Thread by @miamalan

[Thread] 1. How long will it take for the J&J #CovidVaccine to be approved for full registration so we can use it for wider roll-out (outside a study setting) and is there a way around it? bit.ly/3r8Wfd2

2. Full registration by @SAHPRA1 for a branded medicine can take up to two years. But for #COVIDVaccines this process has been sped up - all jabs move right to the front of the queue. bit.ly/3r8Wfd2

3. J&J has applied for full registration via a rolling review (a review process where they submitted data throughout the efficacy trial they did, instead of submitting all info at the end of the trial, so it saves time and Sahpra doesn’t have to review all the data at once).

4. Rolling reviews have 4 steps. Sahpra says it is now at the 3rd step of the J&J review. Sahpra has requested more data from J&J, and is waiting for that data before the process can move to the 4th and final step. bit.ly/3r8Wfd2

5. Glenda Gray, a co-investigator of SA’s J&J implementation study, told @bhekisisa_MG the full registration for the J&J jab will take 3 months (J&J made the application in late 2021). But that’s only when there are no hold-ups, e.g. requests for more data.

6. Because the full registration can still take a while, Sahpra has confirmed to @bhekisisa_MG that J&J is talking to them about also applying for Section 21 approval, that is faster than full registration. bit.ly/3r8Wfd2

7. Section 21 approval is the type of approval the #AstraZeneca jab received from Sahpra. The application took 3 to 4 weeks to process. It is SA’s equivalent of the United States’ emergency authorisation use approval (the J&J jab got EUA in the US on Saturday).

8. So the J&J jab might get 3 types of approval in SA: 1. Registration for use in a study (J&J currently has this approval, that’s why we can conduct an implementation study among health workers) 2. Section 21 approval (faster to get than full registration). 3. Full registration.

9. Business Day reports that Sahpra told them they expect to have the full registration for J&J concluded by mid to end of April — but that's, of course, only if there are no hold-ups. businesslive.co.za/bd/national/he…

10. Will the US/FDA's emergency authorisation use approval speed up Sahpra's approval for full registration? No. Two reasons: 1. Sahpra started to review the J&J data before the the US approval. 2. The #501YV2 variant in SA requires Sahpra to focus more on this data than the US.