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September 22, 2021

Coronavirus company news summary – J&J reports positive Phase III and real-world data for single-shot vaccine – Lilly to supply Covid-19 antibody combo doses to EU

By Chris Lo

Johnson & Johnson’s (J&J) single-shot Covid-19 vaccine has confirmed its strong and long-lasting protection in data from real-world settings and Phase III clinical trials. The protection was observed to increase with a booster shot of the vaccine. When given as a booster, the vaccine was found to be generally well-tolerated. The real-world study compared data from 390,000 people who took the J&J vaccine to that from about 1.52 million unvaccinated individuals.

Eli Lilly has signed a joint procurement agreement with the European Commission (EC) to provide up to 220,000 doses of bamlanivimab and etesevimab to treat Covid-19 patients aged 12 years and above. The treatment is for patients who do not need supplemental oxygen and are at higher risk of progressing to severe disease. These doses will be supplied to participating countries in the European Union (EU) and European Economic Area (EEA), after authorisation for emergency use or marketing.

Ampio Pharmaceuticals has received approval from the Drugs Controller General of India (DCGI) to conduct a Phase II clinical trial of inhaled Ampion for the treatment of Covid-19 patients with respiratory distress. The Phase II trial comes after the therapy showed safety and tolerability as well as decreased all-cause mortality by 78% when compared with standard of care in a Phase I trial. The company presented Ampion to a DCGI Subject Expert Committee, which approved the treatment protocol of AP-019 without any recommended changes.

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