https://www.cnbc.com/2020/05/18/moderna-reports-positive-data-on-early-stage-coronavirus-vaccine-trial.html
Other articles have pointed to the possibility of emergency use of the vaccine as soon as this fall.
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Moderna's closely watched early-stage human trial for a coronavirus vaccine produced Covid-19 antibodies in all 45 participants, the biotech company announced Monday, sending the company's shares surging 35% in premarket trading.
Each participant received a 25, 100 or 250 microgram dose, with 15 people in each dose group. Participants received two doses of the potential vaccine via intramuscular injection in the upper arm approximately 28 days apart.
At day 43, or two weeks following the second dose, levels of binding antibodies in the 25 microgram group were at the levels generally seen in blood samples from people who recovered from the disease, the company said.
Those in the 100 microgram had antibodies that "significantly exceeded levels" in recovered patients. Data on a second dose was not available for the 250 microgram group, the company said.
The vaccine also produced neutralizing antibodies against Covid-19 in at least eight participants, the company said. Experts have said neutralizing antibodies appear to be important in acquiring protection.
Four participants were assigned to receive a 25 microgram dose, while the other four received 100 micrograms. Levels of neutralizing antibodies were at or above levels seen in blood samples, the company said. Data on neutralizing antibodies for the other participants were not yet available, Moderna said.
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The company said it expects to begin a phase 3 trial in July.
Earlier this month, Moderna announced that it was wrapping up phase one human trials on its potential vaccine with the U.S. government and is moving to start phase two trials that would include 600 participants. If the vaccine is found to be effective and safe to use, it could be ready for the market in early 2021, the company said.
The company said the vaccine was generally safe and well tolerated. To date, the most notable adverse events were seen in the 250-dose group where three participants developed "grade 3 systemic symptoms," following the second dose, the company said.
The potential vaccine by Moderna contains genetic material called messenger RNA, or mRNA, that was produced in a lab. The mRNA is a genetic code that tells cells what to build in this case, an antigen that may induce an immune response to the virus.
The phase 1 trial took place at the Kaiser Permanente Washington Health Research Institute in Seattle, Washington. It tested the vaccine on 45 males and non-pregnant females between the ages of 18 and 55.
Other articles have pointed to the possibility of emergency use of the vaccine as soon as this fall.
