Trialling the Covid-19 vaccine

In the early morning of a bright Monday in the seaside city of Savannah, Georgia, the first patients to receive Moderna’s coronavirus vaccine lined up in front of a small medical clinic.

It was the first day of Moderna’s Phase Three clinical trial, which planned to distribute 30,000 doses across the United States, hoping to change the course of the coronavirus pandemic.

In front of the clinic, the press waited to speak to the first person to receive the vaccine. In the corridors of the hospital, staff were busy getting everything ready.

Elissa Greene, one of the first on the list, couldn’t hide her enthusiasm when she went live on CNN. She was the sixth patient to receive the vaccine.

Elissa works as a nurse practitioner and attends her patients at home every day. “I decided to participate because I wanted to have extra protection for my patients and me, even though I was not sure whether I would receive the vaccine,” she said.

Elissa previously applied to phase two but did not qualify because the vaccine was still being tested only on healthy people and she suffers from asthma.

As soon as she heard that phase three was going to take place, she didn’t hesitate for a second: “I bothered the coordinator until we scheduled the date,” she said with a laugh.

Before she was able to receive the first dose, Elissa went through a thorough preparatory process. She took a Covid-19 test to confirm she did not have the virus and a blood test to see if she had antibodies, before receiving the vaccine

Participants also received information about the science behind the vaccine and possible side effects. After signing the 21-page consent form detailing what she should expect over the 25-month study, Elissa was ready to receive the first dose.

“I wasn’t worried at all, I was excited”, says Elissa remembering the day of the first shot. “I went there, and they did all the stuff that the visit required: a detailed medical history check, an exam, they took a lot of blood, I filled out my consent form. After a long time, many hours, I received the first dose”.

She then had to wait to see if there were any immediate side effects. The clinical trial did not produce any serious reactions and most participants tolerated the vaccine well.

After the first dose, only 2.7% of patients felt pain at the injection site. Most of the adverse events found occurred after the second shot (28 days later), with 9.7% reporting fatigue, 8.9% reporting muscle pain, and a few reporting headaches (4.5%), pain (4.1%) and joint pain (5.2%).

After the first shot, Elissa recalls that she “got a very sore arm at the injection site and a little bit of swelling.” When she received the second dose, she also felt pain at the injection site and short-lived tiredness.

Like all participants, Elissa hoped she actually did receive the vaccine: “I think I was in the vaccine group. I don’t think if they put salt water [a placebo] in your arm it would do the same,” she says.   

Although the preliminary results suggest a broad level of safety, the data is subject to change and participants will be monitored over the next two years to ensure that no further side effects arise.

In this case, post-vaccination monitoring is carried out through an app, in which participants are notified periodically, and report if they’ve had any new health issues. They also have regular visits to draw blood for antibody tests.

Participating in clinical trials is a complex, tiring process that can have a great personal cost. There are many reasons why volunteers decide to enrol in such a study, either out of a desire to save lives or out of self-interest, as they may be the first to receive the vaccine if it proves to be successful.

Elissa says she doesn’t feel like a hero: “I just really wanted the vaccine to come out.” The United States is the country hardest hit by the pandemic, and Elissa felt she had to act to save lives because “people don’t take care of themselves and our crazy [now former] President doesn’t even care.”

Elissa has previously worked on vaccine research and she says “this vaccine doesn’t have anything alive in it, so I wasn’t afraid that it would hurt me in any way”.

As Elissa points out, Moderna’s vaccine candidate has been developed with unprecedented technology, messenger RNA, hence its name mRNA-1273. Generally, vaccines take a weakened part of the virus or a fragment of the virus, so that the immune system “learns” to defend itself against the virus if it is later exposed to it again. It is a costly and time-consuming process.

In Moderna’s vaccine, coded mRNA is introduced so that human cells use it to create a harmless viral particle of SARS-COV-2. Then, the immune system recognises and learns to react to that antigen. This process cuts out the middleman as the patient makes their own vaccine. After the Chinese government shared the genetic sequence with the world, it took two days for Moderna’s laboratories to sequence the mRNA-1273 and 27 days to produce the first clinical batch.

Moderna’s vaccine is nearly 95% effective, even more in severe COVID-19 cases. Recent studies also show that new strains of the coronavirus do not affect the efficacy of the vaccine.

The vaccine was first approved in the United States, followed by the European Union and the United Kingdom, and is now being mass-distributed at different paces in different countries, along with the other leading vaccine candidates.

 

 

 

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Featured image by Daniel Schludi via Unsplash.
Edited by Sophie Victoria Brown, Susu Hagos and Jussi Grut.