Sputnik V COVID-19 vaccine: How much do we know about its side effects?

 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.

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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 91.6%Trusted Source.

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.

Common side effects

An interim analysis of phase 3 clinical trial data, published in The LancetTrusted Source in February 2021, reports on the efficacy and safety of the vaccine. Based on the data, the most common side effects were:

• flu-like illness
• headache
• fatigue
• injection-site reactions

These side effects are similar to those of the Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines, as noted by the Centers for Disease Control and Prevention (CDC)Trusted Source.

Authors of the paper state that 45Trusted Source out of 16,427 participants who received the vaccine reported serious adverse events, including deep vein thrombosis, hemorrhagic stroke, and hypertension. However, according to the paper, the independent data monitoring committee has confirmed that none of these were considered related to the vaccine.

Despite these data, there is still a significant controversy surrounding the vaccine. ExpertsTrusted Source have received the results with skepticism due to Russia’s strategy of early approval in August 2020, along with the lack of published raw data or protocol.

Source: Medical News Today