Coronavirus Vaccine: Phase 1 Human Trial Begins; What Happens Next?

A 43-year-old mother-of-two from Seattle has become the first patient to receive the jab on March 17 2020. The covid-19 vaccine was developed by US National Institutes of Health (NIH) scientists and collaborators at biotechnology company Moderna Inc., based in Cambridge, Massachusetts.

Coronavirus Vaccine: Phase 1 Human Trial Begins; What Happens Next?
Coronavirus Vaccine

A dose of an experimental coronavirus vaccine is given to 4 healthy volunteers. It is the first human trial that began in the United States. The trial is taking place at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. It is done to evaluate a candidate vaccine against the deadly virus. 

What is the Coronavirus Vaccine?

The covid-19 vaccine was developed by US National Institutes of Health (NIH) scientists and collaborators at biotechnology company Moderna Inc., based in Cambridge, Massachusetts.

A 43-year-old mother-of-two from Seattle has become the first patient to receive the jab on March 17 2020, as reports the BBC News, quoting news agency Associated Press. The researchers further plans to enroll 45 participants aging from 18 to 55 years in the trial. However, as per experts, the trial will take many months to test the safety of the vaccine. The vaccine, which is named mRNA-1273, contains a harmless genetic code copied from the virus that causes the coronavirus.

According to NIAID Director Dr Anthony Fauci “Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority. The Phase 1 study which is launched in record speed is an important first step for achieving the goal.”

The vaccine must pass through three iterative phases of clinical trials. Only then it will be deemed safe and effective for widespread use. In other words, if the initial tests go well, it can take a minimum of 18 months before the vaccine is available for public use.

Coronavirus vaccine phase 1 trial-

Coronavirus Vaccine Trial

 

The trial evaluates the safety and toxicity of a vaccine at different dose levels, & a drug pharmacokinetics. The main aim of the phase 1 clinical trial is to give information about how the vaccine interacts with a healthy human body, as per the US Food & Drug Administration (FDA). In the 1st trial, the researchers will examine a small group of people, somewhere between 20 and 80 individuals, who would be given different doses.

The phase 1 trial is done by senior investigator Lisa A Jackson, M.D., at KPWHRIl. The volunteers will be provided two jabs into the upper arm muscle in total. There will be a 28-day gap between doses. Each participant will receive a 25 microgram (mcg), 100 mcg or 250 mcg dose at both vaccinations, with 15 people in each dose cohort. 

What happens in coronavirus vaccine phase 1 trial?

A news release by NIH said, "The first four participants will get one injection with a low dose, & the next four participants will receive the 100 mcg dose. Investigators will review safety data before vaccinating the remaining participants in the 25 and 100 mcg dose groups and before participants receive their second vaccinations. Another safety review will be done before participants are enrolled in the 250 mcg cohort.”

After a 14-month period, researchers will monitor how each person metabolises the given treatment. What common side effects emerge due to the different doses. After the phase 1 trial, there will be Phase 2 and Phase 3 trials. The drug will be tested in larger groups of people and over longer periods of time in these trials. 

However, currently, there’s no approved vaccine that can help prevent infection with the coronavirus. Not to forget the deadly virus has claimed around 7,007 lives & infected more than 175,530 people across the world. Now, researchers around the world are working on several treatments to help combat the spread of the deadly virus which has been termed as a global pandemic.