans to continue UK testing in a new protocol for children aged 5 to 18 years, 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 that the same technology it uses for the Covid-19 vaccine has been used in vaccines given to more than 200,000 people, including those over the age of 65, infants, children, HIV-positive adults, and pregnant women.

Typical vaccination trials continue to younger age groups after proving safe and effective in older groups, and the manufacturers of Covid-19 vaccines have indicated they will follow that plan here too.

Moderna’s CEO, Stephane Bancel, said this month that the company is unlikely to have data on children 11 and under for next year that would require a lower dose. He said he expects data for children 12 and older may be available before September.

Public health officials in the U.S., such as White House chief medical adviser Dr. Anthony Fauci, have said they hope 75% to 80% of the U.S. population can be vaccinated by the fall to return life to one or more another form of normality. .

According to a CNBC analysis of Census data, about 78% of the US population, or 255 million people, is over 18 years old. Another 25 million people are between 12 and 17 years old.

Fauci did not immediately respond to a question of whether including children in vaccinations is necessary to reach his goal of 75% to 80% coverage.

“It’s important that all children are vaccinated and the manufacturers can’t do those studies soon enough,” Angela Rasmussen, a virologist and affiliated with the Georgetown Center for Global Health Science and Security, told CNBC on Friday. “The more people of all ages are vaccinated, the better.”