[Thread]. 1. The FDA has announced 60 million doses of #JnJ produced by the manufacturer Emergent Biosolutions in Baltimore are unsuitable for use and therefore have to be destroyed. What does that mean for South Africa? bit.ly/3xieQps
2. SA has procured 31.2 million #JnJ doses. At least 2 million of those doses were sent to Aspen in Gqeberha to put into vials and packaged. These doses were made from batches of ingredients that the FDA investigated for quality.
3. Are the 2 million doses in Gqeberha among the 60 million which are unsuitable for use? The FDA has not yet released a report with the batch nrs, so we don't yet know, but the hlth dpt has been told that some of the doses will almost certainly be affected.
4. When will we know? The hlth dpt hopes to receive a full FDA report tonight. They will then issue a statement with details on which batches we can't use.
5. What about the 480 000 extra doses we're getting for teachers and school staff? Good news: That batch may not be affected, several sources in the hlth dpt have been told. Once that is confirmed, we're likely to be able to fly the batch to SA over the weekend.
6. The 480 000 doses for teachers + school staff has an expiry date of June 28. But the FDA has extended the shelf life of #JnJ from 3 to 4.5 months, so it's likely that those jabs could last for longer. But our regulator, Sahpra, first has to approve the extended shelf life.
7. So what will happen to our 2 million #JnJ doses at Aspen? Those which are among the 60 million doses the FDA says can't be used, will have to be destroyed. But #JnJ will have to replace these, because we have already paid for them.
8. How long will it take to replace our doses that can't be used? We don't know. Why not? The FDA hasn't yet decided if Emergent Biosolutions can now continue to produce #JnJ ingredients. For the past 2 months, nothing has been produced at the factory.
9. Emergent Biosolutions isn't the only factory producing #JnJ ingredients. The US's #JnJ jabs are imported from The Netherlands. But a factory that hasn't been producing (and might not be able to) + millions of doses that have to be destroyed, will slow down supply worldwide.
10. SA has several other #JnJ doses (we've ordered 31 million) that still needs to be produced and won't be affected by the FDA's decision. But #JnJ now has 60 million fewer doses of ingredients to make jabs with, and many countries vaccine orders are affected.
11. Because so many countries (Canada, European countries) are affected by the FDA's decision, there will now be increased pressure on #JnJ to produce doses to replace the ones which can't be used. SA may therefore have to wait longer for its doses.
12. What do we do now? We use our #Pfizer doses until some of our #JnJ doses arrive. We wait for Sahpra to tell us if Sinovac (China) or Spudnik (Russia) will work against the Beta variant identified in SA so we can look at potentially procuring those. We try to talk to Moderna.
13. How many #Pfizer doses have we ordered? 21 million (originally) + another batch of 10 million. We've received 2.5 million of those. Next deliveries:
* 14 June: 636 480
* 21 June: 1,274, 130
For the rest, we don't yet have specific delivery dates.
14. What are the implications of waiting longer for our #JnJ doses? For the waiting period, we'll be vaccinating people against #COVID at half the speed we planned to. Our original vaccination goals will therefore not be reached.
Please see my updated thread: The NYT said the FDA said 60 mil doses can't be used, the FDA didn't include it in their statement (sources in our gov have been given the same nrs reported in the NYT):

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More from @miamalan

13 Jun
[Thread] 1. BREAKING: Both President #CyrilRamaphosa and acting health minister Mamoloko Kubayi-Ngubane have confirmed that the FDA found SA's 2 million #JnJ jabs at Aspen in Gqeberha unsuitable for use. They can therefore not be released.
2. Mamoloko Kubayi-Ngubane (sent to me 17:45):
"I can confirm that 2 mil doses at Gqeberha have been affected + will not be used. Only 1 batch was regarded contaminated from USA + the other 1 was not but because they were stored together, it’s difficult to isolate one batch."
3. #CyrilRamaphosa at the G7 summit this afternoon: “I’m told they [Aspen] have to dispose of those they have already manufactured. They are going to start all over again with another batch.
Read 4 tweets
13 Jun
[Thread] 1. BREAKING: After reviewing FDA data, @SAHPRA1 has decided to not release any #JnJ vaccines in SA which were produced with batches of ingredients deemed unsuitable for use by the FDA. Image
2. Two million already manufactured #JnJ vaccines (SA's first two batches) are at Aspen's Eastern Cape plant. Those jabs will be affected by this decision - some or all may not be suitable for use.
3. @SAHPRA1 hasn't yet told us how many of the 2 million jabs can't be released but on Fri @HealthZA warned in a press releases there is a very real possibility that the jabs may not be suitable for use.
Read 4 tweets
12 Jun
[Thread] 1. What do we know about the #FDA’s decision re #JnJ ingredients made at Emergent BioSolutions?

On 11 Jun, the FDA said:
1. Two batches of #JnJ ingredients are suitable for use — but under special conditions
2. Several other batches are unsuitable for use Image
2. Shortly before the FDA released its statement, the NYT reported:
1. The FDA told #JnJ 60 mil doses of jabs are unsuitable for use because they contain potentially contaminated ingredients made by Emergent BioSolutions
2. 10 mil doses are suitable for use, but with a warning Image
3. The FDA didn’t mention the nr of doses that can’t be used. But the NYT says it’s 60 million. Is that true? We don’t know for sure until the FDA releases its report. The FDA said:
1. Several batches are not suitable for use
2. More batches are still under review Image
Read 13 tweets
9 Jun
[Thread]. 1. Where are we at with #VaccineRolloutSA?
* People who had received 1 #CovidVaccine dose by 7 Jun = 1, 524, 589
* Of those, only 31% (479 768), have been fully vaccinated (they got a #JnJ jab via #Sisonke)
* The rest (1, 043 278) have received the 1st of 2 #Pfizer jabs
2. Here’s a summary of our #VaccineRolloutSA figures so far:
* Total doses = 1, 524, 589
* Total #Pfizer 1st doses = 1, 043 278
* Nr of #Pfizer doses given on Mo, 7 Jun = 82 641 (this is the highest nr of daily doses so far)
3. Where do the 1, 524, 589 doses SA had given by 7 Jun place us in #Africa? @mediahackza tracks 51 countries, SA is 4th:
1. Algeria: 2, 500, 000
2. Nigeria: 2, 225, 765
3. Ethiopia: 1, 856, 968
4. SA: 1, 524, 589

Here's more: bit.ly/3x7h6jp
Read 13 tweets
6 Jun
[Thread] 1. Why did the #FDA not make an announcement on Friday about whether SA can release its #JnJ jabs from Aspen in Gqeberha? bit.ly/3uXc6wr
2. The FDA needed to do a final inspection of Emergent BioSolutions, the company which makes #JnJ's key ingredient. Why? In March, they found 1 batch of ingredients to be contaminated + stopped all production. The company needs to pass an inspection before production can resume.
3. What were the jabs contaminated with? With ingredients of the #AstraZeneca jab. How? Emergent Biosolutions also made the key ingredient of the AZ jab — they produced the #JnJ and AZ key ingredients in one factory + weren't careful enough. That's how the contamination happened.
Read 8 tweets
4 Jun
[Thread]1. When can a province start to vaccinate people of 40+? When 70% of people of 60+ in a province had been vaccinated, @HealthZA said in a presentation this week. #VaccineRolloutSA
2. How many people of 60+ are there? About 5 mil. How many have we vaccinated? We only know we had given 713 584 #Pfizer jabs by Wed, @healthza hasn't given a breakdown of how many are #HealthWorkers and how many are people of 60+. #VaccineRolloutSA
3. What do we know? We have a breakdown of registration figures. 2 247 753 people of 60+ have registered on the EVDS, so about 45%. We've given 713 584 (that's 14% of 5 mil) shots so far (some = HCWs), so we've got a long way to go before we've reached 70% of people of 60+.
Read 4 tweets

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