Topline
Moderna will submit data to regulatory agencies following a clinical trial that showed Covid-19 vaccine generated a strong immune reaction in children aged 6-11 years, the company announced Monday. U.S. regulators have indicated they are ready to make Pfizers shots available to children as soon as possible after concluding that the benefits outweigh any risks.
Moderna's vaccine stimulates strong immune responses in children, according to the company. LightRocket via Getty Images
The Key Facts
The trial involved 4,753 children aged 6-11 years. It was not peer reviewed. Early results showed that the vaccine produced strong immune responses and neutralizing antibodies. Moderna said that the vaccine was half as strong as doses administered to adults and had few side effects. Moderna stated that the most common side effects were headache, fatigue, injection site pain and fever. Moderna stated that the company would submit the results to U.S. Food and Drug Administration, European Medicines Agency and other regulatory bodies around the globe in the near future.
Important Background
Although teenagers and children have a lower risk of contracting severe illness or death from Covid-19 than adults, they can still develop life-threatening illnesses from it. Experts agree that vaccination has clear benefits that outweigh any risks. Infected children can spread the virus to others, which could lead to severe illness or death.
Tangent
Pfizer and BioNTech also have a vaccine that is suitable for children under five years old. A late-stage clinical trial has shown that it is safe and well tolerated in children and provokes a strong immune response.
Big Number
28 million. According to the White House, that's how many children will be eligible to receive the Covid-19 shot, if it is approved for 5- to 11-year olds.
What to Watch
The FDA advisory panel will meet Tuesday to discuss whether or not to endorse the use Pfizer's and BioNTech vaccines in children aged 5-11 years. The FDAs advisory panel will meet Tuesday to discuss whether they endorse the use of the Pfizer and BioNTech vaccines in children ages 5-11. In early November, the Centers for Disease Control and Prevention are expected to meet to discuss rollout. The White House wants to have shots in arms within days after approval. It plans to work with schools districts and hospitals to establish vaccination sites.
Continue reading
Here's How the White House Will Distribute Children's Covid Vaccines. (Forbes).
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FDA now weighs Covid-19 vaccines for children. But will parents let them get the shot? (Forbes)
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