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Russia has an “approved” COVID-19 vaccine, but that doesn’t mean much

News recently broke that the Russian government had approved a COVID-19 vaccine, appearing to give it bragging rights over the USA and other countries developing vaccines. They’ve even announced that members of President Putin’s family have been inoculated with the new vaccine. However, this Sputnik V vaccine is, like its namesake space probe, more a symbolic boast than anything. And unlike in the space race in 1958, Russia is actually behind in the COVID-19 vaccine race of 2020.

What drug approval really means

Drug approval operates country by country, and any government can “approve” anything they want. Moreover, exactly what constitutes “approval” differs from country to country. Some countries have multiple stages of approval that can’t really be compared to the approval processes in other countries. So, the Russian government has “approved” Sputnik V. But that doesn’t mean Sputnik V is the answer to our hopes — in terms of either medical evidence or production capacity.

The Sputnik V vaccine is an adenovirus vector vaccine, most similar to the ChAdOx1 vaccine invented by Oxford University and produced by AstraZeneca and its international manufacturers. But compared to ChAdOx1, Sputnik V is actually very far behind:

  • It has only passed small Phase 1 and Phase 2 trials with a non-final dosing schedule in dozens of patients, whereas ChAdOx1 has passed larger trials with a final dosing schedule in thousands of patients.
  • The Phase 3 trial on Sputnik V has only just been announced and will only begin dosing in September, while ChAdOx1 has already enrolled over ten thousand patients over the last month.
  • The data on Sputnik V is still being kept largely secret, while ChAdOx1 has been the subject of both clinical and preclinical peer-reviewed publications.
  • AstraZeneca has spent the summer making production, packaging, and distribution agreements with a range of partners including Catalent, CEPI, GAVI, and the Serum Institute of India, while Sputnik V has only begun this process and has no firm production partners outside Russia.
  • AstraZeneca and its partners are already setting up production facilities to produce up to 800 million doses in 2020, and two billion in 2021. Russia hopes to be producing 5 million doses of Sputnik V per month by the end of 2020, making it unlikely the country can achieve even domestic herd immunity using this vaccine in 2021, even if it does everything it says it’ll do.

This situation can be summarized thusly:

Some of the other vaccines, like the ones from Moderna and Pfizer/BiONTech, are similarly advanced to ChAdOx1. They have peer-reviewed evidence of immunogenicity, are already well into a Phase 3 trial, and set to produce a billion doses or more in 2021. Others, like those from Sinovac, Sinopharm, and CanSinoBio, all based in China, are behind these, but ahead of Sputnik V. Still others, like the protein vaccines from Novavax, Eli Lilly, etc, haven’t yet entered human trials, but have a much smoother path to producing billions of doses than Sputnik V does.

The bottom line: Sputnik V is several months behind the actual leaders, has less prospect of true mass production and gives no sign of catching up. Many of the manufacturing partners which could help Russia make more doses of Sputnik V are already executing agreements with competing vaccine programs that they made months ago.

Sputnik V approval is a gamble

The Russian government’s decision to “approve” Sputnik V is a boast, a gamble, an attempt to gain more support from other countries for its program, but it’s not the kind of considered judgment of safety and efficacy on the basis of firm clinical evidence which usually underlies a drug or vaccine approval in the developed world. They hope that by announcing this approval they can find more partners to manufacture it, and more countries to buy it than they would by being more reserved. And they can put great articles about it in their state press, including, of course, Sputnik International.

If it later turns out that Sputnik V works, Russia will have beaten the USA and other countries to the punch (nominally, even if not substantively). If not, well that’s why it’s a gamble.  And while some in the press have used the phrase “Russian Roulette” to refer to this gamble, it’s actually relatively low stakes: this approval does not mean that Sputnik V will be widely distributed immediately. This approval doesn’t allow that (there’s a later stage approval that does), and a majority of Russian doctors surveyed don’t have confidence that it’s safe and effective. Even if they did think the vaccine would be effective, Russia won’t have large enough quantities to vaccinate people for months, at least.

It will be great if Sputnik V does work, and Russia can find partners to mass manufacture it (their announced target is one billion doses before the end of the pandemic). If current announcements from other firms all come true, the world will still not have enough doses for global herd immunity before the end of 2021. Any additional dose is a good thing, but right now, Russia’s vaccine doesn’t look likely to help the rest of the world. Who wouldn’t rather manufacture another vaccine that is further along?

We saw this same situation in miniature in China in July, when Cansino’s vaccine was cleared by the state research institute to enter a Phase 3 trial with PLA soldiers for subjects. Some media misreported this news as a final approval, but China was quick to dispel it. The Russian government, by contrast, in a longstanding tradition, seems happy to boast.

This news doesn’t really change anything. Sputnik V will still succeed if it gives good evidence of safety and efficacy in well-run trials and is mass manufactured. If not, it’ll fail. An experimental vaccine by another name is no more sweet.


  • 2 Comments

    • Cia

      It’s important to define what vaccine safety means in this and every other case, as well as what is meant by vaccine efficacy. Most people are unaware that in the US, no vaccine has been tested against a true placebo, to compare outcomes between those who get the vaccine and those who do not. Usually a vaccine trial uses different groups who get different kinds of vaccine: the vaccine being tested vs. the pertussis vaccine (highly reactive in itself) or against a formula which includes the adjuvants like aluminum, the foreign proteins from the cell culture (also highly reactive), antibiotics or other antiseptics, etc, everything but the modified disease pathogen used in the vaccine. So they always get a lot of reactions, it’s just which causes more reactions.

      They were never able to develop a SARS vaccine despite attempts because of antibody-dependent enhancement, meaning that those with antibodies often have a very severe or fatal reaction when exposed to the coronavirus again. I haven’t seen anything yet about how they hope to avoid that problem.

      Fauci said the other day that we shouldn’t expect the coming vaccine to be more than 50-60% effective, also that we don’t know how long vaccine protection will last, that it might be only for a few months, maybe a year. We don’t know yet if any vaccine protection will depend on individual factors, so that maybe half aren’t protected at all. Or maybe it wouldn’t prevent symptomatic illness, maybe just attenuate it.

      And most vaccine reactions are not immediate, but play out over months and years. In most cases a panel of industry reps makes a predetermined list of what kind of reactions they will accept as being probably caused by the vaccine and the timeframe in which they have to occur to be accepted as causal. Usually the trial subjects jot down possible reactions and are interviewed on set days following vaccination: reactions outside the few predetermined ones and those occurring outside the set timeframe are rejected. They simply reject as causal all apparent reactions which do not meet their strict, arbitrary criteria.

      Putin’s daughter volunteered to be in the safety trial, and apparently nothing untoward happened to her. If she and the other trial subjects do not get Covid in the next year, and not many of them die for other reasons, the Russian vaccine may be a successful one in the relative terms which are the only ones you can use for vaccines. But no one should assume that vaccine “safety” trials in the West mean what most people think it should mean.

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      • Ari Allyn-FeuerContributor Cia

        Hey, you’ll be heartened to find out that many vaccines undergo placebo-controlled trials, including all the COVID-19 vaccines currently in Phase 3 trials that we mention here.  🙂  The notion that there are no placebo-controlled vaccine trials is a common anti-vaccination talking point, but it’s not actually true.

        In addition, we haven’t seen any strong evidence of antibody-dependent enhancement in the SARS setting, and Dr. Fauci has never to our knowledge stated that 50-60% was any upper bound on the potential effectiveness of current COVID-19 vaccines.

        Thanks!

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