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On July 20, Oxford researchers announced promising initial results, but with just 1,077 people.

The vaccine developed by the University of Oxford (United Kingdom) against covid-19 has so far yielded results described as « promising ». Richard Fisher is one of the volunteers who was inoculated with this experimental vaccine. This is his story.

I am in a hospital waiting room and my breathing fogs my glasses. Minutes before, I ran down the street on a very humid day to avoid being late for the appointment. Doctors and nurses left me behind with their hurried steps and that made me think that I don’t have a great physical condition.

The last time I was at St George’s Hospital in South London, it was for the birth of my daughter. Now it feels very different. I can smell through my mask the bleach used to clean the floors and the seat next to me is covered with tape to maintain physical distance.

Two hospital workers with masks and personal protection approach with a sign that says: « ANDvaccine trial « As if they were taxi drivers waiting for passengers in the arrival area of ​​an airport.

The poster is for me. I follow them slowly as in a procession, two meters behind, while they talk.

I’m here to assess if I can volunteer in one of the ChAdOx1 nCoV-19 vaccine trials. In the coming weeks, I will know what it feels like to participate in one of the biggest efforts to combat the pandemic.

Of all the candidate vaccine trials, that of Oxford is one of the most advanced.

On July 20, Oxford researchers announced promising initial results, based on a trial of 1,077 people. The vaccine, according to these data, is safe and generates a response from the immune system.

« There is still a lot of work to do … but these initial results are auspicious« Said Sarah Gilbert, the scientist leading the trial.

The final results will only be known with phase 3 of the clinical trial, in which thousands of volunteers participate in the United Kingdom, Brazil and South Africa.

It is for this large-scale stage that I volunteered.

Evaluation

My journey here started one night in May when I saw a tweet from a philosopher at Oxford University about a trial for a vaccine. He had volunteered.

While my wife slept next to me I decided to fill out the volunteer form and forgot about it.

A few weeks later, here I am, in a neurology room now destined for the vaccine trial, as I see one of the Oxford scientists, Matthew Snape, on a screen explaining the scientific basis for the tests and possible side effects.

In total there will be 10,000 volunteers and we will be randomly divided into two groupsSnape says. One will receive a vaccine that offers no protection against the new coronavirus, and one will be inoculated with the Oxford vaccine.

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The Oxford vaccine uses an attenuated version of a flu virus that infects chimpanzees.

The vaccine uses a attenuated version of a flu virus that infects chimpanzees.

It is a technique that Oxford scientists had been working on before the pandemic to combat Middle East Respiratory Syndrome (MERS) and Ebola. This is why they were able to move forward so quickly when they refocused their work in response to covid-19.

Snape explains how they developed the vaccine. First they took the virus that attacks chimpanzees and genetically modified it so that it does not attack humans.

They then incorporated genes that encode covid-19 virus proteins called glycoproteins. Scientists hope that these proteins will generate the immune response necessary to defeat the new coronavirus.

The group that will not receive this vaccine will be inoculated with another vaccine called MenACWY (also Nimenrix or Menveo), which is used to combat meningitis and sepsis.

This is the « control » vaccine that will make it possible to compare its effects against the coronavirus.

The scientists chose a vaccine instead of any placebo for the control group for one clear reason: ensure that all volunteers experience the side effects of an inoculation and cannot deduce which group they are in.

The MenACWY vaccine has been used in adolescents in the UK since 2015. It is also offered to those traveling to areas at high risk of infection, such as sub-Saharan Africa. And Saudi Arabia requires MenACWY vaccination certificates from all participants in the annual pilgrimage to Mecca.

After watching the video, I was asked in detail about my medical history or any previous symptoms of covid-19. They took blood samples and I had to sign a document that stipulates several obligations: for example, I will allow them to publish photos of my inoculated arm and I will not donate blood. Women should also commit to using contraception during the trial.

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« There is still a lot of work to do, » said Sarah Gilbert, the scientist leading the Oxford trial.

I came home feeling more informed, but also a little more nervous than before.

As in any clinical trial, volunteers should be aware of potential side effects, from the mildest (nausea, headaches, etc.) to the most severe (such as Guillain-Barré syndrome, which can cause paralysis and be fatal).

I know the risks of the trial are less, but I must confess that reading the list of possible side effects at once is overwhelming.

They also informed us of « theoretical possibilities » that the vaccine aggravates the symptoms of the covid-19.

Some studies indicate that animals that received experimental vaccines against Severe Acute Respiratory Syndrome (SARS) showed more inflammation in their lungs. Something similar occurred in mouse trials of experimental MERS vaccines.

But those effects were not seen in animal testing of the Oxford vaccine.

I am reassured to know that thousands of people have already been vaccinated in earlier stages of the trial and suffered no severe consequences, as confirmed by the study published in The Lancet on July 20.

(And I want to make absolutely clear that none of the possible side effects justify the unsubstantiated arguments of the anti-vaccine movement).

Vaccination day

A week later, on July 3, I returned to the same room at St George Hospital where I had my first evaluation. It’s supposed to be the day of inoculation, but I’m concerned that I’m going to be left out of the trial.

The doctor, Eva Galiza, left the room 10 minutes ago and has not yet returned. Shortly before, he explained that it was the last day of the St George trial and that they were running out of vaccines.

Galiza is a researcher in pediatric vaccines. To ensure that the study results are reliable, both doctors and volunteers are unaware whether the injected vaccine is against the coronavirus or is lto control.

When Galiza leaves the room I am alone with my thoughts. In England, where I live, it is the day before many confinement rules are lifted and shops, from barber shops to bars, will be allowed to reopen.

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« The most difficult task is for the regulatory body to decide whether the vaccine is safe and will be used with the public, » said John Bell, professor of medicine at the University of Oxford.

I think of friends and family in other parts of the world, each experiencing different stages of this pandemic. While some countries celebrate controlling infections, others continue on an upward death curve.

Last year I lived in Massachusetts. The day of my appointment in St George the news from the United States was discouraging, with more than 40,000 new cases of infection daily.

I also heard the latest figures from Brazil, where a friend and his wife recently returned there. The number of new daily cases in this South American country was close to 1.5 million.

Outbreaks in Brazil are the reason why Oxford researchers expanded their trials to include volunteers in Rio de Janeiro, Sao Paulo and another location in the north of the country. They will also include volunteers in South Africa.

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The Oxford vaccine trial was expanded to include thousands of volunteers in Brazil and South Africa.

The sad truth is that a volunteer like me in the UK is less likely to help scientists determine the vaccine’s effectiveness. Here, at least for now, I am less exposed to a possible infection than someone in Brazil or South Africa, where the pandemic continues to spread.

For the good of all, some of the 10,000 trial volunteers will need to come into contact with the virus.

When Galiza returns to the room she carries a vial in her hand. I can’t see his face behind his mask, but his eyes smile. After weeks of waiting and after a brief inoculation, the vaccine finally circulates in my blood.

There is a 50% chance that I have been injected with the Oxford vaccine and 50% that I have received the control vaccine, and I will not know which one I had until the end of the trial.

Swabs and Waits

After the inoculation came the stage of the long wait. All the volunteers were divided into small groups to monitor possible symptoms.

In my case, seven days after receiving the vaccine, I must rub my tonsils with a cotton swab for 10 seconds. Then I must place the same swab in a nostril and bring it as high as possible. I’ve read that if you do this correctly, you should feel like you’re practically « brushing your brain. » I think that image is a little exaggerated, but I must confess that this test is not something pleasant.

After taking the sample, I must place it in a sealed bag that goes in a sealed box that says: « Category B biological substance », and send it to special mailboxes for « priority shipments ».

The service was recently introduced to facilitate testing of covid-19. A few days later I received a text message telling me that my coronavirus test was negative.

In addition to swabbing, I must fill out a form with questions about my behavior in the previous week. Have I used public transport? How many people who do not live in my home have I spent more than 5 hours with?

I will repeat this weekly routine for at least four months. AND I will have blood samples taken at the hospital until the end of next year.

© Richard Fisher
The British Post Office installed priority mailboxes for sending samples of volunteers and tests of covid-19.

This long and necessary stage is one that many people, including various politicians, do not understand. You cannot invest large sums of money to speed up this process.

The Oxford vaccine has already shown promising results, but only in nail a thousand people. Approving the use of a vaccine for millions of people requires a level of trust that can only be obtained with patience and much more data.

Some health workers will remember several tragic cases of trials. In 1976, for example, due to fears of a new outbreak of influenza A (H1N1) or swine flu, the US government accelerated trials of new vaccines and millions of people were inoculated.

The dreaded pandemic never came, but an estimated 30 people died from adverse side effects. Those mistakes may have contributed to the growth of the anti-vaccine movement..

Health authorities with competence to approve or reject candidate vaccines have an enormous responsibility in their hands.

As scientist John Bell, professor of medicine at the University of Oxford, said in a BBC program, we cannot afford to wait for the definitive evidence that would normally be required in clinical trials of this kind.

« The most difficult task is that of the regulatory body that must decide if the vaccine is safe and will be used with the public. If you say yes, there will be a line of three billion people who want that vaccine. I wouldn’t want that job, « Bell said.

Another important factor is that the approved vaccine may not be the panacea that people expect. In other words, the vaccine may not completely kill the virus, but only mitigate its effects.

This protection is valuable, but whatever happens with trials, we must accept that it is a long-term problem and that the virus could be with us forever.

In my particular case, thinking that there is a 50% chance that I have received a promising vaccine gives me some peace of mind, but it will not make me change my behavior. The researchers clearly explained this.

Until we know for sure that there is an effective vaccine, I will continue to abide by the rules of physical detachment to protect my wife, my daughter, the rest of my family, my friends, and all the people I meet on the street..

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A volunteer receives the Oxford vaccine in South Africa. Confirming the vaccine’s effectiveness in preventing infections requires testing it in countries with a high number of cases.

I am pleased to have the opportunity to play a very small role, along with 10,000 other volunteers, in a trial that has the world on edge.

The rapidity with which the Oxford scientists responded to the crisis and their great commitment impress me.

Before the pandemic, many of these doctors and researchers worked in different fields related to vaccine development, encouraged by their curiosity or an individual mission. They never thought that the expectations of billions of people would depend on them..

Perhaps the Oxford vaccine trials do not give the results that many expect. It could be that it definitely does not meet the safety and efficacy requirements necessary to combat the pandemic.

But this is how science works, in a long-term, collective development that can have negative results. I have never appreciated the importance of this process as much as now.

© BBC

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