COVID Vaccine Tested in People Shows Early Promise

July 15, 2020 – Everyone who received Moderna’s COVID-19 vaccine, mRNA-1273, has developed an immune response to the virus that causes it, the company said in a statement.

The researchers also reported some side effects in the 45 people in the phase I study, but no significant safety concerns, the statement said.

The vaccine is one of hundreds tested worldwide to stop the pandemic that has killed nearly 600,000 people worldwide.

A researcher testing the vaccine described the results as encouraging, but warned that further study was needed. “Above all, the vaccine elicited a robust immune response,” said Evan Anderson, MD, principal investigator of the trial at Emory University, in a press release. Emory and Kaiser Permanente Washington Health Research Institute were the two study sites.

The company is already testing the vaccine on a larger group of people, known as the Phase II trial. He plans to start phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the last step before FDA approval.

The results of the study are published in The New England Journal of Medicine. The study was led by the National Institute of Allergies and Infectious Diseases at the National Institutes of Health.

Test details

Moderna’s vaccine uses messenger RNA, also called mRNA. He is instructed to make state-of-the-art protein, a key protein on the surface of the virus that allows it to enter cells when someone is infected. After his injection, he goes to the immune cells and asks them to make copies of the advanced protein, acting as if the cells had been infected with the real coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different concentration of the vaccine – either 25, 100 or 250 micrograms.

Each person in the study has developed antibodies that can block the infection. The most common side effects reported after the second vaccination in the 100 microgram group were fatigue, chills, headache and muscle pain, ranging from mild to moderately severe.

The phase II study involved 300 healthy adults aged 18 to 55, as well as 300 other adults aged 55 and over.

Moderna says it hopes to include about 30,000 participants in the 100 microgram dose in the United States for the phase III trial. The estimated start date is July 27.

Sources

The New England Journal of Medicine: “A SARS-CoV-2 mRNA vaccine – Preliminary report.”

Press release, Emory University: “The COVID-19 vaccine tested at Emory is safe, generates an immune response, show the first results.”

Press release, Moderna: “Moderna announces the publication in the New England Journal of Medicine of the preliminary results of the phase 1 study of its mRNA vaccine against COVID-19 (mRNA-1273).”

White House press conference, July 14, 2020.

Clinical Trials.gov.


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Jothi Venkat

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