If Moderna Inc’s MRNA.O COVID-19 vaccine proves to be at least 70% effective, the company plans to seek emergency authorization for its use in high-risk groups, the company’s chief executive told Reuters.Moderna’s vaccine candidate – mRNA-1273 – is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. As of Wednesday night, Moderna had enrolled 25,296 participants.
But the company may be able to declare victory early if it is able to show that people who got the vaccine fared much better in its trial that people who did not.Vaccines must demonstrate they are at least 50% moreeffective than a placebo to be considered for approval. To provethat, government officials have said, at least 150 COVID-19infections must be recorded among trial participants with atleast twice as many occurring among the placebo group.
Pfizer COVID-19 Vaccine Trial Reaches Initial Goal of 30,000 Volunteers
Pfizer announced on Wednesday that it has reached its initial goal of 30,000 participants for the phase 3 trial of its coronavirus vaccine. Over the weekend, the drugmaker submitted an “amended protocol” to the U.S. Food and Drug Administration to expand the enrollment for its trial to about 44,000 participants. The company said in a statement that this would help increase the diversity of the trials.
If approved, the new volunteers could include children as young as 16 and people with chronic underlying conditions like stable HIV, Hepatitis C, or Hepatitis B infection, to help provide additional safety and efficacy data.During a presentation to investors on Tuesday, the company said participants were only showing mild to moderate side effects when given the vaccine or a placebo including fatigue, headache, chills and muscle pain.Based on the current infection rates, Pfizer said it is expecting to learn if it created an effective vaccine or not by the end of October.