Pfizer says study of Covid vaccine for children aged 12 to 15 is fully enrolled

Pfizer said it has fully enrolled the Covid-19 vaccine in children between the ages of 12 and 15, a key step before the vaccine can be used in that age group.

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

The vaccine, developed in conjunction with German partner BioNTech, was licensed to people aged 16 and over in December. Studies 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 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 catch the virus and get sick. Some even died. More than 2.5 million cases of Covid-19 had been reported in children since Jan. 14, about 13 percent of all cases, according to a report by the American Academy of Pediatrics and the Children’s Hospital Association.

“Children can continue to get sick and die from Covid-19,” said Dr. Paul Offit, director of the Center for Infectious Disease and Vaccine Education at Philadelphia Children’s Hospital. “As many children have died in the last year of Covid-19 as they have died 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 have been 1,659 cases of syndrome in children, called MIS-C, and 26 deaths associated with it since January 8, according to data from the Centers for Disease Control and Prevention. CDC data show that there were a total of 78 deaths from Covid-19 in children under 4 years of age and 178 in children from 5 to 17 years of age, although these figures do not count all reported deaths in the United States.

Pfizer declined to say when to expect the results of the study, which are dependent on the rate of infections observed in order to compare the rates in the placebo group with those who received the vaccine. With higher rates of infection 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 – vaccine efficacy studies have seen their readings accelerate.

But recruitment for teenage studies has been slower than expected, at least for Moderna’s study of 12- to 17-year-olds, said Moncef Slaoui, chief adviser to Operation Warp Speed, the Trump administration’s vaccine effort. at his last briefing on January 12th.

Since then, about 800 children have been enrolled in the process for more than a month, he said, out of about 3,000 children needed. The Moderna vaccine was approved for people aged 18 and over in December, a few weeks after it began its process in adolescents. Pfizer reduced the trial age to 12 in October.

“While enrollment was lower during the holiday season, we expect to see growth in the new year as planned,” Modern spokeswoman Colleen Hussey said Friday. “We are on track to provide updated data by mid-2021.”

AstraZeneca, whose vaccine developed by Oxford University is in late studies in the United States and is licensed in the United Kingdom, told CNBC on Friday that it intends to continue its studies in the United Kingdom in a new protocol for children aged 5 to 18. years, starting in the following months. “

Johnson & Johnson, whose third phase of adult outcomes is imminent, said it is in talks with regulators about including pediatric populations in its development plan. He noted that the same technology he uses for the Covid-19 vaccine has been used in vaccines given to more than 200,000 people, including people over the age of 65, infants, children, HIV-positive adults and pregnant women.

Vaccine studies are usually conducted in younger age groups, after they have been shown to be safe and effective in older groups, and Covid-19 vaccine manufacturers have indicated that they will follow that plan here as well.

Moderna’s chief executive, Stephane Bancel, said this month that the company is unlikely to have data on children aged 11 and under, which would mean a lower dose before next year. He said data for children over the age of 12 is expected to be available before September.

U.S. public health officials, such as White House Chief Counsel Dr. Anthony Fauci, have said they hope that up to 75 percent to 80 percent of the U.S. population can be vaccinated until they fall to allow life to return to normal. 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 analysis of census data. Another 25 million 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 in order to reach the 75% to 80% coverage target.

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