(WXYZ) — Plans have been announced regarding phase 3 testing for a leading COVID-19 vaccine. Biotech company Moderna says their late-stage trial for the mRNA-1273 vaccine will begin in July.
Moderna had initially tested out 3 dose levels, but are only moving forward with one of them.
Moderna is moving forward with their 100 microgram dose. They had tested out higher and lower doses. But preliminary results found that the 100 micrograms produced antibodies “at or above levels” found in patients who had recovered from the coronavirus.
On top of that, the researchers selected a small group of their participants and tested their antibodies against the virus in the lab. The antibodies were able to neutralize the virus. Which is exactly what we want to happen.
The 100 micrograms will be split between two shots. Participants for phase 3 will range in age - most of them will be between the ages of 18 and 55. But there will be some elderly folks included as well.
Now, Moderna expects to have 30,000 participants. However, not all will be given the mRNA-1273 vaccine. Some will get a placebo or dummy shot instead.
Now, as to when we might hear the results, it won’t likely be until November or December of this year. So still a few months of waiting to find out if this vaccine will work.
When a vaccine candidate starts phase 3, it means it’s in the final clinical trial phase. This stage is critical. It’ll give us most of the safety data. So, it will tell us what side effects there might be, if any are long-term, and it’ll also tell us just how effective it was when compared to participants who were given a placebo.
Now, if a vaccine does well, it can seek approval from the U.S. Food and Drug Administration. But, as I’ve said before, many vaccines don’t survive stage 2 or 3. In fact, the FDS says only 25%-30% of drugs in phase 3 trials get approval.
Doses of the vaccine will be manufactured before we know it really works. Why? Because there are over 329 million Americans. And over 7 billion people that live on this earth. So we need to hit the ground running once we know a vaccine works.
The good news is that health officials say Moderna plans to have close to 100 million doses by late fall, early winter. And they plan to have between 500 million to 1 billion doses by January 2021.
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