Moderna released information on the current human vaccine trial that made its shares skyrocket yesterday. The trial used 45 healthy volunteers and tested them with the current vaccine. Those who received the highest dosage showed an “acceptable level of virus-killing anti-bodies,” but had some somewhat significant side effects of dizziness, fatigue, and nausea.
The “acceptable level” means that the individuals who got the highest dosages showed equal to or more antibodies than the average of those who have recovered from Coronavirus without a vaccine.
Fauci’s researchers developed the first vaccine candidate. 66 days after the Coronavirus outbreak, Moderna had started human trials. Moderna has never had a licensed product, and the Federal government has dumped nearly half a billion dollars into this project.
Here’s a summary of the trial and results:
The results released Tuesday involved three doses of the vaccine, tested in groups of 15 volunteers aged 18-55 who got two shots, 28 days apart. The groups tested 25, 100 or 250 micrograms of the vaccine.
Adverse events after the second dose occurred in seven of the 13 volunteers who got the 25-microgram dose, all 15 participants who received the 100 microgram dose and all 14 who got the 250 microgram dose. In the highest-dose group, three patients had severe reactions such as fever, chills, headache or nausea. One of these had a fever of 103.28 Fahrenheit (39.6 C).
Though these may seem interesting, they are not characterized as “serious adverse events,” which could be events such as seizure, a dangerous drop in blood pressure, etc.
Phase 1 trials aim to ensure a treatment is safe and help determine an effective dose. Phase 2 trials test a treatment in a larger group and get an early read on effectiveness. Phase 3 trials are conducted in a large group of individuals to confirm efficacy and identify rare side effects. Moderna’s Phase 3 trial will be conducted in 30,000 volunteers.
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Matthew – Strictly News