Moderna does one better than Pfizer/BioNTech; touts 94.5% efficacy for its Covid vaccine
The company is the second this month to report promising results for a Covid-19 vaccine even as the virus rages across the U.S.
Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data
The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.
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Moderna publishes Phase III Covid-19 vaccine study protocol as trial enrolls more than 80% of participants
The company said at its R&D day that the Phase III COVE trial of mRNA-1273 had enrolled 25,296 of its planned 30,000 participants, while slightly more than 10,000 had received the first and second doses of the vaccine.
Moderna to supply up to 160M doses of Covid-19 vaccine to Europe
The biotech company reached a deal with the European Commission to supply an initial 80 million doses, while European Union member states will have the option to purchase 80 million more.
Moderna secures more than $1.5B federal government deal to provide Covid-19 vaccine
The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech company has received from the federal government for its vaccine efforts to nearly $2.5 billion.
Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial
The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named COVE.
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Moderna publishes Phase 1 Covid-19 vaccine data showing immune responses
Whether responses are durable and protective is under evaluation, but mRNA-1273 produced neutralizing antibody titers multiple times higher than those of recovered patients. Moderna's stock rose 17% on the Nasdaq when markets opened Wednesday.
Moderna completes enrollment in Phase II Covid-19 vaccine trial
The company said it is on track to start its 30,000-participant Phase III trial this month and has finished manufacturing enough supplies of the vaccine to do so.
Moderna Phase III Covid-19 vaccine study to enroll 30,000 participants starting next month
The company said Thursday that it had finalized the design of the protocol for its upcoming randomized, placebo-controlled trial of its closely watched messenger RNA-based vaccine, mRNA-1273.
Experts cautiously optimistic on Moderna’s early Covid-19 vaccine data as market exuberance fades
Physicians commented that although the data for mRNA-1273 are encouraging, whether the vaccine will actually be effective remains unclear, while other important questions also remain to be answered.
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Head of Trump’s Covid-19 vaccine program to divest more than $10M in Moderna shares after criticism
News media reported that Moncef Slaoui would divest his shares in Moderna, which netted him at least $3 million after the company reported promising preliminary data on its Covid-19 vaccine Monday.
Moderna gets FDA fast-track designation for Covid-19 vaccine
The company said last week that it had received clearance from the FDA to start its Phase II clinical trial, and it is also in the process of finalizing the protocol for its Phase III trial.
Moderna’s Phase II Covid-19 vaccine trial to start this quarter, with Phase III by early summer
The biotech company said in its first-quarter earnings report that the investigational new drug application that it filed with the Food and Drug Administration last week had been cleared. The Phase I study has enrolled three dose cohorts, with six additional ones planned.
Moderna files for FDA go-ahead to run Phase II study of Covid-19 vaccine
The biotech company said approval of its investigational new drug application for the vaccine, mRNA-1273, would depend on success in the Phase I study that it is currently conducting. That study has completed enrollment of its first three cohorts, totaling 45 healthy volunteers aged 18-55.
Moderna gets up to $483M from BARDA for rapid Covid-19 vaccine development
The funding will support the development of the vaccine, mRNA-1273, through to its potential licensing by the Food and Drug Administration. The company said a Phase II study is expected to start in the second quarter.