Encouraging results. Richard Fisher recounts what it was like to volunteer for this vaccine trial.
I am sitting at a hospital reception and my glasses are blurring because of my breathing. A few minutes ago I was going through the humid heat of the streets. I was late to the doctor's on time.
At that time the doctors and nurses were walking comfortably towards the same hospital from me, I knew that my health was not looking good. The last time I agreed to go to St George's Hospital in South London was when my daughter was born.
But today I was feeling a lot of pain.
I could smell the hospital floor cleaning bleach from my mask. And there was a tape on the seat next to me, which meant no one else could sit next to me.
Two hospital staffers came to me wearing their special protective clothing and masks, one of them holding a placard like a taxi driver standing in the passenger section of the airport, which reads 'Vaccine Trial' That is, the trial of the vaccine.
This placard is for me. I followed them, adopting the two-meter distance rule, they are both engaged in their gossip.
I was going through the initial phase of screening for the experimental stages of Oxford University's Covid-19 vaccine development at St. George's. In the coming weeks, I will be able to find out what it feels like to participate in efforts to fight the world's epidemics.
Oxford University's efforts to develop this vaccine around the world are at the forefront.
A few weeks later, on July 20, Oxford University researchers announced the results of experiments on 1,077 volunteers. The announcement said their trial vaccine was safe and would rapidly boost the immune system.
"There's still a lot of work to be done, but the initial results are very encouraging," Oxford University's Sarah Gilbert said in a statement.
The next step will be to test the same vaccine on thousands of people who have volunteered from different parts of the UK, Brazil, and South Africa. I am also participating as a volunteer for this phase of the Corona vaccine development trial, which will test the effectiveness of this vaccine on a large scale.
Screening process
My journey to join this experiment began on a May night when I accidentally saw a tweet from an Oxford University philosopher about vaccine research, and one that I knew needed to be worked on faster. Is.
The philosopher introduced himself as a volunteer for the vaccine experiment. That night while my wife was resting with me, I went to the trial website and registered myself and then forgot about it later.
A few weeks later, I am in the neurology ward at Oxford University for this experimental experiment, where I see Matthew Snape, a key scientist in the experiment, on a big screen, telling a volunteer what to do. Be aware of what we can and cannot do, how vaccine science works, and what unexpected reactions to vaccine use may occur during this experiment.
"These vaccine trials will involve 10,000 people and we will form two groups of volunteers in a random manner," Snap said. One group will be given a vaccine that does not protect against the coronavirus and the other group will be given a vaccine developed for COVID-19 (ChAdOx1).
The virus is based on a common cold or flu-like virus that chimpanzees usually prey on. This is the technique that this research group has been working on since before the outbreak of the virus caused by viruses such as MERS and Ebola. And that's why the group was able to work so fast to develop a vaccine for the new virus, Covid-19.
Earlier this year, as the world began to realize that the epidemic was not going to end soon, the Oxford University group began working on it.
SNAAP also explained the reason for making this video which I am watching. They first acquired the chimpanzee cold virus and then genetically modified it so that it could not spread to humans. The next day, they inserted a gene into Covid-19 that makes a protein called "spike glycoprotein".
If the human body "begins to recognize spike glycoproteins and develop an immune system against them, it is hoped that this will help prevent Covid-19 from attaching to human cells."
About half of the volunteers will be vaccinated, Snape said. The other half will be given the currently licensed vaccine, called 'Main ACWY', (in the case of meningitis or meningitis), to prevent the causes of meningitis (meningitis) or sepsis (sepsis). Is given.
This vaccine is a kind of 'control' in terms of comparison, and it was chosen because it is a harmless substance that is given as a medicine.
This harmless substance was substituted for the original vaccine so that its effects and reactions could be observed as a real vaccine, and they could not work with the group in which the original vaccine was used. Was done
Since 2015, 'Main AC Double Y' has been given to children in the UK as usual. And it has been given as a travel vaccine before going to dangerous parts of the world, including sub-Saharan Africa. Pilgrims entering Saudi Arabia are already asking for confirmation of the main ACWY vaccine.
After watching this video, I was asked about my medical history and whether I ever had symptoms of the coronavirus. My blood test was taken for analysis and I was asked to participate in the various stages of this research.
I was asked to take pictures of the injection site, I would not donate blood, I would use contraceptives if I were a woman of childbearing age, and so on and so forth.
One instruction stopped me for a moment: "I agree that these specimens will be considered a donation to Oxford University." I couldn't help but smile when I learned that some participants would be asked to submit their waste samples.
On my way back home, I was feeling more and more sensible knowing the subject in detail. But at the same time, I was skeptical that, like any clinical trial, participants should be aware of the additional reactions that come with it, such as minor problems (nausea, headaches, etc.). To severe discomfort (Glenn-Bad syndrome, which causes severe weakness in the body and can even lead to death).
I knew that the chances of this trial were slim, but it would be a daunting task to know all the details at once.
During the initial screening, volunteers were made aware of the 'theoretical' level of concern about the vaccine, which may worsen the symptoms of the coronavirus.
A study of animals that had been vaccinated against SARS found that their lungs became inflamed when they were infected with the SARS virus. Another report found that a rat that had been vaccinated during a trial had developed inflammation in its lungs when it contracted the measles virus. However, no such reactions have been reported in any of the animal experiments for the Void vaccine.
Vaccination day
A week later, on July 3, I came to the same glassless room in St. George's where I was scheduled to meet with the screening staff. In a way, it was a day of vaccinations, but now I am worried that I will be exempted from this test.
Dr. Eva Gleza left the room and did not return until ten minutes later. Earlier, he had said that today was the last day of the Oxford University experiment at St George's Hospital and that he now had samples to run out of.
They talked again about my medical history, took more blood for the test, but Dr. Gleza, who is a vaccine researcher on children and who has been recruited for this project, had no idea before he reached the pharmacy. I wondered if I could take part in the trial.
Now I am curious to know what is going to happen next that we are unaware of. To ensure that the results of the vaccine trial are accurate, the participants in the experiment and the doctors who administered the vaccine did not know whether the trial was taking place or whether the syringe contained meningitis. There is a vaccine available.
When she was gone I started thinking of different things in my mind. Thinking about these things, I started thinking about the outside world. In England, where I live, this is the day when lockdowns are being eased and many businesses, from bars to barber shops, can finally open now.
The social distance policy for England is changing, now the distance between two people has to be one meter instead of two meters. The introduction of these changes was creating a state of hegemony as well as unrest.
My mind was thinking of friends and relatives living in different parts of the world, each going through a different experience of this epidemic. Some were celebrating the day as free from the virus, while others were deeply saddened by the rising death toll.
For most of last year, I lived in Massachusetts. The day I was scheduled to be in this hospital, the conditions were very serious for people I knew in the United States. On that day, 40,000 cases per day were recorded in four different days in a week in the United States and throughout the country. The number of victims was alarming.
As I drove, I heard about the growing number in Brazil. A friend and his wife had just returned. The number of victims in Brazil that day was 1.5 million. The widespread of the epidemic in Brazil is one of the main reasons why the Oxford University experiment has been extended to Rio de Janeiro, Sao Paulo, and northern Brazil. Now they are doing the same in South Africa.
The truth is that volunteer scientists like me in the UK can hardly tell if this vaccine is working, because at least for now, compared to areas where the virus is spreading throughout society, my virus Is less likely to be affected. For a larger cause at this level, including me, ten thousand volunteers will face this deadly disease.
When Dr. Gleza returns, she has a bottle in her hand. I couldn't see his face hidden in the mask, but his eyes were smiling. After waiting for several weeks, a syringe needle entered my arm and the vaccine entered my bloodstream with a single injection for a few seconds. And now it's 50-50 probability which trial group I'm in. I will not know until this trial is over.
Cotton wool and wait
The next step is a long wait. Participants in this trial were divided into two groups, each given different times to report the effects and symptoms of their vaccine, give tests and blood samples, and report different times. The next level comes seven days after I get vaccinated and I'm not really looking forward to that time.
I have to clean my throat glands without touching my teeth and tongue with a cotton swab for ten seconds, it is not an easy task, then I have to insert that swab into the nostrils as much as possible. I read somewhere that if you clean your nostrils properly, you will feel like you are 'tickling your brain.' It wasn't bad, but it wasn't comfortable.
I then put the cotton swab in a sealed plastic envelope and put it in a box that says 'Biological Substance B Category', and then put it in the post box with a special system called 'Preferred Post Box'. Send via This special system has been introduced by Royal Mail to send samples of such tests from homes.
A few days later I will receive a message on my mobile phone telling me if my coronavirus test is positive or not.
When samples of throat and nose saliva are taken from a cotton swab, I also fill out a questionnaire about my condition and activities over the past week. 'Did I travel on any public transport?' 'How many people did I spend more than five hours with besides my family?'
I will repeat this process every week for these four weeks, and for the next full year, I will go to the hospital and get my blood tested regularly.
It takes so long that some people, most of them politicians, are unable to understand the experiences of developing a vaccine for the coronavirus. You can't just spend money and expect immediate results.
Now that the first phase of this Oxford University experiment has yielded encouraging results from the safety of its vaccine and the tremendous results that it has the potential to strengthen the immune system, we forget that it is only There was a trial of a thousand people.
To release a new vaccine to millions of people (or to the rest of the world), you need to have a high level of confidence in its effectiveness, which comes from getting more and more data from these tests and patients.
Public health officials will remember well when the vaccine issued went wrong.
Fearing an outbreak of swine flu in 1976, the US government accelerated the development of the vaccine, and millions of people were vaccinated. The outbreak that was feared did not occur, but according to some estimates, about 30 people died as a result of the vaccine.
Such incidents undermine public confidence in the Department of Public Health's guidelines and create the anti-vaccine sentiment, and you won't want that kind of reaction during any outbreak.
In addition to the decision-making power of drug certification bodies around the world, they also have a heavy responsibility. Sir John Bell, Professor of Medicine at Oxford University, told the BBC on July 21 that "we do not have the facilities to wait for final results through clinical trials."
"The most difficult step for any regulator is to decide if a drug or vaccine is safe and effective and to allow its release. I do not want to take such a responsibility. However, this is a very difficult task. If the answer is yes, there will be a sudden queue of three and a half billion people to receive the vaccine
And they shouldn't change, researchers say. When I am not convinced that there is a vaccine that is effective and that protects my wife, daughter, friends, relatives, and strangers who pass by my street every day. , I will continue to adhere to the principles of social distance.
Basically, I, along with tens of thousands of others, am happy to play a small but significant role in this big ordeal that is currently being watched around the world. The speed with which this group from Oxford University began to fight this epidemic and the kind of systematic work and diligence that has been demonstrated is very commendable.
Prior to the outbreak, experts involved in the research we're engaged in their own work in vaccine research centers across the country, where they fought for scientific curiosity or an individual sense of responsibility. He never expected to carry the burden of the hopes or expectations of billions of people on his shoulders.
Scientists may not have succeeded in the vaccine trial at Oxford University, which everyone is now hoping for. The vaccine may not be as effective or as safe as it used to be, but that's how science progresses. It is a long-term, collective effort and fraught with the mistake.
Source; BBC
Comments