Vladimir Putin claims his daughter has received a dose of the “safe” Covid-19 vaccine developed by researchers at Russia’s Gamaleya Research Institute of Epidemiology and Microbiology, but the announcement has raised suspicions around the world.
Just a day after World Health Organization director-general Tedros Adhanom Ghebreyesus said the world would need $US100 billion just to secure and produce a successful vaccine, Russia’s Ministry of Health declared it had approved a registration certificate for a candidate drug that has been tested in 38 people.
It was a shock announcement because, in a field of more than 160 vaccine development efforts, the Russian product had yet to make it out of phase one clinical trials. Initially, the study was due to be completed today, but the results were declared on Monday instead, five days earlier.
The vaccine, dubbed “Sputnik V” by officials, has been given emergency approval under the nation’s Covid-19 arrangements and has been marked safe for use in the Russian population. Mass production will begin next month.
A website spruiking the vaccine says it “induced strong antibody and cellular immune response” in trial patients.
“Not a single participant of the current clinical trials got infected with Covid-19 after being administered with the vaccine,” it said. “The high efficacy of the vaccine was confirmed by high precision tests for antibodies in the blood serum of volunteers … as well as the ability of the immune cells of the volunteers to activate in response to the spike S protein of the coronavirus, which indicates the formation of both antibody and cellular immune vaccine response.”
Russia appears to be using the initiative as a soft-power push, claiming “all leading Western media” have rejected an approach to publish a “forbidden” opinion piece written about the “Sputnik moment” and the nation’s “willingness” to co-operate with “the international community”.
However, the announcement raises more questions than it provides answers. Many experts doubt Russia’s claims and still believe the world’s best chance at a vaccine will come from two candidates currently in the third phase of clinical trials – one in Britain and the other in China.
In two massive efforts, researchers from Oxford University and CanSino Biologics have both published results from large, randomised control studies – single-blind and double-blind respectively – in the medical journal The Lancet.
On Tuesday, Australia’s acting chief medical officer, Professor Paul Kelly, told reporters the Oxford vaccine “would be in my top six, perhaps, of vaccines that are most developed and most hopeful”.
“It’s not the only one, and none of them are ready right now to be rolled out in large numbers to protect us,” he said.
“I don’t have a crystal ball … [but] these types of developments usually take years; it’s not going to be years.”
Oxford University is using a chimpanzee adenovirus as a platform for the delivery of its vaccine candidate. Inside this common virus, which has been engineered so it can’t replicate in the human body, the researchers have inserted a full copy of the code for the spike protein that gives the coronavirus its crown of thorns.
This is also the protein against which the human body produces an immune response. Teaching the body to deal with the protein before the actual SARS-CoV-2 virus turns up is what would, they hope, produce immunity to it.
More than 1000 people were included in the Oxford study, with results published online in The Lancet on July 20. The paper says the vaccine in this stage was “safe, tolerated, and immunogenic” with minor to moderate side effects, easily treated with paracetamol.
The so-called China vaccine trial was a double-blind study involving 603 volunteers who received a single jab, which researchers say “induced significant immune responses in the majority of recipients”. The scientists here used a more common adenovirus type-5 viral vector, but similarly copied the full-length spike gene, taken from one of the original Wuhan strains, into the platform.
“Unlike typical vaccine development, which often takes decades, developing a vaccine to prevent Covid-19 has become a race between humans and the virus,” the study authors say.
“… Both neutralising antibody and T-cell responses were important in eliminating the virus and controlling disease development in patients with Covid-19 who were naturally infected by SARS-CoV-2.
“Antibodies are very likely to be effective against SARS-CoV-2 … But for the vaccine-induced immune responses, whether neutralising antibody alone is capable of preventing infection remains undetermined.”
The Lancet’s editor-in-chief, Richard Horton, said neither vaccine effort so far is “telling you that these vaccines are efficacious in preventing Covid”. What they are showing is a pathway to a vaccine.
“The China study found the immune response in older adults was not as effective,” he said. “So these twists in the vaccine story are going to take place. If we have a vaccine by the end of 2021 we will have done incredibly well.”
Using a completely different technology, known as a “molecular clamp”, a team of scientists from the University of Queensland have developed a candidate vaccine and this week began administering a second dose to about 80 study participants.
“A significant number of UQ students and staff volunteered for the study, which shows great confidence in the work conducted at the university,” lead researcher Professor Paul Young told The Saturday Paper.
“First results will not be available until mid-to-late October. Final results won’t be available until December. It takes time to run the study and do the required analysis.
“All going to plan, there is scope to accelerate the program and have clinical trial data available for registration with relevant regulatory authorities by 2021.”
Horton said there is a “danger” in the fact that the global race to find a vaccine is “very fragmented”. It creates a question over equality.
“The danger of that is that only the strongest countries, those with the most money, might win,” he said. “There is a real danger that the groups most at risk will not get fairly or equitably treated and that would be cause for global shame.”
Australia has only now committed to boosting manufacturing capacity to meet the requirements for vaccine production, pending which ones become successful. The process to build the vaccines is different based on the “platform” used to deliver the shot and there are at least five different categories of these. If there were more than one successful vaccine, for example, deputy chief medical officer Nick Coatsworth said on Wednesday that Australia would “call for those vaccines … to be available to every nation in the world”.
Waiting for the oft-cited but poorly understood “herd immunity”, though, is not an option.
“We are a long way away from herd immunity in any country in the world, including in some of the countries that have been so badly affected, much more badly than here in Australia,” Paul Kelly said on Tuesday.
“So a survey recently, in the last week or so, in Italy, for example, found … only about 2.5 per cent of people in Italy have been infected. And I’m sure people will remember the scenes from hospitals in northern Italy in particular from earlier in the year.
“So we are a long way from that [and] there will be many more cases throughout the world.”
This article was first published in the print edition of The Saturday Paper on August 15, 2020 as "The vaccine hunt".
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