Keeping tabs on Covid-19: EMA approves Moderna vaccine for teens and Japan approves Roche–Regeneron’s treatment
Japan approves Roche’s Covid-19 vaccine as research reveals vaccine can reduce hospitalization by 70 per cent in high-risk patients – read on for the full insight
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Moderna vaccine Spikevax approved for European teenagers
Spikevax, Moderna’s Covid-19 vaccine, has received authorization from the European Medicines Agency (EMA), which said the vaccine was safe for use for 12–17 years old.
Spikevax’s Phase 3 clinical trial met the primary endpoint after successfully bridging immune responses in 3,732 participates.
Sore arms, headache and fatigue were the most common side effects reported by the young vaccine recipients.
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The vaccine, which has already been approved for adults in Europe, is the second Covid-19 vaccine to be approved for children under 17 with Pfizer and German partner BioNTech leading the way in May when it started being used as a vaccine for children as young as 12 in North America and Europe.
Both Pfizer and Moderna have started testing their vaccines in even younger children ranging in age from six months to 11 years old.
The US Food and Drug Administration (FDA) is currently considering whether to extend the use of the Moderna vaccine to the same age group.
Stephane Bancel, CEO of Moderna, said: “We are pleased to announce that we have submitted for an emergency use authorization for our Covid-19 vaccine with the FDA for use in adolescents in the US.
“We are encouraged that Spikevax was highly effective at preventing Covid-19 and SARS-CoV-2 infection in adolescents [in Europe].”
The FDA is yet to authorize the Moderna or Pfizer vaccine in the US for groups under 18 years old.
Japan becomes first country to approve Roche’s Covid-19 treatment
Japan’s Ministry of Health, Labor and Welfare has approved Roche and Regeneron’s Covid-19 vaccine, Ronapreve, to treat mild to moderate Covid-19 patients.
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Designed to block SARS-CoV-2 infectivity, Ronapreve is a combination of two monoclonal antibodies, casirivimab and imdevimab.
According to the results from the Phase 3 clinical trial, Roche’s antibody cocktail lowers hospitalization by 70 percent and symptom duration by four days in Covid-19 patients.
Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, said: “Ronapreve has been shown to improve survival in high-risk, non-hospitalized Covid-19 patients by reducing the risk of hospitalization and death. In addition, its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies.”
Japan is the first country to provide full approval to Ronapreve.
“Today’s approval brings hope to patients in Japan who can now access this important treatment option,” Garraway added.
The antibody cocktail has been authorized for emergency use or temporary pandemic use in multiple regions including Europe, the US, India, Switzerland and Canada.
If you missed Pharma IQ’s last Keeping tabs on Covid-19 update, dive into it here or head to Pharma IQ’s content hub to discover our Keeping tabs archive.
