US – The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided positive opinion for Moderna’s COVID-19 vaccine designed for teenagers.
Following the positive recommendation, the European Commission (EC) will consider authorising the use of the Moderna COVID-19 vaccine adolescents in this age group.
The positive recommendation was based on ongoing trial studies conducted on the vaccine candidate that had the vaccine meet the primary endpoint.
Moderna revealed data from an ongoing Phase II/III study which enrolled 3,732 participants aged 12 to less than 18 years old in the US.
Following two doses of Moderna’s vaccine, no cases of COVID-19 were observed in the vaccine group using the case definition from the adult Phase III study, compared to four cases in the placebo group.
This resulted in a vaccine efficacy of 100%, starting 14 days after the second dose. The jab was also found to be generally well tolerated in the adolescent study, with safety and tolerability profile consistent with the Phase III adult study.
Meanwhile, Moderna plans to expand the size of its clinical trial testing its Covid-19 vaccine in kids ages 5 to 11.
The U.S. drug maker is expanding the trial, which began in late March, to increase the likelihood of detecting potential rare side effects.
Vaccinating children is seen as crucial to ending the pandemic. The nation is unlikely to achieve herd immunity when enough people in a given community have antibodies against a specific disease until children can get vaccinated, scientists say.
Federal health officials will need to balance the risk of potentially rare side effects from the shots against the risks of getting Covid.
In June, health officials said there had been more than 1,200 cases of a myocarditis or pericarditis mostly in people age 30 and under who received the shots.
Myocarditis is the inflammation of the heart muscle and pericarditis is the inflammation of the tissue surrounding the heart.
There have been just 12.6 heart inflammation cases per million doses for both vaccines combined, officials said at the time. They added the benefits still outweighed the risks.
The update comes as parents in the U.S. patiently wait for their children to be eligible to get vaccinated. In May, the FDA permitted the use of the Pfizer-BioNTech Covid vaccine for kids ages 12 to 15. Moderna’s vaccine is expected to be authorized for children as young as 12 any day from now.
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