Pfizer, FDA, CDC Hid Proven Harms to Male Sperm Quality, Testes Function, From mRNA Vaccine Ingredients

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When the COVID-19 vaccine rollout to the public began in late 2020, medical professionals, public health agencies, and government spokespeople all assured the American public that the novel mRNA vaccines did not cause negative systematic effects to human bodies. They promised the public, many of whom were skeptical about the safety of a drug brought to market at “warp speed,” that the vaccines were “safe and effective.” [“Operation Warp Speed: Accelerated Covid-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges.” Operation Warp Speed: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges | U.S. GAO, U.S. Government Accountability Office, 11 Feb. 2021, see this] [“Safety of Covid-19 Vaccines.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 8 Aug. 2022, see this]

As we know, those who questioned or challenged the “safe and effective” assurances were dismissed as  “anti-vaxxers” and accused of wanting to kill others, especially the elderly. [Gostin, Lawrence O., and Eric A. Friedman. “This Is the Best Evidence Yet That Anti-Vaxxers Kill.” Yahoo! News, Yahoo!, 23 June 2022]

Due to this pressure, during the push to vaccinate everyone against COVID-19, few medical and public health experts spoke out about the need for long-term studies to protect Americans against possible catastrophic vaccine-related outcomes, including against possible negative impacts on fertility.

This attack on challengers to public health’s all out push, and the resulting censorship of the emerging problem, resulted in catastrophic harms to male fertility.

Pfizer’s own documents and other medical studies show:

  1. mRNA vaccine ingredients can be transferred from one person to another via skin-to-skin contact, inhalation and via “sexual intercourse,” through bodily fluids. That is to say, vaccine “shedding” can occur via sexual contact, including via exposure to semen. [“A Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARS-CoV-2 RNA Vaccine Candidates Against COVID-19 in Healthy Individuals,” Protocol Amendment 14, pp. 213, 246, 398, 431, 575, 607, 751, 783, 918, 948, 1073, 1103, 1226, 1255, 1378, 1406, 1522, 1549, 1663, 1688, 1813, 1836, 1949, 1969, 2081, 2100, 2211, 2228, and 2337.] In other words, according to Pfizer’s own internal documents, a vaccinated man can expose his sexual partner to the vaccine ingredients, via ejaculation.
  1. Pfizer did not test “male reproductive toxicity”. Male reproductive toxicity is defined as adverse effects (negative impacts) related to sexual function and fertility in adult male [“Summary of the Public Assessment Report for COVID-19 Vaccine Pfizer/BioNTech.” GOV.UK, GOV.UK.]
  1. Pfizer also did not test for adverse effects from vaccinated men’s semen, on the development of their offspring. [“Reproductive Toxicity March 2017 – SCHC.” org, SCHC-OSHA Alliance GHS/HazCom Information Sheet Workgroup, Mar. 2017]
  2. mRNA vaccine ingredients travel throughout the body and gather in organs, including in the testes. [“A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats,” see this, p. 24.]
  1. mRNA vaccines resulting in “anti-sperm antibodies” – that is to say, antibodies that treat sperm as an “invader”, and damage or kill it – is a known adverse event related to this form of vaccination. [“5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-Feb-2021,” see this, p. 30.] [Salvador, Zaira, and Sandra Fernández. “What Are Antisperm Antibodies? – Causes & Treatment.” InviTRA, 8 Jan. 2019]
  1. mRNA vaccines cause a staggering drop in semen concentration and total motile count. [Gat, Itai, et al. “Covid-19 Vaccination BNT162B2 Temporarily Impairs Semen Concentration and Total Motile Count among Semen Donors.” Wiley Online Library, Andrology, 17 June 2022]
  1. By suppressing discussion of this information, public health agencies, medical professionals, and governments globally denied and continue to deny men true informed consent.

Transfer of mRNA Vaccine Ingredients Between Humans

We stated above that Pfizer knew that men can transmit the vaccine ingredients to their partners via sexual intercourse. Pfizer’s clinical trial protocol shows the company suspected that negative fertility impacts may occur in men, from its vaccine. Male trial participants had to follow specific “Male Participant Reproductive Inclusion Criteria.” These were spelled out in all fourteen versions of Pfizer’s protocol:

“Male participants are eligible to participate if they agree to the following requirements during the intervention period and for at least 28 days after the last dose of study intervention, which corresponds to the time needed to eliminate reproductive safety risk of the study intervention(s)”

The inclusion criteria requirements stated that men must:

  • Refrain from donating sperm.

In addition, the men in the Pfizer trials must either:

  • Abstain from heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle. They must be abstinent from heterosexual intercourse with a female of childbearing age on a long-term and persistent basis and they must agree to remain abstinent.

OR the men in the Pfizer trial:

  • Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
  • In addition to male condom use, a highly effective method of contraception may be considered in WOCBP (women of childbearing age) partners of male participants.” [“A Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARS-CoV-2 RNA Vaccine Candidates Against COVID-19 in Healthy Individuals,” Protocol Amendment 14, pp. 213, 246, 398, 431, 575, 607, 751, 783, 918, 948, 1073, 1103, 1226, 1255, 1378, 1406, 1522, 1549, 1663, 1688, 1813, 1836, 1949, 1969, 2081, 2100, 2211, 2228, and 2337.]

In other words, the men in the Pfizer trial agreed to abstain from heterosexual intercourse with childbearing age women or else, if they did have intercourse with women who could bear children, they agreed to use a condom and were advised to add an effective additional method of contraception. Reassuring, right? The Pfizer study constructs regarding total abstinence from sex with women who could bear children, or else the use of both condoms and other contraception,   suggest that Pfizer suspected that vaccinated men’s ejaculate could affect both women and unborn children conceived during the trial or after.

Pfizer’s protocol documents also explain:

“An EDP (Exposure During Pregnancy) occurs if:

  • …A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception.
  • A female is found to be pregnant while being exposed or having been exposed to study intervention due to environmental exposure. Below are examples of environmental exposure during pregnancy:
    • …A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception.” [Protocol Amendment 14, pp. 111, 319, 501, 677, 848, 1009, 1162, 1314, 1461, 1603, 1747, 1889, 2023, 2153, 2279, and 2346.]

Clearly, Pfizer showed strong concern about and precautions against exposure to the “study intervention”  – that is, the mRNA vaccine – via bodily fluids contact such as exposure to ejaculate, and via skin-to-skin contact.

Yet as recently as July 2022, the Centers for Disease Control and Prevention (CDC) assured Americans that COVID-19 mRNA vaccine shedding – “the release or discharge of any of the vaccine components in or outside of the body” – is a “myth.” [“Myths and Facts about Covid-19 Vaccines.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 20 July 2022] Indeed a recent FOIA via America First Legal reveals that Carol Crawford of the CDC coordinated with Twitter employees to target tweets (including one by Dr. Naomi Wolf) about “shedding,” as an example, as CDC put it,  of “misinformation.” But it was not, per Pfizer’s own documents, disinformation at all. According to the manufacturer, “shedding” was a real concern.

mRNA Vaccines’ Adverse Effects on Male Reproduction

National Institutes of Health (NIH) boldly stated on February 1, 2022, “COVID-19 vaccination does not reduce chances of conception…” [“Covid-19 Vaccination Does Not Reduce Chances of Conception, Study Suggests.” National Institutes of Health, U.S. Department of Health and Human Services, 1 Feb. 2022] However,  the NIH’s statement was and is false.

Pfizer did not initially evaluate its vaccine’s male “reproductive toxicity” – i.e., adverse effects on fertility in adult males – during clinical trials because the company was in a rush: “The absence of reproductive toxicity data is a reflection of the speed of development to first identify and select COVID-19 mRNA Vaccine BNT162b2 for clinical testing and its rapid development to meet the ongoing urgent health need.” [“Summary of the Public Assessment Report for COVID-19 Vaccine Pfizer/BioNTech.” GOV.UK, GOV.UK]

But when Pfizer eventually did look at the mRNA vaccine’s impact on male fertility, the company used “untreated male” rats for its “Reproductive and Developmental Toxicity” studies. The untreated males mated with female rats that had been dosed with BNT162b2, Pfizer’s mRNA vaccine. [2.4 Nonclinical Overview, p. 29.]

In other words, Pfizer tested fertility effects on female mammals dosed with its mRNA product but left the males undosed.

Throughout the Pfizer documents, the issue arises that studies were constructed so that Pfizer (and the FDA) did not find what it chose not to look for.

How do scientists determine a new drug’s adverse effects on male fertility if they give only one-half of the reproducing population – the females – the treatment in question?

That same Pfizer document goes on to say, “Macroscopic and microscopic evaluation of male and female reproductive tissues from the repeat-dose toxicity studies with BNT162b2 showed no evidence of toxicity.” [see this, p. 30.]

This statement seems to indicate that the study sought to evaluate whether the vaccine was passed through bodily fluids and/or skin contact during intercourse between the treated females and untreated males.

But how convenient – the male rats’ reproductive tissues were declared free of toxicity; but the male rats had never been vaccinated at all.

developmental toxicity

Figure 1: Untreated Male Rates in Pfizer’s 2.4. Nonclinical Overview.

Since there were no vaccinated male rats at all in the Pfizer reproductive studies during its internal trials, it appears Pfizer, and since the human males in the Pfizer study had to promise to abstain from intercourse with childbearing age women or else use a condom PLUS another effective contraceptive – it appears that Western public health agencies decided to test the effects of mRNA vaccines on men’s reproduction simply by using the “intervention” – the mRNA vaccine  – on human subjects, male as well as female, during a mass vaccination campaign.

mRNA Vaccine Ingredients Travel Throughout the Body and Gather in Organs

As we have seen in other DailyClout/War Room Pfizer Documents Research Volunteer Reports, medical and public health agency professionals assured the U.S. public that the COVID vaccine ingredients remained in the deltoid muscle when injected and did not disperse throughout the body. [Chandler, Robert W. “Pfizer Used Dangerous Assumptions, Rather than Research, to Guess at Outcomes.” DailyClout, DailyClout, 9 Aug. 2022]

However, the FDA received the Pfizer document,” A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats,” on November 9, 2020, over a month before Pfizer’s vaccine received Emergency Use Authorization (EUA) and began to be injected into humans worldwide. The document shows shocking biodistribution results.  [“A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats,” see this, p. 24.]

“Biodistribution” is a method of tracking where given ingredients travel in the body of an experimental animal or a human subject.The document clearly demonstrates that Pfizer’s mRNA vaccine contents – including lipid nanoparticles – enter the bloodstream, travel throughout the body, and accumulate in organs, including in the testes. Reference Table 1, “Mean (Sexes-Combined) Concentration of Total Radioactivity in Whole Blood, Plasma and (Continued) Tissues Following Single Intramuscular Administration of [3H]-08-A01-C01 to Wistar Han Rats – Target Dose Level: 50 µg mRNA/Animal; 1.29 mg Total Lipid/Animal – Results expressed as total lipid concentration (µg lipid equiv/g (mL)) and % of administered dose,” shown below. [“A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats,” see this, p. 24.]

table 1

How did medical and public health leaders remain so staunchly firm in their position that mRNA vaccination did not impact male fertility, even as they had access to Pfizer’s biodistribution study?

These experts who were swearing that the mRNA vaccine  ingredients did not leave the injection site also had access to a 2018 NIH-published paper that clearly shows that nanoparticles — of which lipid nanoparticles are subtype [Murthy, Shashi K. “Nanoparticles in Modern Medicine: State of the Art and Future Challenges.” International Journal of Nanomedicine, Dove Medical Press, June 2007, see this] — could pass into the testes from the blood and cause male reproductive harm. The 2018 study showed that NPs accumulate in the testes to damage sperm quality and amount, as well as their “motility”, or ability to move effectively, a requirement of conception:

“NPs [nanoparticles] can pass through the blood-testis barrier…then accumulate in reproductive organs. NP accumulation damages organs (testis, epididymis…) by destroying Sertoli cells, Leydig cells, and germ cells, causing reproductive organ dysfunction that adversely affects sperm quality, quantity, morphology, and motility…”? [Wang, Ruolan, et al. “Potential Adverse Effects of Nanoparticles on the Reproductive System.” International Journal of Nanomedicine, U.S. National Library of Medicine, 11 Dec. 2018, see this]

To appreciate fully how NPs harm key components of healthy male sexual development and function, one must understand the roles of the damaged organs and cells, all crucial to male sexual health and even to male sexual development, mentioned above.

  • The “epididymis” is involved in transporting sperm from the testes. [Boskey , Elizabeth. “Anatomy and Function of the Epididymis.” Verywell Health, Verywell Health, 30 June 2022]
  • “Sertoli cells” are vital to the development of the testes. “Sertoli cells are of critical importance for testis development…[and] are the master regulators of testis development…” [Pelosi, Emanuele, and Peter Koopman. “Development of the Testis.” Sertoli Cell – an Overview | ScienceDirect Topics, Science Direct, 2017] “During [the sperm developmental process], developing sperm cells are closely linked with the Sertoli cells.” [Carlson, Bruce. “Gametogenesis.” Sertoli Cell – an Overview | ScienceDirect Topics, Science Direct, 2014]
  • “Leydig cells” are present in the testicular interstitial tissue. Their main function is to produce testosterone for the maintenance of sperm creation and development and male body development. [Huhtaniemi, Ilpo, and Katja Teerds. “Leydig Cell.” Leydig Cell – an Overview | ScienceDirect Topics, Science Direct, 2018] Thus, when Leydig cells are damaged, one could say that physical masculinity itself is damaged. This is especially urgent to consider when we reflect on the fact that small boys and teenagers, who have not reached or completed puberty, are being injected with mRNA vaccines containing lipid nanoparticles.
  • “Germ cells” “are…precursors of…sperm cells. [“Germ Cells – Definition, Embryonic to Gametes, vs Somatic Cells.” MicroscopeMaster, MicroscopeMaster.com.]

Thus, these excerpts and citations show that:

  1. lipid nanoparticles gather in human organs including the testes,
  2. nanoparticles are detrimental to normal male reproduction, and
  3. Big Pharma and public health agencies knowingly gambled with harms to boys’ and male teens’  sexual development, and with all ages of males’ testosterone levels, older males’ sperm counts, and male fertility.

A Sperm-Related mRNA Vaccine Adverse Event That Causes Male Infertility


Articles by: Amy Kelly

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