Coronavirus

FDA Staff Review Confirms: Pfizer-BioNTech COVID-19 Vaccine Safe and Highly Effective

It is likely to be approved for distribution by the end of the week.

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The Food and Drug Administration (FDA) today released its staff evaluation report on the safety and efficacy of the Pfizer/BioNTech COVID-19 vaccine. It says the data "suggest a favorable safety profile, with no specific safety concerns identified that would preclude" an Emergency Use Authorization (EUA).

It also says the vaccine is highly effective at preventing COVID-19 infections. The vaccine's efficacy for the prevention of COVID-19 disease after just the first of two doses appears to be 82 percent. After both doses, the rate rises to 95 percent. For comparison, the Centers for Disease Control and Prevention (CDC) estimates the efficacy of seasonal influenza vaccines at around 50 percent.

The COVID-19 vaccine's side effects appear to basically be the same as those experienced from influenza vaccines, including pain and redness at the injection site, fatigue, headache, muscle pain, and fever.

Meeting this Thursday, the FDA's independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) will take this report and other information into account when recommending whether the agency should issue an EUA for the vaccine.

In November, Gen. Gustave Perna, who is overseeing vaccine logistics, stated that the government "will begin distribution of the vaccine within 24 hours after Emergency Use Authorization is approved." In July, the federal government contracted to buy 100 million doses (enough for 50 million people) from Pfizer/BioNTech for $1.95 billion, with the option to acquire up to an additional 500 million doses.

The companies apparently offered then to sell 100 million more doses, but the Trump administration turned them down. Since then, other countries have signed contracts for those vaccines. Although negotiations for future supplies are ongoing, the companies are reportedly saying they cannot supply additional doses for distribution in the U.S. until this summer.

On the other hand, next week the FDA is scheduled to consider Moderna's submission for an EUA for its COVID-19 vaccine, which works the same way as does the Pfizer/BioNTech vaccine. In in preliminary reports, the Moderna vaccine has a similar safety profile and is also 95 percent effective in preventing COVID-19 infections. The government has contracted with the company to buy 100 million doses of these for $1.5 billion. Under the contract, the feds reportedly have the option to buy up to 400 million additional doses. Like Pfizer/BioNTech, Moderna has contracted with other countries, including deals to sell 160 million doses to the European Union and 50 million to Japan.

Yet more COVID-19 vaccines, by AstraZeneca and Johnson & Johnson, are still in clinical trials. The companies' results could be available by the end of January. If they prove to be safe and effective, their vaccines could contribute toward making sure that most Americans are inoculated against the disease by this summer.

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  1. What, there’s a ‘staff picks’ section on the FDA website?

    Also, Trump Vaccine, California will be holding this back for further review. No word in the media why Gavin Newsom is literally killing people over a personal beef with the President.

    1. Also, Trump Vaccine, California will be holding this back for further review.

      Even without the beef, this substance is known to the State of California to cause cancer.

      Maybe dating myself with this question, but have the effects of this drug been investigated in pregnant women? Haven’t heard the usual ‘pregnant, nursing, or plan to become pregnant’ spiel which accompanies… everything.

      1. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/940565/Information_for_Healthcare_Professionals_on_Pfizer_BioNTech_COVID-19_vaccine.pdf

        Fertility, pregnancy and lactation

        Pregnancy

        There are no or limited amount of data from the use of COVID-19 mRNA Vaccine BNT162b2. Animal reproductive toxicity studies have not been completed. COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy. For women of childbearing age, pregnancy should be excluded before vaccination. In addition, women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.

        Breast-feeding

        It is unknown whether COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk. A risk to the newborns/infants cannot be excluded. COVID-19 mRNA Vaccine BNT162b2 should not be used during breast-feeding.

        Fertility

        It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.

        1. Just shut up and let the people who want to Build Back Better and bring in the Great Reset alter your RNA a little bit…

          1. I quit working at shop rite and now I make $65-85 per/h. How? I’m working online! My work didn’t exactly make me happy so I decided to take a chance on something new… after 6 years it was so hard to quit my day job but now I couldn’t be happier. Here’s what I do… USA ONLINE JOBS

        2. “It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.”

          Let’s give it to young people who have a greater chance of dying from shark attacks anyway.

          Straight up evil.

          1. Those are pretty standard disclaimers.

      2. It turns unborn children into Scanners.

        1. The very idea makes my head explode!

          https://www.youtube.com/watch?v=PMY9Yq0_6pU
          Scanners 1981) Head Explosion Shot

        2. Close. Michael Ironsides is still the villain, but I was picturing Total Recall-style thalidomide babies.

      3. COVID vaccine: Women hardest hit.

        1. it’s known women always suffer the most.

    2. Emperor Cuomo is doing the same thing. These thugs are holding on to every shred of power they can for as long as they can. Human life be damned.

    3. the media seems uniquely uninterested in any questions regarding actions taken by democratic gov.

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  2. Finally, my paycheck is $ 8,500? A working 10 hours per week online. My brother’s friend had an average of 12K for several months, he work about 22 hours a week. I can not believe how easy it is, once I try to do so. This is what I do.. Here is More information.

  3. Oh yeah? What was their reviews for Cyberpunk 2077?

  4. Well, good, I hope it works well. Though I am rather concerned that we are going to be subject to a “papers please” regime for vaccination.
    And people need to accept and understand that with a vaccine, the virus isn’t going to just go away. We need to stop this insanity now. Get the vaccine to people at high risk and let people who mostly have very little to fear get on with their lives.

    1. Though I am rather concerned that we are going to be subject to a “papers please” regime for vaccination.
      There is no question, it will happen. Dissenters will be re-educated. And masks will still be mandatory.

    2. That seems to be the plan here in Oregon: the first round will go to healthcare workers (who are of greater likelihood to spread the virus), then to those over 65 with comorbidities, then those under 65 with the same… etc, etc. By the end of January, or early in Feb, those highest-risk individuals should be covered. I am hoping for a total end to all the shutdowns (which are already fewer here than in many other States) by the end of March? (crosses fingers) Masks may still be required for certain industries and personnel, at least for a while — fish-processing plants here have been very hard-hit with the virus, as a for-instance.

      1. Eh, by March COVID-20 will be here and we get Lockdown 2: Electric Boogaloo.

        1. Well, in CA, I wouldn’t be surprised. Our governor here, in spite of being decidedly leftist, has been much more judicious than Gruesome Newsom. Our county has had four deaths and 504 cases in a population of 65,000. Some of the larger urban areas have been rather harder hit.

        2. I don’t know we can’t afford lockdown 1 as the production costs went way overbudget and lockdown 2 is going to need even cooler special effects to make decent box office in china.

          1. With the standard/signature “80/20” approval rating on Rotten Tomatoes.

        3. Lock down 2: the search for more progressive dictorial power

          1. I’d totes stream the entire series with subtitles like that.

            Side note: is “totes” still a thing or even a Z-ism these days? I’m getting old and mellow with age, like bourbon. Of course I could be getting old and mellow with bourbon as it ages. It’s so hard to tell.

    3. nah zeb they are going to try to keep this going. Even with a vaccine they will say we need to social distance and mask up.

      https://www.reuters.com/article/us-health-coronavirus-vaccine-immunity-e-idUSKBN28I0OK

      DOES THE VACCINE MEAN BACK TO NORMAL LIFE?
      Since there is no evidence that the immunization prevents transmission of the virus – and no vaccine is 100% effective – scientists call for continued vigilance, including mask-wearing, hand-washing and social distancing.

      “As with all vaccines, it may work really great in certain patient subsets, but not as well in others … Does that mean you are free to hop on a plane or have 30 people over at your house? Probably not,” said Dr. Michelle Barron, senior medical director for infection prevention at Colorado’s UCHealth.

      She said vaccination campaigns are unlikely to reach “a critical mass” until next spring or early summer.

      1. Oh my God, fuck those people.

        1. these people are evil and of course still collecting a paycheck and are just largely inconvenienced from all this. Social distancing essentially means the doom of countless business’s.

          1. It’s a multi-dose vaccine so yeah, spring, except the first people to get vaccinated this winter can relax earlier.

          2. Not to mention our culture and society and mental health.

      2. I think they will let this one pass, once the vaccine starts going out they will ease the lockdowns and credit Biden for ending the pandemic in his first 100 days in office. That will cement his approval rating at least through the midterms

        Make no mistake though, the next Covid, or swine flu, or west nile, or some guy in Boston getting Ebola, and we will do this all over again. This is now the government’s default response to epidemics

        1. 5 will get you 10 that next time will make this look like free love, tie dye sheets, and waterbed frames did back in the ’60s.

    4. Vaccines are science and science is magically right by virtue of being scientifical.

      1. I think the fact that it is magically right while still hitting women harder proves that it’s actually scientisticle.

    5. Get the vaccine to people at high risk and let people who mostly have very little to fear get on with their lives.

      That’s still a lot of people considering how badly it fucks up fatties.

      1. This.

        For all the lecturing about things we need to do to stop the spread, I’ve never once heard anyone in government say “most of y’all need to lose at least 20 pounds”.

        Apparently you can tell people they’re legally required to stay inside, wear masks and get no closer than 6ft to someone else, but telling them they don’t need another cheeseburger is a bridge too far.

        1. This difference is spreading coronavirus affects other people’s health.

          1. Oldies and Fatties get sickest from covid.

            If we’re doing all the shit to prevent getting the sickest to overwhelm the system, we can’t have the oldies get younger, but the fatties could lose some weight.

      2. Is it the vaccine or the virus that fucks up fatties? Just asking because the lockdown did contribute to my gaining the Covid 19 (pounds).

        Ok, it was 22 at the peak but I’ve finally managed to lose a few. Still it would be nice to know how many the lockdown has hurt for this very reason.

  5. Are the nanobots optional at extra cost? /sarc

  6. So much for the CDC, state and local health agencies’ plans and protocols (for the past nine months) to do contact tracing for everyone who tests positive for covid.
    https://www.newsmax.com/us/contact-tracing-phil-murphy-new-jersey-governor/2020/12/07/id/1000469/

    1. contact tracing was always a hilarious fantasy. Now its a gov workprogram that will never go away.

      1. Yeah, it was already idiotic and pointless at the beginning of march. There was no way it was ever going to be contained or controlled.

        1. Yep. It was always an idea SO DUMB that only government would actually do it.

    2. Several months ago, CDC was complaining that only half of those who tested positive for covid were cooperating with contract tracers, which is an excellent indicator of public mistrust of government health agencies.

      Now its up to 74% in NJ, where most voters ironically voted for Biden, who advocates lockdowns, mask mandates and contract tracing. Then again, the same NJ voters also hypocritically voted for totalitarian Phil Murphy for Governor.

      1. This is encouraging. Now all of those people need to start not cooperating with all the other bullshit. Mass disobedience seems like the only way this shit will end.

  7. needed to get the dig into Trump for not upping on another 100 mil doses when Trump is right to wait for competition in the market to lower the prices. But don’t worry Biden will f that up and get it at twice the market value that any other nation pays

    1. The fact idiots like you still think Trump makes great deals astounds me. I mean, other than profiting off the taxpayers with payments going straight to Mar a Lago, etc.

      The idiot is just impulsive- sometimes he wins (rarely) and mostly he loses. Acting as if he had any notion of anything this whole time about competition and whatever is pure bullshit.

      Need I refer you to the tariffs on Chinese products that WE are paying for Ron?

      1. First more than likely Trump wasn’t involved with the minuta of buying vaccines so its just a typical dig
        2. China was given the opportunity to lower their tariffs but refused so its not Trumps fault we have Tariffs its China’s

        1. Whatever you think of the wisdom of tariffs, it’s also Trump’s fault we have them.

          1. zero tariffs prior to 2016?

            1. I mean the ones Trump Implemented or increased on imports from China. Trump is a free individual and can act independently of what China does.

        2. Well the trade war has certainly gone well. China is booming again and the trade surplus with the US is bigger than ever.

          They have no reason to negotiate with us. How we will get out of this mess I don’t know. What kind of idiot engages in a unilateral trade war with China? Oh right we know what kind.

      2. Acting as if he had any notion of anything this whole time about competition and whatever is pure bullshit.
        How many big buildings have your name on them?

        1. Too much trouble to create a new account as Sam Chrysler to reply, but it’s the thought that counts.

  8. they won’t admit this causes long term effects till we are well in the throes of the zombie apocalypse and even than it will mostly be blamed on masks or not adequately distancing.

    1. No, they will blame Trump

      1. this is a solid point. They’ll hold him personally liable since the companies can’t.

      2. Well, the things you mentioned too. But Trump will have a good helping of blame even though the Democrats didn’t want to credit him for helping it through

    2. LOL. It’s muzzle training for the zombie apocalypse. I love it.

      1. Zombies can’t bite when they have mask on

        1. The mask doesn’t protect me from you it protects you from me.

          1. Bullshit .

  9. OT: Another Trump failure/broken promise: Coal jobs he promised never happened.

    Trump’s promise to “bring those miners back” has not materialized. Kuykendall reports that coal mine employment fell to 40,458 jobs in the third quarter, down 23 percent from the first quarter of 2017 when Trump took office. Coal production is down nearly one-third (31.5 percent) in the third quarter compared with the first quarter of 2017.

    https://wvmetronews.com/2020/12/07/not-even-donald-trump-could-reverse-coals-decline/

    1. Coal production is down by 1/3 just before Christmas? There must be a lot of good little boys and girls out there.

      1. “There must be a lot of good little boys and girls out there.”

        I’ll take ‘Things You Should Never Say to SBP’ for $400, Ken.

    2. Biden will straighten those coal workers out by making them Learn to Code or training them as beekeepers.

    3. At least Trump has been protecting the rapidly growing natural gas fracking industry in WV, PA and OH.

      In sharp contrast, Biden and his left wing environmental worshipers will continue doing whatever they can to shut down the coal, oil and gas industries in the US (so the US is no longer energy independent and so the US can perpetuate war in the middle east).

    4. That’s ok your democrat left wing buddies will not only end coal but natural gas and oil production. They will trash the economy and impoverish tens of more millions. Hope you have some survival skills.

  10. Well, since it’s so safe, there’s no need for the Feds to grant the huge politically connected pharmaceutical company that created it an exemption from liability for it. I’m sure that exemption will be repealed any day now…

    As a side note, has anyone else noticed how that Russian vaccine that was announced months ago but wasn’t developed by a huge politically connected American corporation has been sent down the memory hole?

    1. I read just this week that they’ve started administering it.

      Is there a liability exemption or cap on these vaccines? I know only about the one for pertussis.

  11. Ron you can have mine.

  12. I wont take Kungflu vaccine just like I dont wear a mask.

    Why pussies like Bailey are scared of a virus with a <1% death rate, I will never understand.

    1. We know you don’t understand, we don’t expect you to understand.

  13. Okay. They’ve tested the vaccine and found no reason to put off the Emergency Use Authorization, so they’re not going to authorize use until the end of the week.

    Is this some definition of ‘Emergency” with which I was not previously familiar?

    1. Wait till you see what they did to the definitions of “temporary” and “peaceful”.

  14. Reason, have you investigated the uniqueness of this vaccine — the first mRNA vaccine ever used? How do we know the long-term effects of what the CDC says is a snippet of mRNA that will disolve after it gives “instructions for our cells to make a harmless piece of what is called the “spike protein… Next, the cell displays the protein piece on its surface. Our immune systems recognize that the protein doesn’t belong there and begin building an immune response and making antibodies, like what happens in natural infection against COVID-19.” https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html

    Does this sound just a bit like we are possibly creating auto-immunity (our body attacking our own body) by having such a feature that the immune system will attack permanently attached to all of our cells?

    And, this mRNA must be able to self-replicate since the shot cannot contain enough mRNA to work on every single cell in our bodies.

    1. But GMO foods are bad, mRNA in our bodies good.

    2. Well, no.

      When you get a real virus infection, the hopefully modest number of infected cells present viral proteins on their surface before they die. This signals the immune system to create antibodies so other occurrences of the viral proteins, still on the virus, get gucked up.

      Messenger RNA does not replicate. Cells have no enzymes to replicate RNA. CV19 carries a messenger RNA strand for an RNA replication enzyme because it needs one to replicate. The vaccine has no such RNA.

      When a vaccine particle is absorbed by a cell, the cell produces the spike protein until the RNA molecule degrades [about an hour], and the cell acts as if it had been invaded by a virus, stimulating the immune system. Not many cells get activated in this way, and they don’t die, and after the RNA degrades the cells start doing their normal behavior, in this case acting as part of a shoulder muscle.

      http://book.bionumbers.org/how-fast-do-rnas-and-proteins-degrade/#:~:text=Whereas%20the%20median%20mRNA%20degradation%20lifetime%20is%20roughly,and%20600%20minutes%20%28BNID%20106869%29%20in%20human%20cells.

      After a few days the cells stop presenting spike proteins, and the immune system is on its way to producing clones that in turn produce antibodies.

      -dk

      1. Perfect. Thank you.

      2. Bullshit. This assumes a perfectly functioning cascade of actions in a healthy person. Those are rare. Most of America is overweight with inflammation diseases and immune dysfunction.

        Give me a weakened virus vaccine, attenuated, or nothing. I don’t want some GMO experiment injected in me.

  15. “Dr. Pierre Kory, president of the FLCCC Alliance testifies before Senate Committee on Homeland Security and Governmental Affairs looking into early outpatient COVID-19 treatment”
    […]
    “Newswise — WASHINGTON, D.C. — DECEMBER 8, 2020: Appearing as a witness Tuesday morning before the Senate Committee on Homeland Security and Governmental Affairs – which held a hearing on “Early Outpatient Treatment: An Essential Part of a COVID-19 Solution” – Dr. Pierre Kory, President of the Frontline COVID-19 Critical Care Alliance (FLCCC), called for the government to swiftly review the already expansive and still rapidly emerging medical evidence on Ivermectin.
    The data shows the ability of the drug Ivermectin to prevent COVID-19, to keep those with early symptoms from progressing to the hyper-inflammatory phase of the disease, and even to help critically ill patients recover.
    Dr. Kory testified that Ivermectin is effectively a “miracle drug” against COVID-19 and called upon the government’s medical authorities – the NIH, CDC, and FDA – to urgently review the latest data and then issue guidelines for physicians, nurse-practitioners, and physician assistants to prescribe Ivermectin for Covid-19…”
    https://www.newswise.com/coronavirus/dr-pierre-kory-president-of-the-flccc-alliance-testifies-before-senate-committee-on-homeland-security-and-governmental-affairs-looking-into-early-outpatient-covid-19-treatment/?article_id=742998

    I caught the vid of the testimony on Fox (why no one else seems to have carried it is a mystery). The guy was a bit dramatic, but he claims *DATA*, not his opinion, and the papers are available, awaiting peer review
    Maybe ’emergency’ still doesn’t allow the various government agencies to examine data prior to peer review, which would suggest that the government ‘health agencies’ are not taking it as seriously as they claim.
    Mr. Bailey?

    1. “This anti-parasitic drug can kill COVID-19 virus in 48 hours”
      […]
      “Scientists feel that instead of focusing on new treatments to combat COVID-19, existing treatments like this anti-parasitic drug could bring reprieve to people…”
      https://www.thehealthsite.com/news/this-anti-parasitic-drug-can-kill-covid-19-virus-in-48-hours-783581/

    2. “Doctor explains 99.3% of COVID-19 patients treated with Ivermectin recovered in five days”
      […]
      “After eight months of active clinical observation and attending about 7 thousand patients of Covid-19 in three medical centers located in Puerto Plata, La Romana, and Punta Cana, Dr. José Natalio Redondo revealed that 99.3% of the symptomatic patients who received care in his emergency services, including the use of Ivermectin, managed to recover in the first five days of recorded symptoms…”
      https://dominicantoday.com/dr/local/2020/11/30/doctor-explains-99-3-of-covid-19-patients-treated-with-ivermectin-recovered-in-five-days/

      1. Well maybe.

        https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7521351/

        They are going to have to run some real trials and get FDA approval.

    3. “Ivermectin shows promise in treatment of COVID-19 patients: icddr,b”
      […]
      “Hospitalised patients with mild COVID-19 symptoms, who were administered the drug, subsequently returned negative results in RT-PCR test for the illness, the health research organisation said in a seminar on Monday.
      But the icddr,b pointed out the results were from a small-scale study and extensive research is still needed before the drug can be recommended for wider use in the treatment of coronavirus patients…”
      https://bdnews24.com/health/2020/12/07/ivermectin-shows-promise-in-treatment-of-covid-19-patients-icddrb

      They might look at some of those other results, ya think?

    4. FLCCC Alliance”
      “Frontline Covid-19 Critical Care Alliance”
      Homepage: https://covid19criticalcare.com/

      1. This was never about treating people cheaply and effectively.

        This was about getting the most people sick at the same time and into ICUs, so they can be treated with expensive equipment, drugs, and services.

        Lockdown, masks, and restrictions have only worsened things. The highest hospital admissions are occurring in the areas with the most restrictive rules.

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