Moderna has not yet received approval to give vaccine to teenagers
Moderna said on Monday that its low dose COVID-19 The vaccine is safe and appears to work in children ages 6 to 11, as the manufacturer moves with its rival Pfizer to expand the shots for children.
Pfizer’s child-sized vaccine dosage is nearing widespread use. They are being evaluated by the Food and Drug Administration for youth ages 5 to 11, and may be available as early as November. The company’s vaccine is already authorized for people 12 or older.
Moderna has not yet received approval to offer Teenage, but it is conducting a low-dose study in young children while it waits.
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Researchers tested two shots one month apart for children ages 6 to 11, each containing half the dose given to adults. Moderna said in a news release that preliminary results showed that vaccinated children develop virus-fighting antibodies that young adults produce after full-strength shots.
The study included 4,753 children aged 6 to 11 who received either the vaccine or the dummy shot. Moderna said that like adults, vaccinated youth had temporary side effects including fatigue, headache, fever and injection site pain.
The study was too small to find any extremely rare side effects, such as heart swelling that sometimes occurs after Moderna or Pfizer vaccines, mostly in young men.
Moderna released no further details and did not submit its data to a scientific journal, but said it plans to share interim results with the FDA and global regulators soon. The study is still ongoing, and the company can’t really calculate the vaccine’s effectiveness in preventing infection in children until there are enough COVID-19 cases to compare rates between vaccinated and unvaccinated participants.
The FDA has yet to decide on the company’s application to expand its vaccinations to children 12 to 17 years old, although some countries have approved Moderna’s shots for teens.
But the US is expected to start vaccinating children under 12 next month if the FDA approves a reduced dose of the Pfizer vaccine for children ages 5 to 11. Pfizer reported last week that its child-sized doses proved to be about 91% effective in preventing symptomatic COVID-19 in that age group, even as the extra-infectious delta variant spread widely. Had been.
FDA advisors will weigh in on Pfizer’s evidence in a public meeting on Tuesday. If the agency authorizes Pfizer’s baby shots, the Centers for Disease Control and Prevention is set to recommend next week who should get them.