Thread by @miamalan

[Thread] 1. SA is rolling out its first #CovidVaccines in the form of an implementation study for health workers. That means only workers participating in the study are allowed to get vaccinated. So how come #CyrilRamaphosa could get a shot? bit.ly/3qvrvCC

2. Changes to study protocols can be made if there are good reasons. Protocols are "rule books” that stipulate how a study will be conducted. They explain who can take part and what will be tested. SA's roll-out study will look at real-life implementation of the J&J jab.

3. In the case of the J&J jab, our regulator, @SAHPRA1, adjusted the study’s protocol to:
* Include government officials with health qualifications
* Include #Ramaphosa + #Mabuza
The reason? To “encourage vaccine uptake and reduce vaccine hesitancy”. bit.ly/37p7ohW

4. The union officials who were vaccinated on Wednesday were all health workers — the government defines health workers for the purpose of #COVID vaccinations as everyone working in health settings, not just health professionals such as doctors and nurses. bit.ly/37p7ohW

5. Why is SA not just rolling out the #CovidVaccines so we can get people vaccinated as quickly as possible — why are we starting off with a study if we already know that the J&J jab works? Well, we’re buying time. bit.ly/37p7ohW

6. If SA didn’t start off with a study, we wouldn’t have been able to do any vaccinations until Sahpra had approved the J&J jab for wider roll-out (if done quickly, it takes 3 months). To get approval to use a jab as part of a study, takes 24-48 hours. bit.ly/37p7ohW

7. J&J is giving SA 500 000 free jabs to use in our roll-out study. Those jabs are entering the country under clinical trial registration. That’s why they didn’t have to go for lab testing like the 1 million #AstraZeneca jabs that arrived on 1 Feb. bit.ly/37p7ohW

8. The 9 million J&J #CovidVaccines that SA will receive later this year (we’ll pay for them), will be used for wider roll-out (so not as part of a study). So these jabs need a different type of approval, similar to what the #AstraZeneca jabs got. bit.ly/37p7ohW

9. When the 9 million J&J jabs arrive (obviously in different batches over time because of stock limitations), they will also need to under go for lab tests, just like the #AstraZeneca jabs had to. But the 500 000 we’re getting for research purposes, don’t have to.

10. No country has approved the J&J jab for roll-out because it’s new. Results of the jab’s efficacy were only released on 29 Jan: bit.ly/3s2dgW8. The AstraZeneca data were released on 23 Nov: bit.ly/3bj9nFM. So regulators are all still reviewing the J&J data.

11. When will we see the 1st approvals for roll-out of the J&J jab? The FDA (US) will meet on 26 Feb to make a recommendation about whether or not the jab should be approved. In SA, Sahpra is likely to announce its decision within the next month or so. bit.ly/37p7ohW