Pfizer and BioNTech Begin Human Clinical Trials of COVID-19 Vaccine in U.S.

Pfizer and BioNTech Begin Human Clinical Trials of COVID-19 Vaccine in U.S.

Pfizer, Inc. of New York and BioNTech SE of Mainz, Germany have announced that human clinical trials for an experimental COVID-19 vaccine they have co-developed, known as BNT162, have begun in the United States.1

As part of a global clinical development program, the first human subjects in the U.S. Phase I and Phase clinical II trials of BNT162 received doses of the experimental vaccine at New York University’s Robert I. Grossman School of Medicine in New York City and University of Maryland’s School of Medicine in Baltimore, Maryland.2

In late April 2020, the two companies launched the first human clinical trials of BNT162 in Germany with the goal of testing 200 healthy volunteers between the ages of 18 and 55 years.3

According to Albert Bourla, CEO of Pfizer, “The short, less than four-month time frame in which we’ve been able to move from preclinical studies to human testing, is extraordinary.”1

Clinical Trial Tests Four Variations of BNT162 Vaccine

Phase 1 and Phase 2 clinical trials are designed to be randomized, placebo-controlled, observer-blind, dose-determining and vaccine candidate-selection studies in healthy adults.4 These trials are expected to evaluate the safety, tolerability, immunogenicity and potential efficacy of four different SARS-CoV-2 messenger RNA vaccine candidates using a two-dose or single-dose schedule, at up to three different dose levels and in three age groups (18 to 55 years old, 65 to 85 years old and 18 to 85 years old).4

Each trial participant will receive one of four vaccine candidates—BNT162a1, BNT162b1, BNT162b2, BNT162c2 or a placebo.4 Each vaccine candidate represents a different mRNA format and target antigen.3 Two of the four vaccine candidates are nucleoside modified mRNA (modRNA) vaccines, a third is a uridine containing mRNA (uRNA), and the fourth vaccine candidate uses self-amplifying mRNA (saRNA).3 Each mRNA format is combined with a lipid nanoparticle (LNP) formulation.3

Expanding Human Trials to Thousands of People

Bourla said that if one or two variations of the candidate vaccine appear successful, the companies plan on expanding human trials to a large-scale study with thousands of participants by September 2020.5 He stated:

If things go well, and we feel that the product is safe and efficacious, and the FDA [Food and Drug Administration] and EMA [European Medicines Agency] and other regulatory agencies feel the same, we will be able to deliver millions of doses in the October time frame.5

Pfizer and BioNTech are racing against two other biotechnology companies, CureVac and Moderna, which are also in the clinical trial stage of developing a COVID-19 vaccine using messenger RNA technology.6

mRNA Vaccines May Come with Serious Side Effects

Messenger RNA (mRNA) vaccines, which have never been licensed for use in humans, inject cells with mRNA, usually within lipid nanoparticles, to stimulate cells in the body to become manufacturers of viral proteins.7 According to researchers at University of Pennsylvania and Duke University, mRNA vaccines have potential safety issues, including local and systemic inflammation and stimulation of auto-reactive antibodies and autoimmunity, as well as development of edema (swelling) and blood clots.8


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21 Responses to "Pfizer and BioNTech Begin Human Clinical Trials of COVID-19 Vaccine in U.S."

  1. Anne   May 25, 2020 at 11:45 am

    GOD help us. We must PRAY and place our trust in the Lord, that we will be spared from this evil.

    Reply
    • GrahamB   May 26, 2020 at 1:33 am

      Anne, I’m beginning to feel that ‘Modern Pharmaceutical Medicine’ has put us poor humans beyond his help!

      Reply
    • Steve Scrutton   May 28, 2020 at 8:40 am

      God obviously didn’t make us properly!
      And clearly our doctors think they can do better……

      Reply
  2. MICHAEL   May 25, 2020 at 12:22 pm

    THIS IS REALLY THE FORMULA FOR DISASTER.

    NO ANIMAL TRIALS.
    TEST PERIODS OF AT MOST 30-60 DAYS.
    MRNA VACCINES NEVER BEFORE LICENSED.
    COMPETITION FOR A MARKET THAT MIGHT BE MANDATORY WORLDWIDE BREEDS INTENSE PRESSURE TO COVER-UP ADVERSE EVENTS.
    THE SAME COMPETITION BREEDS A TENDENCY TO BYPASS CRITICAL SAFETY TESTS LIKE INTERACTION WITH PAST VACCINATIONS, INTERACTION WITH OTHER DRUGS AND MEDICAL CONDITIONS, DETERMINATION OF MEDICAL COUNTER-INDICATIONS, ETC.

    Reply
  3. CAWS   May 25, 2020 at 1:55 pm

    I would also like to know ;where are they getting these “healthy volunteers”? Are they doing this of their free will or have they been coerced? Are they prisoners? Immigrants? Homeless people?Orphans? Did they go down to India or Africa or South America and prey on individuals that can’t read the contract release and risk statement?

    Reply
    • Cathy Beekmann   June 24, 2020 at 10:42 am

      There are scads of willfully eager and ignorant human “volunteers” out there who think it is all for the good of humanity!!!

      Reply
  4. Joy Metcalf   May 25, 2020 at 2:01 pm

    All this for a coronavirus which will most likely be gone in two years, just like other coronaviruses.

    Reply
    • GrahamB   May 26, 2020 at 1:47 am

      Right on! And anyway, about 90% of those who are dying from COVID-19 related pneumonia have at least one, and in may cases, more than 1 co-morbidity, so a test on health persons proves absolutely nothing! { In that initial outbreak in Itally, 1 was under 60 and had no known prior conditions, but ALL THE REST had 1, 2 or 3+ preexisting conditions, and an average age of 78.5 years!

      Even if it gave some level of protection to a healthy human, it would be absolutely unacceptable to give it to any of the ‘likely’ future casualties, who will already be predominantly found amongst today’s (surviving) aged and infirm! But if we take the advise, put out on January 26th by the OrthoMolecular News Service.[ http://orthomolecular.org/resources/omns/v16n04.shtml ], then future deaths can immediately be reduced, and ultimately all-but eliminated!

      Reply
  5. Linda   May 25, 2020 at 3:24 pm

    And no information about what ingredients are contained in the placebo. Placebos are saline, but most vaccine placebos have been either another vaccine or an adjuvant which distorts the ability to evaluate side effects.

    Reply
  6. Tom   May 25, 2020 at 3:48 pm

    These mRNA vaccines are a truly horrible, diabolical idea.

    Wouldn’t a healthy immune system that will brush off ‘covid-19’ like it’s just a common cold be preferable to being injected with an experimental vaccine that will infect your cells (permanently tampering with your own DNA) to repurpose them to produce pieces of a virus for the rest of your life with God knows what long-term consequences? And even then, at best you might have some antibodies to show for it (not actual immunity)… How are people so fearful that they are begging to be experimented on with these insane vaccines?

    I’m more concerned about stubbing my toe than I am about ‘THE Coronavirus.’ But these insane DNA-reprogramming vaccines, produced by the most fraud-infested, criminal, psychotic industry in the world (Pharma) which kills hundreds of thousands of Americans a year with toxic side effects for profit? I’m 100% alarmed by that…

    Be ready to stand up against it, because they already want to force it on all of us.

    Also– Pharma always uses another toxin-filled vaccine, or the toxic components of the vaccine being tested (without the antigen) as a ‘placebo.’ Which of course makes the ‘safety’ results completely bogus.

    Look into these new studies if they claim to use a placebo (like the one in this article). See what the placebo actually is made of that the control group gets. I will be very, very surprised if it is, in fact a real placebo.

    Reply
    • Tom   June 1, 2020 at 2:55 pm

      Correction to my comment-

      The mRNA vaccines don’t change your DNA permanently. Instead, they infect your cells and hijack them to produce virus bits using your own existing genetic structures. DNA vaccines, on the other hand, genetically modify the recipient.

      Pharma is currently working on both mRNA and DNA vaccines for coronavirus.

      Reply
  7. Irena Nicoara   May 25, 2020 at 4:51 pm

    So sad that only few people know the reality and most of the people follow them. Let us pray together. Only God can save us!

    Reply
  8. Myra   May 25, 2020 at 5:23 pm

    Does anyone know what “placebo” is being used? When that word is used, the general public is lead to believe that it is a true inert placebo as is supposed to be the case with other pharmaceutical trials. The placebo they are using is most likely another vaccine or vaccine ingredient which is not a true placebo. If the public were to be made aware of that, would it become suspicious about this vaccine and all vaccines or would it remain frightened and brain dead in general, as is the case currently?

    Reply
  9. Gram   May 25, 2020 at 6:44 pm

    I liked all I saw Trump doing for America and Americans, until I heard Pfizer made a $1M campaign contribution to him. What did he do with it???

    Reply
  10. Susan M Birch   May 25, 2020 at 8:07 pm

    They’re going to make up the results of these trials to be exactly what they want it to be…even if it’s exactly opposite! So what’s the point of the trials? They might as well say that they have already been done, same lies either way!

    Reply
  11. Agatha   May 25, 2020 at 8:08 pm

    From The Oxford English Compact Dictionary from 1996 on definition of PLACEBO:
    “A blank sample used as a control in testing new drugs etc.”

    These days other vaccines and substances containing vaccine ingredients are being used as placebo controls when testing new vaccines. It is no secret. And not a true placebo either.

    I wonder what kind of “placebos” these new vaccines will have been tested against?

    Reply
  12. Joan Morrison   May 26, 2020 at 4:21 pm

    This whole scenario absolutely terrifies me. I cannot begin to imagine what the new laws will be imposing this fast track vaccine. The vaccines that have been “properly tested” have numerous and often life altering or threatening consequences. I am so afraid for my children and grandchildren.

    Reply
  13. Mark Morrison   May 26, 2020 at 4:22 pm

    This whole scenario absolutely terrifies me. I cannot begin to imagine what the new laws will be imposing this fast track vaccine. The vaccines that have been “properly tested” have numerous and often life altering or threatening consequences. I am so afraid for my children and grandchildren.

    Reply
  14. Roger Eshleman   May 27, 2020 at 2:01 pm

    Healthy people have little to fear from this version of the coronavirus. According to reputable doctors outside the pharmaceutical industry and the CDC who don’t buy the official propaganda, natural immunity is better than so-called immunity created by vaccines.

    For example, research has shown that the common flu vaccine is ineffective for most of the very young and the very old. Worse yet, it contains adjuvants such as aluminum that create prolonged inflamation in the body and may accelerate aging!

    Roger

    Reply
  15. Sandra Jimenez   May 30, 2020 at 9:48 pm

    They can do all they want to do with vaccines. The government can not make us take a vaccine we are not sure about. So I believe that we are going to be tested with the vaccine but how are we going to resist their pressure. You are talking about $ big money. If people are afraid they will take the vaccine. These times are not for FEAR, these times are for all of US to get it together about helping and defending each other. Those that are not able to learn quick , we must alert them with information. That is what WE do!!!! So let us get to work people.

    Reply
  16. Mary   June 1, 2020 at 4:31 pm

    I doubt there IS a SAFE vaccine anywhere in the world.

    Even more so the MRNA (?) vaccines that are different from the old ones.

    Reply

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