The first human trial of a vaccine against the coronavirus has begun in the United States today.
The vaccine is called mRNA-1273 and was developed by US National Institute of Health scientists and collaborators at biotechnology company Moderna, based in Cambridge, Massachusetts.
The first jabs were given to four healthy volunteers at the Kaiser Permanente Washington Research Institute in Seattle on Monday (local time).
“The open-label trial will enrol 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks,” the NIH said, noting it is only for adults in the Seattle area.
“The first participant received the investigational vaccine today.”
The research institute states a vaccine is “urgently needed” for several important reasons including the large number of people infected, the ability of the virus to spread from person to person and the spread of the coronavirus across so many geographic areas.
“We’re team coronavirus now,” Kaiser Permanente study leader Dr Lisa Jackson told the Associated Press on the eve of the experiment.
“Everyone wants to do what they can in this emergency.”
NIH head of infectious diseases Anthony Fauci said phase one of the study “launched in record speed”.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” he said.
The study will examine the impact of different doses delivered by intramuscular injection in the upper arm.
Participants will receive two doses of the vaccine approximately 28 days apart.
The NIH said the volunteers will be asked to return to the clinic for follow-up visits between vaccinations and additional visits spanning a year after their second shot.
They will be monitored for side effects such as soreness or fever.
“The study is evaluating different doses of the experimental vaccine for safety and its ability to induce an immune response in participants,” the NIH said in a statement.
“This is the first of multiple steps in the clinical trial process for evaluating the potential benefit of the vaccine.”
But it could be another 12 to 18 months before the vaccine becomes available, once it has passed more trial phases to prove it works and is safe.
HOW DOES IT WORK?
Coronaviruses are spherical and have spikes protruding from their surface, giving them a crown-like appearance.
The spike binds to human cells, allowing the virus to gain entry.
The Moderna candidate vaccine carries the genetic information of this spike in a substance called “messenger RNA.”
Injecting human tissue with the spike’s messenger RNA makes it grow inside the body, thereby eliciting an immune response without having actually infected a person with the full-blown virus.
The investigational vaccine, called mRNA-1273, is an mRNA nucleic acid vaccine. It is not made from the SARS-CoV-2 virus and can’t cause infection.
According to Benjamin Neuman, a virologist at Texas A&M University-Texarkana, immunising against the pathogen is a long shot: There has never been a very successful human vaccine against any member of the coronavirus family.
“This is going to be a lot of trial, a lot of error, but we have a lot of options to try,” Dr Neuman said.
Pharmaceuticals and research labs around the world are racing to develop both treatments and vaccines to the new coronavirus.
US President Donald Trump has urged his scientists and drug companies to speed up the process – but experts say fundamental constraints could leave little wiggle room.
“A vaccine has to have a fundamental scientific basis. It has to be manufacturable. It has to be safe. This could take a year and a half – or much longer,” wrote H. Holden Thorp, the editor-in-chief of the journal Science in response to the president’s calls.
“Pharmaceutical executives have every incentive to get there quickly – they will be selling the vaccine after all – but thankfully, they also know that you can’t break the laws of nature to get there.”
An antiviral treatment called remdesivir, made by US-based Gilead Sciences, is already in the final stages of clinical trials in Asia and doctors in China have reported it has proven effective in fighting the disease.
But only randomised trials allow scientists to know for sure whether it really helps or whether patients would have recovered without it.
Another US pharmaceutical company called Inovio, which is creating a DNA-based vaccine, has said it will enter clinical trials next month.
Regeneron is trying to isolate coronavirus-fighting antibodies that can be administered intravenously to confer temporary immunity, and hopes to start human trials by summer.
According to the World Health Organisation, 80 per cent of COVID-19 cases are mild, 14 per cent are severe and about five per cent result are critical, resulting in severe respiratory illness that causes the lungs to fill with fluid which in turn prevents oxygen from reaching organs.
Patients with mild cases recover in a week or two while severe cases can take six or more weeks.
Recent estimates suggest about one per cent of all infected people die.
Originally published as Trial of potential virus vaccine begins