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Categories: The Muslim Times, Vaccine
A doctor involved in a U.S. coronavirus vaccine study said he is hopeful but not convinced that an injection will be available for circulation this year.
Dr. Carlos del Rio, an Emory University professor of medicine, told CNBC on Friday that a Covid-19 vaccine could be ready in some form for distribution by the end of 2020 but cautioned that it’s an unprecedented timeline.
“I am cautiously optimistic,” del Rio said on “Power Lunch,” echoing comments earlier that day from immunologist Dr. Anthony Fauci. “We are developing at a pace that has never been done before.”
Atlanta’s Emory University is one site testing a Covid-19 vaccine candidate from Moderna, which in March initiated the first U.S. clinical trial for a solution. Fauci, a leading health advisor on the White House’s coronavirus response team, in a Friday morning interview on NPR said his projected timetable to develop a vaccine — a 12- to 18-month process — remains “intact” and that it’s “conceivable” an injection could be ready to deploy in December.
“Trying to think that, a year after a virus has been identified, we will have a vaccine ready to deploy and ready to go into massive distribution, it’s simply mind-boggling to me,” del Rio said. “I have to be a little cautious and say I hope it happens, but I don’t want to be — I want to make sure we do it the right way.”
https://www.cnbc.com/2020/05/22/moderna-vaccine-researcher-it-mind-boggling-to-be-done-in-2020.html
Moderna plans to enroll 600 participants in the study, with half of them being 55 years of age or older. Based on the phase 1 study, Moderna plans to test two doses of the drug, which will be compared with a placebo. Each participant will receive an initial vaccination and a booster to increase antibody production.
The phase 2 clinical trial might be able to read out faster than the 45-participant phase 1 study that took about two months to gather data. That’s because all participants can be dosed immediately, unlike in a phase 1 dose-escalation study where safety data from each dose has to be gathered before the next dose can be started. Of course, there are substantially more participants in the phase 2 study, but it shouldn’t be too hard to find 600 people who are interested in enrolling in the study.
Moderna is shooting for starting the phase 3 clinical trial in July. The company is still working on the design of the study, but presumably it’ll need to have thousands of participants to gather enough safety data to get the vaccine approved by regulators.
https://www.fool.com/investing/2020/06/01/moderna-starts-a-phase-2-clinical-trial-for-its-co.aspx
There’s no doubt about it, Moderna’s (MRNA) profile has increased dramatically since the pandemic’s onset.
The biotech name has climbed 206% higher this year, as investors have piled in with the hope that its COVID-19 vaccine candidate, mRNA-1273, might be the one to solve the coronavirus conundrum. Yet, it hasn’t all been positive news. Recently, questions have surfaced concerning the company’s sale of shares following the stock’s latest surge.
Blocking out all of the noise, Oppenheimer analyst Hartag Singh recently attended Moderna’s virtual Science Day to get some visibility on the work going on behind the scenes. The 5-star analyst liked what he heard, to say the least.
“Building on the last two Science Days, Moderna has kept a focus on strengthening its Research Platform science, with (1) increasing mRNA and encoded protein half-lives and stabilizing mRNA while avoiding double-stranded RNA impurities, (2) making a novel squaramide-based ionizable lipid (new LNP) to improve protein expression, and (3) designing a preclinical HIV vaccine program to MRNA’s platform with its rapid iterative design/testing abilities,” Singh said.
Highlights from the presentation included information regarding protein half-lives; Singh notes the duration of response and protein expression is improved by increasing half-lives of mRNA and protein. This is accomplished by “maximizing secondary structure and codon optimality, with a terminal idT added to prevent deadenylation that causes mRNA decay.”
Singh added, “On a broader level, being able to understand and govern half-lives could potentially open new indication opportunities as well as better products for life-cycle management.”
Moderna’s research collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) to develop an HIV vaccine also got a mention, with MRNA’s “unique platform capabilities,” receiving plaudits from both presenting KOLs (key opinion leaders).
https://finance.yahoo.com/news/moderna-mrna-stock-surge-80-234710930.html
Moderna has finalized the design and dosage of its phase 3 COVID-19 vaccine trial, keeping it on track to start the pivotal test next month. Work to get the 30,000-subject phase 3 trial underway is advancing in parallel to ongoing enrollment in earlier phases of development.
Messenger RNA biotech Moderna set out its expectations for the phase 3 trial when it shared a first glimpse at clinical data on its mRNA-1273 vaccine last month. At that time, Moderna expected the phase 3 trial to test a dose between 25 µg and 100 µg, reflecting the adverse events seen in the 250-µg cohort, and get underway in July.
Moderna looks set to hew closely to those proposals. Having spoken to the FDA, Moderna plans to randomize 30,000 people in the U.S. on a one-to-one basis to receive either 100 µg of mRNA-1273 or placebo.
https://www.fiercebiotech.com/biotech/moderna-finalizes-design-phase-3-covid-19-vaccine-trial-ahead-july-start
Israel is close to signing a deal with US biotech firm Modern to supply it with a vaccine against COVID-19 if the company’s drug development is successful, Channel 13 TV reported Sunday.
The company announced last week that it will enter the third and final stage of its clinical trial in July with 30,000 participants.
https://www.timesofisrael.com/israel-said-near-to-deal-with-moderna-to-supply-experimental-coronavirus-vaccine/
As Moderna prepares to launch a Phase 3 trial of its Covid-19 vaccine in July, the company’s CEO says there’s a high probability that the company’s product could reach distribution in 2021.
“It seems to be possible that we could have efficacy data by, let’s say, Thanksgiving,” Moderna (ticker: MRNA) CEO Stéphane Bancel said during conference Wednesday. That data would potentially allow Moderna to fight for approval either late this year or early in the new year, Bancel said.
https://www.barrons.com/articles/moderna-coronavirus-vaccine-will-be-ready-for-distribution-in-2021-51592483405