Sputnik V, developed by the Gamaleya National Center of Epidemiology and Microbiology in Russia, was the first COVID-19 vaccine to be authorized. This Snapshot feature discusses some of the common side effects reported in clinical trials, as well as controversies around potential safety concerns of the vaccine.
All data and statistics are based on publicly available data at the time of publication. Some information may be out of date.
The Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia, developed a COVID-19 vaccine called Gam-COVID-Vac, more commonly known as Sputnik V. It is the first COVID-19 vaccine in the world to be authorized for use against the SARS-CoV-2 virus.
Along with Russia, 64 countries have approved the vaccine. These countries include Argentina, Iran, and India. The vaccine is currently being reviewed in the European Union by the European Medicines Agency.
Sputnik V is a two-part adenovirus viral vector vaccine with an efficacy rate of
Adenoviruses are a type of virus associated with the common cold and other illnesses. They serve as the delivery vehicle for the DNA instructions to produce the spike protein of the SARS-CoV-2 virus in the body. This then triggers the production of antibodies against this spike protein, preparing the immune system for a potential infection.
Each of the two doses uses a different type of adenovirus: first dose with type-26 (Ad26), then a booster dose with type-5 (Ad5). The purpose of using two different types is to lower the possibility of the body developing antibodies against the adenovirus after the first dose, which could make the second dose ineffective.
An interim analysis of phase 3 clinical trial data, published in
Authors of the paper state that
Despite these data, there is still a significant controversy surrounding the vaccine.
An article published in
Adenoviruses, in their natural state, are able to replicate in the body and lead to illnesses, such as the common cold. When used in vaccines, adenoviruses are altered to remove their ability to replicate. For the Sputnik V vaccine, it was noted that the E1 gene was removed from the vaccine in order to prevent replication.
However, Brazil recently rejected the use of Sputnik V, citing concerns around replication. According to Anvisa, the Brazilian Health Regulatory Agency, quality control documents revealed that batches of the vaccine displayed “less than 100 replication-competent particles per dose,” suggesting that the adenovirus does have a small chance of replication.
Shortly after, the Gamaleya National Center released a press statement denying Anvisa’s allegations, referring to Brazil’s decisions as being “of a political nature and [having] nothing to do with the regulator’s access to information or science.”
It stated that only non-replicating adenoviruses are incorporated in the vaccine, and pointed to other strict aspects of quality control.
Scientists have displayed mixed responses, with some criticizing Russia’s lack of transparency and others questioning Anvisa’s interpretation of the data. In the case that the adenovirus is able to replicate, the likely side effects are a mild common cold for most people. For people with weakened immune systems, the risks may be greater.
After CanSino released phase 1 clinical trial data on Convidecia, another Ad5-based COVID-19 vaccine,
According to a
While further research is needed to validate this claim, the researchers advise precaution against using Ad5-based COVID-19 vaccines, particularly in areas of the world with a high number of HIV and AIDS cases.