Thread by @miamalan

BREAKING [Thread] @sahpra1 has registered the Chinese #COVID19 jab of #Sinopharm 4 people of 18+:

1. Internationally, the jab = known as Sinopharm/ BBIBP
2. It was originally developed by the Beijing Institute of Biological Products
3. It’s given as 2 injections, 2-4 weeks apart

2. Who applied for @sahpra1 approval?
1. International companies can’t apply directly to Sahpra 4 authorisation. They have to use a local company
2. #Sinopharm (a Chinese state-owned company) partnered with MC Pharma, a SA pharmaceutical company
bit.ly/3sp7BeP

3. Don’t get confused: Two local companies have applied with @sahpra1 for authorisation use of #Sinopharm’s #COVID19 vaccine:
1. MC Pharma (this is the application that’s been approved)
2. LHC Pharmaceuticals (this application has not yet been approved)

4. When was #Sinopharm’s #COVID19 vaccine registered by @sahpra1?

1. On 31 January (they applied on 23 June, so the approval process took about 6 months)
2. In SA, Sinopharm’s vaccine will be called “COVID-19 vaccine MC Pharma”.
Application date: bit.ly/35NzMwd

5. How does #Sinopharm’s jab work?
1. It's an inactivated jab, so it uses tiny, “dead” bits of #SARSCoV2 (the virus that causes #COVID19) 2 get your body 2 produce antibodies
2. The “dead” bits can’t make you sick because they can’t replicate (their genetic material = destroyed).

6. How well does #Sinopharm work?
1. It provides about 79% protection against ending up in hospital with #COVID19
2. This data is, however, not #Omicron specific, but pertains to protection against the ancestral (original) form of #SARSCoV2

7. One of the conditions for registration is that #Sinopharm/MC Pharma have to submit #Omicron data for their jab (it's a requirement for all jabs). They have not yet done so.

8. Has #Sinopharm received WHO emergency listing?
1. Yes, it was listed on 7 Mary 2021
2. What does this mean? It's like a green light from WHO that the jab can be rolled out globally
3. Jabs need WHO listing for #COVAX to procure them

bit.ly/3Gw7fIj

9. What type of authorisation did #Sinopharm get?
1. #Sinopharm got market authorisation, so it’s fully registered.
2. Market authorisation is different from emergency (section 21) authorisation — it requires more data for approval, but there are more things you can do with it

10. What can you do with market authorisation that you can’t do with emergency authorisation?
1. Emergency/section 21 authorisation = cap on how much of a product can be imported
2. Market authorisation allows 4 off-label use (4 something the product hasn’t been registered)

11. What other #COVID19 jabs have market authorisation in SA?
1. #JnJ (from the start)
2. #Pfizer: Initially, Pfizer had emergency authorisation, but on 25 Jan, @sahpra1 gave Pfizer market authorisation, as enough data had become available for such registration

12. What does #Pfizer’s market authorisation mean?
1. There's no limit on how many doses can be brought into SA (initially, it was capped on 30 mil doses)
2. @HealthZA can decide 2 use it off-label, so 4 “mix and match”, e.g. as a booster after a #JnJ shot

13. When will heterologous boosters (getting boosted with a different jab than the 1 you got vaxxed) become available in SA?
1. On Fri, @healthza said it expected an advisory of the #COVID19 vax MAC this week
2. @healthza needs 2 consider recommendations of the MAC 4 decisions

14. Has @sahpra1 approved heterologous boosters?

1. Sahpra approved #JnJ as a booster after 2 #Pfizer doses in Dec (JnJ applied for approval)
2. Sahpra = not approved #Pfizer as a booster after #JnJ (because #Pfizer hasn’t applied for approval)

15. If @SAHPRA1 hasn't formally approved #Pfizer as a booster after #JnJ, can it still be used as one?
1. Yes
2. Because Pfizer now has market authorisation, the jab can be used off-label, so @healthza can make a policy decision to use it this way (but it will take a while)

16. Will @healthza buy #Sinopharm #COVID19 vaccines?
Unlikely (for the immediate future): @healthza says it’s procured more than enough jabs (the health dpt doesn't have to buy a jab just because Sahpra has approved it)

17. What happens when @healthza has used all the #Pfizer and #JnJ jabs it's procured?

@healthza: “When we need more vaccines, government will go in tender. Times have changed [there are now more manufacturers to choose from, so competitive pricing can be introduced].”

18. Can SA private companies buy #COVID19 jabs?
1. No, only the state can
2. Why?
- To ensure equity
- Manufacturers only sell to governments + aid agencies (so far) as they require buyers to sign no-fault compensation agreements which only countries can generally underwrite

19. Which COVID19 vaccines have been authorised in SA?
1. #Pfizer (market authorisation)
2. #JnJ (market authorisation)
3. #Sinopharm (market authorisation)
4. #Sinovac (conditional authorisation)

20. Which #COVID19 vaccines are still under review for authorisation?
1. #Novavax
2. #Sputnik (the 1st application was unsuccessful)
3. Sputnik Lite
4. #Sinopharm (LHC Pharmaceuticals' application)
Source: bit.ly/3GwQZGQ

21. Read @SAHPRA1's full press release here: sahpra.org.za/news-and-updat…