Moderna Inc’s experimental vaccine for COVID-19 showed it was safe and provoked immune responses in all 45 healthy volunteers in an ongoing early-stage study, said US researchers. Volunteers had high levels of virus-killing antibodies who got two doses of the vaccine. It exceeded the average levels seen in people who had recovered from COVID-19.
Meanwhile, no volunteers experienced a serious side effect. More than half reported mild or moderate reactions such as fatigue, headache, chills, muscle aches, or pain at the injection site. These were more likely to occur after the second dose and in people who got the highest dose.
To put an end to the coronavirus pandemic we need a vaccine. The virus has sickened millions and caused nearly 575,000 deaths worldwide, said Reuters.
Moderna was the first to start human testing of a vaccine for the novel coronavirus on March 16.
Researchers of Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases developed Moderna’s vaccine candidate. He called the results ‘good’ news. He also noted the vaccine produced “reasonably high” levels of virus-killing or neutralizing antibodies.
Moderna shares jumped more than 15% in after-hours trading on Tuesday.
Moderna’s shot, mRNA-1273, uses ribonucleic acid (RNA). It is 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. The body recognizes it as a foreign invader and mounts an immune response against it.
The results released Tuesday 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.
In June, Moderna said it selected the 100-microgram dose for its late-stage study to minimize adverse reactions.
At that dose, Moderna is on track to deliver about 500 million doses per year, and possibly up to 1 billion doses per year from 2021.
In April, Moderna expanded the Phase 1 trial to include adults over 55. They were more at risk of serious disease. Moderna 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 and expects to start a phase 3 trial on July 27.
Phase 1 trials aim to ensure treatment is safe and help determine an effective dose. Similarly, Phase 2 trials test a treatment in a larger group and get an early read on effectiveness. While Phase 3 trials are conducted in a large group of individuals to confirm rare side effects. Moderna’s Phase 3 trial will be conducted in 30,000 volunteers.
Cheers to the new positive development!
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