Covid-19: Sputnik vaccine rockets, thanks to Lancet boost

Mentioning Putin (a vilified figure) in the first sentence indicates that it is a preemptive strike to discredit the journal in anticipation of the publication of successful results of phase III of the trial.

There are obviously issues with peer review but the scientific method is the best we've got.

So Sputnik - V is promoting their vaccine citing the positive reviews in Lancet. What's new here?

Isn't it a standard and common marketing tactic in the pharma industries? Why just the Pharma industries, even the junk food industry of the US or Tobacco industry setup their own think-tanks and finance "scientific" research that attack their critics' claim by publishing papers that contest their criticism.

While the BMJ highlights concerns about the trial data Lancet has, and hints that the "third-world" country regulators may have been swayed by it, I wonder why they ignore the other simpler and obvious explanation - some "third-world" countries trust Russia's competence in biotechnology over their own.

It further boosts the credibility of the Sputnik-V vaccine that Russia is vaccinating its own army and people with it. Of course, that doesn't mean the vaccine is better or safer than the alternatives available, which is a genuine concern that the paper rightly highlights. But in terms of perceptions, that's a huge deal.

It should also be noted that not every regulator has blindly approved the vaccine - third-phase trials of Sputnik-V have now been completed in Russia and are also underway in India, Belarus, the United Arab Emirates, and Venezuela among other countries. [1]

As an Indian, I have confidence in the efficacy of the vaccine not only because Russia is competent in this area but also because Indian regulators have finally approved Sputnik-V's use in India. And more so because it will be manufactured locally by various vaccine makers in India:

    India is the leading production hub for Sputnik V. RDIF has reached agreements with the leading pharmaceutical companies in the country (Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech) aimed at production of more than 850 million doses per year. [2]

(So far, in some of the countries where it is being administered, the criticism against Sputnik-V has mostly been on the quality of the vaccines manufactured. On that aspect, I would feel more confident about Sputnik-V manufactured in India - as one of the largest manufacturers of vaccine in the world, India is quite competent in this area and will have less quality control issues in the Sputnik-V doses manufactured here.

[1]: https://www.dw.com/en/coronavirus-russia-agrees-to-produce-s...

[2]: https://sputnikvaccine.com/newsroom/pressreleases/sputnik-v-...

Interesting read, and also prescient in some ways, since this was probably authored before Brazil recently rejected the Sputnik vaccine because it includes a replicating adenovirus (https://en.wikipedia.org/wiki/Sputnik_V_COVID-19_vaccine#Bra...). The paper talks about potential clotting problems with the Sputnik vaccine but makes no mention of the replicating virus issue.

Here are the key takeaways:

1. The central claim is that peer review is inadequate to evaluate drugs. This assertion reminds me of past analyses (example: https://www.vox.com/2015/12/7/9865086/peer-review-science-pr...) that highlight problems with the peer review process, research more broadly (statistical flaws, replication issues, data manipulation), and how society establishes "truth".

2. The Lancet specifically has made some missteps in how it dealt with the Sputnik vaccine, by not holding authors accountable as they claim to do. In publications concerning Phase 1/2 of validating the Sputnik vaccine, the Lancet acted with some secrecy and did not uphold data sharing agreements that were expected ("The Lancet declined to respond specifically to questions about whether they would uphold the data sharing agreement or whether they had even requested more data from the Sputnik team"). The Lancet had to also publish corrections to Phase 3 papers, and these errors seem to have been avoidable ("inadequate peer review and editorial processes that failed to detect what seem to be obvious errors in reporting the results of this high profile research").

3. The Lancet was used as marketing by the Sputnik team, and their publication of papers claiming vaccine safety/efficacy seem to have been what caused over 40 countries to blindly approve the Sputnik vaccine. These countries were "low and middle income countries without well resourced, independent regulators". In other words, they put faith and trust in the scientific process that was available, because they did not have better options.

4. Regulatory processes in well-funded governments are much more trustworthy than peer-reviewed research. They note that most journals have a very simplistic review process, compared to regulators like the EMA (European Medicines Agency): "At most journals, peer review is undertaken over a few hours, by two or three anonymous, unpaid experts, without publicly declared interests and without access to underlying data. By contrast, the EMA and other major regulators typically use named teams of in-house and external experts, all with declared interests and expertise in different critical aspects of a new product. The regulator also has unlimited access to all the non-clinical, clinical, and manufacturing data. They frequently audit the sponsor and inspect research and manufacturing sites. If they choose to exercise it, they have the power to look at individual patient charts to verify data."

5. Ultimately, all "gold standard" scientific processes need to be scrutinized, challenged, and viewed skeptically, since they are still human-driven processes and are flawed or exploitable through various means. They often rely on trust - for example trusting that experimental data or patient data is legitimate and not manipulated.

6. The Russian government (Putin) seems to have basically made up their claim that the vaccine had gone through the necessary trials. When Putin announced the vaccine in August 2020, only 38 people had received this vaccine in total. There's a risk in taking on drugs from new sources that haven't established their reputation ("The vaccine was developed at an institution in a country with no substantial track record of vaccine development").