2020.05.17 23:14
2020.05.17 23:15
2020.05.18 02:27
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 18, 2020-- Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
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.
mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies. The sole incidence of a grade 3 adverse event in the 25 µg and 100 µg dose cohorts was a single participant at 100 µg who experienced grade 3 erythema (redness) around the injection site. To date, the most notable adverse events were seen at the 250 µg dose level, comprising three participants with grade 3 systemic symptoms, only following the second dose. All adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported.
2020.05.18 04:19
By JIM GERAGHTY
May 18, 2020 10:27 AM
Scientists are seen working on a potential vaccine for COVID-19, in Keele, Britain, April 30, 2020. ( Reuters/Carl Recine)
How often does a Monday morning bring four big pieces of good news?
One: “Moderna Inc. on Monday said human subjects in a Phase 1 trial of a candidate Covid-19 vaccine produced immune responses that were a positive sign of the vaccine’s potential to prevent infection with the new coronavirus. . . . Two weeks after receiving a second dose, people who received the smallest-tested dose of the vaccine created levels of binding antibodies equivalent to those seen in people who have recovered from Covid-19. And people who received a medium dose of the vaccine produced binding antibodies two weeks after a second dose that significantly exceeded the levels seen in recovered patients.”
Elsewhere in the Wall Street Journal, the chief science officer of Johnson and Johnson says his company expects to have sufficient doses “to vaccinate health care workers globally” in early 2021.
Two: “Official data may not show much, if any recovery, in May from April, but a rise in June is quite plausible. If that growth is sustained, this economic contraction could go on record as the deepest since the 1930s, yet also the shortest, lasting as little as two or three months.” As painful as a deep and short recession would be, it beats a deep and long one.
Three: On Rt.live, the latest data indicates that 48 of the 50 states have an Rt level below one, meaning that the average person who catches the coronavirus is spreading it to less than one other person. Minnesota is at exactly one, and Maine is at 1.01. Montana enjoys the lowest Rt figure in the country, at .52. These numbers could start creeping up again as the economy and society reopen, but the country has made enormous progress at slowing down the spread. Six weeks ago, 33 states were above the threshold of one, with Nebraska the highest at 1.2.
Four: “[Tropical storm Arthur] will make its closest approach to the Outer Banks during the day on Monday. By Tuesday, the National Hurricane Center forecasts Arthur to transition into a non-tropical low-pressure system as it moves away from the East Coast.” The last thing we needed was a bad hurricane hitting the coast while everyone is trying to stay six feet apart.
2020.05.19 01:13
There seems to be a realistic hope!
Topline data from COVID-19 vaccine developer Modernaindicated that both doses tested in its phase I study elicited neutralizing antibodies, with overall antibody titers "at or above levels seen in convalescent sera," and the vaccine also "provided full protection against viral replication in the lungs in a mouse challenge model." Moderna said it plans to begin a phase III trial in July.