In this photo made from footage provided by the Russian
Defense Ministry on July 15, 2020, medical workers prepare to draw blood from
volunteers participating in a coronavirus vaccine trial at the Budenko Main
Military Hospital outside Moscow, Russia.
Moscow
sees a Sputnik-like propaganda victory, recalling the Soviet Union’s launch of
the world’s first satellite in 1957. But the experimental COVID-19 shots began
first-in-human testing on a few dozen people less than two months ago, and
there’s no published scientific evidence yet backing Russia’s late entry to the
global vaccine race, much less explaining why it should be considered a
front-runner.
“I’m
worried that Russia is cutting corners so that the vaccine that will come out
may be not just ineffective, but also unsafe,” said Lawrence Gostin, a global
public health law expert at Georgetown University. “It doesn’t work that way.
... Trials come first. That’s really important.”
According
to Kirill Dmitriev, head of Russia’s Direct Investment Fund that bankrolled the
effort, a vaccine developed by the Gamaleya research institute in Moscow may be
approved in days, before scientists complete what’s called a Phase 3 study.
That final-stage study, usually involving tens of thousands of people, is the
only way to prove if an experimental vaccine is safe and really works.
Health
Minister Mikhail Murashko said members of “risk groups,” such as medical
workers, may be offered the vaccine this month. He didn’t clarify whether they
would be part of the Phase 3 study that is said to be completed after the
vaccine receives “conditional approval.”
Deputy
Prime Minister Tatyana Golikova promised to start “industrial production” in
September, and Murashko said mass vaccination may begin as early as October.
Dr.
Anthony Fauci, the top U.S. infectious disease specialist, questioned the
fast-track approach last week. “I do hope that the Chinese and the Russians are
actually testing a vaccine before they are administering the vaccine to anyone,
because claims of having a vaccine ready to distribute before you do testing I
think is problematic at best,” he said.
Questions
about this vaccine candidate come after the U.S., Britain and Canada last month
accused Russia of using hackers to steal vaccine research from Western labs.
Delivering
a vaccine first is a matter of national prestige for the Kremlin as it tries to
assert the image of Russia as a global power capable of competing with the U.S.
and China. The notion of being “the first in the world” dominated state news
coverage of the effort, with government officials praising reports of the
first-step testing.
In
April, President Vladimir Putin ordered state officials to shorten the time of
clinical trials for a variety of drugs, including potential coronavirus
vaccines.
According
to Russia’s Association of Clinical Trials Organizations, the order set “an
unattainable bar” for scientists who, as a result, “joined in on the mad race,
hoping to please those at power.”
The
association first raised concern in late May, when professor Alexander
Gintsburg, head of the Gamaleya institute, said he and other researchers tried
the vaccine on themselves.
The
move was a “crude violation of the very foundations of clinical research,
Russian law and universally accepted international regulations” the group said
in an open letter to the government, urging scientists and health officials to
adhere to clinical research standards.
But
a month later, the Health Ministry authorized clinical trials of the Gamaleya product,
with what appeared to be another ethical issue.
Human
studies started June 17 among 76 volunteers. Half were injected with a vaccine
in liquid form and the other half with a vaccine that came as soluble powder.
Some in the first half were recruited from the military, which raised concerns
that servicemen may have been pressured to participate.
Some
experts said their desire to perform well would affect the findings. “It’s no
coincidence media reports we see about the trials among the military said no
one had any side effects, while the (other group) reported some,” said Vasily
Vlassov, a public health expert with Moscow’s Higher School of Economics.
As
the trials were declared completed and looming regulatory approval was
announced last week, questions arose about the vaccine’s safety and
effectiveness. Government assurances the drug produced the desired immune
response and caused no significant side effects were hardly convincing without
published scientific data describing the findings.
The
World Health Organization said all vaccine candidates should go through full
stages of testing before being rolled out. “There are established practices and
there are guidelines out,” WHO spokesman Christian Lindmeier said Tuesday.
“Between finding or having a clue of maybe having a vaccine that works, and
having gone through all the stages, is a big difference.”
Offering
an unsafe compound to medical workers on the front lines of the outbreak could
make things worse, Georgetown’s Gostin said, adding: “What if the vaccine
started killing them or making them very ill?”
Vaccines
that are not properly tested can cause harm in many ways — from a negative
impact on health to creating a false sense of security or undermining trust in
vaccinations, said Thomas Bollyky, director of the global health program at the
Council on Foreign Relations.
“It
takes several years to develop any drug,” said Svetlana Zavidova, executive
director of Russia’s Association of Clinical Trials Organizations. “Selling
something the Gamaleya (institute) tested on 76 volunteers during Phase 1-2
trials as a finished product is just not serious.”
Russia
has not yet published any scientific data from its first clinical trials. The
WHO’s list of vaccine candidates in human testing still lists the Gamaleya
product as in Phase 1 trials.
It
uses a different virus -- the common cold-causing adenovirus -- that’s been
modified to carry genes for the “spike” protein that coats the coronavirus, as
a way to prime the body to recognize if a real COVID-19 infection comes along.
That’s like vaccines being developed by China’s CanSino Biologics and Britain’s
Oxford University and AstraZeneca.
It’s
not the first controversial vaccine Russia developed. Putin mentioned earlier
this year that Russian scientists delivered an Ebola vaccine that “proved to be
the most effective in the world” and “made a real contribution to fighting the
Ebola fever in Africa.”
Russia’s
Health Ministry authorized two Ebola vaccines for domestic use -- one in 2015
and another one in 2018 -- but there is little evidence either was widely used
in Africa.
In
2019, the WHO considered the 2015 vaccine along with several others for use in
Congo but didn’t pick it. It pointed out that it had been approved for
emergency use after Phase 1 and 2 trials, but not Phase 3. According to
ClinicalTrials.Gov, a website maintained by the U.S. National Institutes of
Health, a study among 2,000 people in Guinea and Russia was still ongoing last
month.
The
2018 Ebola vaccine, according to the WHO, was tested on 300 volunteers in
Russia and completed all three phases. The Associated Press couldn’t find any
records of the studies in the Health Ministry’s registry of approved clinical
trials. As of 2019, both Ebola vaccines were listed by the WHO as “candidate
vaccines.”
Russia’s
Health Ministry did not respond to numerous requests for comment, and the
Gamaleya institute referred an interview request to the ministry.
It
remains unclear whether Phase 3 trials, said to be carried out after the
COVID-19 vaccine receives “conditional approval,” will wrap up by October, when
health officials plan to start mass vaccinations, and how trustworthy the
results will be. The study will supposedly involve 1,600 participants — 800 for
each of the two forms of the vaccine; in comparison, a similar Phase 3 trial in
the U.S. includes 30,000 people.
According
to Dmitriev, countries including Brazil and India have expressed interest in
the vaccine.
For
Lawrence Gostin, this is another cause for concern.
“There
may be many people in the world who don’t care about the ethics and just want
the vaccine,” he said.
********************
Michael
Osterholm: 22:34 into the
podcast
“You may have heard the Russians announcing last week
that they will have a vaccine soon that they would be providing for their
population - that one I have some concerns about in terms of how much safety
and effectiveness data do they have”
