Moderna's Israeli top medical officer: We've shown today that our vaccine works

Daniel Fowler
May 20, 2020

In this case, the Phase 1 results don't tell us anything about whether Moderna's vaccine will work against the virus once it's administered to humans.

Earlier today, the biotech company Moderna reported positive results from a phase 1 study of its experimental COVID-19 vaccine, which was was among the first to begin testing in healthy human volunteers in mid-March.

Eight healthy volunteers saw few adverse effects after taking two doses of the potential vaccine, according to Moderna, its manufacturer based in MA.

The stock of the company jumped 24 per cent in early trading Monday on Wall Street.

"This is a very good sign that we make an antibody that can stop the virus from replicating", said Moderna CEO Stephane Bancel in an interview with the LA Times.

While researchers highlight there is a limit on how much clinical trials can be accelerated, they also point out that unlike with previous vaccine development efforts, the timeline for the availability of an effective COVID-19 vaccine is to be measured not in years but months.

What's next? Moderna will soon start a Phase II trial on 600 participants, and in July will begin a Phase III trial.

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.

Moderna reports positive data in first phase of coronavirus vaccine trial

It can typically take years of clinical trials before a vaccine is considered safe enough to market, and some scientists, including Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, have stated that vaccine won't be ready by the fall.

"I think the results are such that they are being used to plan a next-stage, larger study with selected doses and looking at vaccine side effects that are less frequent", Ernst said. And one who received a third, middle dose of the vaccine between the two doses given to the other patients showed redness around the injection site.

Side effects included fever, muscle aches, and fatigue, and all resolved themselves within in about a day. ("At this time, neutralizing antibody data are available only for the first four participants in each of the 25 µg and 100 µg dose level cohorts.") We reached out to Moderna for more information and will update if we hear back.

Two weeks after patients received the final dose at the 25 and 100 mcg levels, eight saw their antibody levels rise to about the same level as patients who already recovered from COVID-19, according to the report.

Antibodies produced were also shown to be effective at fighting the virus in test tubes. As a result, Phase II studies will only carry forward two dose levels of 50 µg and 100 µg. Chief Medical Officer Tal Zaks said the figures "substantiate our belief that mRNA-1273 has potential to prevent Covid-19 and advance our ability to select a dose for pivotal trials". "We're doing our best to make it as many millions as possible".

Many of these companies who conducting human trials have created, or are in the process of creating RNA vaccines, which can be synthesized and create vaccines more quickly.

Moderna's vaccine is seen as one of the most promising candidates for immunization against the pathogen that has sickened over 4.8 million people worldwide and killed over 318,000 since it first emerged in China last December.

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