JUST IN [Thread] 1. @SAHPRA1 is reviewing 6 #COVID19 #vaccine applications for emergency use authorisation (called Section 21 approval), including new applications for #Sputnik Lite (1 shot of the 2-shot #Sputnik V jab) and #Novavax. 
2. Four of the 6 #COVID19 #vaccine applications are for 2 of the same jabs. So different companies applied 4 approval 4 the same vaccines:
1. #Sputnik (Dr Reddy's Labs, Lamar International)
2. #Sinopharm (MC Pharma, Lamar International; Lamar also applied for Sputnik Lite)
1. #Sputnik (Dr Reddy's Labs, Lamar International)
2. #Sinopharm (MC Pharma, Lamar International; Lamar also applied for Sputnik Lite)
3. On 18 Oct @SAHPRA1 rejected Lamar International's application 4 #Sputnik because of concerns that it might increase HIV negative people's risk of #HIV infection. The application remains open. Lamar needs to submit data to prove the jab is safe.
https://twitter.com/miamalan/status/1450038148323479554
4. Local companies need to submit applications to @SAHPRA1, so an international manufacturer needs to find a local company to partner with. The #Novavax application has been submitted by @CiplaRSA.
5. Why do different companies submit applications for the same jab? It often happens, also with non-COVID meds:
1. It could relate to market share and access issues (market domination)
2. The products might be manufactured at different sites
1. It could relate to market share and access issues (market domination)
2. The products might be manufactured at different sites
6. In the case of the #Sputnik and #Sinopharm applications the products are made by the same sites/developers. But @SAHPRA1 has to review the data submitted by each applicant separately, to make sure it complies with its safety, efficacy and quality standards.
7. So it doesn't mean if one company's application for, say, #Sinopharm, is approved, that the other company will automatically also get approval. Companies risk management plans may, for instance, differ.
8. What's the timeline for the applications? All of the applications have different timelines. Something that hugely influence how long it takes to approve a vaccine is how long a company takes to submit additional data that @SAHPRA1 asks for.
9. Which #COVID19 jabs have already been approved?
1. #Pfizer/BioNTech called “Comirnaty”
2. Janssen (#JnJ) Covid-19 vaccine 3. Sinovac’s called “Coronavac” (submitted by and Curanto Pharma) — this jab has conditional approval
1. #Pfizer/BioNTech called “Comirnaty”
2. Janssen (#JnJ) Covid-19 vaccine 3. Sinovac’s called “Coronavac” (submitted by and Curanto Pharma) — this jab has conditional approval
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