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Large phase 2 trial of Novavax vaccine in South Africa reportedly has data, reporting soon. Minimum of 3,000 people (up to 4,400), mostly HIV-neg but with 240-person HIV-positive group. Biggest group of people with HIV in a Covid vaccine trial so far https://www.pharmaceutical-technology.com/comment/novavaxs-south-african-phase-iib-covid-19-vaccine-trial-likely-to-reveal-results-within-next-fortnight-source-says/ ..1/4
...Not a phase 3 trial, but it has a placebo group & has a vaccine efficacy endpoint for the HIV- group. According to the protocol, an efficacy analysis is triggered if there 50 people sick with Covid-19 (or 21 with moderate or severe Covid-19) ...2/4 https://www.novavax.com/sites/default/files/2021-01/2019nCoV_501_Phase2abSouthAfrica_Version3_Redacted.pdf
...Novavax also released updated version of protocol for their UK phase 3 trial, also expected to report soon. Changes included reducing events needed to 100 with only 1 interim at 50; adding secondary endpoint for asymptomatic Covid-19 (for subset) https://www.novavax.com/sites/default/files/2021-01/2019nCoV_302Phase3UK_Version3_FinalClean_Redacted.pdf ...3/4
...It's a protein subunit vaccine, so more traditional type that could be manufactured quite widely if agreed with Novavax. Current agreed production capacity reportedly major because of manufacture in India. I've collected records for the vaccine here https://www.zotero.org/groups/2528572/covid-19_vaccine_results/tags/NVX-CoV2373%20Novavax/library 4/4
...PS on Novavax: part of the change to the protocol for the UK trial is to calculate number of events (Covid illnesses) based on a minimum expected efficacy of 70% - it had been 60% https://twitter.com/hildabast/status/1321188501136666625
