Coronavirus

Moderna COVID-19 Vaccine 'Highly Effective,' Says FDA Analysis

Now we wait for the FDA to get around to approving it later this week.

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The COVID-19 vaccine from Moderna Therapeutics is 94.1 percent effective at preventing infection from the coronavirus that causes the illness, according to the Food and Drug Administration's (FDA) staff analysis. This efficacy rate was calculated based on the finding of 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group. Additional good news is that 11 cases of severe COVID-19 occurred in the placebo group whereas none occurred in the vaccine group. Furthermore, the report notes that the vaccine was similarly efficacious for all "age groups, genders, racial and ethnic groups, and participants with medical comorbidities [like obesity and diabetes] associated with high risk of severe COVID-19."

The Moderna vaccine is based on the same messenger RNA (mRNA) technology used to develop the Pfizer and BioNTech vaccine for which the FDA just issued an Emergency Use Authorization (EUA) over the weekend. Therefore it seems highly likely that the Vaccines and Related Biological Products Advisory Committee, the outside panel of experts advising the FDA, will vote to approve this vaccine as well when the panel gets around to meeting this Thursday.

The reported side effects of the Moderna vaccine appear to be a bit more frequent than those of the Pfizer/BioNTech vaccine but resolve for most people after a day or so. In addition, the FDA report notes that the trial data are too limited to determine if it is possible for vaccinated people who nevertheless become infected and remain asymptomatic to transmit the virus to unvaccinated people. This is the case for the Pfizer/BioNTech vaccine, too.

For full efficacy, both the Moderna and Pfizer/BioNTech vaccines require two doses administered several weeks apart. The first inoculations with the Pfizer/BioNTech vaccine began yesterday. The federal government has contracted with Pfizer/BioNTech to purchase 100 million doses (enough for 50 million people) and 200 million doses from Moderna (enough for 100 million people).

The federal government is now trying to obtain an additional 100 million doses of the Pfizer/BioNTech vaccine sometime in the second quarter of 2021. Overall, that would be enough vaccine to protect 200 million Americans. That many doses would be sufficient to vaccinate most Americans over age 18, keeping in mind that the risk of dying from COVID-19 for people under age 18 is very low.

Two of the other vaccines—Sanofi and AstraZeneca—backed by the federal government's Operation Warp Speed have hit clinical trial road bumps that suggest that they may not be available (if ever) until the latter part of 2021. On the other hand, the clinical trial results from Johnson & Johnson's one-dose vaccine are expected to be available before the end of January. If the trial results turn out to be promising, the company will seek an EUA in early February and that would add a third vaccine to the U.S. arsenal. Johnson & Johnson has contracted with the federal government to supply 100 million doses before the end of the first quarter of 2021. That would then just about cover the whole U.S. population.

NEXT: Wish a Not-So-Fond Farewell to Outgoing Attorney General William Barr

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  2. The COVID-19 vaccine from Moderna Therapeutics is 94.1 percent effective at preventing infection from the coronavirus that causes the illness, according to the Food and Drug Administration’s (FDA) staff analysis………VISIT HERE FOR FULL DETAIL.

    1. The link’s in Russia. Click at your own risk.

  3. The Specter of the Trump vaccine casts a shadow across America…

    1. I urge all Good Americans to get the Trump Jab, with capital J.

      Start off with Nancy, Joe, and Chuck on live TV getting the Trump Jab from Tony. With Trump off to the side smiling.

      So when we get the jab, the masks and lock-downs are finished, right?

  4. I wonder if you could mix and match the Pfizer and Moderna vaccines. Meaning, get the initial shot with PFZ, and then the second shot Moderna. Since they both have the same MOA, why not?

    We need to do everything we can to increase supply. Maybe mixing and matching is a way to do that.

    1. Whoah, now. Mixing and matching wasn’t specifically tested and approved by the FDA. It’ll probably kill you.

      1. It turns you into Absorbing Man.

  5. Thanks FDA for telling us something we knew a month ago. It’s good to see you’ve almost decided to finish causing unnecessary deaths.

    Anyone who has lost a loved one to COVID in the last few weeks should be furious.

    1. Yeah if only the vaccine had been there when your 97 year old great grandfather on his 3rd pig valve with no memory of anything that happened before this morning who’s been wheelchair bound in the nursing home for 20 years died he might have lived another 9 days!

    2. It was for safety reasons. Trump could win.

    3. Too late. It takes 4 weeks to be effective .

    4. No vaccine would have saved anyone who died in the last few weeks — or in the next few. Their fates are done and dusted. It’s the deaths a month or two from now that could have been prevented.

      Pfizer requested the Emergency Use Authorization on November 20. The British equivalent of the FDA approved it on December 3. The FDA itself fardeled around until December 10 before convening its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to pass on its safety, and incidentally to provide a scapegoat if things go pear-shaped. The committee approved, but there was every indication the FDA would have to think it over for a few days before issuing its approval.

      Then Trump told Dr. Stephen Hahn, head of the FDA, that if it wasn’t approved by midnight on the 10th, he would be cleaning out his desk by noon on the eleventh. Presto! it came to pass.

      Say what you will about Trump, he knows how to get the attention of the bureaucracy.

    1. I really want an odd couple spinoff that stars Stephen Miller and Louis farakhan

  6. Remember this is the same FDA that says vapes contain tobacco and cause hart attacks retroactively.

  7. Am I the only one concerned about the ethics of MRNA and how they use fetal cell lines to develop the vaccines? I get the feeling that a big bonus for these companies with the rush is that nobody has time to even have the ethical conversation, much less finding out about what’s in the vaccines in the first place. So they get a bunch of people to take it, who might not have wanted to if they knew more about it and the ethical dilemma it might pose, just because it’s too much of a “crisis” for us to be allowed to ask ourselves if it’s in line with our values.

    1. Feature not a bug. Once you’ve forced a mandatory vaccine on people with religious, moral and ethical objections to using aborted fetal cells then they instantly become hypocrites who get no say whenever the topic of legal infanticide comes up.

      1. and if you don’t want to kill babies for research, then you want to kill grandma…… although we won’t talk about the fact that no grandma in existence wants babies to be killed supposedly for her sake.

        1. Nobody killed any babies so they could be used in research. The mothers aborted because they didn’t want to have a child for whatever reason and then the cells were obtained by researchers. There’s a difference.

          1. It’s a step towards getting people used to the idea. Doctors in China now perform abortions with the intention of using the fetuses in research.

            1. Ahem the technical term is product of conception

          2. >>Nobody killed any babies so they could be used in research.

            mom decided to and pawned the job off on a “doctor”

          3. What a difference. /rolls eyes.

            All for a weak ass virus.

        2. Have you met Leona Helmsley?

      2. Mandatory vaccine? Since when?

        You don’t want to use a vaccine that depends on fetal stem cells? Wait for J&J’s vaccine to come out.

        1. I’m not going to get a vaccine even if fetuses aren’t used. But I see the MRNA vaccines as being morally unsettling, on top of the unknown long term side effects.

          1. Why don’t you tell me how the vaccine works in basic molecular and cell biology terms.

        2. mRNA vaccines don’t use fetal stem cells, adult stem cells, or animal stem cells. Cool your jets.

    2. https://twitter.com/AlexBerenson/status/1338853313563987971?s=19

      1/ The @Moderna_TX vaccine data shows even higher rates of serious side effects than the @pfizer data. The second dose is the problem – almost 1 in 5 people under 65 had a grade 3 or 4 adverse event after receiving it, compared to 1 in 50 who received placebo…
      2/ Fevers are of particular note: 1.6% of people under 65 spiked fevers over 102 after the second dose, and about 1 in 1000 had fevers over 104.

      That was 50 times the rates of fever in the placebo arm (178 cases to 3).

      1. Why hasn’t twitter banned Alex Berenson for dispensing information that goes against the narrative?

  8. I get the Pfizer vaccine [dose 1/2] on Thursday; I don’t normally get to the head of the line on these things, but I really want this nightmare of hysteria and lockdowns to end, which in some respects are even worse than the virus itself. Will see how it goes.

    1. Do you really think you’ll be exempt from lockdowns and mandates after your (second) vaccine? No, you have to remember that we are all in this together.

      1. I do what I can; as far as government idiocy, expediency, and political signaling goes, there will never be a vaccine against that. But if getting vaccinated helps to bring about population immunity that will presage a moving off of this and on to the next crisis, I think it’s worth it.

        1. The more you give, the more they demand.

    2. I think you’re looking at this backwards.

  9. highly effective a quoi?

  10. So effective that you can still be infected and pose a killer zombie threat to society and you’ll still need be in a mask bowing before the Leprechaun Lizard.

    Everyone in this whole sordid scam can go straight to hell.

    Am I the only one who is considering the whole basis of this hysteria is rooted on some bad science?

    Dr. Drosten is at the top of the list having spread the lie about asymptomatic spread and pushing PCR even though he knew it was unreliable. Then there’s Neil Ferguson at Imperial College for his shitty models.

    Then there’s Tedros who heads the WHO but was a Marxist terrorist.

    And Fauci and his stupid retarded lies and gaslighting praising Biden’s ‘awesome plan’ among other dumb shit he’s said included lying about masks.

    What about NIH boss Francis Collins going on a conference call with Michael Milken? Remember him?

    Now we have this out of Ontario:

    https://www.youtube.com/watch?v=i1r7kgrg3-c

    We’re run by psychopaths.

    So know what? You can take this vaccine, lockdowns and virus and shove it up your hysterical asses.

    1. Ditto.

  11. So what happens when people get the first shot and think they’re good, but forget about the booster?

    1. They’ll still have some resistance built up, though this concern is why the public health authorities are incredibly eager to get their hands on J&J’s trial results.

      https://www.wsj.com/articles/a-shot-instead-of-two-at-saving-lives-11607643152

      The Pfizer study wasn’t designed to put a number on first-dose efficacy, but the data in Pfizer’s “cumulative incidence curves” suggest at least 75% efficacy for two weeks after one dose. The question is whether to use the 100 million doses on 50 million people, of whom two doses would protect roughly 47.5 million, or to give one dose each to 100 million people and protect at least 75 million.

  12. A moron above claimed that this vaccine was developed using fetal cells. Not true. Not maybe … not true. Fetal cells would add nothing to developing an mRNA vaccine – simply not useful.

    But lies are so much better than truth.

    Now, for the bad news. This is a new technology, and there is no way to be sure that it will be safe over the long term. That would require long-term follow-up. Which, of course, has not happened. More likely than not, it’s safe. But if someone claims certainty, he/she is lying.

    1. And this is on top of the known fact that for the vast majority of the population the virus poses no serious health risk and the vaccine is superfluous.

      1. There are 300,000 Americans who would disagree with you — if they could.

  13. “Now we wait for the FDA to get around to approving it later this week.”

    Just how long does it take them to put on their robes and pointy hats?

    1. Twenty-one days for Pfizer. What’s your guess for the over/under on Moderna?

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  15. I hope the vaccines are safe and effective – but never trust the government or big pharma to be forthcoming or truthful. That is not in their best interests. Hiding the truth usually is.

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