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This morning we reported that the EMA is taking another closer look at the Moderna vaccine, again side effects have occurred with the Moderna vaccine. Now the Moderna CEO is coming forward with positive news!
Moderna has just given this important update on its COVID vaccine
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This is the next step in the vaccine maker’s fight against the pandemic.
In recent months, research has been published highlighting the highly protective nature of Moderna’s COVID vaccine. This is good news for the more than 154 million people who have already received the vaccine: a recent study by the Centers for Disease Control and Prevention (CDC) found that the vaccine offers the highest level of protection of any licensed vaccine – with 93 percent efficacy against hospitalization, even for the contagious delta variant. In mid-October, the CDC and the U.S. Food and Drug Administration (FDA) also approved booster vaccines for Moderna, providing even better protection for millions of eligible people. Now Moderna is announcing another important step in its fight against the COVID pandemic.
Vaccination study with good results
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Moderna announced that the first results from its vaccination study in children are finally available. Researchers at the manufacturer analyzed the response of more than 4,700 participants aged six to 12 years to two 50-microgram doses of vaccine administered 28 days apart.
According to the study, Moderna’s vaccine is both safe and effective in children in this age group. The researchers also found that the children in the Moderna study had antibody levels that were 1.5 times higher than those of young adults, even though they received only half of an adult dose (100 micrograms) with each vaccination.
Vaccine is well tolerated
Moderna said its vaccine was “generally well tolerated, with a safety and tolerability profile generally consistent with that of the Phase 3 COVE trial in adolescents and adults,” noting that most adverse events were mild or moderate in participating children. According to the manufacturer, the children experienced some of the side effects common in adults, including fatigue, headache, fever, and pain at the site of infection.
“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 regulatory authorities around the world and remain committed to doing our part to end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
Currently still approved for adults
Currently, Moderna’s vaccine is only approved for use in adults 18 and older. In June, the manufacturer submitted study results to expand the use of its vaccine in adolescents ages 12 to 17, but the FDA has not yet announced a decision for that age group. The agency reportedly postponed its decision in mid-October to further examine whether this vaccine could lead to an increased risk of myocarditis, according to the Wall Street Journal.
Myocarditis is a rare inflammatory heart disease that was more common in younger men after they received a second vaccination with an mRNA vaccine. Four Scandinavian countries in Europe – Finland, Sweden, Denmark and Norway – recently decided to discourage the use of Moderna in younger age groups because of this rare reaction, citing a higher risk in recipients of this vaccine.
In response, Paul Burton, Moderna’s chief medical officer, said, “I think people can be reassured that the risk of myocarditis with an mRNA vaccine is low, it seems to be balanced between the different products,” according to the WSJ. Burton added that the FDA’s own data on Moderna vaccinations in 18- to 25-year-old men showed no significant difference in the rate of myocarditis in people who received the Moderna or Pfizer vaccine.
“Some countries want to be ultra-conservative, of course that’s their right, but based on the data I’ve seen, I would recommend vaccination to every young man in my family”.