Dr Reddy’s Gears For Sputnik Light In India, Jab For Adolescents
No Immediate Action Envisaged In US Subpoena
Dr Reddy’s is to press ahead with India filing plans for single-dose COVID-19 vaccine Sputnik Light and also expects to “build on” the Russian partner’s trial in adolescents of the two-dose Sputnik V. The company also pilots a partnered first-of-its-kind cashless digital health offering.
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With an emergency approval, Zydus Cadila has commercialized the world’s first plasmid DNA vaccine for human use and the first COVID-19 vaccine for use in adolescents in India. Will efficacy against the Delta variant help tide over hesitancy towards a new technology or a lack of publicly published data hamper acceptance?
Rare Or Common Events? COVID Vaccine Trials In Children Boost Safety Databases, Triggering Fears Of Heart Events
US FDA seems to want Moderna and Pfizer to study their mRNA vaccines in 3,000 people ages five to 11, suggesting the rate of myocarditis in younger children may be higher than in older teens. Such a finding, and even the hunt for it, could push back any COVID-19 vaccine authorization for this population.
Strides will consider making RDIF’s Sputnik Light vaccine after filling orders for Sputnik V, which it expects to launch in October. The COVID-19 portfolio is being expanded and the Indian company is set to make a Para IV filing for a diabetes product in December, CEO R Ananthanarayanan tells Scrip.