The Drugs Controller General of India (DCGI) has granted Emergency Use Authorization (EUA) to Zydus Cadila’s three-dose plasmid DNA vaccine, ZyCoV-D, for Covid-19. Designed for needle-free administration with the PharmaJet applicator, ZyCoV-D is described by Zydus Cadila as the world’s first approved DNA vaccine for the disease. The vaccine secured authorisation for use in adults and adolescents aged 12 to 18 years, the first approval for a Covid-19 vaccine in India targeting this younger age group. The company intends to produce 100-120 million doses of the vaccine each year, and will also seek approval for the vaccine’s two-dose regimen.
US health officials are investigating reports that Moderna’s Covid-19 vaccine may be associated with an increased risk of myocarditis in younger adults than previously assumed, the Washington Post reported. The regulatory investigation is focusing on data from Canada that suggests the risk of the inflammatory heart condition could be higher after vaccination with Moderna’s vaccine when compared to the mRNA jab produced by Pfizer and BioNTech. The Moderna vaccine has not yet been approved for use in adolescents in the US, while the Pfizer/BioNTech shot was cleared for 12- to 15-year-olds in May. Meanwhile, Moderna has mandated Covid-19 vaccination for all of its employees in the US. The company noted that the requirement is effective from 1 October 2021 and will consider medical or religious exemptions.
AstraZeneca has reported positive data from the Phase III PROVENT trial of its antibody combination, AZD7442, for the prevention of Covid-19. AZD7442 was observed to lower the risk of symptomatic illness development by 77% versus placebo. Among participants treated with the drug, none reported severe Covid-19 cases or related deaths. AZD7442 was found to be well tolerated, and preliminary analyses revealed adverse events were balanced between the treatment and placebo arms.