Moderna shares soar after entering phase 3 clinical trials
Moderna announced earlier this month that it is completing a first phase of human testing of a potential vaccine in partnership with the US government and is about to begin a second phase, which will include 600 participants. If the vaccine proves to be effective and safe to use, the company says it could be ready for sale as early as 2021..
The first coronavirus vaccine to be tested in humans appears to be safe and capable of stimulating an immune response against the virus, pharmaceutical company officials said..
Moderna shares jump 39% in premarket on Monday.
These findings are based on the results of the first 8 people, each of whom received two doses of the vaccine since the program began in March. Each participant received a dose of 25, 100, or 250 mcg, 15 people in each group. Participants received two doses of the potential vaccine by intramuscular injection into the upper arm approximately 28 days apart.
These people, healthy volunteers, produced antibodies that were then tested in human cells in the laboratory and were able to stop the virus from replicating – a key requirement for an effective vaccine. The levels of these so-called neutralizing antibodies were similar to those found in patients who recovered from the virus in public places..
These initial results are based on low to medium dose tests. The only adverse effect at these doses that was observed, there was redness and soreness at the injection site of one of the patients.
The company said it is on an accelerated schedule: Phase 2, involving 600 people, will begin soon, and Phase 3, with thousands of healthy people, will begin on July 3. The Food and Drug Administration gave the company approval for a second phase earlier this month..
If these trials are successful, the vaccine could become available for widespread use by the end of this year or early 2021, Dr. Tal Zaks, Chief Medical Officer at Moderna. How many doses may be ready is not yet clear, but Dr. Sachs stated: «We do our best to produce as many millions of doses as possible».
There is currently no proven treatment or vaccine for coronavirus. Dozens of companies in the United States, Europe and China are striving to produce vaccines in a variety of ways. Some use the same technology as Moderna, which involves a segment of genetic material from a virus called an RNA or mRNA messenger that tells cells what to produce – in this case, an antigen that can trigger an immune response to the virus.
Experts believe neutralizing antibodies are very important for getting protection from the virus.
According to the World Health Organization, more than 100 vaccines are being developed worldwide. At least eight vaccines are being tested in humans.
Moderna said additional tests in mice that were vaccinated and then infected showed that the vaccine could prevent the virus from replicating in their lungs, and that the animals have levels of neutralizing antibodies comparable to those in humans who received the vaccine..
Moderna, which partnered with the National Institutes of Health to develop a vaccine, was the first company to publish data on a human coronavirus vaccine trial..