Moderna is an American biotech company developing a coronavirus vaccine. It’s showing early signs of success in testing.
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Moderna
Moderna is an American biotech company that focuses on drug discovery and development based on messenger RNA (mRNA). They have developed a coronavirus vaccine, mRNA-1273, that’s showing early signs of success in the first phases of human testing.
On May 18, Moderna released the data for the interim Phase 1 of testing their coronavirus vaccine. The Phase 1 study of the vaccine was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The company issued a press release stating that: “these data 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.”
Here’s what you need to know about the Moderna coronavirus vaccine:
Summary of our SARS-CoV-2 #vaccine (mRNA-1273) interim Phase 1 data. Read more: https://t.co/aIq34ullAh#mRNApic.twitter.com/BVbYuWTkOy
Moderna (@moderna_tx) May 18,2020
The results of the interim first phase study, a small early-stage human trial, were released on May 18. The study showed that the vaccine produced virus-neutralizing antibodies at the levels seen in patients recovered from COVID-19. The early results are based on eight patients who were administered the vaccine in two different doses (25 µg and 100 µg). The samples are not yet available for the other participants.
All participants were given different doses of the vaccine and the study found that there was a dose-dependent increase in their body’s immune response. The biotech company also indicated that the vaccine was “generally safe and well tolerated.” It indicated only one instance of what’s called a grade 3 adverse effect in one participant who experienced redness around the injection site. According to Moderna, “All adverse events have been transient and self-resolving.”
Tal Zaks, the Chief Medical Officer at Moderna, said of the results: “These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg.”
We are thankful for the support of @BARDA and @RickABright to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2 https://t.co/Sn20aJVr8Zpic.twitter.com/vP0F9C1MYz
— Moderna (@moderna_tx) April 16,2020
On May 12, Moderna received the Food and Drug Administration (FDA)’s Fast Track designation, which will be useful in speeding up the review process of the vaccine. This means that Moderna can proceed to Phase 2 of the study, which will take place soon. The company is also working on its protocol for Phase 3, which it hopes will begin in early summer of 2020.
The Phase 2 study will look at two different dose levels, 50 µg and 100 µg, to ultimately choose the best dose for study.
