Vaccine Maker Moderna Moves to Next Phase of Testing
May 12, 2020
n May 12, Moderna Therapeutics, based in Cambridge, Mass., received
fast-track approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate, mRNA-1273. Days earlier, the FDA gave the company the green light to
proceed to Phase 2 testing of the vaccine, which is expected to begin shortly. The company plans to launch the final stage of human testing, Phase 3, this summer, assuming the Phase 2 studies are complete, says Dr. Stephen Hoge, president of Moderna.
Fast-track designation boils down to a more expedited review process by the FDA. In particular, it means the agency can review data on a rolling basis so an entire application for approval isn’t held up until the final piece of data is collected and analyzed. “It’s validation that the FDA believes this is a very credible exercise,” says Hoge.
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Moderna’s vaccine relies on a relatively new technology based on the mRNA of the virus; it involves injecting fragments of the viral genetic material into the body, which then stimulates the body’s immune system to fight the novel coronavirus.
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Currently,
there are around eight vaccines being tested in people, using different technologies. Public health experts believe that multiple vaccines may be needed in order to meet global demand to immunize and protect as many people as possible from COVID-19 in coming years.
Moderna's experimental coronavirus vaccine gets FDA's 'fast track' status | Daily Mail Online
May 12, 2020
Moderna Inc said on Tuesday the US Food and Drug Administration (FDA) granted 'fast track' designation to its experimental coronavirus vaccine to speed up the regulatory review process.
The company has been racing to develop a safe and effective vaccine against the novel coronavirus that has killed more than 285,000 people globally. It expects to start a late-stage study of the vaccine in early summer.
It's up against competitors like Johnson & Johnson and Novavax, which yesterday received more funding than any other vaccine maker from the epidemic preparedness group CEPI.
However, Moderna had a leg up in the race to create a coronavirus vaccine.
Along with it's NIH and Vaccine Research Center partners, Moderna started developing a vaccine against SARS amid the 2003 outbreak of that virus, the closes cousin to the one that causes COVID-19.
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There are no approved treatments or vaccines for the COVID-19 respiratory illness caused by the new coronavirus, though some drugs are being used on patients under an emergency-use authorization.
The agency's fast track status is designed to expedite the review of treatments and vaccines meant for serious conditions.
A vaccine or treatment that gets the status is eligible for more frequent meetings with the FDA.
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Moderna, using the platform it had created to develop a SARS vaccine, was able to create a candidate vaccine in January.
By February, it shipped its vaccine to the US government.
Now, there are two Phase 1 trials the shot underway, and on May 6, Moderna's stocks shot up after the FDA greenlit its Phase 2 study.
A Phase 3 trial is set to start late this spring or early this summer.
Moderna CEO says no single drugmaker can produce enough coronavirus vaccine doses for the planet
May 12, 2020
Moderna CEO Stephane Bancel said he hopes U.S. and international regulators approve several coronavirus vaccines from multiple companies, because no single manufacturer will be able to meet global demand.
“The odds that every program works are really low, obviously, but I really hope we have three, four, five vaccines, because no manufacturer can make enough doses for the planet,” Bancel said during CNBC’s
Healthy Returns Virtual Summit.
Moderna has developed one of the leading coronavirus vaccine candidates in the world. The company is currently wrapping up phase one human trials on it in Seattle and is about to start phase 2 two trials,
it announced last week. If it’s effective and safe to use, it could be ready for market in early 2021, the company said.
Bancel said Moderna is working closely with Dr. Anthony Fauci’s team at the National Institute of Allergy and Infectious Diseases as well as the Centers for Disease Control and Prevention to determine the best plan to distribute the vaccine, which could be ready in 12 to 18 months within the U.S.