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Russia COVID-19 vaccine shows promising results but experts say approval is premature as Nigeria refer received samples to labs

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Photo credit: © Russian Defense Ministry's press service/TASS

SAT, SEPT 05 2020-theG&BJournal- Report published Friday in The Lancet Journal on the Russian Vaccine, the Sputnik V, said the vaccine induced a strong immune response in all 76 participants.

‘’Nonetheless, there are widespread concerns that the approval is premature. At the time of approval, the vaccine had not even started phase 3 trials, nor had any results on the earlier stage trials been published,’’ Lancet report said.

The Nigerian Government received samples of the vaccine on Friday delivered by Russia’s ambassador to Nigeria, Alexey Shebarshin, to the Minister of Health, Dr Osagie Ehanire who referred the vaccine promptly to the National Agency for Food and Drug Administration (NAFDAC) and the Nigeria Institute of Pharmaceutical Research and Development. Ehanire twitted that he discussed Nigeria’s interest in learning about the vaccine with the Russia Ambassador.

On Aug 11, 2020, Russia President Vladimir Putin announced to the world that he tested the vaccine already on his daughter effectively making the country the first in the world to approve a vaccine against COVID-19 (SARS-CoV-2). The vaccine is based on two adenovirus vectors and was developed by the Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia.

The Lancet said, presumably the results from the trial were available to the Russian Ministry of Health, adding, for regulators such as the US Food and Drug Administration (FDA) and the European Medicines Agency, however, data on immune response alone would not generally be an adequate basis for approving a vaccine.

It quoted Peter Openshaw, professor of experimental medicine at Imperial College London (London, UK) as saying “Immune response might not be directly proportional to the degree of protection—you can only find this out in large-scale trials.”

“We have no idea whether this vaccine is safe or whether it works”, cautions Ashish Jha, Dean of the Brown University School of Public Health (Providence, RI, USA). “It is really worrying when people start to bypass the standard process we have for vaccine development.”

Those behind the Russian vaccine have offered a combative response to such criticism. The official website was established with the stated aim to “provide accurate and up-to-date information about Sputnik V and to combat the misinformation campaign launched against it in the international media”.

Large-scale clinical trials of the vaccine, involving over 40 000 people, were scheduled to begin in Russia in the last week of August. “A number of countries, such as United Arab Emirates, Saudi Arabia, the Philippines, and possibly India or Brazil, will join the clinical trials of Sputnik V locally”, noted the official website.

Lancet said, Russian Direct Investment Fund (RDIF), the country’s sovereign wealth fund chief executive officer Kirill Dmitriev has confirmed that Russia has received international requests for 1 billion doses of its vaccine.

On Aug 26, 2020, Russian news agency TASS reported that the country would supply more than 2 million doses of Sputnik V to Kazakhstan.

Russia, which has seen almost 1 million cases of COVID-19, said that it would be able to provide 500 million doses of Sputnik V per year.

Openshaw points out that the places that have expressed interest in the vaccine are unlikely to start mass administration until they are assured that it is safe and effective. “There is a huge difference between Russia registering a vaccine within its own borders, which it is entitled to do, and international approval or WHO prequalification”, he said.

Countries all over the world have preordered millions of doses of other prospective COVID-19 vaccines, with the rollout contingent on the results of the phase 3 studies. For example, the USA has purchased 100 million doses of Moderna’s mRNA vaccine candidate and 300 million doses of Astrazeneca’s adenovirus vector vaccine. Other countries might choose to make similar arrangements with the Gamaleya Center. Press reports have quoted the Azerbaijani Foreign Minister saying that the country was “ready to consider the possibility of purchasing a Russian vaccine against coronavirus after the completion of procedures for its recognition by the WHO”.

According to WHO, as of Aug 28, 2020, nine vaccine candidates were in late-stage trials. These included separate adenovirus vector vaccines, a couple of mRNA vaccines, and several inactivated virus vaccines. There are plenty of vaccine candidates in earlier stages of evaluation. Experts are confident that at least one of the candidates will be successful. COVAX, a joint initiative between Gavi, the Coalition for Epidemic Preparedness Innovations, and WHO, aims to ensure any eventual vaccine is distributed fairly and equitably. 92 low-income and middle-income countries are eligible for support. The initiative is backing a range of vaccine candidates, including seven in clinical trials.

Given the pace at which the candidates are moving through the stages of development, Jha wonders why Russia felt it was necessary to skip straight to approval. “I do not think it makes sense; the difference between doing things correctly and not doing things correctly is a matter of a few months”, he said. “It seems like a very small gain, and the middle of a pandemic is not the time to be cutting corners.” There has been speculation that the approval has been motivated by nationalism. Most countries would welcome the positive publicity generated by being the first to bring a vaccine against SARS-CoV-2 to market. The USA has also invoked the space age in its fight against COVID-19; it named its drive to secure 300 million doses of vaccine by January, 2021, Operation Warp Speed.

If Sputnik V does not work or results in some kind of unforeseen adverse event in the phase 3 trial, that could affect the public perception of the vaccine process. Moreover, an ineffective product could actually worsen the pandemic—those who received the vaccine might stop taking precautions against contracting SARS-CoV-2. “There is a huge risk that confidence in vaccines would be damaged by a vaccine that received approval and was then shown to be harmful”, said Openshaw. A sizeable group of vaccine-hesitant people are already laying the groundwork on social media to discredit any potential COVID-19 vaccine. “We really do not want to make life any easier for those who are trying to undermine science”, said Jha.

On the other hand, it is entirely possible that Russia will hold off vaccinating its general population until it has received favourable results from the phase 3 trial. In which case, the announcement of the approval of Sputnik V might amount to a political gesture, rather than a serious attempt to circumvent the standard process of vaccine development. The FDA has stipulated that a vaccine against COVID-19 should be at least 50% effective. Sputnik V might well meet this criterion.

But until the phase 3 trial is completed and the results are made available, it will not be possible to make any judgement. “It is certainly not advisable for any vaccine to be used in an uncontrolled way before it has been through proper testing to determine whether the immune response it produces is actually protective, and there are no unexpected adverse events”, stressed Openshaw.-with Lancet report.

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