CHICAGO (Reuters) – Moderna Inc’s (MRNA.O) The experimental vaccine for COVID-19 was shown to be safe and elicited immune responses in all 45 healthy volunteers in an early-stage study, US researchers reported Tuesday.
FILE PHOTO: A sign marks the headquarters of Moderna Inc, which is developing a coronavirus vaccine, in Cambridge, Massachusetts, USA, May 18, 2020. REUTERS / Brian Snyder
The volunteers who received two doses of the vaccine had high levels of anti-virus antibodies that exceeded the average levels seen in people who had recovered from COVID-19, the team reported in the New England Journal of Medicine.
No study volunteer experienced a serious side effect, but more than half reported mild or moderate reactions such as fatigue, headache, chills, muscle aches, or injection site pain. They were more likely to occur after the second dose and in people who received the highest dose.
Experts say a vaccine is needed to end the coronavirus pandemic that has sickened millions and caused nearly 575,000 deaths worldwide.
Moderna was the first to begin human testing of a vaccine for the new coronavirus on March 16, 66 days after the release of the virus’ genetic sequence.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, whose researchers developed the candidate vaccine for Moderna, called the results “good news” and noted that the study found no serious adverse events and that the vaccine produced levels ” reasonably high “in neutralizing or virus-killing antibodies.
“If your vaccine can induce a response comparable to natural infection, that’s a winner,” Fauci said in a phone interview. “So we are very satisfied with the results.”
Moderna shares rose more than 15% in after-hours trading on Tuesday.
The US government supports Moderna’s vaccine with nearly $ 500 million and has chosen it as one of the first to participate in large-scale human trials. A successful vaccine could be a turning point for Cambridge, Massachusetts-based Moderna, which has never had a licensed product.
Moderna’s injection, 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 recognizes as a foreign invader, and generates an immune response against it.
Results published Tuesday included three doses of the vaccine, tested in groups of 15 volunteers ages 18 to 55 who received two injections, 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 received the 25 microgram dose, the 15 participants who received the 100 microgram dose, and the 14 who received the 250 microgram dose. In the highest dose group, three patients had severe reactions such as fever, chills, headache, or nausea. One of them had a fever of 103.28 Fahrenheit (39.6 C).
“We didn’t see any events characterized as serious adverse events,” said lead author Dr. Lisa Jackson of the Washington Kaiser Permanente Health Research Institute in Seattle, referring to reactions that require hospitalization or 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 approximately 500 million doses per year, and possibly up to one billion doses per year, starting in 2021, from the company’s internal manufacturing site in the US. And the strategic collaboration with the Swiss drug manufacturer Lonza (LONN.S)
“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 is nothing here that can prevent one from advancing to Phase 2 / Phase 3 testing,” he said.
In April, Moderna expanded the Phase 1 trial to include adults over the age of 55, who are at increased risk for severe disease, with the goal of enrolling 120 volunteers. Moderna said she will follow the study volunteers for a year to look for side effects and check how long the immunity lasts.
Moderna began its phase 2 test in May and hopes to start a phase 3 test on July 27.
Phase 1 trials aim to ensure that a treatment is safe and to help determine an effective dose. Phase 2 trials test a treatment in a larger group and get an early reading of effectiveness. Phase 3 trials are carried out on a large group of individuals to confirm efficacy and identify rare side effects. The Moderna Phase 3 trial will be conducted on 30,000 volunteers.
Report by Julie Steenhuysen in Chicago; Editing by Matthew Lewis and Richard Pullin
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