Moderna Just Gave This Major Update on Its COVID Vaccine

This is the next step in the vaccine manufacturer's fight to end the pandemic.

Over the last few months, research has come out touting the high levels of protection afforded by Moderna's COVID vaccine. For the more than 154 million people who have already received this shot, it's been a stream of good news: One recent study from the Centers for Disease Control and Prevention (CDC) found that it stays the most protective of any of the approved vaccines—maintaining an effectiveness of 93 percent against hospitalization, even amid the more contagious Delta variant. In mid-October, the CDC and the U.S Food and Drug Administration (FDA) also approved Moderna booster shots, allowing even more protection for millions of eligible individuals. Now, Moderna is announcing another major step in its fight to end the COVID pandemic.

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On Oct. 25, Moderna shared that the first results from its vaccination study in children were finally in. Researchers for the manufacturer analyzed the response of two 50-microgram vaccine doses given 28 days apart among more than 4,700 participants six to 12 years old.

According to the study, Moderna's vaccine is both safe and effective in children of this age group. The researchers also found that the children in Moderna's study had antibody levels that were 1.5 times higher than those seen in young adults, despite being given only half the amount of an adult dose (100 micrograms) in each shot.

Moderna said that its vaccine was "generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adolescents and adults," noting that the majority of adverse reactions in the participating kids were mild or moderate in severity. According to the manufacturer, children experienced some of the common side effects seen in adults, like fatigue, headache, fever, and infection site pain.

"We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints," Moderna CEO Stéphane Bancel said in a statement. "We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages."

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Currently, Moderna's vaccine is only authorized for use in adults 18 and older. In June, the manufacturer submitted study results to expand the use of its vaccine in adolescents 12 to 17 years old, but the FDA has still not announced a decision for this age group. The agency allegedly delayed its decision in mid-October to further assess whether this vaccine might lead to an increased risk of myocarditis, as reported by The Wall Street Journal.

Myocarditis is a rare inflammatory heart condition that has appeared more common in younger men after they received a second shot of an mRNA vaccine. Four Nordic countries in Europe—Finland, Sweden, Denmark, and Norway—recently chose to recommend against the use of Moderna in younger age groups as a result of this rare reaction, citing a higher risk among recipients of this vaccine.

In response, Moderna Chief Medical Officer Paul Burton said, "I think people can be reassured that the risk of myocarditis with an mRNA vaccine is low, it appears to be balanced between the different products," per the WSJ. Burton added that the FDA's own data on Moderna vaccinations among 18 to 25 year old men did not show a significant difference in the rate of myocarditis among people who got the Moderna or Pfizer vaccine.

"Some countries want to be ultraconservative, it's of course their prerogative, but with the data I've seen I would be comfortable with anybody in my family who is a young male getting the vaccine," Bancel told the WSJ.

RELATED: Moderna CEO Predicted When the Pandemic Will Be Over for Good.

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