Mia Malan Profile picture
26 Apr, 19 tweets, 12 min read
[Thread]. 1. This morning @ZweliMkhize announced that the Sisonke trial, which uses #JohnsonandJohnson’s #COVID19 jab, will resume on Wednesday. So what happens now?
2. Up until now, the Sisonke trial has vaccinated about 300 000 #HealthWorkers. @SAHPRA1 paused the trial in April, after the FDA/CDC in the US temporarily halted its #JandJ roll-out due to the occurrence of 8 rare blood clotting disorders among about 7 million vaccinated people.
3. None of the blood clots that occurred in the US, occurred in SA's Sisonke trial (likely because it’s so rare and we’ve only vaccinated about 300 000 people vs. the US’s 7 mil). The US unpaused its #JandJ roll-out on Fri after the FDA cleared the jab. bit.ly/2PsRgGA
4. How many #HealthWorkers will Sisonke vaccinate? 500 000, so they’ve got about 200 000 left to do. 500 000 workers are just less than half of a total of 1.2 million workers who need to get vaccinated against #COVID19 in SA. So how will the rest get vaccinated?
5. Sisonke will have 95 vaccination sites. The sites will also be used for SA’s commercial roll-out among health workers (beyond the Sisonke trial). #Mkhize this morning: Phase 1 (#HealthWorkers) will end on May 16. The idea is to have all 1.2 million workers vaccinated by then.
6. Where are the 95 sites? A list will be published in the next edition of “I Choose Vaccination Bulletin” on the SA coronavirus website. (The last edition was published on Feb 27th). Note: These are only 95 of an eventual 3 338 sites: bit.ly/3u4OW7q
7. Who counts for #HealthWorkers? Everyone who works at a health site, so not just doctors and nurses, also cleaners, receptionists, porters, etc. Traditional healers can also now register on the EVDS to get vaccinated as health workers. Register here: vaccine.enroll.health.gov.za/#/
8. Are there new rules for when someones gets a #JohnsonandJohnson jab? Yes.
1. Intensified pre-vaccination screening + post vaccination monitoring.
2. Sisonke participants have to be informed of the potential blood clotting risk (even though the risk is only 1 in a million).
9. What about those #HealthWorkers who haven’t yet been vaccinated, but had already registered to get a jab via Sisonke, without being informed about the blood clotting risk? They'll receive an SMS asking them to consent again on a form where the risk is indicated.
10. The new #JandJ consent form will be accompanied by a patient info leaflet that will spell out everything a Sisonke trial participant needs to know about the safety and efficacy of the J&J #COVID19 jab. This info is more or less the same as the guidance of the FDA in the US.
11. Can anyone in SA get vaccinated with the #JandJ jab? No. For now, @SAHPRA1 says pregnant +lactating women can’t. @WHO recommends the same. Why? We don’t yet have conclusive evidence about the risk the jab holds for these groups. bit.ly/2QW58tl
12. So what symptoms (that could indicate the risk of developing a blood clot) do people getting the #JandJ jab need to look out for?
1. Severe, unrelenting headaches
2. Abdominal pain
3. Vomiting
4. Blurry vision

More here: bit.ly/3gDGYOV
13. What should you do if you received a #JandJ jab + have symptoms that indicate you're at risk of a (note: extremely rare type of) blood clot?
1. Seek medical attention/call the #COVID hotline.
2. Report the symptoms on @SAHPRA1’s Med Safety App.

bit.ly/3dQpZak
14. In the case of severe vaccine-related injury, you’ll be able to claim from SA's vaccine injury fund, though many details re this fund are still lacking. #Mkhize says forms with step by step guidelines will soon be published. You won’t need a lawyer. bit.ly/3aEF6Sg
15. When will SA start to vaccinate people other than #HealthWorkers? 17 May (people over 60). Which jabs will we use? #JohnsonandJohnson (only one shot required) and #Pfizer (two shots required).
16. When will our first batches of jabs arrive? These dates change all the time. Latest: 1.1 million doses (of 31 million) #JohnsonandJohnson jabs. “Within the coming days”. Where will the jabs come from? Aspen in Gqebherta. 650 000 doses #Pfizer (of 30 million): “Before May 17.”
17. Will we be able to use the #JohnsonandJohnson and #Pfizer jabs immediately after arrival? No. Samples of the jabs will first have to be tested at the National Control Lab in Bloemfontein. Only after the jabs have been cleared, can they be distributed to vaccination sites.
18. Who will transport the jabs to provinces? Three companies have been appointed (contracts = from April 2021 to 31 Dec 2022):
1. DSV Logistics
2. Imperial logistics
3. Biovac
19. How many vaccination sites will there be in total? 3 338. How many are ready? 2 369 have been registered on a masters facility list and are undergoing approval. How will you know where they are? The sites will be published on @HealthZA + the SA coronavirus websites.

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More from @miamalan

22 Apr
[Thread] 1. Just in from Wednesday's cabinet briefing:
* The #CovidVaccine roll-out is still scheduled to start on May 17.
* There are now 3 338 vaccination sites (a list with the names hasn't been released).
2. When will can we start to use the 31 million #JohnsonandJohnson jabs that we've bought and will the first 1 million (from Aspen in SA) still land this week? We don't know. Neither @SAHPRA1 (our regulator; it needs to authorise use) nor @healthZA have made an announcement.
3. What do we know? Sahpra has recommended that the Sisonke trial (it uses J&J jabs) should resume. But before that can happen, Sahpra has to approve new docs submitted by the researchers (the study has to adhere to new rules set by Sahpra, e.g. better screening for blood clots).
Read 8 tweets
16 Apr
[Thread] 1. Stravos Nicolaou (from Aspen and SA's vaccine oversight committee): Phase 2a (people of 60 and older) and Phase 1b (health workers getting commercial vaccines) of our roll-out will run concurrently.
2. Stravos Nicolaou: Soon, SA will significantly ramp up the number of people vaccinated per day. We'll do two things: open up many more vaccination sites than what the Sisonke study had and have many more deliveries of #CovidVaccines.
3. Stravos Nicolaou: SA's #CovidVaccine pipeline: In total we've procured 61 million vaccine doses: 31million J&J, 30 million Pfizer - they will arrive over the course of 2021. We also have 500 000 Pfizer doses coming from COVAX.
Read 4 tweets
16 Apr
[Thread] 1. People in South Africa who are 60 years and older can register on the government's electronic vaccination system from 4pm today (it was announced at a press briefing this morning). bit.ly/32h0Kar
2. At this stage, the system will only allow you to register and not yet allocate you a site or date to get vaccinated at (because a vaccination date depends on when our first batch of vaccines arrives and when Sahpra makes an announcement about the resuming of J&J's roll-out).
3. #ZweliMkhize: What do you need to register online? Internet access (smart phone, tablet, computer), an ID or passport, a cell phone number (so the system can send you text messages re appointments) and if you have a medical aid, your med aid number/card.
Read 8 tweets
13 Apr
[Thread] 1. #ZweliMkhize says there is no evidence that J&J is linked to blood clots. SA is pausing its roll-out as a precautionary measure to find out if there is something to be concerned about before we proceed.
2. Helen Rees (Sahpra's chair): Vaccine safety is always at the top of our list. In the case J&J, the nr of blood clot cases is very low: 6 cases out of almost 7 million vaccinated people in the US. We need to find out if the cases are accidental or linked to the jab.
3. Helen Rees: This process is called a causality assessment. It's normal to do with new jabs. Why? In trials, jabs are tested on 1000s of people. When you roll them out, millions of people get them. So there's a chance for side effects you didn't see in the trial to occur.
Read 5 tweets
8 Apr
[Thread] 1. VACCINE ARRIVAL UPDATES: According to #ZweliMkhize, J&J has confirmed that just over 1 mil #CovidVaccines will be delivered to SA between 22 + 24 April. They will all come from the local Aspen plant (previously we only knew they'd arrive in the 3rd/4th wk of April).
2. #ZweliMkhize: The 2nd and 3rd J&J #CovidVaccine batches in May and June (900 000 per month) will come from Belgium (the first batch will come from Aspen in SA), so delivery will be more complex. We'll get an exact delivery date within the next 2 weeks.
3. #Pfizer 1st batch of #CovidVaccines is likely to arrive in April. Next week, Pfizer will tell SA how many doses + also a specific delivery date (if there are no payment glitches). #ZweliMkhize previously said we'll get 5.5 million doses between April + June.
Read 5 tweets
6 Apr
[Thread] 1. The two jabs — #JohnsonandJohnson and #Pfizer — that SA will (so far) use in its national #CovidVaccine roll-out have now both been approved for use by our regulator, @SAHPRA1. So what now — when will you get your jab?
2. The next batch of J&J jabs (200 000) will arrive on 10 April. But these #CovidVaccines are for use in SA's Sisonke trial (our implementation study) and only #HealthWorkers can be vaccinated with them. They can’t be used for our wider, national roll-out.
3. Our 1st commercial batch — 1 million J&J jabs — will land in the 3rd/4th wk of April. The diffs between this batch + the Sisonke jabs: we’re paying for this batch + can use it outside of a research setting. The Sisonke jabs came for free but we can only use them for the study.
Read 12 tweets

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