Early Moderna Data Supports Vaccine by 2021

A sparsely populated Wall Street in the midst of the coronavirus pandemic in New York

Enlarge Image A sparsely populated Wall Street in the midst of the coronavirus pandemic in New York AP John Minchillo

The first coronavirus vaccine to be tested in people appears to be safe and able to stimulate an immune response against the virus, its manufacturer, Moderna announced Monday.

Two weeks after the second dose was given, the folks in the 25 microgram group had antibodies at roughly the same levels as patients who had recovered from COVID-19.

Moderna said the vaccine appeared to show a dose response, meaning that people who the 100 mcg dose produced more antibodies than people who got the lower dose.

Yes, but: The data is limited, and there's no data yet on people older than 55 - a group that is at the highest risk of getting infected. Its vaccine, developed jointly with the National Institute of Allergy and Infectious Diseases which is headed by Dr. Anthony Fauci, was the first to undergo human trials in the United States.

"We need to bring the full power of the biomedical research enterprise to bear on this crisis", NIH Director Dr. Francis S. Collins said in a statement. Results on eight of those participants revealed they developed neutralizing antibodies - which are believed to be key in providing protection from the virus - at levels seen in patients who've recovered from COVID-19.

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After the results, the company has dropped the idea of administering 250 mcg doses to participants. A Phase 2 clinical trial of the vaccine will begin soon, according to the company, and a Phase 3 trial is slated to start in July.

The only side effect of the drug administration was minor redness and slight pain from the site of the injection to those who received a higher dosage.

Worldwide, about a dozen vaccine candidates are in the first stages of testing or nearing it.

Wall Street has been anxiously awaiting a coronavirus vaccine to help the reopening of a global economy that's been frozen to stop the disease from spreading.

In upcoming phases of the trial, researchers will be trying to strike a balance around the effectiveness of the vaccine at lower doses - because the lowest effective dose will allow for greater production volume when the time comes. But in all eight people, the vaccine successfully stimulated the body to create antibodies capable of neutralizing the virus in the test tube, so it can no longer infect cells.

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The most notable side effects reported from the early testing of Moderna's vaccine were three participants with "flu-like" symptoms following a second shot of the highest dose.

The vaccine has also proved effective when tested on mice.

The mid-stage trial will involve about 600 people and is expected to begin shortly.

These two studies combined, said Tal Zaks, chief medical officer at Moderna, "substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials". Although mRNA vaccines have been studied for several years, so far none has been licensed by the FDA. Antibodies are not synonymous with real-world immunity.

A bit of context: Over 100 HIV vaccines have been tested over the years, many with successful Phase I trials.

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