Developing the Covid-19 vaccine

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bob sterman
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Re: Developing the Covid-19 vaccine

Post by bob sterman » Thu Jun 17, 2021 7:21 am

Anyone else watch the BBC Horizon Special "The Vaccine" last night?

Much of it was filmed during the vaccine development process. So there was a segment where a researcher at Queensland University was explaining how, for their protein vaccine, they planned to use a protein from HIV as a “molecular clamp” to help prevent the coronavirus spike protein in the vaccine from changing its conformation.

Hmmmmm...what could possibly go wrong????

Spoiler - trial volunteers developed antibodies to the clamp protein, leading them to test positive on certain rapid HIV tests.

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Re: Developing the Covid-19 vaccine

Post by Martin_B » Thu Jun 17, 2021 7:37 am

bob sterman wrote:
Thu Jun 17, 2021 7:21 am
Anyone else watch the BBC Horizon Special "The Vaccine" last night?

Much of it was filmed during the vaccine development process. So there was a segment where a researcher at Queensland University was explaining how, for their protein vaccine, they planned to use a protein from HIV as a “molecular clamp” to help prevent the coronavirus spike protein in the vaccine from changing its conformation.

Hmmmmm...what could possibly go wrong????

Spoiler - trial volunteers developed antibodies to the clamp protein, leading them to test positive on certain rapid HIV tests.
At the time they didn't know if the vaccine would have a high efficiency, and/or if it would result in testing positive to HIV (although no-one from the trial actually has HIV) but yeah, they discontinued that trial over 6 months ago. Unfortunately it had looked promising and seems to be the trial the Australian government backed heavily.

When the trial was stopped it had sucked up quite a bit of money and Australia seems to have decided to concentrate on ramping up the manufacturing of the AZ vaccine in Melbourne rather than developing our own vaccine. That worked out well!
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bob sterman
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Re: Developing the Covid-19 vaccine

Post by bob sterman » Thu Jun 17, 2021 8:01 am

Martin_B wrote:
Thu Jun 17, 2021 7:37 am
At the time they didn't know if the vaccine would have a high efficiency, and/or if it would result in testing positive to HIV (although no-one from the trial actually has HIV)
Yes. But if your technology is based on the fact that people develop antibodies to the proteins in the vaccine - it's not exactly totally unforseeable that they might develop antibodies to the HIV protein that's included.

That HIV clamp protein might be really good at its job - but it's from the virus that, prior to COVID, was perhaps most widely tested for using rapid antibody assays.

AstraZeneca jab recipients probably now have a nice level of protection against the ChAdOx1 chimp adenovirus. But as people don't frequently need to take ChAdOx1 antibody tests - it's not so much of a problem!

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Re: Developing the Covid-19 vaccine

Post by jimbob » Thu Jun 17, 2021 8:16 am

bob sterman wrote:
Thu Jun 17, 2021 8:01 am
Martin_B wrote:
Thu Jun 17, 2021 7:37 am
At the time they didn't know if the vaccine would have a high efficiency, and/or if it would result in testing positive to HIV (although no-one from the trial actually has HIV)
Yes. But if your technology is based on the fact that people develop antibodies to the proteins in the vaccine - it's not exactly totally unforseeable that they might develop antibodies to the HIV protein that's included.

That HIV clamp protein might be really good at its job - but it's from the virus that, prior to COVID, was perhaps most widely tested for using rapid antibody assays.

AstraZeneca jab recipients probably now have a nice level of protection against the ChAdOx1 chimp adenovirus. But as people don't frequently need to take ChAdOx1 antibody tests - it's not so much of a problem!
Would that be a potential pathway to an HIV vaccine? - it is presumably a part of the HIV virus that doesn't change much (or I guess it would be useless for rapid HIV assays)
Have you considered stupidity as an explanation

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Re: Developing the Covid-19 vaccine

Post by tom p » Fri Jun 18, 2021 11:17 am

jimbob wrote:
Thu Jun 17, 2021 8:16 am
bob sterman wrote:
Thu Jun 17, 2021 8:01 am
Martin_B wrote:
Thu Jun 17, 2021 7:37 am
At the time they didn't know if the vaccine would have a high efficiency, and/or if it would result in testing positive to HIV (although no-one from the trial actually has HIV)
Yes. But if your technology is based on the fact that people develop antibodies to the proteins in the vaccine - it's not exactly totally unforseeable that they might develop antibodies to the HIV protein that's included.

That HIV clamp protein might be really good at its job - but it's from the virus that, prior to COVID, was perhaps most widely tested for using rapid antibody assays.

AstraZeneca jab recipients probably now have a nice level of protection against the ChAdOx1 chimp adenovirus. But as people don't frequently need to take ChAdOx1 antibody tests - it's not so much of a problem!
Would that be a potential pathway to an HIV vaccine? - it is presumably a part of the HIV virus that doesn't change much (or I guess it would be useless for rapid HIV assays)
I think that may have already been tried, and failed, and that's why they had bits of HIV protein lying around that they knew how to do stuff with.
The failed attempts to make an HIV vaccine really helped speed up development of COVID vaccines

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Re: Developing the Covid-19 vaccine

Post by jimbob » Fri Jun 18, 2021 1:24 pm

tom p wrote:
Fri Jun 18, 2021 11:17 am
jimbob wrote:
Thu Jun 17, 2021 8:16 am
bob sterman wrote:
Thu Jun 17, 2021 8:01 am


Yes. But if your technology is based on the fact that people develop antibodies to the proteins in the vaccine - it's not exactly totally unforseeable that they might develop antibodies to the HIV protein that's included.

That HIV clamp protein might be really good at its job - but it's from the virus that, prior to COVID, was perhaps most widely tested for using rapid antibody assays.

AstraZeneca jab recipients probably now have a nice level of protection against the ChAdOx1 chimp adenovirus. But as people don't frequently need to take ChAdOx1 antibody tests - it's not so much of a problem!
Would that be a potential pathway to an HIV vaccine? - it is presumably a part of the HIV virus that doesn't change much (or I guess it would be useless for rapid HIV assays)
I think that may have already been tried, and failed, and that's why they had bits of HIV protein lying around that they knew how to do stuff with.
The failed attempts to make an HIV vaccine really helped speed up development of COVID vaccines
That would make sense
Have you considered stupidity as an explanation

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Sat Jun 19, 2021 3:04 am


Coronavirus: those with BioNTech jabs have stronger antibody response than those who receive Sinovac, Hong Kong study shows

Some who received Sinovac vaccine might need third booster shot, major HKU study suggests
Expert says antibody tests might prove useful in clearing travellers for shortened quarantine

A major Hong Kong study has found “substantially higher” levels of antibodies in people vaccinated against Covid-19 with BioNTech jabs, compared to those who received the Chinese-made Sinovac vaccine.
https://www.scmp.com/news/hong-kong/hea ... e-stronger

That’s all I get before the paywall.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Sat Jun 19, 2021 3:28 am

Woodchopper wrote:
Sat Jun 19, 2021 3:04 am

Coronavirus: those with BioNTech jabs have stronger antibody response than those who receive Sinovac, Hong Kong study shows

Some who received Sinovac vaccine might need third booster shot, major HKU study suggests
Expert says antibody tests might prove useful in clearing travellers for shortened quarantine

A major Hong Kong study has found “substantially higher” levels of antibodies in people vaccinated against Covid-19 with BioNTech jabs, compared to those who received the Chinese-made Sinovac vaccine.
https://www.scmp.com/news/hong-kong/hea ... e-stronger

That’s all I get before the paywall.
Paywall? I don't see no stinkin' paywall.

HK friend says HK ers much prefer Pfizer to any Chinese vax. Mostly political methinks.
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Re: Developing the Covid-19 vaccine

Post by bob sterman » Sat Jun 19, 2021 6:38 am

Herainestold wrote:
Sat Jun 19, 2021 3:28 am
HK friend says HK ers much prefer Pfizer to any Chinese vax. Mostly political methinks.
Err....more likely mostly coz it works better (see Israel vs Chile).

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Sat Jun 19, 2021 2:44 pm

In Brazil a whole town was vaccinated with CoronaVac, thought to have an efficacy from stage 3 trials of 50%. Symptomatic cases and deaths fell by 80% and 95%. So maybe CoronaVac isn't so bad after all.
BEFORE THE pandemic, Celso Vigo walked for 90 minutes each day through the streets of Serrana, a town of 45,000 people surrounded by sugarcane fields in the state of São Paulo. But when covid-19 hit, the 75-year-old retired bank clerk, who played football “well into my 60s”, was reduced to doing loops around his house. It reminded him of how Brazil, too, was going in circles. After a second wave killed 87,000 people in April, cases and deaths remain high.

But Serrana was given a way out. Between February and April, all adults were offered jabs as part of a study by the Butantan Institute, which produces CoronaVac, a vaccine developed by Sinovac, a Chinese firm. More than 95% of serranenses got jabbed, despite Jair Bolsonaro, the president, claiming that it was unsafe. Preliminary results released on May 31st showed that symptomatic cases and deaths fell by 80% and 95%, respectively. Only two covid-19 patients remain hospitalised in the local clinic (both refused the vaccine). Mr Vigo is once again pounding the pavements.

Serrana is a tantalising glimpse of an alternative reality in Brazil—one in which Mr Bolsonaro did not squander his chances to mount an effective public-health campaign and, later, to buy vaccines. But the study also has global implications. In phase three trials, CoronaVac had efficacy rates as low as 50%, the minimum required by the WHO. The lower the efficacy, the higher the share of people who must be jabbed to slow contagion. The trial in Serrana sought to discover that share. The town was split into four cohorts, that got jabbed in successive weeks. Contagion dropped dramatically after three out of the four had received two doses of the vaccine, suggesting that herd immunity is attained at around 75%.

These results could boost vaccine uptake across Brazil, hopes Ethel Maciel, an epidemiologist. But 75% is a long way off. Only 11% of Brazilians are fully vaccinated, and the rate has slowed because of a shortage of ingredients for CoronaVac, which are imported from China. Chile, which has vaccinated 45% of its population, mostly with CoronaVac, is also suffering near-record cases.

These results could boost vaccine uptake across Brazil, hopes Ethel Maciel, an epidemiologist. But 75% is a long way off. Only 11% of Brazilians are fully vaccinated, and the rate has slowed because of a shortage of ingredients for CoronaVac, which are imported from China. Chile, which has vaccinated 45% of its population, mostly with CoronaVac, is also suffering near-record cases.

But Serrana itself has become an oasis. On a recent morning, children ran round a fountain in the plaza. Across the street a fabric shop that caters to elderly women had a steady stream of customers. A gang of old men occupied their usual benches. They discussed Mr Bolsonaro’s decision to host the Copa América, a football tournament, even though a third wave seems imminent. “Stupid,” a 97-year-old said. Half of them scattered when an outsider showed up. “We’re still scared,” explained Florivaldo Leandro, a retired police officer. Serrana’s calm came at a cost, he said. “We lost friends, neighbours and relatives. Our conscientiousness was forced upon us.”
https://www.economist.com/the-americas/ ... t-covid-19
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Re: Developing the Covid-19 vaccine

Post by bob sterman » Sat Jun 19, 2021 5:13 pm

Herainestold wrote:
Sat Jun 19, 2021 2:44 pm
In Brazil a whole town was vaccinated with CoronaVac, thought to have an efficacy from stage 3 trials of 50%. Symptomatic cases and deaths fell by 80% and 95%. So maybe CoronaVac isn't so bad after all.
Sorry to dampen your Sinovac-CoronaVac enthusiasm but here's the data since the Serrana success story was all over the news on June 1st. With a Pfizer success story for comparison.

Yes - I've taken a snapshot in time in way that could be seen as "spin". But until we get the published paper on the Serrana trial - that's partly spin too.
Serrana.jpg
Serrana.jpg (92.07 KiB) Viewed 458 times

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Sat Jun 19, 2021 6:28 pm

I think the big difference is Israel sealed their borders and kept the variants out. Impossible to do that in a city in Brazil.
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Sun Jun 20, 2021 7:28 pm

Good results from one of Cuba's experimental covid vaccines. Interestingly it is a three dose vaccine.
Cuba’s Soberana 2 vaccine candidate has shown 62 percent efficacy with just two of its three doses, state-run biopharmaceutical corporation BioCubaFarma has said, citing preliminary data from late phase trials.

The Communist-run country has opted not to import foreign vaccines but rather to rely on its own. Experts say it is a risky bet but if it pays off, Cuba could burnish its scientific reputation, generate much-needed hard currency through exports and strengthen the vaccination drive worldwide.
Excellent move by Cuba, an example to follow for other independent countries.

https://www.msn.com/en-us/news/world/cu ... ar-AALf8YR
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Re: Developing the Covid-19 vaccine

Post by jdc » Sun Jun 20, 2021 9:15 pm

Herainestold wrote:
Sun Jun 20, 2021 7:28 pm
Good results from one of Cuba's experimental covid vaccines. Interestingly it is a three dose vaccine.
Cuba’s Soberana 2 vaccine candidate has shown 62 percent efficacy with just two of its three doses, state-run biopharmaceutical corporation BioCubaFarma has said, citing preliminary data from late phase trials.

The Communist-run country has opted not to import foreign vaccines but rather to rely on its own. Experts say it is a risky bet but if it pays off, Cuba could burnish its scientific reputation, generate much-needed hard currency through exports and strengthen the vaccination drive worldwide.
Excellent move by Cuba, an example to follow for other independent countries.

https://www.msn.com/en-us/news/world/cu ... ar-AALf8YR
Looks like it is a 3-dose protocol but with 2 doses of Soberana 2 and the 3rd dose being Soberana Plus. Soberana 2 is a conjugate vaccine (spike-protein fragments with deactivated tetanus toxoid) and Soberana Plus seems to be just the spike-protein fragments.


https://www.nature.com/articles/d41586-021-01126-4
We also have a trial with 450 convalescent individuals, who recovered from COVID-19 or were asymptomatic, in which we’re testing Soberana Plus, a booster dose that contains spike-protein fragments. This vaccine is designed to re-stimulate the initial immunity people got from a previous infection.

What I can reveal is that during the previous trial phases, two doses of Soberana 02 generated an antibody response in about 80% of vaccinated people. But applying a third, booster dose of Soberana Plus raised that percentage to 100%, all of them with neutralizing antibodies that can block the virus from entering cells.
https://www.ilfoglio.it/salute/2021/05/ ... i-2333854/
without a third dose, the level of antibodies against Rbd elicited by two doses in the groups of one hundred volunteers examined was lower than that observed in the group consisting of recovered convalescents up to the fifty-sixth day from the first dose. from natural infection. Also, the third dose with Soberana plus worked better than a third dose of Soberana 2.
As for neutralizing antibodies, it was observed that the response induced by three doses of vaccine is close to (but does not exceed) that induced by natural infection, and the type T response (cellular response) shows that one in three or one in four of vaccinated individuals (depending on the type of T cells considered) do not respond to the vaccine.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Mon Jun 21, 2021 3:31 am

Here is a story about ? Vietnam and Cuba cooperating to manufacture a Cuban vaccine.
Vietnam would cooperate with Cuba to produce a Cuban Covid-19 vaccine after the Institute of Vaccines and Medical Biologicals (IVAC) receives the necessary production tech.
The Abdala vaccine produced by Cuba has passed all three phases of human trials, with the third involving around 48,000 people aged 19-80. However, the vaccine has yet to undergo clinical trials in any other country, Cuban Minister of Public Health Jose Angel Portal Miranda said Wednesday.
Cuba could produce around 100 million Abdala vaccine doses a year, of which only 30 million doses would be reserved for domestic use. As such, Cuba is willing to cooperate with Vietnam on vaccine supply and tech transfer to produce it, said Miranda, adding it could even open two production facilities in Vietnam in case of high demand.
Vietnam is also producing four domestic Covid-19 vaccines: Nanocovax by Nanogen, Covivac by IVAC, and two others by the Vaccine and Biological Production Company No. 1 (Vabiotech) and the Center for Research and Production of Vaccines and Biologicals.
https://e.vnexpress.net/news/news/vietn ... 95654.html
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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Mon Jun 21, 2021 8:38 am


CureVac COVID vaccine let-down spotlights mRNA design challenges
Scientists are searching for explanations to disappointing final-stage trial results. These insights could help guide the future development of mRNA vaccines.
https://www.nature.com/articles/d41586-021-01661-0

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Tue Jun 22, 2021 5:04 am

Cuban vaccine '92 per cent effective'
Another three dose vaccine from Cuba this one 92% effective.
Cuba says its three-shot Abdala vaccine against the coronavirus has proved 92.28 per cent effective in last-stage clinical trials.

The announcement came just days after the government said another homegrown vaccine, Soberana 2, had proved 62 per cent effective with just two of its three doses.

"Hit by the pandemic, our scientists at the Finlay Institute and Center for Genetic Engineering and Biotechnology have risen above all the obstacles and given us two very effective vaccines," President Miguel Diaz-Canel tweeted.

The announcement came from state-run biopharmaceutical corporation BioCubaFarma, which oversees Finlay, the maker of Soberana 2, and the Center for Genetic Engineering and Biotechnology, the producer of Abdala.
https://au.news.yahoo.com/cuban-vaccine ... 32745.html
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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Fri Jul 02, 2021 11:34 am


Scientists quit journal board, protesting ‘grossly irresponsible’ study claiming COVID-19 vaccines kill

Several reputed virologists and vaccinologists have resigned as editors of the journal Vaccines to protest its 24 June publication of a peer-reviewed article that misuses data to conclude that “for three deaths prevented by [COVID-19] vaccination, we have to accept two inflicted by vaccination.”

Since Friday, at least six scientists have resigned positions as associate or section editors with Vaccines, including Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai, and Katie Ewer, an immunologist at the Jenner Institute at the University of Oxford who was on the team that developed the Oxford-AstraZeneca COVID-19 vaccine. Their resignations were first reported by Retraction Watch.

“The data has been misused because it makes the (incorrect) assumption that all deaths occurring post vaccination are caused by vaccination,” Ewer wrote in an email. “[And] it is now being used by anti-vaxxers and COVID-19-deniers as evidence that COVID-19 vaccines are not safe. [This] is grossly irresponsible, particularly for a journal specialising in vaccines.”

The paper is a case of “garbage in, garbage out,” says Helen Petousis-Harris, a vaccinologist who directs the Vaccine Datalink and Research Group at the University of Auckland and who also resigned as a Vaccines editor after reading the paper. Diane Harper, an epidemiologist at the University of Michigan, Ann Arbor, who was founding editor-in-chief of Vaccines, also resigned, as did Paul Licciardi, an immunologist at Murdoch Children’s Research Institute in Parkville, Australia, and Andrew Pekosz, a respiratory virologist at the Johns Hopkins University Bloomberg School of Public Health.

The resignations began Friday, the day after the paper was published. By early Monday, Fanny Fang, the journal’s managing editor, wrote to the editorial board members that Vaccines—a reputable open-access journal launched in 2013 by Basel, Switzerland–based publisher MDPI—had opened an investigation into the paper. “We are treating this case with the utmost seriousness and are committed to swiftly correcting the scientific record,” she wrote.

Later on Monday, Vaccines’s editors published an Expression of Concern about the paper. “The major concern is the misrepresentation of the COVID-19 vaccination efforts and misrepresentation of the data,” they wrote.

The paper has drawn nearly 350,000 readers as of 1 July and has been tweeted by antivaccination activists with hundreds of thousands of followers.

None of the paper’s authors is trained in vaccinology, virology, or epidemiology. They are: Harald Walach, a clinical psychologist and science historian by training who describes himself as a health researcher at Poznan University of Medical Sciences in Poland; Rainer Klement, a physicist who studies ketogenic diets in cancer treatment at the Leopoldina Hospital in Schweinfurt, Germany; and Wouter Aukema, an independent data scientist in Hoenderloo, Netherlands.

The three peer reviewers on the paper, two of them anonymous, did not offer any substantial criticism of the authors’ methodology in these brief reviews. One of them, Anne Ulrich, a chemist who directs the Institute of Biological Interfaces and is chair of biochemistry at the Karlsruhe Institute of Technology in Germany, wrote that the authors’ analysis “is performed responsibly … and without methodological flaws … and the results were interpreted with the necessary caveats.”

Ulrich reiterated that view in a 1 July email to ScienceInsider: “The analysis by Walach et al. was done in my opinion responsibly and without flaws,” she wrote.

One of the anonymous reviewers wrote that the manuscript “is very important and should be published urgently,” offering almost no other comment.

Vaccines did not respond to a list of questions, including how the peer reviewers were chosen.

Petousis-Harris says: “It’s very evident from their reviews that they don’t have any topic expertise. The authors don’t either. It’s a bit remiss when you don’t bring any of a large body [of expert vaccine safety scientists] into your study and manuscript review.”

To draw their conclusions, the paper’s authors computed COVID-19 deaths prevented by vaccines by using data from a study of 1.2 million Israelis, half of whom received the Pfizer-BioNTech vaccine and half of whom did not. They estimated that 16,000 people needed to be vaccinated to prevent one COVID-19 death—a measure that is problematic, critics say, because as a vaccine succeeds, the number of people that must be vaccinated to prevent a death grows ever-larger.

To compute deaths “caused” by vaccine side effects, they used EU data on the number of vaccine doses delivered in the Netherlands and data from that country’s national database for adverse drug reaction reporting, which was more voluminous than registry data from other EU countries.

The Netherlands Pharmacovigilance Center, called Lareb, is similar to the United States’s VAERS reporting system, in which anyone can file a report of an adverse event that occurs after vaccination; the existence of a report in the database does not prove a vaccine caused an adverse event or death. Such databases are not used to systematically assess vaccine risks, but to search for early signals of rare but real vaccine side effects, such as the clotting disorder associated with some COVID-19 vaccines, that can then be followed up with systematic study.

The website of the Dutch registry clearly notes its reports do not imply causality. But the authors reported that, using it, they found “16 serious side effects per 100,000 vaccinations and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination.”

On 25 June, the day after the paper’s publication, Lareb’s head of science and research, Eugène van Puijenbroek, sent an email to Vaccines’s editors, criticizing the paper and requesting a correction or retraction.

“A reported event that occurred after vaccination is … not necessarily being caused by the vaccination, although our data was presented as being causally related by the authors,” van Puijenbroek wrote. “Suggesting all reports with a fatal outcome to be causally related is far from truth.”

He also took the authors to task for stating in the paper that “the Dutch [registry] data, especially the fatal cases, were certified by medical specialists.”

“This point is simply incorrect,” van Puijenbroek wrote. “The authors seem to refer to [Lareb’s] policy plan. However, in this plan (in Dutch), it is nowhere mentioned that the reports are ‘certified’ by medical specialists.”

In an email to ScienceInsider, van Puijenbroek also worried that the paper will erode public willingness to report to the Dutch registry. “[People who report adverse events to us] have to be sure that the data they are contributing will be used in a correct and scientific sound way. Articles like this undermine this confidence.”

Walach, the first author, says he stands by the paper. He adds that the clinical trials of the vaccines that are now authorized for emergency use, which involved tens of thousands of people, “were not big enough or long enough to really see whatever safety concerns you will have.”

Aukema adds that he’s pleased about the controversy, because it means “the [COVID-19 vaccine safety] topic is getting a lot of attention. I’m happy about that.”

The three authors submitted a rebuttal to Vaccines’s expression of concern on 29 June. In it, they write that they interpreted Lareb’s public statements “to mean that those reports that are obviously without any foundation are taken out such that the final data-base is at least reliable to some degree.”

The authors also insist that they did not imply that the side effects reported in the Dutch registry were necessarily caused by COVID-19 vaccines. “Currently we only have association, we agree, and we never said anything else.”

Petousis-Harris says she has been pleased with what she sees as a speedy and serious response from the leadership at Vaccines, and that her resignation may not be permanent.

“It has been a good, solid, respectable journal. And if [the paper] is going to be retracted … then I would still be happy to part of the team.”
https://www.sciencemag.org/news/2021/07 ... g-covid-19

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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri Jul 02, 2021 12:10 pm

Don't the editors see the papers before they're published, or what is the point of editors?

I've heard of Harald Walach though, he's an author of this f.cking pile of sh.t and this other f.cking pile of sh.t.
reputable open-access journal launched in 2013 by Basel, Switzerland–based publisher MDPI
Lol.
molto tricky

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Re: Developing the Covid-19 vaccine

Post by tom p » Fri Jul 02, 2021 12:55 pm

shpalman wrote:
Fri Jul 02, 2021 12:10 pm
Don't the editors see the papers before they're published, or what is the point of editors?
I used to work in scientific journal publishing (aimed at the pharma industry). An editorial board member is not the same as an editor.
Essentially they are people who are experts in the field who can be called upon by the production editor to propose review papers or to be asked questions. They are nor generally consulted before every paper is published otherwise (a) they wouldn't do it & (b) there would be no point in peer-reviewers.

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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri Jul 02, 2021 1:00 pm

Well, the article seems to have been retracted today.
molto tricky

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Re: Developing the Covid-19 vaccine

Post by tom p » Fri Jul 02, 2021 1:08 pm

The paper has now been retracted.
It should never have come close to being published. It's a f.cking shitshow & heads should roll.
those incompetent frauds wrote:We checked the Adverse Drug Reaction (ADR) database of the European Medicine Agency (EMA: http://www.adrreports.eu/en/search_subst.html#, accessed on 28 May 2021; the COVID-19 vaccines are accessible under “C” in the index). Looking up the number of single cases with side effects reported for the three most widely used vaccines (Comirnaty by BioNTech/Pfizer, the vector vaccination product Vaxzevria marketed by AstraZeneca, and the mRNA vaccine by Moderna) by country, we discovered that the reporting of side effects varies by a factor of 47 (Figure 1). While the European average is 127 individual case safety reports (ICSRs), i.e., cases with side effect reports, per 100,000 vaccinations, the Dutch authorities have registered 701 reports per 100,000 vaccinations, while Poland has registered only 15 ISCRs per 100,000 vaccinations. Assuming that this difference is not due to differential national susceptibility to vaccination side effects, but due to different national reporting standards, we decided to use the data of the Dutch national register (https://www.lareb.nl/coronameldingen; accessed on 29 May 2021) to gauge the number of severe and fatal side effects per 100,000 vaccinations. We compare these quantities to the NNTV to prevent one clinical case of and one fatality by COVID-19.
Strange they chose to use the one with the greatest reporting rate, rather than the average. Or, better still, rather than the whole database, since number of doses was available for all MS, so you didn't need to just pick one and could have had a far greater amount of data to work with. I wonder why they did that.
If they had to pick one country and they knew anything at all about ICSR reporting, they would have picked France. Their system operates through regional centres (as well as a centralised portal). The reports from the regional centres actually are followed-up and verified by doctors. Some of the best quality ADR reports you can get. Netherlands, like the UK & US, has a central portal and anyone can report. Also they, like the UK, have one of the smarter systems so that reports can be loaded into the database before any of their staff has looked at them & then they can review for a possible signal quicker and more easily without a backlog at the data entry stage. The major drawback of this in this scenario is that there are lots of patient reports which might not have things like seriousness assigned appropriately (e.g. someone reports that their post-vax arm-pain is disabling 'cos they can't reach up for things on a high shelf with that arm for a few hours - makes the report serious, the same as if a patient went into ICU for a life-threatening reaction).
The authors then incorrectly translated "serious" into "severe", which has different connotations.
Lastly, the data was wrong in another direction. LAREB wouldn't receive the cases that were reported directly to Pfizer/AZ/whoever, so there is actually an underestimate there (those would be reviewed, along with the LAREB data, by the MEB (Medicines Evaluation Board) in NL). Another reason to use the EMA numbers, which includes all of them from everyone.

I wish I had the time to tear into every one of the errors in this article.

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shpalman
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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri Jul 02, 2021 1:18 pm

The "academic editor" was listed as being this guy: https://publichealth.nyu.edu/faculty/ralph-diclemente

Who doesn't appear to know anything particularly specialized about vaccines either.
molto tricky

tom p
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Re: Developing the Covid-19 vaccine

Post by tom p » Fri Jul 02, 2021 1:29 pm

shpalman wrote:
Fri Jul 02, 2021 1:18 pm
The "academic editor" was listed as being this guy: https://publichealth.nyu.edu/faculty/ralph-diclemente

Who doesn't appear to know anything particularly specialized about vaccines either.
I wonder what, in his expert opinion, he thinks publishing this crock of sh.t will have on the behaviour of the public?

Herainestold
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Tue Jul 06, 2021 1:44 pm

India making Sputnik V.
MOSCOW, July 6 (Reuters) - Indian drug manufacturer Morepen Laboratories has begun production of the Russian Sputnik V coronavirus vaccine, the Russian Direct Investment Fund (RDIF), responsible for marketing the shot internationally, said on Tuesday.

The first test batch made by the Indian manufacturer in the state of Himachal Pradesh will be shipped to Gamaleya, the Moscow institute which developed the vaccine, for quality controls, RDIF said in a statement.
https://www.reuters.com/world/india/ind ... ce=twitter
Delta changes everything.

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