Is there something even better? This article wastes a lot of text repeating over and over that there are problems without getting to the most important ones.
The submitted link considers the Moscow Times article and copies verbatim (in the leaked report section) the quotes regarding randomization and side effects.
For what's worth, Brazilian regulators also had a bunch of issues with data provided for Sputnik. Issues were also raised when facilities were inspected.
Same feeling here. Curiously enough the domain is called "For better science", where we'd have expected neutrality and impartiality to be the guiding principles of any report.
Apart from that, it is hard to believe that any of the vaccine reports and clinical trials are unbiased. Unfortunately there are too many conflicts of interest and money on the table for any information to be taken at face value. The beauty of science is that now that the vaccines are out there it becomes easier to independently access them and move our knowledge further in the right direction.
And on that note, regardless of the final outcome for Sputnik V, at least there will be lessons learned for the future development of vaccines and increased scrutiny in their manufacturing process.
For what it's worth, the blog has a pretty similar tone even when writing about less politically-fraught topics; it's usually focused on fraud in the life science literature.
> at least there will be lessons learned for the future development of vaccines and increased scrutiny in their manufacturing process.
I’m nagging, but we’ve gone to extraordinary lengths to set a precedent where pharmaceutical companies are relieved of the burden of demonstrating the safety of their products and also relieved of the risk of providing relief to anyone harmed by said products.
20 years later, emergency measures to protect Americans from terrorism are in effect today. I doubt Pfizer will be vulnerable to class-action suits ever again.
>The beauty of science is that now that the vaccines are out there it becomes easier to independently access them and move our knowledge further in the right direction.
I mean that groups without any conflict of interest can gather population level data and evaluate for themselves how effective the vaccines are, and how likely it is for the clinical trial data to have been correct.
There is a reason publications and conferences require disclosure of conflicts of interest, and that is because those with a conflict of interest are biased to find positive results (and hide negative results) that align with their financial goals.
>I mean that groups without any conflict of interest can gather population level data and evaluate for themselves how effective the vaccines are,
It won't work because for every such group, there will be 10 groups with high conflict of interest that can counter any finding of your hypothetical group, and journals with conflict of interests will reject the findings of that group, but instead give high visibility to the reports of high-conflict of interest groups..
Quickly no one will dare to research the said topic.
I think that what is sort of a sideline in this article is really a more important story. The Lancet and NEJM have completely debased themselves and destroyed centuries of institutional credibility in their handling of covid related research. I don't know where it goes from here but they have both burned themselves to the ground.
The Lancet does this all the time. To add a few more examples to the sibling comments: The fraudulent HCQ paper*, the absurd Iraq war casualty calculation.
In general, assume that whenever there's politics or the opportunity to shock, the Lancet won't be very thorough with its articles.
* The conclusion being accidentally right doesn't cover for the fraudulent data.
The article shows evidence of sloppiness, not really of fraud. Neither would really surprise me, given the high political stakes. But I suspect that if Russia went for full-on fraud, they would do a much better job than this.
Case in point: the doping scandal at the Sochi winter olympics. It was evil, yes, but you cannot help but admire how detailed and well-executed the operation was. They designed and built a whole building around the scheme! Supposedly, even the FSB (reincarnation of KGB) was involved. If not for a senior whistle-blower, I think we would never know.
I'm sure that if there was some top-level prikaz to cook the books, there would be no discernible flaws in the data whatsoever.
The last article about Sputnik that I read on HN stated that many countries are awaiting their promised doses, because Korea and India cannot produce enough of it.
As the tone of article is bit aggressive, I have own observations, my relatives who lives in Russia were fully vaccinated with Sputnik and all 4 of them (one family) got a very hard COVID with delta, two of them were on oxygen therapy. Doesn’t mean anything but my feelings are that there are some lie about that vaccine efficiency for no reason except political benefits.
This kind of political wars are very harmful for vacination process. Of course there is a chance of the fraud but the same chance is for other vaccines as well and we need to talk about it. But is it a good time for such a fight?
Russia isn't the only country to have trialed Sputnik. From a recent Nature article (July 2021) titled "Mounting evidence suggests Sputnik COVID vaccine is safe and effective" [1]:
---
Figures released by the United Arab Emirates Ministry of Health, on some 81,000 individuals who had received two doses of the vaccine, suggested 97.8% efficacy in preventing symptomatic COVID-19 and 100% efficacy in preventing severe disease.
Since then, an as-yet unpublished study from the Buenos Aires health ministry in Argentina, involving 40,387 vaccinated and 146,194 unvaccinated people aged 60–79, found that a single dose of Sputnik Light reduced symptomatic infections by 78.6%, hospitalizations by 87.6% and deaths by 84.7%.
---
Or, here is an article on Moscow Times published today reporting a trial from a different Russian group, independent from the manufacturer [2]:
---
The study tracked outcomes for almost 14,000 patients who contracted Covid-19 in St. Petersburg between July 3-Aug. 9. It was led by Anton Barchuk, head of the Institute for Interdisciplinary Health Research at the European University in St. Petersburg, and eight other scientists from Russian universities.
Of the 12,154 patients who tested positive for Covid-19 in the study and were not vaccinated, some 467 were hospitalized — a ratio of 3.8%. Meanwhile just 17 of the 1,291 vaccinated patients who caught the infection — 1.3% — were hospitalized. After adjusting for age and sex, the scientists assessed the vaccine’s effectiveness at preventing hospitalizaiton among those who were infected with Covid-19 at 81%.
---
I am pretty sure Sputnik V is fine. It has been administered to tens of millions inside Russia itself. If there were massive problems with it, we would know by now.
>I am pretty sure Sputnik V is fine. It has been administered to tens of millions inside Russia itself. If there were massive problems with it, we would know by now.
No, we wouldn't. Because most of the Vaccine AEFI tracking is based on voluntary reporting, and is known to only report around 1% of the events.
Even if it was not the case, we wouldn't still know without a control group. Basically this is why systematic trials are done to measure these things.
So this logic does not absolve Sputnik vaccine, or any other current vaccines in use.
> In any case, the vaccine is likely to have very severe adverse effects and may be even unsafe, given the aggressive cover-up by the Russian authorities, statements from authorities abroad, and anecdotal reports from those who took the vaccine.
"A preprint from the Italian Hospital of Buenos Aires in Argentina reported no cases of clotting disorders or adverse events of special interest among 683 health-care workers vaccinated with Sputnik V. And an analysis of 2.8 million doses of Sputnik V administered in Argentina reported no deaths associated with vaccination, and mostly mild adverse events. Furthermore, a study posted as a preprint in May, from the republic of San Marino, found no serious adverse events in 2,558 adults who received one dose of Sputnik V and 1,288 who received two doses." - https://www.nature.com/articles/d41586-021-01813-2
It's not really ethical to keep the control group unvaccinated once Phase III was over and the EUA was approved. Ethics aside, the control group would probably leave the trial to get vaccinated anyway.
How do you establish long term safety of the vaccine if you don't have a control group of randomly chosen, unvaccinated people? And if you don't, then how did it get approved?
How long are you talking? I mean, nothing stops these people from going off and getting the vaccine themselves; what are you going to do, send mailers to them to never get a covid vaccine for the rest of their lives so that we can study them?
Because that would be like saying, just because all you got is a binocular with very limited magnification/resolving power, satelites for jupiter does not exist, because you cannot see them through it.
It absolutely is possible to retain a control group when developing a vaccine for a disease with CFR and R0 markedly lower than that of the measles. In fact they even had it, until January.
You are incorrect, the FDA only approved extending the emergency use authorization yesterday, but for some reason the media suggested that it was formally approved.
> On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.
Approving the biologics license application _is_ the formal approval. The reason the media is reporting that the FDA gave formal approval is because the FDA did in fact do that.
The letter goes on to say:
> On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.
So as well as granting formal approval, they _also_ extended the EUA.
Why did they do both?:
The extension of the EUA covers the existing vials of vaccine in the field and the supply chain which don’t have the approved labelling. Drug and biologic products are approved for sale under conditions that include specific labelling (the brand, in this case “Comirnaty” and the prescriber/patient instructions) and for specific indications.
The stock in the supply chain doesn’t meet those requirements, but it would be wasteful to recall it. Additionally, the EUA authorises more indications than the full BLA: kids 12-16, for one. The old stock, and now the new Cominarty-labelled stock, are authorised for these populations under the extended EUA.
Thank you for the informative and insightful comment.
Perhaps surprisingly, I also thank GP (rangoon626). Even if their claim was wrong, it nudged you to write this clarification, in accordance with Cunningham's Law.
Forgive my ignorance here, but wasn't this already the case? Nobody has needed to get a prescription for the vaccine, just like a flu shot. Perhaps I am misunderstanding this comment?
Certainly we have been going along under an EUA, without individual prescriptions.
I'm just as ignorant as you, and your point about the flu shot is a good one. I'm not aware of a prescription being required for that.
But as I read the document, it implied that with a regular approval and without the EUA, a prescription would be required and so that was one of the reasons for renewing it.
The precise mechanics vary on a state-by-state basis, but in a lot of cases a MD will write a blanket “prescription” that covers a class of patients, and that’s what fulfils the legal requirement for a prescription to dispense/administer a drug. In others, healthcare workers who don’t ordinarily have prescription authority are granted authority to prescribe vaccines by a state law.
The “prescription” here isn’t something the patient will see or be aware of, it’s just part of how the legal requirements around dispensing medications and the logistics of vaccination providers interact.
This is barely a critique of the science of the vaccine trial; it's 60% political pandering and inclusion of various public figures (completely irrelevant to the science) and their yappings about geopolitical context, peppered in with some potentially valid complaints about the approval process and the reporting by Gamaleya.
So I'm wondering why exactly there's this tremendous conspiratorial thinking about a vaccine that made claims... that turned out be completely on target with both the trial data and its epidemiological impacts in the countries where it's being applied.
because big politic. Covid is first and foremost a humongous wealth, resource and power redistribution and grab, at all levels, from local to global. It is being a pandemic is a distant second.
"OGA [The Office of Global Affairs] used diplomatic relations in the Americas region to mitigate efforts by states, including Cuba, Venezuela, and Russia, who are working to increase their influence in the region to the detriment of US safety and security. OGA coordinated with other U.S. government agencies to strengthen diplomatic ties and offer technical and humanitarian assistance to dissuade countries in the region from accepting aid from these ill-intentioned states. Examples include using OGA’s Health Attaché office to persuade Brazil to reject the Russian COVID-19 vaccine"
[1] https://www.themoscowtimes.com/2021/08/20/leaked-sputnik-v-r...