Walgreens pharmacist Jessica Sahni is holding the Pavizer-BioNTech coronavirus (COVID-19) disease vaccine at the New Jewish Home in New York, December 21, 2020.
Yuki Iwamura | Reuters
Pfizer said they had fully registered their Covid-19 vaccine trial in children ages 12 to 15, a key step before the vaccine could be used in that age group.
The study, an extension of the one used to support the Authorization of Emergency Use of the vaccine in people 16 and older, has recorded 2,259 children between the ages of 12 and 15, Pfizer told CNBC on Friday. His entry on the government website for clinical trials has been updated to note that he no longer employs subjects.
The vaccine, developed by German partner BioNTech, was approved for people aged 16 and over in December. Tests are needed in younger age groups 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 am very uncomfortable sending my children back to school, where – despite the best efforts at school – there is a real risk of a contract for Covid-19,” Anderson told CNBC in October.
Although Covid-19 does not affect children as much as adults, they still catch the virus and become ill. Some have even died. More than 2.5 million cases of Covid-19 in children have been reported as of Jan. 14, 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 diseases physician at Philadelphia Children’s Hospital. “So many children died this year from Covid-19 and died from the flu. And we recommend the flu vaccine for children.”
Offit also pointed out that children can suffer from a disease called Covid-19-related multisystem inflammatory syndrome, “which can be debilitating.”
There have been 1,659 cases of the syndrome in children, reported MIS-C, and 26 related deaths as of January 8, according to data from the Centers for Disease Control and Prevention. There have been a total of 78 deaths from Covid-19 among children 4 and younger, and 178 in children 5 to 17, CDC data show, although these numbers do not account for its all deaths reported from the USA.
Children come up to attend class at PS 361 on the first day of return to class during a coronavirus (COVID-19) outbreak in Manhattan City, New York City, New York, USA , December 7, 2020.
Carlo Allegri Reuters
Pfizer declined to say when it expected results from the trial, which depends on the rate of infections seen to be able to compare levels in the placebo group with those receiving the vaccine. With higher disease rates across the U.S. since the fall – the seven – day average of daily cases is now around 187,500, according to a CNBC study of Johns Hopkins University data – vaccine effectiveness tests have spoiled their readings.
But recruitment for trials in adolescents has been slower than expected, at least for the Moderna study in children ages 12 to 17, Moncef Slaoui, chief adviser to Operation Warp Speed, a Trump administration vaccination effort, said at the meeting his last January 12.
Since then, about 800 children had been enrolled in the trial over a month, he said, out of about 3,000 missing. The Moderna vaccine was approved for people 18 and older in December, weeks after it began its trial in adolescents. Pfizer lowered the age of the test to 12 in October.
“While enrollment was lower over the holiday season, we expect to see an increase in the new year as expected,” Moderna spokeswoman Colleen Hussey said on Friday. the way to provide updated data around mid-year 2021. “
AstraZeneca, which has the vaccine developed by Oxford University in end-of-term trials in the US and authorized in the UK, told CNBC on Friday that it plans to continue UK testing in a new protocol for children of the same age. 5 and 18 “starting in the coming months.”
Johnson & Johnson, which expects third-level results in adults, said it is in discussions with regulators about including child numbers in their improvement plan. He noted the same technology he uses to use the Covid-19 vaccine in vaccines given to more than 200,000 people, including people over 65, infants, children, adults HIV- advanced and pregnant women.
Vaccine trials usually go on to younger age groups after being safe and effective in older groups, and Covid-19 vaccine manufacturers have stated that they will follow the plan here as well.
Moderna chief executive Stephane Bancel said this month the company is unlikely to have data on children aged 11 and under, which would include a lower dose, by next year . He said he expects data for children 12 and up to be available by September.
U.S. public health officials, such as White House chief medical adviser Dr. Anthony Fauci, have said they hope up to 75% to 80% of the U.S. population could be vaccinated by the fall to allowing life to return to some sort of norm. .
About 78% of the U.S. population, or 255 million people, are over the age of 18, according to a CNBC survey of Census data. Another 25 million people are between 12 and 17 years old.
Fauci did not immediately respond to a question as to whether it is necessary to include children in vaccines in order to reach his goal of 75% to 80%.
“It is important that all children receive the vaccine and that the manufacturers cannot perform these tests quickly enough,” said Angela Rasmussen, a pathologist and associate at the Georgetown Center for Health Science and Security. Global, to CNBC on Friday. “The more people of any age who get the vaccine, the better.”