Thread by @miamalan

[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

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

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

4. What do we know? Sources in SA's gov say they’ve been given similar nrs: 60 million can’t be used + 10 mil (not part of the 60 mill) have been cleared. The FDA's report will clear this up.

5. What else do we know? On 11 Jun, the day of the FDA statement, #JnJ released a statement re jabs destined for Europe:
“In alignment with the precautionary measures recommended by the European Medicines Agency, the Company will not release certain batches of its ... vaccines.”

6. Late Jun 11, @healthza released a statement and said:
1. Two million of SA’s already made #JnJ jabs at Aspen in Gqebherha can’t yet be released, as they need further assessment by @SAHPRA1
2. There's a “real possibility” that Sahpra could rule that the jabs can’t be used

7. @healthza also said in its statement:
1. 300 000 cleared/unaffected #JnJ doses will be shipped to SA “as a matter of extreme urgency”
2. The expiry date of the doses has been extended from 3 to 4.5 months (before the extension they expired on 28 June)

8. The hlth dpt told me the 300 000 doses = for school staff (480 000 = originally ordered, but they were reduced to 300 000 because of concerns that we wouldn’t be able to use the 480 000 before the original expiry date of June 28. The shelf life was only extended after that).

9. The 300 000 doses for school staff are likely to be flown to SA early next week (if #JnJ releases them in time). Sahpra has to approve the extended expiry date (from June 28 to early August), but that's not a long process.

10. #JnJ doses at Aspen: Is it only SA’s which were made with ingredients from the batches the FDA is investigating? Unlikely. Aspen also fills and finishes millions of imported JnJ jabs destined for distribution to other African countries via the AU.
bit.ly/3wiyv8V

11. What other implications do the potentially unusable #JnJ batches hold for Africa? The NYT says it puts a dent in the US gov’s plans to share jabs with poorer countries, as J&J jabs = one of the 3 vaccines (Pfizer, AstraZeneca and JnJ) the Biden administration plans to share.

12. What about the almost 500 000 #JnJ doses used in our #Sisonke study? The ingredients they were made with were not produced by Emergent BioSolutions, so they're not contaminated, says one of the co lead investigators, @LindaGailBekker:

https://twitter.com/LindaGailBekker/status/1403413363569446916

13. When will we have final answers re:
1. How many doses cannot be used? (60 mil?)
2. How many doses can be used under special conditions (10 million which are not part of the 60 mil?)

The hlth dpt seems to think Sahpra will receive a report over the weekend/early next week.