Moderna says Covid-19 vaccine shows promise in early trials, excites markets

Moderna Inc's experimental COVID-19 vaccine, the first to be tested in the United States, produced protective antibodies in a small group of healthy volunteers, according to very early data released by the biotech company on Monday.

The data comes from eight people who participated in a 45-subject safety trial that kicked off in March. Moderna vaccine is one of more than 100 under development that aims to protect against the novel coronavirus that has infected more than 4.7 million people worldwide and killed more than 317,000.

In general, the study showed that the vaccine was safe and that all study participants produced antibodies to the virus.

An analysis of the response in the eight individuals showed that those who received a 100 microgram dose and who received a 25 microgram dose had levels of protective antibodies to fend the virus that exceeded those found in the blood of people who recovered from COVID. 19, the illness caused by the coronavirus.

The news,  issued in a release by the U.S. biotechnology company, lifted shares of Moderna by 20%.

Moderna launched a $ 1.34 billion offering at $76 per share Monday night. The company had previously said it planned to sell $ 1.25 billion of common stock to raise funds for vaccine development and manufacture of vaccines.

"These are significant findings, but it is a first-stage clinical trial that included only eight people. It was designed for safety rather than efficacy," said Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security who was not involved in the study.

The first data provide a glimmer of hope for a vaccine among the most advanced in development.

Adalja said that many glitches can occur between now and the time when this vaccine is tested for efficacy in thousands of people. "What we do see is encouraging," he said.

Scientists are trying to understand the level of antibodies that will eventually protect against the novel coronavirus, and how long this protection lasts.

Moderna said that the vaccine showed a dose-response, which means that people who received a 100 mcg dose produced more antibodies than people who received the lowest dose.

The vaccine got the green light to start the second stage of human testing. Last week, US regulators gave the case a " fast-track " status to speed up the regulatory review.

In Phase II, or middle, stage, designed to improve test efficacy and find the optimal dose, Moderna said it would drop plans to test the 250 mcg dose and test the 50 mcg dose instead.

Reducing the dose required to produce immunity can help spare the amount of vaccine needed in each shot, which means that the company can eventually produce more vaccine. 

MAXIMIZING NUMBER OF DOSES

"In the context of the pandemic, we expect demand to outstrip

supply much, and the lower the dose, the more people we hope to protect," said medical Medical Officer Tal Zaks.

In April, the U.S. government placed a big bet on Moderna, backing his vaccine with $ 483 million from the Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Department of Health and Human Services (HHS).

The company said the grant would allow it to supply millions of doses per month in 2020, and with further investment, tens of millions per month in 2021 if the vaccine proves successful.

"We are investing in expanding manufacturing so that we can increase the number of doses we can produce to help protect as many people as possible from SARS-CoV-2," Moderna Chief Executive Stéphane Bancel said, using the official name for the new virus.

Zaks said in an interview, in May, Moderna struck a 10-year strategic collaboration with the Lonza Group which would eventually allow the company to produce up to 1 billion 50 mcg doses by the end of 2021.

Zaks said the company is developing a plan to provide vaccines to countries outside the United States.

"The United States is ready to be the primary beneficiary of this vaccine,"  Zaks said, adding that the company believes it has an " ethical obligation to make this vaccine available to anyone who needs it worldwide."

Moderna said it expects to start a larger test in the late stage, or Phase III, trial in July.

There are currently no COVID-19 approved treatments or vaccines, and experts predict that a safe and effective vaccine can take 12 to 18 months from the start of development, which in Moderna's case was in January.
The most notable side effects reported in the early testing of the Moderna vaccine were three participants with "flu-like" symptoms following a second shot at the highest dose. The company said it believed the symptoms were an indirect measure of a strong immune response.

Source: TheEconomicTimes

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