Moderna's COVID-19 vaccine: Final trials to begin on July 27
What's the story
Moderna Therapeutics has come a long way with its candidate vaccine to prevent COVID-19, the novel coronavirus disease.
Now, the US-based pharma giant has confirmed that it is set to begin the third and final stage of human trials for the experimental shot on July 27, in the United States.
Here's all you need to know about it.
Phase-3
Phase-3 trial in outbreak regions
The Phase-3 trial of Moderna's shot, dubbed mRNA-1273, will be taking place across 87 sites.
The chosen locations are in Washington DC as well as 30 states, including some worst-hit regions like Texas, California, Florida, Georgia, Arizona, and North and South Carolina.
A large study of the vaccine in outbreak regions like these is necessary to validate its efficacy for widespread public use.
Twitter Post
President Trump also wrote a cryptic tweet
Great News on Vaccines!
— Donald J. Trump (@realDonaldTrump) July 15, 2020
Details
30,000 volunteers to be included in the trial
In the final study, the candidate vaccine will be tested on 30,000 individuals as part of a randomized placebo-controlled trial.
This will generate additional data on its effectiveness and side-reactions, which will be reviewed by the Food and Drug Administration (FDA) for emergency-use approvals.
If all goes according to the plan, it should get the approvals and be ready for emergency use by early-2021.
Results
So far, the results have been promising
Backed by funding from the US government, the Moderna vaccine has seen some delays to go into the final trials, but the results from early-stage tests have shown promise.
Specifically, in the Phase-1, the shot was tested on 45 healthy volunteers and was able to generate an immune response against the virus in all the cases.
It was, in fact, confirmed to be safe.
Result details
High level of antibodies with two doses
According to the results, the volunteers who got two doses of the mRNA-1273 vaccine generated high levels of antibodies to fight off an active version of the novel coronavirus.
The volunteers did not show any major side-effects, except mild-to-moderate fatigue, headache, chills, muscle aches, or pain where the shot was injected.
These minor reactions were mostly noted after the second dose.
Information
Manufacturing being handled by Lonza
Along with testing, Moderna is also working with drugmaker Lonza to boost the manufacturing of the vaccine. The companies plan to have sufficient doses ready for distribution by the time of approvals and will manufacture 500 million doses, perhaps even 1 billion, starting in 2021.