Moderna’s COVID-19 vaccine boasts a nearly 95% effective rate in early data

[jmyrlefuller]

https://www.latimes.com/world-nation/story/2020-11-16/2nd-coronavirus-vaccine-shows-early-success-in-u-s-tests

Moderna said its vaccine appears to be 94.5% effective, according to preliminary data from the company’s ongoing study. A week ago, competitor Pfizer announced its own COVID-19 vaccine appeared similarly effective — news that puts both companies on track to seek permission within weeks for emergency use in the U.S.

Dr. Stephen Hoge, Moderna’s president, welcomed the “really important milestone” and said that having similar results from two different companies is what’s most reassuring.

[rustynail]

Fauci says masks will still be required.

[mystery-ak]

New Vaccine Developed In Conjunction With Trump’s ‘Operation Warp Speed’ Is 94.5% Effective, Company Says
By  Ryan Saavedra
•
Nov 16, 2020   DailyWire.com

A new Moderna vaccine that was developed in conjunction with Trump administration’s Operation Warp Speed is nearly 95 percent effective, according to the company.

“The analysis evaluated 95 confirmed Covid-19 infections among the trial’s 30,000 participants,” CNBC reported. “Moderna, which developed its vaccine in collaboration with the National Institute of Allergy and Infectious Diseases, said 90 cases of Covid-19 were observed in the placebo group versus 5 cases observed in the group that received its two-dose vaccine. That resulted in an estimated vaccine efficacy of 94.5%.”

more
https://www.dailywire.com/news/breaking-new-vaccine-developed-in-conjunction-with-trumps-operation-warp-speed-is-94-5-effective-company-says

[catfish1957]

Biden (Operation Warped Brain) will take the credit.  No justice.......

[PeteS in CA]

https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy

Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 16, 2020-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001).

A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.

NIH started working with Moderna in late January, one of the months Biden & the Dems claim Trump wasted.

So here are the major milestones, past and soon coming in vaccines and treatments:

* Pfizer is likely to receive Emergency Use Authorization (EUA) for its vaccine within weeks;

* Moderna is likely to receive EUA for its vaccine within weeks;

* Depending on how much credit the FDA gives testing done in the UK, South Africa, and Brazil, AstraZeneca could receive EUA for its vaccine within weeks;

* Eli Lilly last week received EUA for the monoclonal antibody (mab) treatment developed with AbCellera (begun in January 2020 as part of AbCellera's participation in a 2018 DARPA project to develop fast response processes to disease outbreaks);

* Regeneron is likely to receive EUA for its mab treatment within a few weeks or even days;

* GlaxoSmithKline could receive EUA for its mab treatment within a month or two;

* Gilead received authorization about 4 weeks ago (not just EUA) for the use of Veklury (remdesivir) in treating Covid-19.

[skeeter]

Biden (Operation Warped Brain) will take the credit...

Wait for it, he's not up yet.

[PeteS in CA]

Moderna also announced this info today regarding the "shelf life" of its vaccine, https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-longer-shelf-life-its-covid-19-vaccine

Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 16, 2020-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days. Stability testing supports this extension from an earlier estimate of 7 days. mRNA-1273 remains stable at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.

“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. The ability to store our vaccine for up to 6 months at -20° C including up to 30 days at normal refrigerator conditions after thawing is an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world.”

One of the half-truths (or third-) Biden told was that Covid-19 vaccines would have to be transported and stored at -70 degrees. That may be true of Pfizer's but that was known at the time to be false wrt Moderna's and AstraZeneca's. This announcement shows that Moderna's can be stored for a useful time at less cold temps that originally thought.

[PeteS in CA]

https://www.nationalreview.com/the-morning-jolt/great-news-on-the-vaccine-front/

Great News on the Vaccine Front

Arguably even better news than hearing that Pfizer’s coronavirus vaccine is 90 percent effective: The pharmaceutical company Moderna announced this morning that the company’s “experimental vaccine was 94.5 percent effective in preventing COVID-19 based on interim data from a late-stage clinical trial” and — this has big consequences for shipping and distribution — it can be stored in regular refrigerator temperatures.

Stéphane Bancel, CEO of Moderna, said in a released statement, “This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters . . . I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point.” (BARDA is the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services.)

My emphasis. What a contrast from that female at Pfizer who played disingenuous word games to try to pretend the Trump Administration had no part in Pfizer's vaccine being close to Emergency Use Authorization.

[jmyrlefuller]

@PeteS in CA I'm recalling a while back when they were still in the Phase 1/2 trials that one of the vaccine candidates was producing way more of an immune/antibody response compared to the other candidates. Was that the Moderna one?

[PeteS in CA]

@PeteS in CA I'm recalling a while back when they were still in the Phase 1/2 trials that one of the vaccine candidates was producing way more of an immune/antibody response compared to the other candidates. Was that the Moderna one?

@jmyrlefuller, I'm not sure. While the focus right now tends to be on Pfizer and Moderna (both very similar efficacy rates), there are 5 vaccines currently in Phase III test, AstraZeneca Johnson & Johnson, and Novavax being the other three. Of those five, J & J is the only one being tested in a single-dose regimen (a two-dose regiment being about to start). There are other vaccines the Trump Administration has been working with that are in earlier Phases: Dynavax just started Phase I in India; Inovio just started Phase II; Sanofi is in Phase I/II; Vaxart (an oral vaccine) is in Phase I.

&&&&&&&&&&&&&&&&&&&&

One point mentioned in this article, https://saraacarter.com/trump-vaccines-all-took-place-on-my-watch/ , that I think many media people have missed:

Trump: Vaccines ‘all took place on my watch’

“This is a really a historic day. This is the vaccine that President Trump partnered with on January 13th, and now over 90% effective vaccine in one of the largest clinal trials ever. Now we have Pfizer, we have Moderna and thanks to President Trump’s vision we have been making both of those and four other vaccines at commercial scale productions,” said Azar.

My emphasis. When Pfizer, Moderna, and others receive EUA, they will already have 10s of millions of doses already produced and ready to ship. OWS has never been simply and effort to develop, test, and approve a vaccine. It has always been a development-lab-to-patients'-arms effort, even before being given a cornball project name.

[jmyrlefuller]

My emphasis. When Pfizer, Moderna, and others receive EUA, they will already have 10s of millions of doses already produced and ready to ship. OWS has never been simply and effort to develop, test, and approve a vaccine. It has always been a development-lab-to-patients'-arms effort, even before being given a cornball project name.

I noticed that a couple of weeks ago. They were producing commercial-scale vaccines even before they announced the efficacy, which shows how much confidence they had in their work.

[jmyrlefuller]

HHS aims to get 20 million doses administered, 40 million manufactured by New Year's—enough to cover a good chunk of the most vulnerable.
https://nypost.com/2020/11/16/hhss-azar-we-hope-to-vaccinate-20m-against-covid-19-in-december/

[Gefn]

The question is would you take it?

Some people definitely would but would an anti vaccine person?

[catfish1957]

The question is would you take it?

Some people definitely would but would an anti vaccine person?

I will, but will not be in the first wave....   

[PeteS in CA]

The question is would you take it?

Some people definitely would but would an anti vaccine person?

An "anti vaccine person", by definition, would not. Based on what I know, I would take any of the vaccines that successfully completed their tests. Because of its politically-motivated snub and disingenuous word-gaming announcement last week I prefer the others over Pfizer, but I'm not young and "proper" weight.