But panel member Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital, said the 16-and-up authorization would speed the vaccine’s testing in and approval for younger children. That is vital for the world’s protection from COVID-19, he said, since in the United States and most places, “most vaccines are delivered early in life.”
While vaccines given to tens of thousands of people so far appear to be safe, the lack of understanding of the inflammatory syndrome means that children in any trials should be followed closely, said Dr. Emily Erbelding, director of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases.
Under a 2003 law, vaccine companies are required eventually to test all their products on children. By late last month, Pfizer had vaccinated approximately 100 children 12-15 years of age, said spokesperson Jerica Pitts.
Moderna has started enrolling 3,000 children age 12 and up in another clinical trial, and other companies have similar plans. Assuming the trials show that the vaccines are safe and provide a good immune response, future tests could include progressively younger children, moving to, say, 6- to 12-year-olds next, then 2- to 6-year-olds. Eventually, trials could include younger toddlers and infants.
Similar stepdown approaches were taken to test vaccines against human papillomavirus (HPV), influenza and other diseases in the past, Erbelding noted. Such trials are easiest to conduct when researchers know that a measurable immune response, like antibody levels in the blood, translates to effective protection against disease. Armed with such knowledge, they can see whether children were protected without them having to be exposed to the virus. Federal scientists hope to get that data from the Moderna and Pfizer adult vaccine trials, she said.
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December 16, 2020 at 07:01PM
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Pediatricians want kids to be part of COVID-19 vaccine trials - Roll Call
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