Share this page!

Hilda Bastian, PhD Profile picture
Twitter logo
18 May, 8 tweets, 3 min read
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
...Big differences between CombiVacS & the UK Com-COV trial which reported recently are the gap in dosing interval: it was 4 weeks in the first results of UK trial, it's at least 8 weeks in the Spanish trial. And not compared to same-same injections...4/n
...Back to CombiVacS in Spain: people were stratified in the trial, so age, gender are similar between vax & control groups. Mean age is 44, just over half women...5/n
... They reported on 2 tests for neutralizing antibodies - there was a large increase in both of them for the vaxed group at 7 & 14 days, & no change in the control group in that time...6/n
...They also tested blood sample reactions to pseudovirus with the SARS-CoV-2 spike protein. That found a 7-fold rise in titers. This study didn't have a comparison group of same-same injections, but that's higher than they expected would occur with same-same injections...7/n
...There were no serious adverse events. Researchers concluded adverse reactions were similar to those seen after same-same injections. The most common systemic adverse event was headaches - at 44% that's definitely not higher (it's lower, if anything). Severity not reported. 8/8

• • •

Missing some Tweet in this thread? You can try to force a refresh
　

Keep Current with Hilda Bastian, PhD

Hilda Bastian, PhD Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @hildabast

Hilda Bastian, PhD Profile picture
20 May
Preprint of results for Sinovac CoronaVac phase 1/2 trial in 3-17 year-olds: 72 in phase 1, 480 in phase 2. They tested half & full doses, & immune responses were higher than they are in adults, with a very low rate of adverse reactions ...1/n papers.ssrn.com/sol3/papers.cf…
...Firstly, it's clear why they have gone on to do another large study in under-18s (clinicaltrials.gov/ct2/show/NCT04…). The children were all Han ethnicity & they want to test in other parts of the country to get more diversity...2/n
...Although their results suggest for very small children, half-dose might have been enough, it didn't seem to reduce adverse reactions. That's presumably why the next trial is only full dose...3/4
Read 4 tweets
Hilda Bastian, PhD Profile picture
17 May
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
Read 4 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

Did Thread Reader help you today?

Support us! We are indie developers!

This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!

Follow Us on Twitter!

Like this author's thread?

Get emails when @hildabast has new unrolls!

Check out other threads from @hildabast!

Read all threads by @hildabast

:(