Walgreens pharmacist Jessica Sahni will hold the vaccine against Pfizer BioNTech coronavirus disease (COVID-19) at the New Jewish Home in New York on December 21, 2020.
Yuki Iwamura | Reuters
The study, an extension of the study used to support the company’s emergency approval for the vaccine in people aged 16 and over, enrolled 2,259 children between the ages of 12 and 15, Pfizer told CNBC on Friday. It is entry A government clinical trial website was updated to determine that subjects are no longer being recruited.
The vaccine, developed with a German partner BioNTech, was authorized for people aged 16 and over in December. Studies in younger age groups are needed to ensure the correct dose as well as safety and effectiveness 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 school’s best efforts, there is a real risk of getting 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. As of January 14, more than 2.5 million cases of Covid-19 have been reported in children, about 13% of all cases 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 an infectious disease doctor at Philadelphia Children’s Hospital. “In the past year, as many children died of Covid-19 as of influenza. And we recommend an influenza vaccine for children.”
Offit also pointed out that children can suffer from a disease related to Covid-19 called multisystem inflammatory syndrome, “which can be debilitating”.
There have been 1,659 cases of the syndrome in children referred to as MIS-C and 26 related deaths as of Jan. 8 Data from the Centers for Disease Control and Prevention. There have been 78 deaths from Covid-19 in children under 4 years of age and 178 in children between 5 and 17 years of age. CDC data show, although these numbers do not explain all deaths from the United States.
Children compete for class at PS 361 on the first day of returning to class during the coronavirus disease (COVID-19) pandemic in the Manhattan neighborhood of New York City, New York, United States, on December 7, 2020.
Carlo Allegri | Reuters
Pfizer declined to say when it expected results from the study, which would depend on the observed infection rate, to compare the rates in the placebo group with those who received the vaccine. With infection rates higher in the US since the fall – the 7-day average of daily cases is now 187,500, according to a CNBC analysis of Johns Hopkins University data – vaccine effectiveness studies have shown their readings have sped up.
However, enrollment for adolescent trials has been slower than hoped, at least for Moderna’s trial in children ages 12-17, Moncef Slaoui, chief advisor to Operation Warp Speed, the Trump administration’s vaccine effort, said at their last meeting on Dec. January.
By then, around 800 children had been included in the study for over a month, of which around 3,000 were needed. Moderna’s vaccine was authorized for people aged 18 and over in December, weeks after started his study in adolescents. Pfizer lowered the age of his trial to 12 years in October.
“While enrollment was lower during the holiday season, we expect an increase in the new year as planned,” said Moderna spokeswoman Colleen Hussey on Friday. “We are on track to provide updated data by mid-2021.”
AstraZeneca, whose vaccine, developed by Oxford University, is in late study in the United States and authorized in the UK, CNBC Friday said it plans to continue the UK studies in a new protocol for children aged 5 to 18 “from the coming months”.
Johnson & Johnson, whose results from the third phase in adults are expected immediately, said it was in talks with regulators about including the pediatric population in their development plan. The same technology used for the Covid-19 vaccine was found to have been used in vaccines given to more than 200,000 people, including people over 65, infants, children, HIV-positive adults, and pregnant women .
Typically, vaccine trials are conducted in younger age groups after they have been shown to be safe and effective in older groups, and Covid-19 vaccine manufacturers have stated that they will follow that plan here too.
Stephane Bancel, Managing Director of Moderna, said This month, the company is unlikely to have data for children ages 11 and younger that would include a lower dose until next year. He said he expected data for children 12 years and older could be available before September.
U.S. public health officials such as White House Chief Medical Officer Dr. Anthony Fauci, have said They hope that by the fall of 75% to 80% of the US population could be vaccinated so life can return to some form of normal.
About 78% of the US population, or 255 million people, are over 18 years old, according to a CNBC analysis of the census data. Another 25 million people are between 12 and 17 years old.
Fauci did not immediately respond to a query about the need to include children in vaccinations in order to meet his goal of 75% to 80% coverage.
“It is important that all children are vaccinated, and manufacturers cannot conduct these trials fast enough,” Angela Rasmussen, virologist and subsidiary at the Georgetown Center for Global Health Science and Safety, told CNBC on Friday. “The more people of all ages are vaccinated, the better.”