The drug firm Moderna has begun a examine that may check its Covid vaccine in youngsters beneath 12, together with infants as younger as six months outdated, the corporate stated on Tuesday.
The examine is anticipated to enroll 6,750 wholesome youngsters in the US and Canada. Moderna declined to say what number of had already signed up or acquired the primary photographs, in line with a spokeswoman, Colleen Hussey.
“There’s an enormous demand to search out out about vaccinating youngsters and what it does,” stated Dr. David Wohl, the medical director of the vaccine clinic on the College of North Carolina, who will not be concerned the examine.
In a separate examine, Moderna is testing its vaccine in 3,000 youngsters ages 12 to 17 years, and should have outcomes for that age group by summer time. The vaccine would then need to be approved to be used in youngsters, so it could not be instantly accessible.
Many mother and father need safety for his or her youngsters, and vaccinating youngsters ought to assist to provide the herd immunity thought of essential to stopping the pandemic. The American Academy of Pediatrics has called for expansion of vaccine trials to include children.
Vaccine side effects like fever, sore arms, fatigue and achy joints and muscles can be more intense in children than in adults, and doctors say it is important for parents to know what to expect after their children are inoculated.
Each child in Moderna’s study will receive two shots, 28 days apart. The study will have two parts. In the first, children ages 2 years to less than 12 may receive two doses of 50 or 100 micrograms each. Those under 2 years may receive two shots of 25, 50 or 100 micrograms. (One adult dose is 100 micrograms.)
In each group, the first children inoculated will receive the lowest doses and will be monitored for reactions before later participants are given higher doses.
Then, researchers will perform an interim analysis to determine which dose is safest and most likely to be protective for each age group.
Children in part two of the study will receive the doses selected by the analysis — or placebo shots consisting of salt water.
Moderna developed its vaccine in collaboration with the National Institute of Allergy and Infectious Diseases. The company and the institute are also working together on the study, along with the federal Biomedical Advanced Research and Development Authority.
The children will be followed for a year, to look for side effects and measure antibody levels that will help researchers determine whether the vaccine appears to provide protection. The antibody levels will be the main indicator, but the researchers will also look for coronavirus infections, with or without symptoms.
Dr. Wohl said the study appeared well designed and likely to be efficient, but he questioned why the children were to be followed for only one year, when adults in Moderna’s study are followed for two years. He also said he was somewhat surprised to see the vaccine being tested in children so young this soon.
“Should we learn first what happens in the older kids before we go to the really young kids?” Dr. Wohl asked. Most young children do not become very ill from Covid, he said, though some develop a severe inflammatory syndrome that can be life threatening.
Pfizer and BioNTech are testing their vaccine in children ages 12 to 15, and have said the plan is to move to younger groups; the product is already authorized for use in those 16 and up in the United States.
Last month, AstraZeneca began testing its vaccine in Britain in children 6 years and older.