Distracted by the other EMA thing, I'm only just catching up with the 218-page EMA assessment report for the J&J vaccine ema.europa.eu/en/documents/a…

For background, my summary from the 62-page FDA report is here absolutelymaybe.plos.org/2021/03/16/com…

Tweeting about what's new or different...1/n
...As usual, in-depth look at quality of manufacturing. "No raw materials of human or animal origin are used" in the final production. The cell line used to optimise production of the vaccine vector is PER.C6, which has already been studied for safety...2/n
...Current batches manufactured mostly in Leiden & emerging in Baltimore: they've shown consistency in the European manufacture - EMA wants them to follow-up with data showing the Baltimore production is comparable (this is all standard) ...3/n
...From first scan, looks as though J&J have publications/preprints of all the preclinical animal studies (or close to), but there's quite a bit of detail here. Plus a reproductive toxicity study in rabbits: no cause for concern on reproduction or fertility ...4/n
...If you're interested in their early phase immunogenicity study, there might be some more detail here than there was in the publication - that's here: nejm.org/doi/10.1056/NE… ...5/n
...Something FDA didn't report: there was an increase in SARS-CoV-2 infections at 2 sites in Brazil. Because of concerns about variants, an originally unplanned analysis of immunogenicity was done for people randomly selected from there & other sites in Brazil, SA, USA ...6/n
... All up, that was 188 people in Brazil, 118 in SA, 74 in the US. Results are shown (Table 11): antibody & responder rates were similar across the sites. A higher rate of participants from Brazil had signs of previous SARS-CoV-2 infection ...7/n
...If you're interested in their ongoing immunogenicity studies internationally, there's some detail in here on those. (Perhaps of particular interest to people interested in the 2-dose issue.) ...8/n
... Just an aside here - the EMA is consolidating their position as the producer of the best evaluations of these vaccines with this report - it's very impressive (& I'm not halfway through yet)...9/n
...Where was I? Oh yeah - the 2 doses question. Although people had Ad26 (the viral vector) antibodies, "it did not suggest an apparent negative impact of antiAd26 vector immunity induced by the first vaccine dose on the post-dose 2...responses"...10/n
...Onto the phase 3 ENSEMBLE trial: this is the same data as in the FDA report. They have a bit on statistics, which FDA didn't (probably covered in the protocol:jnj.com/coronavirus/en… ) ...11/n
... After 28 days, they conclude, efficacy wasn't so different between SA, Latin America, USA. Onset was later for SA ⬇️ "It might be hypothesised that Ab and/or T cell responses of higher magnitude are needed for
protection against the SA variant."...12/n
...The majority of Covid-19 classified severe was based on self-measured oxygen saturation measures ...13/n
...About 2% of people had 1 or more solicited adverse events rated severe, mostly judged related to the vaccine - but only about half the solicited adverse events overall were judged related. (My explainer on the language here & what will follow): absolutelymaybe.plos.org/2021/02/21/a-r…) ...14/n
...The judgments on serious adverse events (SAEs) seem the same as for the FDA (an exception will follow). (Of note given recent events: none of the thromboembolic events described here are like the ones under investigation in Europe for another vax at the moment) ...15/n
...Exception is not related to this specific vaccine, but to a previous vaccine: there had been some people who had incidental HIV infections in a trial of a previous vaccine. For those who knew this & were wondering: there were no incidental HIV infections in this trial ...16/n
...No safety concerns were noted for the 601 people living with HIV who participated in this trial, but it's too small a group to draw conclusions ...17/n
...They looked at safety data on pregnancy for the few (4) in this trial, but also for previous J&J vaccine: "did not reveal any safety concern related to Ad26-based vaccine exposure during pregnancy"...18/n
...Because so few people had mild Covid-19 in this trial, EMA concludes efficacy against Covid-19 ...19/19

And now we go to breaking news on the Oxford-AstraZeneca vaccine from the US...

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More from @hildabast

22 Mar
Oh this is great news! 🥳

Oxford-AstraZeneca vaccine: 79% efficacy & possibly increasing over time

Press release for interim efficacy results from the US trial for 32,449 people, randomized 2:1 to placebo (140 events - symptomatic Covid-19)... 1/n

... Typo in previous tweet: 141 events. (No confidence intervals provided.)

...Vaccine efficacy was consistent across ethnicity & age, include older. It was 80% for people aged 65 & older.

No breakdown of events by vaccine & placebo...3/n
Read 8 tweets
21 Mar
Out of the several different major vaccination strategies internationally, the UAE's is one of the most unusual. There are 4 vaxes available (Sinopharm Beijing, BNT-Pfizer, Sputnik V, Oxford-AstraZeneca), & free vaccination now open to everyone 16+ khaleejtimes.com/coronavirus-pa… ...1/n
... When you apply for an appointment, you choose the vaccine you want.... "Press 1 for Sinopharm...."

(Here from when there were 3 vaccines) khaleejtimes.com/coronavirus-pa… ...2/3
...Over 56% of the population has had at least 1 dose; over 72% of seniors & people with chronic diseases. As of now, open to everyone.


JHU's tracker says 23% of the population is fully vaccinated coronavirus.jhu.edu/vaccines/inter… 3/3
Read 4 tweets
11 Mar
The Danish Health Authority has suspended use of the Oxford-AstraZeneca Covid vaccine for 14 days as a precaution while an investigation into serious adverse events proceeds...1/n sst.dk/da/Nyheder/202… HT @iamPWK
...There is no confirmation that the vaccine caused any of the serious adverse events (SAEs) under investigation: this is a precaution, while the investigation proceeds. The SAEs are related to blood clots in Austria & Denmark ...2/n
...There were 2 thrombosis-related (blood clot) SAEs in Austria & the first investigation was whether it was related to a specific batch of vaccine. The EMA (Euro drug regulator) determined that there wasn't a problem with the batch...3/n
Read 5 tweets
10 Mar
Data & Safety Monitoring Board for phase 3 trial of Sinopharm's vaccines in Peru - about 12,000 people, 2 vaccines vs placebo - has recommended discontinuation of the Wuhan vaccine arm for inadequate efficacy (*not* the Beijing vax in use globally) ...1/n cayetano.edu.pe/cayetano/es/no…
...The university running the trial have sought the permission of the drug regulator to unblind participants & offer the volunteers in the Wuhan & placebo arms vaccination with the Beijing vaccine which did meet efficacy criteria (results aren't ready for release though)...2/n
...Sinopharm recently issued a press release saying the Wuhan vaccine efficacy rate was 75%. They applied to NMPA (China's drug regulator for authorization). NMPA authorized it on Feb 27 ...3/4 english.nmpa.gov.cn/2021-02/27/c_5…
Read 4 tweets
3 Mar
Preprint of results from the Novavax phase 2 trial in South Africa with efficacy outcomes, with 4,387 participants. Sequencing done for most of the people with Covid-19: 93% were infected with B.1.351 ("SA" variant). ...1/n medrxiv.org/content/10.110…
...Small trial, so a lot of uncertainty in efficacy results.

Vaccine efficacy rates:

Overall (not previously infected with SARS-CoV-2): 49.4% (CI 6-73)
HIV- : 60.1% (CI 20-80)*
Against B.1.351 variant: 51.0% (CI 0.6-76)

* 6% of people in the trial living with HIV

...About 30% of people tested positive for previous SARS-CoV-2 infection, & their risk of getting sick with Covid-19 was the similar to people who'd never been infected before. Placebo group: 5.3% vs 5.2%. Previous protection didn't protect against the variant ...3/n
Read 8 tweets
1 Mar
Public Health England released leaked study - it's a copy of a manuscript submitted to a preprint server. It's not a study of who was vaccinated, but of vaccination status of people seeking Covid tests for symptoms ...1/n khub.net/documents/1359… HT @michael_jshaw @TheGazmanRants
...This study is a test negative case control study - it's a study design that's been used in a variety of vaccines. (Here's an article about this type of controlled study: journals.lww.com/epidem/Abstrac…)...2/n
...It's data from tests for the general community (called Pillar 2: doesn't include eg hospital testing). Data was linked to the National Immunisation Register, on Feb 22. Vaccination began in the UK on Dec 8 (with BNT-Pfizer), followed soon by Oxford-AstraZeneca vaccine...3/n
Read 7 tweets

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