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Moderna reported that it's phase one results show that experimental vaccine for COVID-19 is safe and induces an immune response in it's early stage study. $MRNA Shares surged 16% on the news.

Moderna Virus

U.S. researchers reported on Tuesday that the Moderna vaccine was safe and provoked immune responses in all 45 healthy volunteers in an ongoing early-stage study, While no study 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.

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The reactions were more likely to occur after the second dose and in people who got the highest dose, the team reported in the New England Journal of Medicine. Moderna was the first to start human testing of a vaccine for the novel coronavirus on March 16, some 66 days after the genetic sequence of the virus was released.

“The world urgently needs vaccines to protect against COVID-19,” said Dr Lisa Jackson of Kaiser Permanente Washington Health Research Institute in Seattle and lead author of the study.

Highlights

  • Interim analysis of original cohorts of Phase 1 study evaluated two-dose vaccination schedule of mRNA-1273 across three dose levels (25, 100, 250 µg) in 45 healthy adults ages 18-55 years; results reaffirm and expand upon positive interim data announced on May 18th
  • Neutralizing antibody titers were observed in 100% of evaluated participants; at the 100 µg dose level selected for Phase 3, the geometric mean titers were above those seen in convalescent sera
  • Vaccination with mRNA-1273 elicited Th1-biased CD4 T cell responses
  • mRNA-1273 was generally safe and well-tolerated
  • Data support 30,000 participant Phase 3 study expected to begin on July 27
  • Conference call to be held on Wednesday, July 15 at 8:00 a.m. ET

The federal 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.

Moderna’s mRNA-1273, uses chemical messenger ribonucleic acid (RNA)that contains instructions for making proteins. The vaccine instructs cells to make proteins that mimic the outer surface of the coronavirus, which the body recognizes as a foreign invader, and mounts an immune response against. The results released on Tuesday involved three doses of the vaccine.

They were 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. The team reported that individuals who got two doses of the vaccine had high levels of virus-killing neutralizing antibodies that exceeded the average levels seen in people who had recovered from COVID-19.

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,” Jackson said, referring to reactions that require hospitalization or result in death.

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. Moderna said it will follow study volunteers for a year after the second shot, to look for side effects and check how long immunity lasts. 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. The drug would come from the company’s internal U.S. manufacturing site and strategic collaboration with Swiss drugmaker Lonza (LONN.S). Reuters reported “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. “A little fatigue and headache and myalgia (muscle pain) and pain at the injection site is a small price to pay for protection against COVID-19.”

Source: Reuters, New England Journal of Medicine

From The TradersCommunity Research Desk

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