Interim readout from Novavax phase 3 from the 15k UK & 4.4k phase 2b from South Africa. High efficacy in the UK: 89.3% (95% CI: 75.2 – 95.4) - lowered a bit by the new variant...1/n ir.novavax.com/news-releases/…
...SA results heavily affected by new variant. Overall efficacy was 60% efficacy (95% CI: 19.9 – 80.1) for the bulk of people who were HIV- : very wide confidence intervals, because it's a small trial. With small HIV+ group included, (efficacy of 49.4%; 95% CI: 6.1 – 72.8) ...2/n
...Critically, the primary efficacy result, as for the other vaccines, is for people who hadn't had a previous SARS-CoV-2 infection. But 1/3 did. No data released for them, but previous infection may not protect against the new "SA" variant ...3/n
...Bottom line: it does protect against the SA variant, but not as well as against the original & "UK" variants. Novavax is working on vaccine targeting the new strain.
Press release doesn't discuss safety & adverse events (AEs): AEs were very low in early phase results ...4/n
...It's protein subunit vaccine; requires same distribution & use as common vaccines (hep B & some other common ones also this category).
They also announced they have recruited 16k of the 30k needed for their US trial.... 5/6
...Giant sigh of relief: another high efficacy vaccine! And because of the capacity to produce it in India at very large scale - it's one of the handful that could be a billion doses - this is huge. (Though massive quantity hasn't already been produced.) 6/6
...PS! Back to the UK trial. 27% were over 65, so around 4,000 people. Only 1 severe illness in each of the trials - both were people in the placebo groups.
...34% were over 60 (14,672 people). Diverse, from South Africa & the Americas. 41% had co-morbidities putting them at risk of severe Covid-19. Protection was consistent across age, race, & part of the world - even though 95% in SA were infected with the new "SA" variant...2/n
...First trial powered to answer the severe Covid-19 question: efficacy was 85% at 28 days after the injection (no event breakdown or confidence intervals). For moderate to severe, efficacy was 66%, varying a bit in the 3 regions (from 57% in SA to 72% in the US...3/n
Meanwhile, a few days ago the EMA published its EPAR (public assessment report) on the Moderna vax (HT @pajz_) ema.europa.eu/en/documents/a… It's 169 pages ...1/n
...There was "a major objection" to the US manufacturing sites, so they were withdrawn. Complete transfer for Europe to Swiss manufacturing due to conclude soon. (There have been Qs in the US about a batch there reuters.com/article/us-hea…)...2/n
...If you're interested in the chemical & biological aspects of this vaccine, there are pages for you to dig into - not an area I have any expertise in. Small amount of detail of reproductive toxicity study (in rats): no cause for concern....3/n
It's on the agenda this week: possibly a decision on the Oxford/AstraZeneca vaccine from EMA's (Euro drug regulator) Human Medicine Committee? Applicants will be questioned at the meeting.
Last night, I tweeted ⬆️ that the EMA (Euro drug regulator) meeting was considering the Oxford/AstraZeneca vaccine. I included a link to EMA processes, because the language on the agenda suggested there could be a problem: this is the explanation I mean in that link ....1/n
...German newspapers now reporting a claim the efficacy rate for people over 65 is only 8% & approval is indeed in question for that age group, at least (Paywalls: I can't read in full.) Rumor at this point, but a limit ...2/n bild.de/bild-plus/poli…, handelsblatt.com/politik/deutsc…
TGA, Australia's drug regulator, has issued a 2-year provisional approval for Tozinameran (BNT/Pfizer vaccine) from age 16, & released its 42-page assessment report tga.gov.au/auspar/auspar-… ...1/n
...One of the conditions is TGA approval of at least 20 vials from each batch before release...2/n
..Study of reproductive safety in rats has been completed & found no signs of concern related to pregnancy. This wasn't completed when the FDA reported. No data is in this report though. Otherwise it's the same data basis...3/n
For everyone else who's on ENSEMBLE-Watch - the big J&J trial for their Ad26.COV2.S vaccine - some background & context in case a press release lands soon. (On Wednesday, Stanford got the word to lock their data abc7news.com/johnson-and-va… so it is on!)...1/5
...It's a big trial - close to the size of the Pfizer trial for Tozinameran, substantially bigger than Moderna's - & the most international one. And co-primary endpoints are for moderate to severe Covid-19, including 1 at a month - which is longer than we've seen previously...2/5
...You can see the protocol for the trial here: jnj.com/coronavirus/co… (Note, it was originally for 60,000 but they got so many events it was cut back to 40)...3/5
Sputnik V news: ANMAT, Argentina's drug regulator, has now extended authorization to people 60+ & released some data this time. Here's the listing of what they've received & analyzed (but it's not published) ... 1/n argentina.gob.ar/noticias/ampli…
...The new data on people 60+ they received: in 2,144 people, vaccine efficacy of 91.8% (95% CI 67.1% -98.3%). Almost all those people had antibodies by 28 days ...2/n
...ANMAT reports there's now data for 19,866 people who received both Sputnik V injections, with no serious adverse events (SAEs) judged to be vaccine-related. There were 47 SAEs in vax group vs 23 in placebo. Safety similar for older people in small safety study. 3/3