With husband Stephen by her side, Erin Shih hugs her children Avery 6 and Aidan 11 after receiving their second Moderna COVID-19 vaccines at Kaiser Permanente Los Angeles Medical Center on Friday, June 25, 2021.
Sarah Reingewirtz | MediaNews Group | Getty Images
Modern said Monday that in a study of children ages 6-11, a smaller dose of its Covid-19 vaccine is safe and produces a strong immune response.
Two 50-microgram doses of the vaccine, half the dose given in adults, resulted in antibody levels 1.5 times higher than in young adults, the company said in a press release, citing early data from a phase 2 / 3 study.
The syringes were generally well tolerated even in young children, according to the company, with the most common side effects being fatigue, headache, fever, and pain at the injection site. The vaccine has been tested on more than 4,700 children.
Moderna plans to submit the data to the Food and Drug Administration, the European Medicines Agency and other health authorities “in the near future”.
“We look forward to filing with regulators worldwide and remain committed to doing our part in ending the COVID-19 pandemic with a vaccine for adults and children of all ages,” said Stephane Bancel, CEO of Moderna, in a statement.
The new data comes the day before an important FDA advisory committee meeting to discuss whether to make a recommendation Pfizer and BioNTech‘s vaccine for children ages 5 to 11. The FDA could approve the vaccinations within days of the meeting, and the Centers for Disease Control and Prevention could approve them as soon as next week.
FDA staff said late Friday that Pfizer’s vaccine appears to be highly effective in preventing symptomatic infections in primary school children.
Many parents say they are careful to get their children vaccinated as the kids are entering the new school year and the Delta variant is still spilling across America. The number of new Covid cases in children remains exceptionally high with more than 1.1 million new child cases in the past six weeks, according to the American Academy of Pediatrics.