Developing the Covid-19 vaccine

Covid-19 discussion, bring your own statistics
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shpalman
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Re: Developing the Covid-19 vaccine

Post by shpalman » Tue Jan 05, 2021 11:02 pm

Herainestold wrote:
Tue Jan 05, 2021 9:53 pm
Realistically, how long before it could be authorized if everything goes smoothly? Six months? A year?
Probably about a year.
molto tricky

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Re: Developing the Covid-19 vaccine

Post by shpalman » Wed Jan 06, 2021 9:48 am

molto tricky

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Re: Developing the Covid-19 vaccine

Post by shpalman » Wed Jan 06, 2021 1:03 pm

molto tricky

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Tue Jan 12, 2021 7:35 am

Some info on the Sinovac vaccine
The CoronaVac COVID-19 vaccine developed by China’s Sinovac Biotech has a general efficacy of less than 60% in its clinical trial in Brazil, the news portal UOL reported on Monday, citing two sources that had seen the results.
https://www.reuters.com/article/us-heal ... ce=twitter
Indonesia’s food and drug agency on Monday granted emergency use approval to a Covid-19 vaccine developed by China’s Sinovac Biotech, as it became the first country outside China to give the regulatory green light to the vaccine.
The authorisation came after interim data from a late-stage human trial in Indonesia showed the vaccine was 65.3 per cent effective, said Penny K. Lukito, who heads the country’s food and drugs regulator BPOM.
https://www.scmp.com/news/asia/australa ... arge-scale

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Re: Developing the Covid-19 vaccine

Post by shpalman » Tue Jan 12, 2021 10:29 am

molto tricky

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Tue Jan 12, 2021 4:21 pm

Woodchopper wrote:
Tue Jan 12, 2021 7:35 am
Some info on the Sinovac vaccine
The CoronaVac COVID-19 vaccine developed by China’s Sinovac Biotech has a general efficacy of less than 60% in its clinical trial in Brazil, the news portal UOL reported on Monday, citing two sources that had seen the results.
https://www.reuters.com/article/us-heal ... ce=twitter
Indonesia’s food and drug agency on Monday granted emergency use approval to a Covid-19 vaccine developed by China’s Sinovac Biotech, as it became the first country outside China to give the regulatory green light to the vaccine.
The authorisation came after interim data from a late-stage human trial in Indonesia showed the vaccine was 65.3 per cent effective, said Penny K. Lukito, who heads the country’s food and drugs regulator BPOM.
https://www.scmp.com/news/asia/australa ... arge-scale


The authorisation came after interim data from a late-stage human trial in Indonesia showed the vaccine was 65.3 per cent effective, said Penny K. Lukito, who heads the country’s food and drugs regulator BPOM.

“These results meet the requirements of the World Health Organization of a minimum of efficacy of 50 per cent,” she said, noting trial results in Brazil and Turkey.
A Brazil-based trial showed last week that Sinovac’s vaccine candidate is 78 per cent effective
while Turkish researchers said in December the vaccine showed 91.25 per cent efficacy
based on interim analysis.
So we have efficacies of 65, 78 and 91 from three different trials.

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Wed Jan 13, 2021 7:27 am

Herainestold wrote:
Tue Jan 12, 2021 4:21 pm
Woodchopper wrote:
Tue Jan 12, 2021 7:35 am
Some info on the Sinovac vaccine
The CoronaVac COVID-19 vaccine developed by China’s Sinovac Biotech has a general efficacy of less than 60% in its clinical trial in Brazil, the news portal UOL reported on Monday, citing two sources that had seen the results.
https://www.reuters.com/article/us-heal ... ce=twitter
Indonesia’s food and drug agency on Monday granted emergency use approval to a Covid-19 vaccine developed by China’s Sinovac Biotech, as it became the first country outside China to give the regulatory green light to the vaccine.
The authorisation came after interim data from a late-stage human trial in Indonesia showed the vaccine was 65.3 per cent effective, said Penny K. Lukito, who heads the country’s food and drugs regulator BPOM.
https://www.scmp.com/news/asia/australa ... arge-scale


The authorisation came after interim data from a late-stage human trial in Indonesia showed the vaccine was 65.3 per cent effective, said Penny K. Lukito, who heads the country’s food and drugs regulator BPOM.

“These results meet the requirements of the World Health Organization of a minimum of efficacy of 50 per cent,” she said, noting trial results in Brazil and Turkey.
A Brazil-based trial showed last week that Sinovac’s vaccine candidate is 78 per cent effective
while Turkish researchers said in December the vaccine showed 91.25 per cent efficacy
based on interim analysis.
So we have efficacies of 65, 78 and 91 from three different trials.
The above 78% in Brazil was only based on partial data. Once all the data is included the rate drops to 50.4%, in addition the Turkish result was based on interim data..

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Wed Jan 13, 2021 7:28 am

Woodchopper wrote:
Tue Jan 12, 2021 7:35 am
Some info on the Sinovac vaccine
The CoronaVac COVID-19 vaccine developed by China’s Sinovac Biotech has a general efficacy of less than 60% in its clinical trial in Brazil, the news portal UOL reported on Monday, citing two sources that had seen the results.
https://www.reuters.com/article/us-heal ... ce=twitter
Indonesia’s food and drug agency on Monday granted emergency use approval to a Covid-19 vaccine developed by China’s Sinovac Biotech, as it became the first country outside China to give the regulatory green light to the vaccine.
The authorisation came after interim data from a late-stage human trial in Indonesia showed the vaccine was 65.3 per cent effective, said Penny K. Lukito, who heads the country’s food and drugs regulator BPOM.
https://www.scmp.com/news/asia/australa ... arge-scale
Updated information from Brazil:
A coronavirus vaccine developed by China's Sinovac Biotech was just 50.4% effective at preventing symptomatic infections in a Brazilian trial, researchers said on Tuesday, barely enough for regulatory approval and well below the rate announced last week.

The latest results are a major disappointment for Brazil, as the Chinese vaccine is one of two that the federal government has lined up to begin immunization during the second wave of the world's second-deadliest COVID-19 outbreak.

Several scientists and observers blasted the Butantan biomedical center for releasing partial data just days ago that generated unrealistic expectations. The confusion may add to skepticism in Brazil about the Chinese vaccine, which President Jair Bolsonaro has criticized, questioning its "origins."

"We have a good vaccine. Not the best vaccine in the world. Not the ideal vaccine," said microbiologist Natalia Pasternak, criticizing Butantan's triumphant tone.

Last week, the Brazilian researchers had celebrated results showing 78% efficacy against "mild-to-severe" COVID-19 cases, a rate they later described as "clinical efficacy."

They said nothing at the time about another group of "very mild" infections among those who received the vaccine that did not require clinical assistance.

Ricardo Palacios, medical director for clinical research at Butantan, said on Tuesday that the new lower efficacy finding included data on those "very mild" cases.

"We need better communicators," said Gonzalo Vecina Neto, a professor of public health at the University of Sao Paulo and former head of Brazilian health regulator Anvisa.

Piecemeal disclosures about Chinese vaccine trials globally have raised concerns that they are not subject to the same public scrutiny as U.S. and European alternatives.
https://news.trust.org/item/20210112200813-hntnt

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Re: Developing the Covid-19 vaccine

Post by shpalman » Wed Jan 13, 2021 12:21 pm

“EU Health Commissioner Stella Kyriakides announced during our (EU lawmakers) group meeting this morning that the vaccine manufacturer Johnson & Johnson is likely to submit an application for approval to the EU for their vaccine in February,” said Peter Liese, who represents health matters for the EU’s centre-right group, the assembly’s largest.
Guardian live blog
molto tricky

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Wed Jan 13, 2021 3:48 pm

Woodchopper wrote:
Wed Jan 13, 2021 7:27 am

The above 78% in Brazil was only based on partial data. Once all the data is included the rate drops to 50.4%, in addition the Turkish result was based on interim data..
50.4%. That sounds like a failure to me.

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Re: Developing the Covid-19 vaccine

Post by Bird on a Fire » Wed Jan 13, 2021 3:57 pm

It's hardly a failure, though it's less successful than some other candidate vaccines.

It's more successful at reducing dangerously symptomatic cases than at reducing infections in general, but that's still quite useful (especially in a country where healthcare resources are way overstretched already).

So while it won't reduce the need for other measures, as vaccinated folks can still get infected and have (typically milder) symptoms, and therefore are still infected - not that Brazil was really doing anything anyway - it will still save lives.
THINK BIG AND UPEND THE SYSTEM

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Wed Jan 13, 2021 4:14 pm

Bird on a Fire wrote:
Wed Jan 13, 2021 3:57 pm
It's hardly a failure, though it's less successful than some other candidate vaccines.

It's more successful at reducing dangerously symptomatic cases than at reducing infections in general, but that's still quite useful (especially in a country where healthcare resources are way overstretched already).

So while it won't reduce the need for other measures, as vaccinated folks can still get infected and have (typically milder) symptoms, and therefore are still infected - not that Brazil was really doing anything anyway - it will still save lives.
I don 't imagine they will apply for approval in the USA or Europe.

Given a choice (and I realize individuals will not have a choice), who would take it if you could get Pfizer or Moderna?

It looks like the mRNA vaccines have an advnatage over the more traditional inactivated virus vaccines. It will be very interesting to see the results of the trials for vaccines using differen t mechanisms.

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Re: Developing the Covid-19 vaccine

Post by Fishnut » Wed Jan 13, 2021 4:47 pm

Not sure if this is the right thread to ask, but it seems as good as any. An elderly friend of the family had her second vaccine on saturday (yay!). On monday she passed out at home and ended up being taken into hospital for tests. This wasn't due to the vaccine - she had the same issue back in October but the doctor's couldn't find work out what was wrong and discharged her. My question is, will her passing out and hospitalisation be counted in the adverse effects statistics? I remember hearing stuff about how they count any health issue for a set period after vaccination regardless of causality and it got me curious if it was actually true.

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Re: Developing the Covid-19 vaccine

Post by tom p » Wed Jan 13, 2021 4:56 pm

Fishnut wrote:
Wed Jan 13, 2021 4:47 pm
Not sure if this is the right thread to ask, but it seems as good as any. An elderly friend of the family had her second vaccine on saturday (yay!). On monday she passed out at home and ended up being taken into hospital for tests. This wasn't due to the vaccine - she had the same issue back in October but the doctor's couldn't find work out what was wrong and discharged her. My question is, will her passing out and hospitalisation be counted in the adverse effects statistics? I remember hearing stuff about how they count any health issue for a set period after vaccination regardless of causality and it got me curious if it was actually true.
It will only be counted if someone reports it to the MHRA or the Marketing Authorisation Holder (presumably Pfizer). If you ever suspect (even the slightest suspicion) that a person has had a reaction to any kind of medicine, you can report it directly to the MHRA: https://www.yellowcard.gov.uk/
If you think it was not related, then you should not report it.
So you know, it only counts as hospitalisation if the patient was hospitalised overnight. If they go in for tests, but are released the same day, then it's not a hospitalisation for the adverse drug reaction statistics

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Re: Developing the Covid-19 vaccine

Post by Fishnut » Wed Jan 13, 2021 5:03 pm

tom p wrote:
Wed Jan 13, 2021 4:56 pm
Fishnut wrote:
Wed Jan 13, 2021 4:47 pm
Not sure if this is the right thread to ask, but it seems as good as any. An elderly friend of the family had her second vaccine on saturday (yay!). On monday she passed out at home and ended up being taken into hospital for tests. This wasn't due to the vaccine - she had the same issue back in October but the doctor's couldn't find work out what was wrong and discharged her. My question is, will her passing out and hospitalisation be counted in the adverse effects statistics? I remember hearing stuff about how they count any health issue for a set period after vaccination regardless of causality and it got me curious if it was actually true.
It will only be counted if someone reports it to the MHRA or the Marketing Authorisation Holder (presumably Pfizer). If you ever suspect (even the slightest suspicion) that a person has had a reaction to any kind of medicine, you can report it directly to the MHRA: https://www.yellowcard.gov.uk/
If you think it was not related, then you should not report it.
So you know, it only counts as hospitalisation if the patient was hospitalised overnight. If they go in for tests, but are released the same day, then it's not a hospitalisation for the adverse drug reaction statistics
Thanks, that's useful to know. I swear I'd heard how car accidents and the like had been counted as 'adverse reactions' but it sounds like that's probably apocryphal.

She was kept in overnight this time but again the tests revealed nothing.

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Re: Developing the Covid-19 vaccine

Post by tom p » Wed Jan 13, 2021 5:14 pm

Fishnut wrote:
Wed Jan 13, 2021 5:03 pm
tom p wrote:
Wed Jan 13, 2021 4:56 pm
Fishnut wrote:
Wed Jan 13, 2021 4:47 pm
Not sure if this is the right thread to ask, but it seems as good as any. An elderly friend of the family had her second vaccine on saturday (yay!). On monday she passed out at home and ended up being taken into hospital for tests. This wasn't due to the vaccine - she had the same issue back in October but the doctor's couldn't find work out what was wrong and discharged her. My question is, will her passing out and hospitalisation be counted in the adverse effects statistics? I remember hearing stuff about how they count any health issue for a set period after vaccination regardless of causality and it got me curious if it was actually true.
It will only be counted if someone reports it to the MHRA or the Marketing Authorisation Holder (presumably Pfizer). If you ever suspect (even the slightest suspicion) that a person has had a reaction to any kind of medicine, you can report it directly to the MHRA: https://www.yellowcard.gov.uk/
If you think it was not related, then you should not report it.
So you know, it only counts as hospitalisation if the patient was hospitalised overnight. If they go in for tests, but are released the same day, then it's not a hospitalisation for the adverse drug reaction statistics
Thanks, that's useful to know. I swear I'd heard how car accidents and the like had been counted as 'adverse reactions' but it sounds like that's probably apocryphal.

She was kept in overnight this time but again the tests revealed nothing.
I hope it turns out to be nothing serious.

This (the car accidents thing) happens in clinical trials, where the law (in the EEA) requires all adverse events notified to the investigator to be recorded. This is so that dodgy companies cannot game the system by claiming that these events should be excluded or anything and then make their drug look safer than it is.
Then the car accident (this was one of the serious adverse events in the active arm of one of the HPV vaccine trials, if memory serves) has to be included in the final application, but can be (justifiably in this case) explained away (the trial subject was a passenger, if memory serves) amd the regulator can decide whether or not they agree with the explaining away.
If the investigator (the doctor in charge of a site or one of their minions) OR the sponsor (the company running the trial) think that the event was related to the drug, then it is classed as a reaction (rather than an unrelated event). If it is unexpected (we know before a trial starts that there will be some adverse reactions and we can usually guess at the common ones based on the drug class or mechanism of action or earlier phase trials) & serious (fatal, life-threatening, disabling, requiring hospitalisation, a congenital anomaly or any other medically serious reason), then it should be reported to the regulators within 7 or 15 days so they can decide whether or not to revoke permission to continue the trial, otherwise it just gets reported at the end of the trial & then, if it's for a vaccine, misused by frauds trying to prove it's unsafe.

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Re: Developing the Covid-19 vaccine

Post by Fishnut » Wed Jan 13, 2021 5:51 pm

tom p wrote:
Wed Jan 13, 2021 5:14 pm
Fishnut wrote:
Wed Jan 13, 2021 5:03 pm
tom p wrote:
Wed Jan 13, 2021 4:56 pm

It will only be counted if someone reports it to the MHRA or the Marketing Authorisation Holder (presumably Pfizer). If you ever suspect (even the slightest suspicion) that a person has had a reaction to any kind of medicine, you can report it directly to the MHRA: https://www.yellowcard.gov.uk/
If you think it was not related, then you should not report it.
So you know, it only counts as hospitalisation if the patient was hospitalised overnight. If they go in for tests, but are released the same day, then it's not a hospitalisation for the adverse drug reaction statistics
Thanks, that's useful to know. I swear I'd heard how car accidents and the like had been counted as 'adverse reactions' but it sounds like that's probably apocryphal.

She was kept in overnight this time but again the tests revealed nothing.
I hope it turns out to be nothing serious.

This (the car accidents thing) happens in clinical trials, where the law (in the EEA) requires all adverse events notified to the investigator to be recorded. This is so that dodgy companies cannot game the system by claiming that these events should be excluded or anything and then make their drug look safer than it is.
Then the car accident (this was one of the serious adverse events in the active arm of one of the HPV vaccine trials, if memory serves) has to be included in the final application, but can be (justifiably in this case) explained away (the trial subject was a passenger, if memory serves) amd the regulator can decide whether or not they agree with the explaining away.
If the investigator (the doctor in charge of a site or one of their minions) OR the sponsor (the company running the trial) think that the event was related to the drug, then it is classed as a reaction (rather than an unrelated event). If it is unexpected (we know before a trial starts that there will be some adverse reactions and we can usually guess at the common ones based on the drug class or mechanism of action or earlier phase trials) & serious (fatal, life-threatening, disabling, requiring hospitalisation, a congenital anomaly or any other medically serious reason), then it should be reported to the regulators within 7 or 15 days so they can decide whether or not to revoke permission to continue the trial, otherwise it just gets reported at the end of the trial & then, if it's for a vaccine, misused by frauds trying to prove it's unsafe.
Ah, that makes sense. Thanks!

Hopefully she'll be ok. Her daughter is coming over from Athens at the weekend to stay with her as she's 91 and lives alone. She's got one of those alert buttons but if she passed out and fell down the stairs or something... A neighbour is staying with her until then. Fortunately with her being vaccinated we can feel less worried about covid but honestly, the risk/benefit at the moment would still have someone staying with her, even if she was unvaccinated.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Thu Jan 14, 2021 2:49 pm

For the elderly the Pfizer vaccine is a better choice than the Moderna vaccine.
The difference pertains to the efficacy across different demographic groups—specifically, people of different ages. According to the FDA's analysis of the Pfizer-BioNTech vaccine, in the clinical trials on almost 44,000 subjects, it was 95.0% effective in persons aged 16-55, and 93.8% effective in those over age 55—that is, essentially the same. By contrast, regulators' review of the clinical studies with the Moderna vaccine found a pronounced age-dependent difference: "The [Vaccine Efficacy] in participants ≥65 years of age appears to be lower than in younger adults 18 to <65 years (86.4% compared to 95.6%)" (emphasis added).

Thus, of every hundred people under age 65 vaccinated with the Moderna vaccine, we can expect that about five will fail to develop an immune response after the two shots; among those 65 or over, about 14 will not be successfully immunized. (The failure rate for the Pfizer-BioNTech vaccine was approximately five in a hundred for all age groups.) The numbers are small, but the bottom line is, if you're 65 or older and you have a choice, I'd recommend that you get the Pfizer-BioNTech vaccine.
I don't think people have a choice, but still, something to keep in mind.

http://www.henrymillermd.org/24994/crit ... -the-covid

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Re: Developing the Covid-19 vaccine

Post by shpalman » Sat Jan 16, 2021 12:18 am

shpalman wrote:
Wed Jan 13, 2021 12:21 pm
“EU Health Commissioner Stella Kyriakides announced during our (EU lawmakers) group meeting this morning that the vaccine manufacturer Johnson & Johnson is likely to submit an application for approval to the EU for their vaccine in February,” said Peter Liese, who represents health matters for the EU’s centre-right group, the assembly’s largest.
Guardian live blog
Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine
https://www.nejm.org/doi/full/10.1056/NEJMoa2034201
molto tricky

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Sat Jan 16, 2021 12:54 am

shpalman wrote:
Sat Jan 16, 2021 12:18 am
shpalman wrote:
Wed Jan 13, 2021 12:21 pm
“EU Health Commissioner Stella Kyriakides announced during our (EU lawmakers) group meeting this morning that the vaccine manufacturer Johnson & Johnson is likely to submit an application for approval to the EU for their vaccine in February,” said Peter Liese, who represents health matters for the EU’s centre-right group, the assembly’s largest.
Guardian live blog
Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine
https://www.nejm.org/doi/full/10.1056/NEJMoa2034201
Intriguing. What do you think the Phase III trials of J&J will show?

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Re: Developing the Covid-19 vaccine

Post by jdc » Sat Jan 16, 2021 4:52 pm

Bit of speculation here: https://www.barrons.com/articles/new-da ... 1610629796
The data helped bolster an emerging consensus that the Johnson & Johnson (ticker: JNJ) vaccine Phase 3 data, expected later this month, will show that the vaccine is very effective, if not quite as effective as the Moderna (MRNA) and Pfizer (PFE) vaccines.

But that effectiveness gap might not matter, given other advantages of the Johnson & Johnson vaccines over those that already have authorization from the Food and Drug Administration.

“The expectation is to have 80, 85%, or maybe more, efficacy,” said Dr. Moncef Slaoui, chief advisor to the federal government’s Operation Warp Speed, of the Johnson & Johnson vaccine, speaking on a panel at J.P. Morgan’s health care conference shortly before the New England Journal paper was posted online.

Moderna’s vaccine demonstrated 94.1% efficacy in its Phase 3 trial, while Pizer’s vaccine demonstrated 95% efficacy.

Yet while the Moderna and Pfizer vaccines were tested in a two-dose regimen, the Johnson & Johnson Phase 3 trial set to report results later this month tests a single shot of the vaccine. Slaoui suggested that it isn’t realistic to imagine that every person who gets the first shot of the Moderna or Pfizer vaccine will return for the second shot, and experience the full protection of those vaccines.

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Re: Developing the Covid-19 vaccine

Post by shpalman » Sat Jan 16, 2021 5:48 pm

Herainestold wrote:
Sat Jan 16, 2021 12:54 am
shpalman wrote:
Sat Jan 16, 2021 12:18 am
shpalman wrote:
Wed Jan 13, 2021 12:21 pm


Guardian live blog
Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine
https://www.nejm.org/doi/full/10.1056/NEJMoa2034201
Intriguing. What do you think the Phase III trials of J&J will show?
I think it'll show that it's about 90% effective because just about all of the decent "Western" vaccines are, including maybe even the Oxford/AstraZeneca one assuming you use the "wrong" dose regime and not the officially approved one.

But I'm not sure how they expect to get approval for it in February:
shpalman wrote:
Wed Jan 13, 2021 12:21 pm
“EU Health Commissioner Stella Kyriakides announced during our (EU lawmakers) group meeting this morning that the vaccine manufacturer Johnson & Johnson is likely to submit an application for approval to the EU for their vaccine in February,” said Peter Liese, who represents health matters for the EU’s centre-right group, the assembly’s largest.
Guardian live blog
The Phase III trial can't be far enough along if Phase II results have only just been published.
molto tricky

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Re: Developing the Covid-19 vaccine

Post by jdc » Sat Jan 16, 2021 6:09 pm

shpalman wrote:
Sat Jan 16, 2021 5:48 pm
The Phase III trial can't be far enough along if Phase II results have only just been published.
I think there are two Phase III trials and the Phase II results that have been published might be from the trial that preceded the second Phase III trial.

https://www.jnj.com/our-company/johnson ... y-enrolled
The large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) of the investigational Janssen COVID-19 single-dose vaccine candidate is now fully enrolled with approximately 45,000 participants. [...] Interim data from the ENSEMBLE trial is currently anticipated to be available by the end of January 2021. However, as this trial is dependent on disease events, the timing is approximate.
A separate Phase 3 clinical trial of the investigational Janssen COVID-19 vaccine candidate to explore a two-dose regimen of Janssen’s vaccine candidate (ENSEMBLE 2) is ongoing.

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Re: Developing the Covid-19 vaccine

Post by jdc » Sat Jan 16, 2021 6:16 pm

Ensemble started 21 Sept and Ensemble2 started 15 Nov. https://www.jnj.com/coronavirus

Actually, if it's the same vaccine and it's just dose and number of doses that are different between Ensemble 1 and 2, would there be two Phase I / II trials? Maybe they've just been slow to publish the results from the one Phase I / IIa trial? It started in July and I'm sure I saw something last year about them having data from phase I/II trial(s).

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Re: Developing the Covid-19 vaccine

Post by jdc » Sat Jan 16, 2021 6:20 pm

Here we go. It's in your NEJM link. One trial, several cohorts.
The trial was initiated on July 22, 2020, at 12 centers in Belgium and the United States. Trial participants included healthy adults between the ages of 18 and 55 years and those 65 years of age or older. The younger group was divided into cohort 1a (with a target enrollment of 375 participants) and cohort 1b (an exploratory cohort for in-depth analysis of immunogenicity, with a target enrollment of 25 participants). The older age group was included in cohort 3, with a target enrollment of 375 participants. In November 2020, enrollment was initiated in cohort 2 to collect longer-term data comparing a single-dose regimen with a two-dose regimen

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