Phase 3 Trial Results Grant New Validity to Controversial Sputnik V Vaccine

On February 2nd, results from a Phase 3 clinical trial showed the Sputnik V vaccine, developed by the Gamaleya Institute in Moscow, was 91.6% effective against COVID-19. The vaccine was first met with skepticism after it was approved by the Russian government before the start of the trial back in August 2020. Now, it joins the fight against COVID and could provide a viable alternative for lower-income countries that are struggling to get other vaccines.

Since the beginning of the COVID-19 pandemic, more than 104 million people have tested positive worldwide, and over 2.26 million people have died. Vaccines are considered one of the main tools to put an end to the pandemic as they stop or slow down viral transmission. However, lower-income countries are struggling to obtain vaccines, as richer countries negotiate bilateral deals with vaccine makers.

Currently, the number of vaccines approved for emergency use in two or more countries has increased. However, vaccines from American and European companies, such as Moderna, Pfizer-BioNTech, and AstraZeneca, have been difficult to acquire. This has created a vacuum that countries like China and Russia have been trying to fill.

Sputnik V and the Phase 3 Clinical Trial

Sputnik V was developed by the Gamaleya Research Institute, and it consists of two intramuscular doses of two different viral vectors (1st dose: rAd26, 2nd dose: rAd5). Both vectors carry the gene for the viral glycoprotein S.

Sputnik V has been surrounded by controversy since the vaccine was approved for emergency used before the Phase 3 clinical trials began. Also, it has been approved for emergency use in Russia, Mexico, Paraguay, Argentina, Hungary, and others without publicly available data on safety and efficacy was released.

The safety and efficacy of the Sputnik V vaccine were determined on the randomized, double-blind, placebo-controlled, multicenter Phase 3 clinical. The trial enrolled almost 22,000 people over the age of 18 in 25 hospitals across Russia. Three-fourths of the patients received the vaccine, and the rest received a placebo. Key results are:

• The vaccine was 91.6% effective overall. Only 16 out of 14, 964 people that received the vaccine were infected by COVID-19 compared to 62 out of 4,902 people that received the placebo.
• The vaccine was 91.8% effective in the elderly, as only 2 out of 1,611 people that received the vaccine contracted COVID-19.
• The vaccine was 100% effective against moderate or severe COVID-19 as no cases were reported in the vaccinated group versus 20 cases in the placebo group.
• There were no severe side effects associated with the vaccine

Sputnik could become one of the most used vaccines worldwide. It can be stored in a normal fridge, which allows for easier distribution. Since its approval back in 2020, more than 50 countries placed orders for the Sputnik vaccine. Just recently announced that Mexico would import 7.4 million doses by April. In addition, Russia and India agreed to produce 100 million doses in India. The company responsible for the production is Hetero, which aims to produce 100 million doses per year. Sputnik is posed to become a big competitor on the vaccine market, and the results from the Phase 3 clinical trials will give more validity to this vaccine.

Related Article: Johnson & Johnson’s COVID-19 Vaccine Draws Mixed Reactions as it Registers 66% Efficacy

References

1. https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-idUSKBN2A21IT
2. https://coronavirus.jhu.edu/
3. https://www.sciencedirect.com/science/article/pii/S0140673621002348?via%3Dihub#!
4. https://www.nytimes.com/live/2021/01/27/world/covid-19-coronavirus
5. https://www.washingtonpost.com/world/who-chief-warns-of-catastrophic-moral-failure-as-rich-countries-dominate-vaccine-supplies/2021/01/18/033644a0-5978-11eb-a849-6f9423a75ffd_story.html
6. https://www.statista.com/statistics/1123927/sputnik-v-exports-from-russia-by-country/

Author

Daniel Ojeda