A medical practitioner in Lagos, Dr. Cosmas Odoemena, says Russia has set a bad precedent that can affect safety measures for the production of vaccines in future.
He cited what he described as Russia’s ‘premature approval’ of its candidate COVID-19 vaccine — Sputnik V — as reason for the statement.
Odoemena said Russia’s action also poses a potential health risk, adding that already following Russia’s ‘misstep’ is China, which has decided to approve Sinovac’s COVID-19 vaccine candidate.
Speaking with PUNCH HealthWise in an exclusive interview, the physician said Russia “jumped the gun” by hastily approving the vaccine for use, without completing the processes vaccines undergo before they’re considered safe for public use.
“There are majorly three phases of a vaccine or drug trial. The Russian vaccine went through the first two phases but has not gone through the third.
“Russia did not even publish its trials until a few days ago when it did in The Lancet, a peer-reviewed journal. The country is just about to start the phase three human trials.
“There are over 300 candidate vaccines for COVID-19, with many in more advanced stages of development than Russia’s Sputnik V.
“Yet it went on to announce its approval for production before completing the last trial. It is highly unethical,” Odoemena said.
He noted the controversies surrounding vaccine production bordering on ethical issues, adding, “They relate to research and testing, informed consent and equitable distribution of the vaccines. But vaccines must still complete the mandatory protocols.”
He said the result obtained from phase two human trials of the Russian vaccine was not enough to draw conclusions on safety and efficacy.
Highlighting the importance of the three phases of vaccine trials, the physician said the drug manufacturing company, AstraZeneca, stopped its Oxford University randomised clinical trial when one of the participants developed an unexplained illness.
He then warned that using a vaccine that had yet to undergo the final trials wherein it is tested on an increased number of consenting people could destroy humanity.
“Now, there are almost eight billion people in the world. And we are all different, even in our genetic makeup.
“In phase one trial, the vaccine is tested on a small group of people, say, between 20 and 80. This is meant to determine how the vaccine works, and to pick adverse effects. Even then, one life matters.
“Using a small number of people reduces the risk of introducing a dangerous vaccine to the world.
“Imagine trying out a vaccine on all humans without testing it on a small number of consenting people first. Humanity could be destroyed. If it passes phase one, then it is pushed to more people in phase two.
“Between June 18 and August 3, Russia enrolled 76 participants in both trials — that is 38 candidates in each study. Thirty-eight is a relatively small number for phase two human trials. In phase three human trials, over 10,000 people can be enrolled,” he explained.
Comparing the Sputnik V vaccine with the inactivated polio vaccine developed by American physician Jonas Salk in the 1950s, Odoemena rated the Russian effort low.
Salk had worked incessantly for two-and-a-half years, and his vaccine was the first to be deployed in the treatment of the paralytic disease.
According to Medical Britannica citation on Salk, the large-scale use of his IPV began in February 1954, when it was administered to American schoolchildren.
Said Odoemena, “For the trial of the Salk Polio vaccine developed in the early 1950s by American physician Jonas Salk, over one million people were enrolled. However, with a small number of people, adverse reactions may not occur.
“But as you increase the number, adverse reactions may be seen and documented.”
He said the fact that the world was desperately in need of a COVID-19 vaccine did not mean that billions of lives should be exposed to an “uncertified treatment regimen.”
“Everyone knows that, for us to deal decisively with the COVID-19 pandemic, the world will require a vaccine. The world will be grateful for the vaccine. But you can’t put the world at risk by releasing for public use something that has not been certified safe.
“Remember, not everyone might contract the virus. So, imagine someone who has been healthy all along being given the vaccine, and ultimately dying from it.
“Russia did not consider this before releasing the Sputnik V vaccine. President Vladimir Putin has been criticised by his people for the way he handled the COVID-19 pandemic in Russia,” Odoemena said.
He noted that Russia’s “hasty vaccine approval” was aimed at getting ahead of the West, adding “It’s a cheap way to score a political point.
“The fact that the vaccine was named after the world’s first artificial satellite, called Sputnik and launched by the Soviet Union on October 4, 1957, says it all,” he said.
He said it was time Nigeria got serious and worked towards producing its own COVID-19 vaccine by deliberately investing in scientific research, warning that the ongoing crop of vaccines under production had practically been paid for.
“Let me let you know that most of the vaccines that are in advanced stages have all been paid for by big countries like the US.
“So, if an effective vaccine comes out now, they will first give it to their people before countries like Nigeria can get them.
“It’s time Nigeria woke up from its slumber. It cannot continue to be a toddler when it comes to scientific research.
“It must invest deliberately in research. The least I expect from Nigeria is to call our medical scientists to brainstorm on getting a vaccine.
“At worst, Nigeria could sponsor some vaccine trials abroad and also sponsor indigenous scientists to be a part of such researches. Eventually, the knowledge can be brought back home for the benefit of the nation.
“Nigerian scientists have great ideas, and with the internet age, we are at par with information with our colleagues abroad. The main difference is, they have the support and we don’t.
“As far as I know, Nigeria is not producing any COVID-19 vaccine, nor is it a part of any trials for any vaccines.
“Nigeria is only waiting to use vaccines produced elsewhere. But if any vaccine has passed through all the safety checks and is certified safe for use, Nigeria as a country can bring it into the country for public use.
“However, vaccines cannot be forced on anybody,” Odoemena said.