A recent announcement by Russia that it has developed a COVID-19 vaccine has been met with scepticism worldwide.
I am all for vaccines, but there is a process how a vaccine is licensed.
Vaccines are among the safest medical products on the market because they must undergo extensive testing of their safety and effectiveness before they can be put on pharmacy shelves.
Furthermore, once launched, there are several systems in place to monitor their safety in the general population.
Scientific studies show that just like all medicines, vaccines come with small risks of side effects. Serious side effects are very rare.
Vaccines must go through several human trials. These phases are:
Phase One: Trials are small and simple: the vaccine is administered to a small group of healthy individuals at different doses to see which dose is safe.
Phase Two: Trials are bigger, use a few hundred people and compare a vaccinated group of individuals against a control group who are given a placebo. This tests whether the vaccine triggers an adequate immune response and checks are made for any serious side-effects.
Phase Three: These are the biggest trials in the pre-licence phase, a crucial stage to ensure that a vaccine candidate actually works. The trials randomly put individuals into two groups, a vaccinated group versus a control group, and follows them for months to see whether vaccinated individuals are actually less likely to contract the disease than individuals who are administered the control. Phase three trials are huge with tens of thousands of individuals so as to pick up rare but potentially serious side-effects that cannot be picked up by the smaller numbers of the first two phases.
Phase Four: These are post-licence and launch tests to check whether a vaccine causes extremely rare side effects.
Phases one and two only show that a vaccine does not cause harm and that there is some degree of antibody response within a month of vaccination. There have been several vaccine candidates that appeared promising up to phase two with no harm and an antibody response, but they were useless at actually preventing disease. This included, for example, an HIV vaccine.
The international scientific community has no idea whether the Russian COVID vaccine is safe and effective
The putative Russian vaccine has been registered for phases 1 and 2 but no results of these two phases are available for international scientific scrutiny. It has been claimed that this vaccine produces antibodies, but these may not last, may not provide sufficient protection, or may fail for several reasons due to the complexity of the immune system.
In effect, anyone taking this product will be taking part in a clinical trial, but without a proper control group.
Furthermore, there is no evidence that a Russian phase three trial has even been started, much less completed.
At this point in time, the international scientific community has no idea whether the Russian COVID vaccine is safe and effective.
The Russian vaccine has skipped most of the testing phases
There are several hundred vaccines in development and the only difference between Russia’s putative vaccine and the others is that the Russian vaccine has skipped most of the testing phases.
We would all love to have such a vaccine in hand. But it remains to be seen whether this one meets the criteria of safety and effectiveness.
Another worry is that an ineffective vaccine at this time will further exacerbate vaccine hesitancy and vaccine scepticism and may lead to reduced uptake of a truly safe and effective COVID vaccine in 2021, preventing the eventual development of herd immunity by COVID vaccination.
Victor Grech is a consultant paediatrician.