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Recently Russia announced that they have approved the first vaccine for COVID-19, which they are calling Sputnik V. The reference to the first artificial satellite, arguably the most famous scientific and technical “win” for the former Soviet Union, reveals the propaganda angle of this approval (although it was pretty clear even without the name, which was a bit of overkill). The scientific community, however, does not seem as impressed as Putin would like, and this episode just revives concerns that the race to develop a vaccine for COVID-19 is coming at the expense of safety.

Scientific data was not released for Sputnik V, so we only have Russia’s overview to go by. They claim that clinical trials for the vaccine were started in mid-June, and that the vaccine produces “stable immunity”. I find these two statements to be contradictory. So at most we have two months of data, but most likely six weeks. After six weeks you can only determine that the vaccine produces antibodies for six weeks, which is not very long. Even if antibody titers are “stable” and not decreasing in that time, there is no guarantee they won’t plummet after 10 weeks or 16 weeks.

Further, the study only involved 76 participants. By all accounts this was a modest phase II clinical trial, used to determine safety and show that a clinical benefit is plausible. It is not a definitive efficacy trial, however – you cannot use this data to conclude that the vaccine works. Phase III clinical trials, with thousands or even tens of thousands of participants, are needed for that.

What we need is to give thousands of study participants the vaccine, and thousands more a dummy vaccine, and then observe them for at least several months to see how many of them contract COVID-19. Along the way their antibody and infection status would need to be objectively measured. To say that the vaccine works, we would need to see that those in the treatment group were significantly less likely to contract COVID-19 than the placebo group. You, of course, cannot get that data in six weeks with 76 participants.

The type of vaccine used is a live attenuated adenovirus, a virus that causes the common cold, modified with the spike proteins of SARS-CoV-2, so as to provoke immunity against that virus. Other vaccines in development use a similar approach.

Sputnik V is not further along in development than many other vaccines – Putin just decided to jump the gun and approve the vaccine prior to phase III testing. For example, a vaccine in development by the National Institute of Allergy and Infectious Diseases (NIAID) and Moderna, Inc. of Cambridge, Massachusetts has also already completed a phase II trial (actually still ongoing but they published interim results) showing high levels of neutralizing antibodies, and good safety data. This is an mRNA vaccine. The data shows a better result from two doses 28 days apart than a single dose. They are now entering phase III clinical trials. Other vaccines are at a similar stage of research.

A good phase III clinical trial is going to take at least several months. Normally they would take years. The total time to develop vaccines is often 10-15 years, and so developing a COVID-19 vaccine essentially in one year is extremely expedited. What are the legitimate concerns this speedy development process raises?

Much of the time it takes to develop a new vaccine is due to regulatory inefficiency, not the science itself. So a lot of time can be removed simply by giving the highest priority to expedited review and approval along the way. There is also much you can do to speed up the science simply by throwing lots of resources at the process. If you have lots of labs and scientists with adequate funding researching a vaccine, it can happen quickly. Vaccine technology already exists, we are not starting from scratch. The research is mostly a matter of applying this proven technology to a new virus.

There are still a lot of unknowns, however. Every virus is different, and it has proven challenging to develop vaccines to other coronaviruses, such as SARS-CoV-1. We need to know, of course, that vaccines are safe – they don’t provoke a harmful immune activity. In rare circumstances, a vaccine response can even make infection more likely. The immune system is complex, and we cannot totally predict how it will response to our interventions. We need clinical trials to determine the net effect.

We also don’t know how effective the antibodies produced by a vaccine will be. Do they actually prevent infection, reduce the severity if infection occurs, and/or reduce the spread of the virus? And we need to know how to dose the vaccine and how long effective immunity lasts. Some vaccines require two, or even three doses, and some require frequent revaccination.

Of course, figuring all this out requires time. We cannot know that immunity lasts for a year, for example, until we have followed subjects for a year (which last time I checked, takes at least a year).

All of this has to be weighed against the fact that we are still in the grips of a pandemic. There is a risk vs. benefit calculation we have to make in expediting vaccine development. But there is a sweet spot – developing a vaccine as quickly as we can without significantly compromising safety or efficacy. By all account, Western companies who are developing vaccines are in the sweet spot, they are being transparent with their data, and they are being conservative with their claims (all markers of good science).

I am hopeful that one of the vaccines in development will legitimately cross the finish line by the end of the year (not just be prematurely declared victorious). But then we have to ramp up production and distribution. That is another factor to consider – we don’t want to waste time and resources producing millions or billions of doses of a vaccine that doesn’t work well, or produces only short-lived immunity. Diverting production and distribution resources to a vaccine that ultimately does not produce herd immunity will only delay rolling out a more effective vaccine.

There is also a public perception angle to all this. An effective vaccine campaign will require public buy-in (in non-totalitarian countries). Prematurely approving a vaccine for propaganda purposes is counterproductive to public perception. This will only stoke fears that the vaccine is being “rushed” (rather than properly expedited).

The ultimate goal is achieving sufficient herd immunity that the pandemic comes under control (whatever that eventually looks like). We want to get there as quickly as possible. It is increasingly looking like we will not get there without a vaccine, so this effort is critical. This is a time to double-down on science – which means we need good science, including transparency, rigorous methodology, honest interpretation of data, and not making claims that go beyond the evidence. Scientists and governments need to be honest with the world about the state of this pandemic and our efforts to fight it.

The Sputnik V episode, in this light, is extremely counterproductive. It does highlight the inherent contradiction between the needs of legitimate science and the culture of totalitarian societies. The two don’t mix.

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Posted by Steven Novella

Founder and currently Executive Editor of Science-Based Medicine Steven Novella, MD is an academic clinical neurologist at the Yale University School of Medicine. He is also the host and producer of the popular weekly science podcast, The Skeptics’ Guide to the Universe, and the author of the NeuroLogicaBlog, a daily blog that covers news and issues in neuroscience, but also general science, scientific skepticism, philosophy of science, critical thinking, and the intersection of science with the media and society. Dr. Novella also has produced two courses with The Great Courses, and published a book on critical thinking - also called The Skeptics Guide to the Universe.