Wait, WHAT?! Russia already approved a COVID-19 vaccine?


A: Sort of, and not really.

In a surprising announcement Tuesday, Russia claimed it had approved the world’s first COVID-19 vaccine, which was only tested in 76 people thus far.

Russian President Vladimir Putin endorsed using the vaccine, ambitiously dubbed “Sputnik V,” claiming that his adult daughter had received it.

In reality, the Ministry of Health issued a “registration certificate” to allow the vaccine to be given to a “small number of citizens from vulnerable groups.” Meanwhile, a Phase III trial in a larger number of people is slated to begin.

What type of vaccine is this?

The vaccine uses a standard “viral vector” approach that other groups are also pursuing. The technique modifies adenoviruses, which would ordinarily cause a common cold, by adding a gene for the spike protein from SARS-CoV-2. In theory this primes the immune system to recognize the real virus should infection occur.

See our most recent update on vaccine candidates here.

So the good news is that this is a viable vaccine approach by a company that has a track record for vaccine development in this area. Less good is that the data on the early Phase I and Phase II safety checks and immune response have not been publicly released.

What’s the big concern? On the face, it sounds like the vaccine is bypassing some important steps to test both its safety and efficacy (whether it actually prevents infection).

These are not trivial checks: Vaccines can have rare side effects that aren’t evident until tested in larger groups of people (Phase III trials). Also, an ineffective vaccine can give people a false sense of security that makes them less cautious about avoiding infection. Such problems can seriously harm public confidence in current and future vaccines, which would be *very* costly for human health.

Emergency use of the vaccine for high risk groups may seem like a good idea, but can lead to its own problems as outlined in this excellent thread by Dr. Ellie Murray.

In reality, this announcement may be more nationalistic posturing than actual circumventing of the scientific process- Phase III trials are proceeding, and the vaccine is only planned for limited use so far.

Nonetheless shortcuts with safety are not recommended, especially if they damage confidence in vaccines and science in the long run.

Aside from that, the worldwide effort to produce a SARS-CoV-2 vaccine at “warp speed” is unprecedented and we are enthusiastically cheering for ALL nations’ successes…when they actually arrive!

Read more:

New Scientist

Science Mag

Link to original FB post.