A leading coronavirus vaccine developer has been forced to hold a late-stage trial after a UK volunteer candidate suffered a suspected serious adverse reaction.
AstraZeneca Plc – which is working alongside the University of Oxford – has confirmed it had had to pause development of the vaccine “to allow review of safety data”.
It is unclear whether the vaccine front runner made the decision itself or was ordered by a regulatory agency, reports Stat News.
Findings from scientific studies of this vaccine, named “Sputnik V,” are not available. Large safety and efficacy trials are only now getting underway. But despite only two months of preliminary testing in people, Russian President Vladimir Putin called the vaccine “quite effective” and it’s received regulatory approval.
As an epidemiologist who studies vaccine hesitancy and vaccine-preventable disease, I’m concerned about this news from Russia. After essential workers and high-risk groups are vaccinated, I would want to be among the first in line for an approved COVID-19 vaccine, but the medical research system must make sure any vaccine is safe and effective before distributing it to the population at large.
Clinical trials have a valuable role
Before any drug, vaccine or medical device is licensed for use in the general population, it needs to go through several rounds of large-scale testing. These studies are designed to make sure the intervention is safe and effective, and to understand what the appropriate dosage will be.
In the face of the coronavirus pandemic, scientists around the globe are focusing their efforts on developing a COVID-19 vaccine. They’re working at anunprecedented pace to move through the necessary clinical trials to end up with a safe and effective vaccine. One of the most time-consuming parts of clinical trials is enrolling participants, and pharmaceutical companies have sped up this process by lining up volunteers early, obtaining important baseline data from them even before a vaccine candidate is available.
Here’s how drugs are tested and approved in the U.S.
Problems if the vaccine is released too early
Carefully conducted clinical trials are necessary to identify any problems with the vaccine. For example, studies of a new type of measles vaccine in the early 1990s found that it was detrimental to baby girls, and so it was never licensed to the general population. The existing measles or measles-mumps-rubella vaccine available in the U.S. and other countries is highly safe and effective.
It could also be that the vaccine is not effective in some categories of people. Phase I and II clinical trials have small sample sizes and may not include individuals from high-risk groups. For example, a recently published phase II clinical trial of a COVID-19 vaccine excluded obese people, those with chronic diseases and pregnant women. However, these are all groups that should be able to get the vaccine in the future. More studies, including phase III trials, are necessary to discover if the vaccine works in the general population. Preliminary results should be available by the end of 2020.
The concern is that by introducing the vaccine early, without adequate testing of safety, effectiveness and dosing, the population may be presented with a vaccine which is not safe or not effective, and with little information on which vaccine schedule is best.
Food and Drug Administration Commissioner Dr. Stephen Hahn has said the FDA will not “cut corners” in approving a COVID-19 vaccine in the U.S. despite an accelerated program, dubbed Operation Warp Speed.
In 1956, boxes of polio vaccine were rushed for delivery, but only after clinical trials concluded and it was approved by the FDA. Bettmann via Getty Images
Rushing to market
But is there ever an ethical reason to release a vaccine early, even without going through all phases of clinical trials?
Although it would be wonderful to get a vaccine into the population quickly, there could be substantial downsides if researchers and manufacturers cut corners. Imagine a vaccine that often had serious side effects that weren’t caught in small trials before it was widely administered.
An untested vaccine wouldn’t just harm the people vaccinated. If negative perceptions about the safety or efficacy of a COVID-19 vaccine spread throughout the population, it could limit how many people are willing to get the shot and perpetuate disease transmission.
Trust in vaccination programs is crucial. Russia, in fact, provides an important historical example. In the 1990s, trust in the country’s public health system rapidly decreased, and rates of diphtheria-tetanus-pertussis vaccination fell as a result. A large outbreak of diphtheria then spread through eastern Europe, leaving over 4,000 people dead.
Hasty rollout of a COVID-19 vaccine could prime people not only to not trust the COVID-19 vaccine, but also to doubt vaccination and public health systems as a whole.
Vaccinations should be developed by impartial scientists and evaluated by nonpartisan government officials. By cutting red tape, procedures can be prioritized and sped up, but they must not be skipped.
Moscow (CNN)Russian President Vladimir Putin announced the approval of a coronavirus vaccine for use on Tuesday, claiming it as a “world first,” amid continued concern and unanswered questions over its safety and effectiveness.
“A vaccine against coronavirus has been registered for the first time in the world this morning,” Putin said on state TV. “I know that it works quite effectively, it forms a stable immunity.”
“I hope our foreign colleagues’ work will move as well, and a lot of products will appear on an international market that could be used.”
The vaccine — developed by the Moscow-based Gamaleya Institute — has been named Sputnik-V. The name is a reference to the surprise 1957 launch of the world’s first satellite by the Soviet Union.
The treatment is yet to go through crucial Phase 3 trials where it would be administered to thousands of people.
Putin added that one of his daughters had already taken it; he said she had a slightly higher temperature after each dose, but that: “Now she feels well.”
The claim of victory by Putin in the global push to make an effective vaccine against Covid-19 comes amid suggestions that Russia has cut essential corners in its development.
Critics say the country’s push for a vaccine is partly due to political pressure from the Kremlin, which is keen to portray Russia as a global scientific force.
Russia has released no scientific data on its testing and CNN is unable to verify the vaccine’s claimed safety or effectiveness.
Despite this, Russian officials have told CNN that at least 20 countries and some US companies have expressed interest in the vaccine.
Russia is just one of many countries rushing to produce a vaccine for Covid-19, which has now infected more than 20 million people, killing more than 730,000 around the world.
In June, the Chinese government approved the use of an experimental coronavirus vaccine for the country’s military. The vaccine, known as Ad5-nCoV, was jointly-developed by the Beijing Institute of Biotechnology — part of the Chinese government’s Academy of Military Medical Sciences — and vaccine company CanSino Biologics.
Earlier this month, the Kremlin denied allegations Russian spies hacked into American, Canadian and British research labs to steal vaccine development secrets.
Researchers in the U.S. have shown both preventive and treatment effects of an antibody cocktail in animal models of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) – the agent that causes coronavirus disease 2019 (COVID-19).
A combination of two monoclonal antibodies significantly reduced airway viral load and virus-induced pathology in models of both mild and severe disease.
Christos Kyratsous and colleagues from Regeneron Pharmaceuticals, New York, had previously identified that a combination of the antibodies REGN10933 and REGN10987, which targets the SARS-CoV-2 spike protein, potently neutralizes the virus in vitro. The spike protein is the main surface structure the virus uses to bind to human host cell membranes and gain viral entry. The research is published on the preprint server bioRxiv* in August 2020.
Now, teaming up with collaborators at Texas Biomedical Research Institute in San Antonio and BIOQUAL in Rockville, Maryland, the researchers have demonstrated the efficacy of the antibody cocktail in two animal models: the rhesus macaque and the golden hamster.
The authors say their findings provide evidence that this REGN-CoV-2 therapy, which is currently being tested in clinical trials of COVID-19, may provide significant clinical benefit in both the prevention and treatment setting.
