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Novavax COVID-19 Vaccine Shows 90.4% Overall Efficacy

Novavax COVID-19 Vaccine Shows 90.4% Overall Efficacy

“In the placebo-controlled, observer-blinded study randomized 2:1, NVX-CoV2373 demonstrated overall efficacy of 90.4% (95% CI: 82.9, 94.6)…”

Novavax might give America its fourth COVID-19 vaccine after a trial showed it is 90.4% overall efficient.

The vaccine also protects people from moderate and severe COVID-19 in the PREVENT-19 Phase 3 trial.

Stanley C. Erck, Novavax President and Chief Executive Officer, said: “Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection. Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.”

Novavax wants to file for FDA authorization in the third quarter after it completes the “final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.”

Novavax could manufacture 100 million doses per month by the end of the third quarter if it receives FDA authorization. It could also have “150 million doses per month by the end of the fourth quarter of 2021.”

The vaccine resulted in “consistent, high efficacy among circulating variants.” From the press release:

In the placebo-controlled, observer-blinded study randomized 2:1, NVX-CoV2373 demonstrated overall efficacy of 90.4% (95% CI: 82.9, 94.6), achieving its primary endpoint. Seventy-seven cases were observed: 63 in the placebo group and 14 in the vaccine group. All cases observed in the vaccine group were mild as defined by the trial protocol. Ten moderate cases and four severe cases were observed, all in the placebo group, yielding a vaccine efficacy of 100% (95% CI: 87.0, 100) against moderate or severe disease.

Efficacy endpoints were accrued from January 25 through April 30, 2021 — a time when the Alpha (B.1.1.7) variant, first identified in the U.K., became the predominant strain in the U.S. Other strains, including Variants of Interest (VoI) and Variants of Concern (VoC), were also on the rise during the PREVENT-19 endpoint accrual window. Click here for CDC definitions of variants.

Sequence data are available for 54 of the 77 cases. PREVENT-19 met its key secondary endpoint, demonstrating 100% efficacy (95% CI: 80.8, 100) against variants not considered VoC/VoI. Of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, which represented 82% of the cases, vaccine efficacy was 93.2% (95% CI: 83.9, 97.1), achieving a key exploratory endpoint of the study. Thirty-eight of the VoC/VoI cases were in the placebo group and 6 were in the vaccine group.

NVX-CoV2373 also showed success among “high-risk” populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure): vaccine efficacy was 91.0% (95% CI: 83.6, 95.0), with 62 COVID-19 cases in the placebo group and 13 COVID-19 cases in the vaccine group.

I love that it tested on people under 65-years-old with health problems. The fast trials of the other vaccines caused my rheumatologist to hesitate right away. After her own observation, she gave me the okay in March to get it, but I had to give her daily updates and not take my immuno-suppressant medicine.

Novavax might encounter some roadblocks since we already have three vaccines. The FDA could tell the company to apply for a full license, which takes several months.

Erck hopes the date “gives everybody an incentive to pay attention to our filings.”

Natalie Dean, a University of Florida biostatistician, described the results as “strong” and puts Novavax “in that high tier.”

The vaccine could help out with booster shots:

By the time Novavax gets the green light from the U.S. government, it may be too late to contribute to the country’s first wave of vaccinations. But many vaccine experts expect that, with waning immunity and emerging variants, the country will need booster shots at some point. And the protein-based technology used in the Novavax vaccine may do a particularly good job at amplifying protection, even if people have previously been vaccinated with a different formulation.

“They may be really the right ones for boosters,” said Dr. Luciana Borio, who was the acting chief scientist at the F.D.A. from 2015 to 2017.

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Comments

UnCivilServant | June 14, 2021 at 9:56 am

I couldn’t tell from the article, is this a traditional or mRNA treatment?

    billdyszel in reply to UnCivilServant. | June 14, 2021 at 10:34 am

    It’s a traditional vaccine, protein based. Not mRNA or Viral Vector.

    MarkSmith in reply to UnCivilServant. | June 14, 2021 at 10:39 am

    Like most of the Covid-19 vaccine candidates, the Novavax candidate requires two shots spaced three weeks apart. But candidate NVX-CoV2373 actually works differently than the other vaccines that have made it this far. It’s a protein subunit vaccine, which means that it uses a lab-made version of the SARS-CoV-2 spike protein. This spike protein alone can’t make anyone sick. But to make sure that the body still generates the protective antibodies against it, Novavax has inserted an ingredient called an adjuvant, which acts as a hypeman for the immune system to signal it to spring into action.

    https://www.msn.com/en-us/health/medical/what-is-the-novavax-vaccine-and-how-does-it-work/ar-BB1cixrd

      geronl in reply to MarkSmith. | June 14, 2021 at 6:46 pm

      Spike proteins alone can damage human bodies.

      https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.121.318902

      “In the new study, the researchers created a “pseudovirus” that was surrounded by SARS-CoV-2 classic crown of spike proteins, but did not contain any actual virus. Exposure to this pseudovirus resulted in damage to the lungs and arteries of an animal model—proving that the spike protein alone was enough to cause disease. Tissue samples showed inflammation in endothelial cells lining the pulmonary artery walls.”

Are they reporting 90% efficacy to relative or absolute risk?

Does it cause the production of the spike protein like the other shots?

It would be nice to have some real information here.

    TX-rifraph in reply to Zachary. | June 14, 2021 at 10:15 am

    And then we can consider whether believe any of it. How they respond to questions and challenges will give us a clue.

    billdyszel in reply to Zachary. | June 14, 2021 at 10:35 am

    It doesn’t cause production of spike protein, but it does deliver spike protein in a nanoparticle.

I wonder how many people actually got covid and then got the vaccine? Wonder if the exposure can be attributed to the ie, if 28 M reported recovered case combined with an additional 100 M unreported cases since the symptoms to mild to report, we are at 128 M exposed people (at minimum) how many are people that also got the shot? 172 M have gotten the shots, it is reasonable to say only about 30M people did not have the Covid antibody in their system before the shot. So all measures of death by shot should be based on 30 M. With over 5 K deaths from the shot. That makes the death and adverse reaction a lot higher if we are only looking at people who did not already have the antibody. Additionally, it brings in the question of the actual efficacy of the vaccines.

Cases

https://www.worldometers.info/coronavirus/

Shots:

https://usafacts.org/visualizations/covid-vaccine-tracker-states/

172,758,350

Backtracking here, I find it fascinating that so many prospective virus-stomping technologies that WORK had been in the pipeline for so long that companies could run from zero to full production in less than a year. Even better (bear with me), if Covid had been a real killer with lethality rates up in the twenty or thirty percent range for the general populace, it seems that a similar multitude of vaccines could have been getting into arms within *weeks* of it breaking out.

And with luck, this capacity for stomping rising viral threats will be encouraged, not taxed and regulated to death.

    puhiawa in reply to georgfelis. | June 14, 2021 at 12:49 pm

    This tech, which I agree could be a game changer for many diseases that one could not imagine a vaccine for, arose from DARPA grants in 2013 to Moderna, whose research into RNA came to DARPA’s attention, and a couple Universities that had done excellent DARPA work in the past including the Univ. of Texas. The goal of the research was to establish a protocol for developing a vaccine very quickly in the event a bio-weapon was released on the populace as a whole or a targeted military segment, such as the navy or military fort.

      dunce1239 in reply to puhiawa. | June 15, 2021 at 11:49 pm

      with this available all the mRNA jabs should be discontinued it is no longer any real danger of high fatalities from getting the wuflu.

JusticeDelivered | June 14, 2021 at 12:40 pm

I gather that this will not be available for fall. It sounds like is a good canadate for a followup for the J&J which I received. I agree that people at low risk should avoid vaccinations for CCP Coronavirus, but I was at considerable risk, and decided to get vaccinated with the vaccine I deemed as the least risky.

    healthguyfsu in reply to JusticeDelivered. | June 14, 2021 at 1:54 pm

    I think everyone who is at low risk of a vaccine side effect should get vaccinated. This is not some poison microchip conspiracy, and it is stupid to continue to peddle in that kind of information for those that do.

      Ironclaw in reply to healthguyfsu. | June 14, 2021 at 5:41 pm

      You can trust the assholes that have been lying to us continually for the last year and a half. I will not and because the pedophile wants it, I refuse to get it.

        Dathurtz in reply to Ironclaw. | June 14, 2021 at 6:43 pm

        Lied about transmissibility. Lied about asymptomatic transmission. Lied about masks. Lied about death reporting. Lied about origins.

        I think I am gonna trust ’em this time.

      geronl in reply to healthguyfsu. | June 14, 2021 at 6:49 pm

      The government and media have been telling us lies about COVID from the start, why should we trust them now?

      dunce1239 in reply to healthguyfsu. | June 15, 2021 at 11:51 pm

      Your comment indicates that you think all jabs a have equal risks.

Classic subunit vaccine, yields antibody response:

https://www.verywellhealth.com/novavax-covid-19-vaccine-5093292

“The Novavax vaccine uses a custom-made spike protein that mimics the natural spike protein in the SARS-CoV-2 virus. Novavax has for years worked on developing its recombinant nanoparticle technology, and created the first COVID-19 vaccine using this method in the spring. By summer, early clinical trials showed that the vaccine appeared to be safe, and more advanced trials entered the planning stage in the United States and other countries.”

“The two-dose vaccine works by introducing a protein that prompts an antibody response, which blocks the ability of future coronavirus to bind to human cells and prevents infection. The protein is combined with Novavax’s Matrix-M adjuvant, which is important in enhancing the immune response elicited by the protein antigen. ”

It’s still the spike protein, but the dosage is more controlled because mRNA is not manufacturing the protein within the body.

More smoke. We are now allowed to say hydroxychloroquine and ivermectin based treatments are effective. None of these vaccines have gone through the usual trials. Anybody that gets any of these has volunteered to be a test subject.

What is the actual risk reduction of this new vaccine? Does it even break 5%?

    healthguyfsu in reply to Dathurtz. | June 14, 2021 at 1:55 pm

    I’d rather get the vaccine than take either of those. Those treatments aren’t without side effects if they do work.

      LibraryGryffon in reply to healthguyfsu. | June 14, 2021 at 2:04 pm

      Remember, that HCQ and ivermectin have been in use for decades, so we know a lot about side effects and how to manage them. These RNA shots, not so much.

      My question would be, can someone with a thrombophilia safely get this shot? I was specifically warned against the J&J by both my doctor and a pharmacist.

      Dathurtz in reply to healthguyfsu. | June 14, 2021 at 2:08 pm

      To each their own. HCQ has been given out millions of times over decades and was considered totally safe by virtually everybody up until Trump mentioned it.

      But that is totally in the same league as my wife’s poor hair dresser for got the Moderna and developed blood clots in her brain and is disabled now.

      Valerie in reply to healthguyfsu. | June 14, 2021 at 5:17 pm

      Feel free, and allow me the same freedom.

      Hydroxychloroquine and Ivermectin have been subjected to business slander and you have been affected by it. Those two drugs have been used for many decades, and at higher dosages, for longer terms, than required for treatment of COVID-19.

      They are effective, and there’s plenty of proof.

      https://covid19criticalcare.com/wp-content/uploads/2020/11/FLCCC-Ivermectin-in-the-prophylaxis-and-treatment-of-COVID-19.pdf

      And yet, neither is absolutely necessary, provided treatment is started early.

      My son’s girlfriend got sick, so they both went in and got tested. She tested positive for COVID-19, and he tested negative.

      Those unmitigated bastards sent them both home to self-quarantine without treatment.

      I sent them a care package with zinc 95mg, a zinc ionophore, Quercetin, 500 mg, sufficient for a 5-day course of treatment, plus C, 1000 mg, D 10,000 mg and a multivitamin with trace selenium sufficient for a month.

      I sent the package overnight, and by the time I got the package to Mailboxes, my son was already crashing. He had it, too.

      They were sick for two days of treatment, better on the third, and well by the 5th, just like the curve for viral suppression in the original hydroxychloroquine paper.

      He later tested positive for antibodies, and donated serum for treatment of other patients.

      What we have here, folks, is a cure for the common cold, and flu, because they all reproduce in the same manner, in the same type of cells.

      Ironclaw in reply to healthguyfsu. | June 14, 2021 at 5:46 pm

      Both of those drugs have been used safely for decades by people who take them continually for years on end. The side effects are known and can be watched for.

    I urge everyone to watch Dr. Pierre Kory (renowned cardiologist
    “Dr. Pierre Kory is board-certified in critical medicine, pulmonary diseases, and internal medicine. He has worked closely with critical COVID-19 patients across the US throughout the pandemic. He is the chief of the critical care service and medical director of the trauma and life support center at the University of Wisconsin.” https://dryburgh.com/ivermectin-pierre-kory/)
    and Dr. Brett Weinstein (prof of biology) interview on covid/ivermectin.
    . Youtube has banned it for “misinformation”, but it appears here. Long, but well worth the watch!
    https://www.gloria.tv/share/VduEFAawHgke21UUbhyojxWqD
    Eye opening.

The problem with Hydroxychloroquine and Ivermectin appears to be that big pharma does not make big bucks.

    txvet2 in reply to TX-rifraph. | June 14, 2021 at 8:18 pm

    Same thing for naturally acquired immunity.

    billdyszel in reply to TX-rifraph. | June 15, 2021 at 4:28 am

    Bigger problem for pharma is that emergency authorization of a new vaccine can’t be granted if there’s an effective treatment. Big pharma needs to block any effective treatment to keep selling the vaccines.

A vaccine for what exactly?

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