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HomeWeekly RoundupDiscovery Health CEO: We need vaccine clinical data not assurances

Discovery Health CEO: We need vaccine clinical data not assurances

Medical aid scheme Discovery Health CEO Ryan Noach has emphasised the importance of Phase 3 clinical trial data on COVID-19 vaccines, urging manufacturers to produce trial evidence alongside assurance to the general public.

Polity reports that speaking during a virtual webinar, he said: “What is important is the Phase 3, which is called the double blinded randomised trial, where human subjects at large scale, to achieve statistical relevance, must receive either prescriber or vaccine, without the subject or the doctor knowing what they are receiving. They must demonstrate two outcomes from the Phase 3 trial: trial 1 that the vaccine is safe and trial 2 the vaccine is effective. The safety and efficacy data emerges from the Phase 3 trials, which leads to approval.”

He explained that the AstraZeneca vaccine is built on the adenoviral vector platform, which is a tried and tested method used for many other kinds of vaccines, over many tens of years, emphasising its safety.

He added that Johnson & Johnson vaccines are important for countries like South Africa, as it is a single dose vaccine compared with other approved vaccines, which are double dose vaccines. It can also be kept stable at typical refrigeration levels.

The report says he touched on the Sinopharm vaccine, saying neither Russia or China have produced any Phase 3 clinical trial data, despite claims that they did. He pointed out that the data was never published, it is not available for inspection, it has not been submitted to regulators for approval and no one knows about its safety and efficacy, despite assurances from manufacturers that it is safe.

He explained that as a clinician, he did not take assurance from manufacturers without evidence.

Ten vaccines are already approved and licensed, with a further 22 in Phase 3 of clinical trials.

Polity reports that Noach raised some concern with the Moderna and BioNTech companies, which use the messenger RNA technology. Noach said because the technology has never been used before, there is no long-term understanding of how this technology affects the body or the safety data showing that it is completely safe.

“The focus of a lot our work at the moment through the task teams that we are working in, supporting the Health Department, is to try and get more vaccines before June, about 10m doses. We would like to vaccinate the higher risk people sooner,” Noach said.

The report says he reinforced the safety of approved vaccines, which will not only have individual and public health benefits, but also an immediate impact on the economy.

 

[link url="https://www.polity.org.za/article/trial-data-important-to-prove-vaccine-safety-discovery-health-ceo-2021-01-28"]Full Polity report (Open access)[/link]

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