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Hilda Bastian, PhD Profile picture
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17 May, 4 tweets, 2 min read
Press release from Sanofi & GSK: that phase 3 trial is starting in a few weeks & they hope to have their adjuvanted protein subunit Covid vaccine in use in 2021 ...1/n sanofi.com/en/media-room/…
...They say the phase 2 trial with 722 people in the US & Honduras has good results, but there's not much to go on in the press release. You can see the trial register entry in my collection of records on this vaccine: zotero.org/groups/2528572… ...2/n
...You can see more about the vaccine itself here: sanofi.com/en/our-covid-1… ...3/4
...Press release details on the plans for phase 3: they will test a 10µg dose with GSK adjuvant, in 2 formulations (1 already for the B.1.351 ("SA") variant, 1 original). 35,000 people in multiple countries. Plus other studies testing it as a variant-booster for other vaxes. 4/4 Image

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More from @hildabast

Hilda Bastian, PhD Profile picture
18 May
Preliminary results of CombiVacS, the Spanish phase 2 trial of BNT-Pfizer vax at least 8 weeks after AZ announced: major boost in neutralizing antibodies - more than in other studies of 2 doses of AZ - without a higher rate of adverse reactions ...1/n english.elpais.com/society/2021-0…
...The results from @SaludISCIII are here isciii.es/Noticias/Notic…

Trial register record is here: clinicaltrials.gov/ct2/show/NCT04…

They're reporting immediately after Data Monitoring Board so people can get their 2nd shots ASAP - control group will now be getting a BNT-Pfizer shot...2/n
... 441 people under the age of 60 got a shot of BNT-Pfizer vaccine; the control group of 232 people had no intervention (no vax or placebo). They reported neutralizing antibodies 14 days after the shot, adverse reactions in 1st 7 days. T-cell data not yet reported ...3/n
Read 7 tweets
Hilda Bastian, PhD Profile picture
16 May
Italy: study linking vaccine registry (began Dec 27) & Covid-19 surveillance; 7.37m vaxed people up to Apr 4, when 65% had received 1 dose of BNT-Pfizer (Comirnaty). Here you see how they compare to everyone vaxed to date (VaxZevria=AZ, Janssen=J&J)...1/n Image
...This is how many had 1 or both doses in the study, compared to whole of Italy in early May: blue = fully vaxed, maroon = 1 dose. No one has had a second dose of AZ vaccine, but most people with mRNA fully vaxed.
And here's the link to the report epicentro.iss.it/vaccini/pdf/re… ..2/n Image
..There's no control group in this study or breakdown by region/context for the pandemic, so before we look at what happened to Covid-19 diagnoses in vaccinated people, here's Covid-19 diagnoses in Italy across the same time (from Our World in Data) ourworldindata.org/coronavirus ...3/n Image
Read 8 tweets
Hilda Bastian, PhD Profile picture
14 May
Latest results for test-negative case-control study of Covid vax in US healthcare workers - & they get frequent testing.

March 18 data: 623 tested positive (cases) & 1,220 tested negative (controls). About a quarter Moderna vax, BNT-Pfizer the rest ...1/n cdc.gov/mmwr/volumes/7…
...You can see the protocol for this study here: cdc.gov/vaccines/covid… ...2/n
...Most of these healthcare professionals (HCPs) who got tested for Covid-19 were in roles that have substantial patient contact, most were aged 19-49, female, non-Hispanic white, underlying conditions that put them at risk if they got Covid-19 ...3/n
Read 4 tweets
Hilda Bastian, PhD Profile picture
14 May
This one's frustrating - I can't actually find the preprint, just the press release, so perhaps the preprint will answer some questions. It's claiming a 12-week delay of BNT-Pfizer is better than the 3-week prescribed interval. Several problems...1/n
...It's signs of immune response in a small group of people: 99 had the 3-week interval, 73 had the 12-week interval. 3 problems in that: small number, immune response not health outcome, & no mention of how the differences in the people were taken into account ...2/n
...Why is that a problem? Because we need to know whether who was the highest priority for the vax contributed to the observed results - the 3-week interval is how the rollout started the vax first. For example, ...3/4
Read 4 tweets
Hilda Bastian, PhD Profile picture
6 May
They've registered Sputnik Light in Russia, again on very thin data, again not waiting for phase 3. It's not a new vaccine: it's the 1st half of Sputnik V - an adenovirus 26 shot. Given the production problems since early on with the other half (Ad5)...1/n sputnikvaccine.com/newsroom/press…
...it's not surprising. (The Ad5 shot is the one there was a lot of controversy about recently because of replication-competence.) So it becomes a single-shot adenovirus vax (like J&J's & CanSino's) & it's half the price: full Sputnik V was expensive for Covid vax...2/n
...The data basis? 3 things: Immunogenicity results of a phase 1/2 trial with 110 people - some outcomes summarized in the press release only. Here's the trial register entry for it...3/n clinicaltrials.gov/ct2/show/NCT04…
Read 10 tweets
Hilda Bastian, PhD Profile picture
5 May
Results of an analysis of adverse events after Sputnik V vax in San Marino. From those vaccinated early, so some healthcare workers & mostly older people. Median age 68, so a much lower rate would be expected than for a general population ...1/n (Preprint) medrxiv.org/content/10.110…
...Everyone who got vaccinated was invited to participate, but it appears to have had a very low response rate: eg 1,946 out of 8,799 aged 60-89 did (22%): nothing reported to gauge how similar they were to those who didn't. Total group is 2,588, of whom 1,288 had both shots..2/n
...People were contacted 7 days after vaccination, then at 1 month & 3 months. So there would be more recall bias than in a trial with a diary method, but less recall bias at 7 days than for later data...3/n
Read 5 tweets

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