Sputnik V Approved & Moves to Phase 3, US Officials Skeptical

Aug 16, 2020 | Coronavirus, COVID-19, Gamaleya, News, Russia, Sputnik V, Vaccine

Sputnik V Approved & Moves to Phase 3, US Officials Skeptical

As we last covered on August 11, Russia’s Gamaleya/Sputnik V vaccine presents both a chance at solving our global pandemic and a need to scrutinize the evidence for efficacy and safety, along with myriad scientific and ethical questions related to how the vaccine was evaluated before use. On August 16, 2020, Tass offered us a vaccine update from the Russian perspective: Stage 3 trials, “may begin in 7-10 days,” according to the Gamaleya Federal Research Center’s Director Alexander Gintsburg. Tens of thousands of people will participate. The director also said that on August 17, “We will present the first version of the protocol on post-registration research. Given this great interest and attention of the public and the press, I think that the Health Ministry won’t delay the process and will approve the protocol within a week. So, I believe within seven or ten days at maximum everything will begin.” Tens of thousands of subjects are anticipated to participate in this research, and the work will be conducted in the Moscow Region. Tass notes that the vaccine was registered August 11, and production was launched on August 15. 

Mixed Messages on Timeline for Wide Distribution

So, Russia effectively has a two-track system in that the Sputnik V is approved for use now and is also undergoing Phase 3 trials simultaneously. On Thursday, Live Science gave us an update as to the “approval.” They note that despite prior reports of approval for “widespread use,” it has only been ok’ed for “a small number of people at high risk of infection, such as health care workers.” Most presumed that Putin’s announcement meant that Sputnik V would be widely used. But, the Russia Ministry of Health registration certificate only covers a small group of people and also, “The certificate also states that the vaccine cannot be approved for widespread use until January 1, 2021, although statements by various Russian health officials seem to contradict that clause.” For example, Kirill Dmitriev, head of the Russian Direct Investment Fund, says, “People outside of clinical trials will have access to the vaccine in August, and some, already on the massive scale, in October.”   

Russia Offers Help, US Says “Nyet”

According to Russian officials, as reported by CNN, they have offered “unprecedented cooperation” with Operation Warp Speed, but the “US is not currently open” to these proposals. One official said that US mistrust of Russia is interfering with cooperation. The US White House says that President Trump has been briefed on Sputnik V and that US vaccines go through “rigorous Phase 3 testing and high standards.” A US official told CNN that the vaccine is “so half-baked in the United States that it hadn’t even piqued US interest in a serious way before the rollout.” Another official said, “There’s no way in hell the US tries this (Russian vaccine) on monkeys, let alone people.” Russian officials also said their nation is open to sharing the vaccine and that it would ok US-based production. While Russia says that there has been interest from some US pharma firms, no details have been disclosed. Russia has not released any of the data from its testing, so “CNN is unable to verify the vaccine’s claimed safety or effectiveness.” Per US officials, they do not have any samples of Sputnik V.

Clearly, this is a complicated story that is fast-developing. Maybe Sputnik V will work and be safe; if that is shown to be the case, then obviously, the US should accept offers to share the technology. However, the fact that Russia has made declarations of “approved” while still embarking on Phase 3 trials could also make the most open-minded Western scientists a bit leery. Regardless, given the high political tensions between the US and Russia, it is hard to know whether official statements are as accurate as possible or, instead, biased by international rivalry. 

Call to Action: TrialSite works on identifying and delivering updates and information about clinical research that is both objective and independent in nature. 

Much of the content in today’s press has infused bias, and it is not always easy to decipher between the truth and the spin, the actual versus the positioned, the facts versus propaganda. We’ll keep trying. 

1 Comment

  1. Jason K Milner

    It’s an adenovirus platform correct. So no one has a sample of this vaccine outside Russia?

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