Thread by @miamalan

[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.

4. The final #FDA inspection was postponed and only happened on Fri. The FDA now needs to finalise a report on whether Emergent Biosolutions' pharmaceutical practices are up to standard in order to give them permission to resume production of #JnJ's key ingredient.

5. Part of the #FDA report will focus on the results of analysis conducted on 4 other #JnJ key ingredient batches (other than the March batch that we already know was contaminated). @healthza says there 4 batches under investigation. Our #JnJ jabs were made with all of them.

6. When will we hear the #FDA's decision now? All we know is that the FDA sent SA and other affected countries (Canada, Europe) a notice on Thu saying their report will now be released in the week of June 7. Until then, we can't use our #JnJ jabs.

7. Will the #FDA automatically rule our #JnJ jabs are safe to use? NO. They can say:
1. All the batches are contaminated.
2. Some of the batches are contaminated.
3. None of the batches are of a sufficient standard to use in the US, but Sahpra can decide what to do in SA.

8. Is it only SA that can't use its #JnJ jabs? NO. Any country that got jabs made with the key ingredient batches in question, can't use their jabs. Canada + many European countries are in the same position.