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Alt 18-05-2020, 15:47   #12
Benjamin
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Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
May 18, 2020
, https://investors.modernatx.com/news...article_inline

Zitat:
Immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29). Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 µg and 100 µg dose levels. All participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose. At day 43, two weeks following the second dose, at the 25 µg dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43, at the 100 µg dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Samples are not yet available for remaining participants.

At this time, neutralizing antibody data are available only for the first four participants in each of the 25 µg and 100 µg dose level cohorts. Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.
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Moderna reports positive data on early-stage coronavirus vaccine trial, shares surge
PUBLISHED MON, MAY 18 2020

https://www.cnbc.com/2020/05/18/mode...ine-trial.html

Zitat:
  • Moderna’s closely watched early-stage human trial for a coronavirus vaccine produced Covid-19 antibodies in all 45 participants.
  • Each participant received a 25, 100 or 250 microgram dose, with 15 people in each dose group.
  • 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.
Zitat:
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.

“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 [micrograms],” Moderna chief medical officer Dr. Tal Zaks said in a statement.

“When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials,” Zaks added.

Scientists hope the antibodies provide some degree of protection against getting Covid-19, but they can’t say that definitively yet since it hasn’t been studied and some patients appear to have been reinfected after recovering from the virus.
Zitat:
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.
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Coronavirus Vaccine Trial by Moderna Shows Promising Early Results
The company said its preliminary test in 8 healthy volunteers was safe. It is on an accelerated timetable to begin a larger human trial soon.

By Denise Grady, May 18, 2020,
https://www.nytimes.com/2020/05/18/h...e-moderna.html

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MRNA - Moderna Inc. (NAS):












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