Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints

This was exciting news to encounter in my inbox this morning:

Wednesday, November 18, 2020 – 06:59am

Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;

170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group

Efficacy was consistent across age, gender, race and ethnicity demographics;

observed efficacy in adults over 65 years of age was over 94%

Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved

Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled;

no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe

The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021

“Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world”

Source: Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints | Pfizer

-ACP

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16 thoughts on “Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints”

  1. Mind you, mRNA injectables are not “vaccines”.
    Semantics matters, and “vaccines” refer to the injection of a dead or weakened virus (or bacteria) for our immune system to respond against. “Vacca” in Latin means cow, and the term “VACCine” refers to Dr. Jenner´s protective innoculations of COWpox blister fluids in 1796.

    mRNA injectables are a completely different animal based on a completely different (experimental) concept. The only commonality with vaccines — nothing else — is that they are also injectable, period. mRNA injectables deliver the coronavirus RNA in a vehicle uptaken by our DNA which would then trigger an immune response to it… supposedly all trouble-free.

    So mRNA injectables code for the spike protein as our own body becomes a spanking new manufacturing plant thru a never massively-applied biological conundrum. The mRNA is taken up by the cell cytoplasm, enters the ribosomal system, and is translated to a protein… without ever making a single “mistake” or provoking un-intended consequences along a new, cumbersome experimental way with lots of moving parts. The idea being that our own body ends up successfully synthesizing the coronavirus spike protein (absolutely trouble-free) so as to manufacture neutralizing antibodies to the spike protein.

    But by no means are these mRNA injectables anything close to a “vaccine” as we have understood them to be, learned about them, and used for centuries now. So these yet-unproven microscopic mRNA robocops better stick to and satisfactorily fulfill only their specifically assigned mission once injected into our bodies… and nothing else, or else.
    As Dr. Ofitt has clearly left on record and Dr. Anthony Pearson can attest, “an EUA is an FDA-permission to use something (including stuff that later failed) even though there may not be clear data showing something is safe or effective…So there is a clear learning curve before us “. Just saying…

    Reply
  2. Trust in institutions, authorities and Big Pharma is scraping the bottom of the barrel, and rushing these vaccines into mass use with extremely high expectations of efficacy is setting up the potential for a devastating loss of trust in the vaccines should they fail to live up to the claims of 100% safety and 95% effectiveness”

    Method #1, the Pfizer trial :
    Half of the 44,000 volunteers receive the vaccine and the other half get a placebo shot.
    Then the researchers wait around to see how many of the volunteers randomly come down with Covid.
    Pfizer reports that out of 170 cases of Covid, 162 were in the placebo group and eight were in the vaccine group.

    So a grand total of 0.386% of the 44,000 volunteers (LESS than 4 per THOUSAND) came down with Covid by means unknown.
    And then this VERY tiny sample is the foundation of grandiose claims of 95% effectiveness

    Will the Pfizer vaccine offer rock-solid protection against sustained exposure to the virus?
    Can vaccinated people transmit the virus to unvaccinated people?
    Will the vaccine protect at-risk people without causing any adverse effects in the most vulnerable groups, including those with autoimmune disorders?

    Credit:
    http://charleshughsmith.blogspot.com/2020/11/vaccines-too-little-too-late.html

    Method #2, the real trial :
    Take 100 politicians, authorities and Big Pharma executives, give them two doses of vaccine and then have them serve 4-hour shifts in a crowded ward of severely ill Covid patients for a week, without any masks or protective gear. In other words, expose them to sustained, intimate contact with patients with severe cases of Covid, spending hours every day in a soup of virus.

    Then we need to know if the vaccinated people can still transmit the virus to unvaccinated people.
    So at the end of their shift, the 100 politicians, authorities and Big Pharma execs clean up and then crowd into a poorly ventilated bar with 100 unvaccinated volunteers, singing, dancing and breathing the same fetid air for two hours every night.

    Next, repeat this trial protocol with another 100 people, 50 of whom have chronic conditions such as hypertension, metabolic disorders or COPD, and 50 who are 65 years of age or older.The only way we’ll really know if the vaccine is effective for at-risk people is to do a rigorous test like this.

    Third, repeat the trial protocol with 100 people who have autoimmune disorders or family histories of autoimmune disorders.
    There is no other way to discover the potentially harmful consequences of the vaccine on those with a propensity for autoimmune disorders other than a rigorous test of the vaccine, i.e. sustained exposure to the virus over extended periods of time.

    Lastly, monitor all the volunteers daily for six months for any side effects of the vaccine. It will take years to really know what side effects may manifest, but six months would at least establish a baseline of safety.

    Got it ?
    Say no more and pray lots.

    Reply
    • Evidence-based medicine re the current Pfizer vaccine trial.
      • Unknown fuzzy “protection” of sorts yet to be defined…NOTHING more (please read previous comment above)
      • Tremendous scale-up and roll-out problems many knowledgeable people with lots of experience in manufacturing logistics and field deployment insist cannot be solved in fit-for-purpose manner as described below.
      • Supposedly ONLY 170 Covid+ out of 44,000 volunteers since July 27, means contagion rate was 4 per THOUSAND in 3.5 months… (???)

      Pfizer says:
      “…Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled…” etc.etc.etc

      So Pfizer DID study all of the 44,000 participants, of course.
      Which means that Pfizer would be ONLY reporting “some” 170 Covid+ subjects selected somehow thru certain (necessarily biased) “filters” we know nothing about. If that were the case, trial design is very poor (sorry FDA) and should be rejected altogether.

      Pfizer says:
      “…The observed efficacy in adults over 65 years of age was over 94%…”

      But the only randomized sample in the Pfizer Trial was for side effects, NOT infection.
      https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine

      “… A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination…”
      Not a single word of which refers to Covid+ findings

      Fully contradicting the above, 25 thousand subjects in Argentina participated in the same Pfizer trial with (at least) 10 per CENT contagion rate in the same 3.5 months… or 50 (FIFTY) times higher infectivity (wtf…)

      Spanking-new experimental mRNA vaccines are, by definition, unstable attacked by RNAses that are present EVERYWHERE
      * Mandatory 2 shots exactly 3-weeks apart for several BILLION people worldwide is a very risky plan.
      * Only well-trained and well-funded military can run and execute the required logistics and only with the support of a well-developed country infrastructure all the way down to millions of jab sites.
      * Landing a fully-equipped platoon on planet Jupiter in winter-time is a far FAR far easier project

      So thank you, but no thank you…

      Reply
      • We definitely need to continue to make sure we do our due diligence on these vaccines. I found this Peter Attia podcast with Paul Offit, co-inventor of the rotavirus vaccine and Profess or Vaccinology at U Penn to be very enlightening (https://peterattiamd.com/pauloffit/).That interview is from about a week ago and likely requires a subscription. An earlier interview with Eric Topol from october 5 is free on Medscape (https://geneticliteracyproject.org/2020/10/05/video-vaccine-expert-paul-offit-talks-with-medscapes-eric-topol-on-the-pitfalls-and-promise-of-covid-operation-warp-speed/)
        Offit also just published in the Philadelphie Inquirer an op-ed on the safety of these vaccines (https://www.inquirer.com/opinion/commentary/covid-vaccine-safety-trials-us-2020-20201106.html)

        After listening to him I have confidence that the process, although shockingly quick, is solid. However, I won’t be lining up to get a vaccine on day one and would like to see what things look like after 6 weeks of widespread innoculation with the first vaccine approved.

        Reply
        • Dr. Pearson, thank you so much for your truly excellent and most valuable links.
          BTW, your last paragraph speaks volumes re “Warp Speed” vaccines.

          I obviously share your views and attitude.
          My only question is if 6 weeks would be anywhere near enough.
          WS vaccines (as important as they are) are not the only issue here.
          I´d rather go for a good long 12 months and then some… always with our careful & arch-famous ´watchful waiting´… worldwide.

          Dr. P, we still know little about this virus, even less about these EUA-WS vaccines.
          And it´s not only vaccine innoculation that matters.
          Rather worldwide community (“herd”) immunization which is a completely different animal.
          As James Carville would have said and I´ll keep repeating ” It´s pace and coverage, stupid”

          And let us please not confuse ´traditional´ vaccines with Warp Speed vaccines eventually to be approved only for “EUA – EMERGENCY USE Authorization” which in and of itself is obviously not “normal” in any sense of the term.

          Reply
          • The Offit/attia podcast is really good. You can skip the early discussion about Offit’s club foot as a child (although I personally found it fascinating because it reminded me of Madamme Bovary’s husband) and his development of the rotavirus vaccine which took a dozen years or so and cut to the very detailed discussion of the types of SARScov2 viruses being developed and learn oodles in less than an hour.
            For me, this is a personal risk calculation. What is your exposure? What is your risk should you get it? What is the risk and effectiveness of the vaccine that is administered to you?
            If you’re high on the first two answers for sure then you likely will want to be an early vaccinator. If not, wait and see what more we learn on the third question.

            Reply
  3. Not a doctor here, just an ordinary gal curious and SO happy to ask some real doctors/scientists. They gave people this vaccine, and then set them loose in the world, correct? So who is to say who may have been exposed to Covid, and who wasn’t? If you weren’t exposed, and did not get Covid, but did receive the vaccine, it wouldn’t make a difference since you were never exposed. So where do the 94%, 95% numbers come from? Seems to me, if having received the vaccine and then ASSUREDLY being exposed to Covid (which I understand they cannot do to people LOL) is the only way to say that something is effective or measure it effectively, yes? Where do these rates of efficacy come from? Needing a primer on vaccine efficacy in Nor Cal….

    Reply
    • Lisa,
      If you want a detailed analysis of this topic try this article….https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30773-8/fulltext
      When you take a really large number of individuals and randomize them to a treatment (meaning randomly assign them active treatment or placebo) and then measure an outcome (SARS-COv2 infection) you basically control for all other variables that might influence the outcome other than the treatment. One such variable is exposure to SARS-COv2. If I remember right there were like 90 cases in. the placebo arm and 8 in the vaccinated arm so 82 more cases divided by 90 gets you to 90% or so.
      The detailed article examines what should count as a case.

      Reply
  4. Antonio, estoy de acuerdo con usted en que la noticia ha sido muy emocionante pero, fundamentalmente y por encima de cualquier otra consideración, lo que ha sido es extremadamente interesada y en consecuencia fuente de ingentes cantidades de dinero que han pasado a engrosar la cuenta del CEO de Pfizer, a tenor del incremento del valor de las acciones de su empresa a raiz del conocimiento publico de la noticia. Lo que Pfizer ha hecho al pronunciarse a mitad de estudio sobre las “expectativas” del resultado de su vacuna no es ético desde el punto de vista del inversor de a pie y probablemente roce la ilegalidad respecto a las normas que rigen los mercados de valores de cualquier pais civilizado. Pero no ha sido este el único aspecto criticable ni el mas grave; de mayor gravedad me parece que Pfizer se haya pronunciado sobre el resultado de un estudio a medio camino de su conclusión y sin que las autoridades sanitarias hayan dado por tanto ni el visto bueno ni el visto malo a sus resultados. Espero con impaciencia la segunda parte de este articulo , que es evidente que ha dejado intencionalmente sin concluir y en la que me imagino que expondrá con la brillantez que le caracteriza su opinión critica sobre lo ocurrido en lo referente al apartado científico. En el aspecto económico, como inversor / especulador que soy ya me he manifestado yo ( es evidente por mis palabras que la noticia me ha pillado situado en el mercado con el pie cambiado …)

    Discúlpeme como ya hizo en otra ocasion por escribir mi comentario en mi lengua materna. El traductor de Google es casi ya infalible 😉

    Un afectuoso saludo desde el departamento de urgencias del HUBU en la ciudad de Burgos, España, donde la lucha contra el coronavirus está siendo feroz.

    Reply
    • Per Google translsate
      Antonio, I agree with you that the news has been very exciting but, fundamentally and above any other consideration, what has been is extremely interested and consequently a source of huge amounts of money that have gone to swell the account of the CEO of Pfizer, based on the increase in the value of the shares of his company as a result of public knowledge of the news. What Pfizer has done when pronouncing itself in the middle of the study on the “expectations” of the result of its vaccine is unethical from the point of view of the common investor and probably borders on illegality with respect to the rules that govern the securities markets any civilized country. But this has not been the only objectionable aspect or the most serious; More seriously, it seems to me that Pfizer has ruled on the result of a study halfway to its conclusion and without the health authorities having therefore given either the go-ahead or the go-ahead to its results. I am impatiently awaiting the second part of this article, which it is evident that he has intentionally left unfinished and in which I imagine he will present with the brilliance that characterizes his critical opinion on what happened in relation to the scientific section. In the economic aspect, as an investor / speculator that I am, I have already expressed myself (it is evident from my words that the news has caught me in the market with a changed foot …)

      Excuse me as you did on another occasion for writing my comment in my mother tongue. Google translate is almost foolproof 😉

      Warm regards from the HUBU emergency department in the city of Burgos, Spain, where the fight against the coronavirus is being fierce.

      Reply
  5. I would be more optimistic about this vaccine, and others as they come along, if all – that is ALL – the data were published and available to be thoughtfully reviewed by peers and the general public alike.
    I personally prefer to wait for a full FDA approval, then enough clinical history for my trusted conservative GP to give the OK.

    Reply
    • I’m with You, Jeffrey. Even with technology, I like to see how it goes before jumping onto the bandwagon. Even more so with vaccinations and medications.

      Reply
    • Jerry,
      Indeed! A topic being hotly debated right now.
      Emerging evidence suggests that citizens of Georgia, either the country or the state, will be at the end of the queue for COVID vaccines.

      Reply

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