It was announced on February 20, 2021, that Ghana through the Ministry of Health, has authorised the registration and use of the Russian COVID-19 vaccine, Sputnik V. The vaccine was approved under the emergency use authorisation procedure.
In a statement released on the website of the developers of the Vaccine, the CEO of the Russian Direct Investment Fund, Kirill Dmitriev, said:
“Ministry of Health of Ghana has thoroughly reviewed the data on safety and efficacy of Sputnik V also proven by publication in The Lancet and approved the use of the vaccine. This is another positive example of vaccine cooperation between Russia and partners across the world to save lives and protect the population.”
In this report, Fact-Check Ghana reviews what has been published about the Sputinik V vaccine focusing on clinical research of the vaccines, its effectiveness and approvals and objections it has received so far.
The Vaccine and the Developer
The Sputnik V COVID-19 vaccine, originally known as Gam-COVID-Vac, was developed by the Gamaleya Research Institute of Epidemiology and Microbiology and was approved for use by the Russian Ministry of Health in August 2020.
Gamaleya is one of the elite government-financed research and development labs in Russia. It is located in Siberia and the Central Research Institute is a military/defense based research operation.
In the past, the Gamaleya Research Centre is noted to have successfully developed licensed vaccines against the Ebola virus with GamEvac-Combi and GamEvac-Lyo being one of such vaccines.
The Gam-COVID-Vac vaccine (Sputnik V) was developed by a cellular microbiologists team of the Gamaleya Research Centre being led by scientists from the Russian Academy of Sciences, some of whom had worked on the vaccines for the Ebola Virus.
Approving during Clinical Research Phase I-II and Criticism from International Vaccine Scientists
The Vaccine was approved for use in August 11, 2020 after it had commenced its phase I-II clinical research on June 17, 2020. Thus, Russian authorities approved the administration of the vaccine barely two months into trial. This attracted criticism from many international vaccine experts.
On 4 September, data on phase I–II trial was published, indicating preliminary evidence of safety and immune response. It had 76 participants. Half of the participants were injected with the liquid form of the vaccine and the other half with the soluble form. It is reported that the first half of the participants were from the military, raising concerns and further criticisms that the service personnel were forced to engage in the trial.
In September, 27 scientists wrote an open letter to the editor of The Lancet medical journal, the journal that published the data on the clinical trial I and II, questioning the reliability of the data published and stating that it is incomplete and had shown some “unlikely patterns.”
“There are several data patterns which appear repeatedly for the reported experiments,” the open letter, as reported in the media, said. “On the ground of simple probabilistic evaluations the fact of observing so many data points preserved among different experiments is highly unlikely.”
The open letter added that “no conclusions can be definitively drawn on the reliability of the data presented, especially regarding the apparent duplications detected.”
Despite the criticisms, Russian authorities continued to administer the vaccine to its citizens including one of the daughters of President Putin.
The Lancet Report, Its Effectiveness and Ongoing Clinical Research Phase III
On 2 February 2021, an interim analysis from the phase III trial conducted in Moscow was published in The Lancet, indicating 91.6% efficacy after the second vaccination. The report also indicated that the vaccine has no unusual side effects.
The trial which spanned September 7, 2020 to November 24, 2020 had 20,000 participants. The Lancet report stated that: “this interim analysis of the phase 3 trial of Gam-COVID-Vac showed 91·6% efficacy against COVID-19 and was well tolerated in a large cohort.”
Also, it was observed that over-60-years-old group in the trial (oldest participant was 87) had essentially the same efficacy (91.8%) as for all ages. The lowest age participants were 18 years old.
The Lancet report helped to dispel doubts and skepticisms about the Sputnik V vaccine, according to media reports.
Renowned Virologist Prof Ian Jones from Reading University is noted to have commented on the Lancet report that:
“The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency. But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of Covid-19.”
There’s still an ongoing phase III study on the vaccine involving 40,000 volunteers in Moscow. It is scheduled to run until May 2021.
Countries that have Approved and Authorised the Use of Sputnik V for Use
As at February 22, 2021, according to the Gamaleya Research Centre, Ghana is the 31st country in the world and the fifth in Africa to have authorised the emergency use of the vaccine.
Beside Ghana, the following are the countries that have approved the Sputnik Vaccine:
Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (entity of Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent and the Grenadines, Kazakhstan, Uzbekistan, Gabon and San Marino.
Sputnik V not yet approved by EU, despite contrary rumours
Despite the wide approval of the Sputnik across many countries, the European Union is yet to approve the vaccine for its 27 member states as at Monday, February 21, 2021.
There were rumors indicating the EU had approved the vaccine, but the European Medicine Agency (EMA), the body responsible for the approval, issued a statement on its website debunking them.
“The European Medicines Agency has to date not received an application for a rolling review or a marketing authorisation for the vaccine developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia, the Sputnik V vaccine (Gam-COVID-Vac), despite reports stating the opposite,” the statement said.
The agency further added that: “The developers have received scientific advice from EMA providing them with the latest regulatory and scientific guidance for the development of their vaccine. In line with the Agency’s transparency policy, the vaccine is included in the list of COVID-19 medicines and vaccines that have received scientific advice from the Agency.”
The EMA says it is in dialogue and collaborating with the company to define the next steps.
It must be noted, however, that Hungary, a member of the EU, has broken rank with the Union’s decision and approved Spunik V for its citizens. According to media reports, Viktor Orbán, Hungarian Prime Minister, criticised the EU for potentially endangering lives, gave the vaccine a six-month emergency use authorisation.