Final stage of COVID-19 vaccine trials

September 25
Healthcare

Post-registration trials of the COVID-19 vaccine continue in Moscow. It’s readily available to the public at the research centres based at outpatient and inpatient clinics. Trial volunteers need to fill out a form and undergo a simple selection process in the form of a medical checkup at an outpatient clinic and go through a few tests to rule out any possible counter-indications. Find out about the research centre based at City Clinic No. 46 and why the vaccine is considered perfectly safe.

Yulia Ivanko, Mos.ru

Pioneers

Pensioner Sergei Arsentyev was one of the first people to sign up at City Clinic No. 46. and now it’s time for him to get his injection.

 

Beautician Svetlana Veselova decided to take part in the trials as her personal contribution to expediting the mass production of the vaccine.

“When I first read about this project I immediately decided to sign up for a jab. I am not afraid of this disease. I believe in our doctors,” she commented.

Yulia Ivanko, Mos.ru

Pulmonologist Nadezhda Berdnikova from Davydovsky Clinical Hospital No. 23 is in charge of the clinical trials at City Clinic No. 46. She is responsible for organising the study of the vaccine, communicating with vaccine recipients and helping doctors with complicated matters related to the vaccine. Between 80 and 100 people visit the centre every day.

 

The centre is open daily from 7 am to 10 pm. Convenient timeslots are allocated for the selected candidates.

180-day observation

During the first medical checkup, potential vaccine recipients will need to give extensive details about their medical history, coexisting conditions and any medicine they are currently taking, including any probiotics. They will also need to take a swab test for COVID-19 and a blood test for antibodies.

Those who have already had COVID-19 (and show IgG antibodies at over 10 in their blood) will not be accepted for the trials. Having antibodies means the person may have been asymptomatic and developed immunity.

Yulia Ivanko, Mos.ru

People are also tested for HIV, syphilis, Hepatitis B and C, drugs and alcohol in their blood. Women also have to take an express pregnancy test. If at least one test is positive, a candidate will be rejected. Other restrictions include cancer and flare-ups of certain chronic diseases, as well as eczema and any allergy to medication. A person may be deferred from getting vaccinated if he or she earlier had a flu jab. It is recommended to wait at least 30 days before the next vaccination.

Test results will be ready in two or three days. Unless any of the tests require deferment, the candidate will see a doctor once more and then be vaccinated in the shoulder. It is necessary to spend another half an hour at the clinic after the inoculation in case a volunteer doesn’t feel well.

Further observation continues remotely. Anyone who feels unwell or has any questions can call the 24/7 hotline to speak to a doctor. Trial participants also need to download a mobile app to document how they are getting along by filling out a questionnaire once every few days.

Yulia Ivanko, Mos.ru

Doctors will contact a person if his or her answers on the questionnaire raise any red flags.

If the vaccine recipient cannot install the app for technical reasons or simply does not want to, doctors will contact him or her once every few days by phone.

Another visit to the clinic will be required after 21 days after the first jab to get the second dose of the vaccine. Then there will be an observation period of five months.

Yulia Ivanko, Mos.ru

How the vaccine works

People often ask whether the vaccine is efficient and safe and whether any adverse effects can be expected. Possible side effects of the coronavirus vaccine are similar to that of any other jab. It can be a brief rise in body temperature, a headache, fatigue, muscle ache, nasal congestion, sore throat, rash or an allergy-like response.

These unpleasant symptoms are mild and go away with no additional help. If necessary, the volunteers can call the hotline or visit the clinic for medical help at any time, including in case of emergencies.

Participants in the COVID-19 vaccination trials are not restricted in their movements and can continue with their usual daily routine. The vaccine does not contain the virus itself so it is impossible to get infected.

“The vaccine has high immunological potency, that is, it helps to form strong immunity against COVID-19. At the same time, it does not contain a weakened form of the virus or protein molecules. It only contains a tiny part of the coronavirus gene that is supposed to trigger antibodies and form long-term immunity. It is impossible to contract the virus from the vaccine, even in a mild form,” Nadezhda Berdnikova explained.

She added that as of today, there are no ways to prevent COVID-19 that are 100 percent reliable. Therefore, it is extremely important to take safety precautions such as wearing face masks and gloves in public and observing social distancing.

Two-stage vaccination

Many healthcare facilities are currently offering the COVID-19 vaccine as part of the ongoing clinical trials. 

“The vaccine contains two components that must be injected about 20 days apart. The entire study will take about six months during which the volunteers will be kept under observation remotely,” Nadezhda Berdnikova explained.

Yulia Ivanko, Mos.ru

Before participating in the trial, people need to read and sign an informed consent form. Doctors will answer any questions about the document. According to Nadezhda Berdnikova, very few people opted out after reading the terms and conditions.

“I would like to thank our volunteers. They take this research with great responsibility and commitment.”

How to apply

Some 60,000 people have already signed up for the vaccination programme.

Only Russian citizens aged 18 and above who have a mandatory medical insurance policy issued in Moscow are allowed to be vaccinated. Eligible citizens are welcome to sign up for the vaccine trial by submitting an online application.

Yulia Ivanko, Mos.ru

Within two weeks of doing this, they will be contacted and invited to undergo a medical checkup at a convenient time.

The vaccine developed by the Russian Healthcare Ministry’s Gamaleya National Research Centre for Epidemiology and Microbiology has been through two stages of the clinical trials and is considered safe. The vaccine does not contain the virus itself; therefore, it is impossible to contract the disease or transmit it to others.

Source: mos.ru

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