Moderna COVID-19 vaccine shows 'promising results', Phase 3 trial this month -- read more
Volunteers who got two doses of the Moderna vaccine had high levels of virus-killing antibodies that exceeded the average levels seen in people who had recovered from COVID-19. The firm expects to start a Phase 3 trial for its COVID-19 vaccine on July 27.
As scientists across the world are scrambling to develop a vaccine for the novel coronavirus, US biotech firm Moderna's experimental vaccine for COVID-19 showed it was safe and has been found to induce immune responses in all of the volunteers who received it in a Phase 1 study.
The firm expects to start a large Phase 3 trial for its COVID-19 vaccine candidate on July 27 -- the final trial stage before regulators consider whether to make the vaccine available, according to details released on Tuesday. Modena's vaccine is expected to be the first in the United States to begin Phase 3 trials.
The vaccine provoked immune responses in all 45 healthy volunteers in an ongoing early-stage study, according to US researchers. The early results, published in the New England Journal of Medicine on Tuesday, showed that the vaccine worked to trigger an immune response with mild side effects -- fatigue, chills, headache, muscle pain, pain at the injection site -- becoming the first US vaccine candidate to publish results in a peer-reviewed medical journal.
Volunteers who got two doses of the vaccine had high levels of virus-killing antibodies that exceeded the average levels seen in people who had recovered from COVID-19, said the team. Moderna said in a press release that, if all goes well in future studies, "the company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021."
Moderna was the first to start human testing of a vaccine for the novel coronavirus on March 16, 66 days after the genetic sequence of the virus was released.
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, whose researchers developed Moderna's vaccine candidate, called the results "good news," noting that the study found no serious adverse events and the vaccine produced "reasonably high" levels of virus-killing or neutralizing antibodies.
"If your vaccine can induce a response comparable with natural infection, that's a winner," Fauci said in a telephone interview. "That's why we're very pleased by the results." Moderna shares jumped more than 15% in after-hours trading on Tuesday.
The US government is supporting Moderna's vaccine with nearly half a billion dollars and has chosen it as one of the first to enter large-scale human trials.
A successful vaccine could be a turning point for Cambridge, Massachusetts-based Moderna, which has never had a licensed product.
WHAT IS MODERNA'S VACCINE?
Moderna's shot, mRNA-1273, uses ribonucleic acid (RNA) - a chemical messenger that contains instructions for making proteins. When injected into people, the vaccine instructs cells to make proteins that mimic the outer surface of the coronavirus, which the body recognises as a foreign invader, and mounts an immune response against.
The results involved three doses of the vaccine, tested in groups of 15 volunteers aged 18-55 who got two shots, 28 days apart. The groups tested 25, 100 or 250 micrograms of the vaccine.
Adverse events after the second dose occurred in seven of the 13 volunteers who got the 25-microgram dose, all 15 participants who received the 100 microgram dose and all 14 who got the 250 microgram dose.
In the highest-dose group, three patients had severe reactions such as fever, chills, headache or nausea. One of these had a fever of 103.28 Fahrenheit (39.6 C).
"We didn't see any events that are characterized as serious adverse events," said lead author Dr Lisa Jackson of Kaiser Permanente Washington Health Research Institute in Seattle, referring to reactions that require hospitalization or result in death.
In June, Moderna said it selected the 100-microgram dose for its late-stage study to minimize adverse reactions.
At that dose, Moderna said the company is on track to deliver about 500 million doses per year, and possibly up to 1 billion doses per year, starting in 2021, from the company's internal US manufacturing site and strategic collaboration with Swiss drugmaker Lonza .
"It's a good first step," said Dr William Schaffner, a vaccine expert at Vanderbilt University Medical Center who was not involved in the study. "There's nothing here that would inhibit one from going ahead to the Phase 2/Phase 3 trials," he said.
In April, Moderna expanded the Phase 1 trial to include adults over 55, who are more at risk of serious disease, with the aim of enrolling 120 volunteers. The firm said it will follow study volunteers for a year to look for side effects and check how long immunity lasts. It started its phase 2 trial in May.
-- Phase 1 trials aim to ensure a treatment is safe and help determine an effective dose.
-- Phase 2 trials test a treatment in a larger group and get an early read on effectiveness.
-- Phase 3 trials are conducted in a large group of individuals to confirm efficacy and identify rare side effects.
Moderna's Phase 3 trial will be conducted in 30,000 volunteers. It's vaccine candidate is one of 23 in clinical trials around the world, according to the World Health Organization.
Overall, "the safety and immunogenicity data in this preliminary report are promising, and they support continued development of this vaccine. However, we must bear in mind the complexity of vaccine development and the work still to be done before Covid-19 vaccines are widely available," Dr Penny Heaton, chief executive officer of the Bill and Melinda Gates Foundation, wrote in an editorial accompanying the Phase 1 study in the New England Journal of Medicine.