US COVID-19 vaccine green lighted for second stage of human testing

The study, which was not designed to prove the vaccine works, offered an early glimmer of hope that it could provide protection against the virus.

Vial 1 of Box 1. This is the vaccine candidate to be used in Phase 1 clinical trial at the Clinical Biomanufacturing Facility (CBF) in Oxford, Britain, April 2, 2020. Picture taken April 2, 2020 (photo credit: SEAN ELIAS/HANDOUT VIA REUTERS)
Vial 1 of Box 1. This is the vaccine candidate to be used in Phase 1 clinical trial at the Clinical Biomanufacturing Facility (CBF) in Oxford, Britain, April 2, 2020. Picture taken April 2, 2020
(photo credit: SEAN ELIAS/HANDOUT VIA REUTERS)
Early data from Moderna Inc's COVID-19 vaccine, the first to be tested in the United States, showed that it produced protective antibodies in a small group of healthy volunteers, the company said on Monday.

The data are from eight people who took part in a safety trial that kicked off in March as the global pandemic caused by the novel coronavirus was spreading.

In the trial of 45 volunteers, conducted by the National Institute of Allergy and Infectious Diseases, eight volunteers who got two doses of the vaccine produced protective antibodies roughly on par with people who recovered from a natural infection of the virus that causes the COVID-19 illness, the U.S. biotechnology company said in a news release.

The study, which was not designed to prove the vaccine works, offered an early glimmer of hope that it could provide protection against the virus.

The news lifted shares of Moderna about 20% to $79.39 in mid-morning trading and drove the broader stock market higher.

Scientists are still trying to understand what level of antibodies will ultimately prove protective against the novel coronavirus, and how long that protection will last.

The vaccine appeared to show a dose response, meaning that people who got higher doses had higher levels of antibodies.

Moderna's vaccine has gotten the green light to start the second stage of human testing, and last week, U.S. regulators gave the vaccine "fast-track" status to speed up the regulatory review.

"Our coronavirus vaccine works," Tal Zaks, Moderna Inc's Israeli Chief Medical Officer said in an interview with N12 on Monday.
"I personally am not surprised that the vaccine works, this is the ninth virus we attempt to find a vaccine for, while the other eight worked," Zaks claimed. "even with the lowest dosage of the vaccine we managed to stimulate the pantiens' immune system."

"We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2," Moderna Chief Executive Officer Stéphane Bancel said.


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The company's vaccine is at the forefront of the efforts to arrest the fast-spreading virus. Last week, it won the U.S. health agency's "fast-track" label to speed up the regulatory review. Moderna expects to start a larger late-stage trial in July.

There are currently no approved treatments or vaccines for COVID-19, and experts predict a safe and effective vaccine could take 12 to 18 months to develop. The company has signed deals with Swiss contract drugmaker Lonza Group AG and the U.S. government to produce massive quantities of its vaccine.

The vaccine, mRNA-1273, was also found to be generally safe and well tolerated in the early-stage study, the drug developer said.

One person in the trial experienced redness around the injection site, which was characterized as a "grade 3" side effect. No serious side effects had been reported, the company said.
Jerusalem Post Staff contributed to this article.