Does the NZ datasheet for the Pfizer/BioNTech Covid-19 vaccine (“COMIRNATY”) provide sufficient information to facilitate informed decision making?

Published 13 February 2021

Article at a glance

Introduction

  • On February 3, 2021, NZ’s pharmaceutical medicines regulator, Medsafe, gave provisional approval for Pfizer’s Covid-19 vaccine “COMIRNATY” to be used in NZ and published a datasheet for the vaccine on its website.  The vaccine was given provisional approval even though a major clinical trial of the vaccine has not yet been completed.
  • The provisional approval of “COMIRNATY” is subject to 58 conditions which have been published on the NZ government’s online Gazette.
  • Analysis of the information on the datasheet for “COMIRNATY” on Medsafe’s website shows that it omits information that is important for understanding the risks of the vaccine.

Information that is omitted from the datasheet includes:

  • The deaths of two of the clinical trial participants who received Pfizer’s Covid-19 vaccine.
  • Over 300 deaths reported in people vaccinated with COMIRNATY since the vaccine has been in use overseas, including sudden cardiac death in previously healthy adults, anaphylaxis and autoimmune thrombocytopaenia leading to fatal haemorrhagic stroke. (Ed note: This number based on VAERS data and was correct at the time that this article was published online on February 13 – reported deaths have since risen substantially.)
  • A significantly higher rate of “Nervous system disorders” was reported in trial participants who received the vaccine compared to those who received the placebo.
  • Reports of muscle spasms in some of the trial participants who received the vaccine that were sufficiently severe as to result in their withdrawal from the trial – and reports of similar symptoms in people who have received COMIRNATY since it has been in use in the United States.
  • The section on pregnancy and breastfeeding on the datasheet omits the fact that the United States VAERS system include reports of foetal death in the second trimester of pregnancy after the pregnant women have been vaccinated with COMIRNATY.

Analysis of the conditions upon which COMIRNATY’S approval is subject shows that Pfizer has not yet supplied Medsafe with important data on aspects of the safety of  COMIRNATY.

Data about COMIRNATY which Pfizer has not yet supplied to Medsafe includes:

  • Information relating to the possibility that the novel lipids in the vaccine may contain genotoxic contaminants.
  • Information about whether the vaccine may contain proteins that may cause recipients to develop autoimmune conditions.
  • Information about the DNA template which is used to manufacture the mRNA in the vaccine.
  • Information relating to other types of RNA, including double stranded RNA (dsRNA) that may be present in the vaccine (in addition to the mRNA that codes for the spike protein for SARS-CoV-2).

COMIRNATY will be in use in New Zealand before Medsafe has received much of the information that it has asked Pfizer to supply

  • The earliest deadline set by Medsafe for a response for its request for information relating to the above safety concerns specified above is February 2021.  In relation to some of these safety concerns  Medsafe has specified March as the month for an interim report but the full report is not due until July. Despite this, a vaccination campaign using COMIRNATY  is due to begin on February 20, 2021.

Medsafe has refused to answer a request for information about Covid-19 vaccines that was made under the Official Information Act

Medsafe has refused to answer a request for information made under the Official Information Act about Pfizer’s (and other companies’) Covid-19 vaccines on the grounds that doing so would “be likely unreasonably to prejudice the commercial position of the person who supplied the information.” 

The NZ government has indemnified Pfizer so it can market COMIRNATY in NZ without any financial risk if people are injured or killed

The NZ government has given Pfizer indemnity so that Pfizer cannot be sued if people in NZ are injured or die as a result of being vaccinated with COMIRNATY.

Pfizer expects to make many billions of dollars from sales of COMIRNATY in just one year

Projected earnings for Pfizer during 2021 from sales of  COMIRNATY are in the range of 15 billion or higher.

Please recommend to health professionals that you know that they read this article

The full article, below, is comprehensively referenced and includes notes that discuss possible mechanisms for some of the adverse events (including deaths) reported following vaccination with COMIRNATY.

I hope that you will take the time to share the link (or print a version of this article) for your family doctor, practice nurse, local pharmacist and other health professionals that you know to help them make a more informed decision about whether or not COMIRNATY is appropriate for themselves or their patients.

Does the NZ datasheet for the Pfizer/BioNTech Covid-19 vaccine (“COMIRNATY”) provide sufficient information to facilitate informed decision making?

On February 3, 2021, the NZ Herald online and other outlets carried a story that Medsafe had approved the Pfizer/BioNTech Covid-19 vaccine known as COMIRNATY.  [1] [2]

A NZ government press release listed the some of the occupations of the first people that the government wants to be injected with this vaccine:

“…we will start vaccinating first our border workers and the people they live with. People such as cleaners, the nurses who undertake health checks in MIQ, security staff, customs and border officials, airline staff and hotel workers will be among the first to get the vaccine.” – PM Jacinda Ardern [3]

Medsafe head Chris James “admitted that data received from clinical trials and reports from overseas regulatory partners didn’t confirm that any of the [Covid-19] vaccines reduced transmission” according to an article first published by Radio NZ.  [4]

On February 3 vaccine it was reported that the vaccine would arrive in NZ by the end of March; [4] on February 12, the NZ Herald reported that the vaccine had arrived and would be in use on February 20. [26]

Medsafe published the datasheet for the vaccine on its site as of February 3. [5]

As datasheets are a primary tool for health professionals to learn about the side effect profile of prescription medications and vaccines (particularly those with which they are unfamiliar) let’s drill down into the datasheet to see how well it serves health professionals in NZ (and their patients).

Pfizer’s Coivd-19 vaccine, COMIRNATY does NOT have full approval from Medsafe. The vaccine has only “provisional” approval.  This is not surprising given that the final data collection date for the “primary outcome measure” for the Phase 1/2/3 clinical trial (Study C4591001) for this vaccine is August 3, 2021 and the trial will effectively continue until 2022. [6] There are more than 50 important conditions [7]  attached to the provisional approval of this experimental vaccine which will be discussed later in this article.

What the NZ datasheet says (and some commentary about what it could say – but doesn’t)

The NZ datasheet provides information about the vaccine including how to administer it and some of the potential adverse effects.

Anaphylaxis:

What the NZ datasheet says about anaphylaxis and COMIRNATY 

In relation to anaphylaxis (a severe, life-threatening allergic reaction), the datasheet states:

“Events of anaphylaxis have been reported”.  It further states that “appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction.”

What the NZ datasheet does NOT say about anaphylaxis and COMIRNATY 

What the NZ datasheet does not say is that while there were no cases of anaphylaxis during the Phase 1/2/3 clinical trial (Study C4591001), some recipients of the Pfizer vaccine began to suffer anaphylactic reactions to the vaccine within days of it being used in the UK and USA.

In response, Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) put out a statement saying:  “Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine.” [8] On December 30, 2020, the MHRA subsequently amended its advice to read “Allergies – anyone with a previous history of allergic reactions to the ingredients of the vaccine should not receive it, but those with any other allergies such as a food allergy can now have the vaccine.” [8b]

(Further discussion about this vaccine and anaphylaxis may be found in the references and notes section.) 

Adverse reactions:

What the NZ datasheet says about adverse reactions following vaccination with COMIRNATY

Quoting from the NZ datasheet:

“The most frequent adverse reactions in participants 16 years of age and older were injection site pain (>80%),  fatigue  (>60%),  headache  (>50%),  myalgia  and  chills  (>30%),  arthralgia  (>20%), pyrexia and injection  site  swelling  (>10%)  and  were  usually  mild  or  moderate  in  intensity  and  resolved  within  a  few  days  after  vaccination.  A slightly lower frequency of reactogenicity events was associated with greater age.”

A tabulated presentation of the data fromStudy C4591001 [9] that is included in the NZ datasheet provides the impression that side effects from the vaccine used in the clinical trials are mostly self-limiting.

The NZ datasheet acknowledges that there were four cases of acute peripheral facial paralysis (also known as facial palsy) in the COMIRNATY group compared to none in the group that received the saline placebo. (According to the published article on Study C4591001 21,720 people were vaccinated with BNT162b2 (COMIRNATY) and 21,728 with the placebo.) [9] It is to their credit, that Pfizer/BioNTech used a saline solution as a placebo.  (By contrast the trials conducted of the AstraZeneca Covid-19 vaccine developed by Oxford University – which has also been ordered by the NZ government – used a meningococcal vaccine as a “placebo”.) [10]

What the NZ datasheet does NOT say about adverse reactions following vaccination with COMIRNATY

#1) “Nervous system disorders” were reported to occur at three times the rate in vaccine recipients than in placebo recipients in Study C4591001

The NZ datasheet does not mention the fact that “Nervous system disorders” are reported to have occurred in 6.9% of the vaccine group versus 2.3% of the placebo group. according to the Public Assessment Report Authorisation for Temporary Supply Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection” (henceforth to be abbreviated as the “Public Assessment Report”). [11]

The term “Nervous system disorders” can include headaches but can also encompass more serious conditions such as seizures, Guillain- Barre Syndrome, transverse myelitis etc., however, if the above conditions occurred in any participants in Study C4591001, this was not noted in the “Public Assessment Report”.

In relation to this adverse event category it is interesting to note a new paper that shows that the spike protein of SARS-CoV-2 may adversely affect the blood brain barrier.  [12]

While seizures, Guillain-Barre Syndrome, transverse myelitis were not listed as occurring in people who participated in Study C4591001in the“Public Assessment Report”, a 32-year old physician from Mexico was reportedly in intensive care after developing encephalomyelitis following vaccination with Pfizer’s Covid-19 vaccine. [13]

It is possible to use the search tool developed by the National Vaccine Information Center at the link below to search the VAERS database for specific conditions of interest such as seizures, Guillain-Barre Syndrome, transverse myelitis etc. 

https://medalerts.org/vaersdb/index.php

(Further discussion about the different adverse events that are reported in the UK “Public Assessment Report” in relation to COMIRNATY may be found in the references and notes section, at the end of this article, under the heading “Further notes on adverse events”.)

#2) “Muscle spasms” were noted in two clinical trials and have been reported by people who have received COMIRNATY overseas (but there is no mention of these on the NZ datasheet)

The Pfizer reporton the FDA website at the following link https://www.fda.gov/media/144246/download [14] reports that “1 participant in the 30 μg dose group” (in the Phase 1 study) “reported severe muscle spasms” but the muscle spasms were considered to be “not related to study intervention”, presumably meaning that the study investigator did not think that the vaccine was responsible for this symptom.  (Page 29)  

The Phase 1 trial of the Pfizer vaccine was designed to include only 60 people and all participants received a version of Pfizer’s experimental vaccine candidate that contained higher or lower amounts of the active ingredient mRNA; only 10 people received the 30 μg dose (Page 22). 

The Pfizer document on the FDA website [14] also states that five  study participants who received the experimental vaccine experienced “musculoskeletal and connective tissue disorders” that were sufficiently severe as to result in their withdrawing from Study C4591001. None of the placebo recipients had to withdraw from the study due to symptoms of this nature.  The disorders that resulted in withdrawal from the study by some of the vaccine recipients were described as “events of muscular weakness, muscle spasms, myalgia, and pain in extremity”. (Page 52)  [Emphasis added]

Study C4591001 had of 37,706 participants, approximately half who received the experimental vaccine and half who received the placebo.  According to the Pfizer document there was a median of two months follow up of the volunteers in this trial. In total, “Thirty-four (34) participants in the BNT162b2 group and 25 participants in the placebo group had an AE [adverse event] leading to withdrawal.” (Page 33)

Unfortunately, videos are now beginning to surface on social media of people suffering from peculiar symptoms involving severe muscle spasms or involuntary movements (dystonia) after receiving mRNA vaccines.  (Dystonia can be a symptom of injury to the brain due to head trauma, a stroke, an infection, an adverse reaction to a medication or poisoning with toxic metals such as lead.) The link below shows two such videos, one of a woman who reportedly received the Pfizer mRNA vaccine and one who received the Moderna shot which is also an mRNA product.

The following link includes reports to the US VAERS system that include the word “‘twitching”:  https://medalerts.org/vaersdb/findfield.php?EVENTS=on&PAGENO=1&PERPAGE=10&ESORT=NONE&REVERSESORT=&VAX=(COVID19)&WRITEUP=twitch

NB:  It is sobering to read some of the reports accessible via the above link and see that Guillain-Barre Syndrome listed as a diagnosis category in some of the cases.  

NB: It is possible to use the search tool developed by the National Vaccine Information Center at the link below to search the VAERS database for specific conditions of interest such as dystonia, etc.

https://medalerts.org/vaersdb/index.php

#3) Other serious reported adverse effects have occurred in people who have been vaccinated with COMIRNATY

An Israeli teenager was recently reported to have developed chest pain, an accelerated pulse and shortness of breath which was diagnosed as being due to myocarditis inflammation of the heart muscle).  A news report dated February 1, 2021 stated that the previously healthy young man (aged 19) was admitted to the Intensive Care Unit of Assaf Hospital.  He was hospitalised five days after his second dose of the Pfizer vaccine.  [15]

The above case may possibly be the second such case of myocarditis in an Israeli teenager who has received the Pfizer vaccine. On January 24, 2021 the Jerusalem Post reported  that a 17 year old boy had been admitted to  the ICU department of Safra Children’s Hospital after feeling intense pains in his chest a few days after receiving the second dose of the coronavirus vaccine”.  [16]

#4) There were two deaths in trial participants who received the vaccine (but there is no mention of these on the NZ datasheet)

The NZ datasheet makes no mention of the deaths of the two participants who received the experimental vaccines in the Phase 2/3 Study C4591001 .

According to the UK “Public Assessment Report” [11]: “A  participant died 3 days after Dose 1; the provisional cause of death was atherosclerotic disease. A participant experienced cardiac arrest 60 days after Dose 2 and died 3 days later.” (Page 43)

In light of these deaths, it is worth considering the results of a recent study that suggests that the spike protein of SARS-CoV-2 is potentially capable of causing injury to the cardiovascular system. The mRNA in COMIRNATY is designed to trick the body into synthesising the spike protein from SARS-CoV-2. Therefore there is a possibility that people who receive this vaccine (or any other Covid vaccine that contains the spike protein or forces the body to manufacture this protein) could suffer injury to their cardiovascular system. https://www.mdpi.com/2076-393X/9/1/36/htm

(For a discussion of other possible mechanisms by which vaccination against SARS-CoV-2 may cause cardiovascular complications, please see the references and notes section at the end of this article under the heading “Further notes on cardiovascular complications”.)

Four people who received the placebo (saline) injection as part of the Phase 2/3 study c4591001trial are also reported to have died.  No information was given as to the cause of death of these participants. In the UK Public Assessment Report”.

#5) There have been over two hundred deaths in people who received COMIRNATY in countries where the vaccine is already in use (but there is no mention of these on the NZ datasheet)

As previously stated, the Pfizer mRNA vaccine COMIRNATY was granted a “provisional” approval in NZ on February 3, 2021.  COMIRNATY is already in use in the UK where it has “authorisation for temporary supply” and in the USA  the vaccine is in widespread use under an “emergency use authorization” (EUA).

The vaccine is also in use in a number of other countries including Israel, Italy and Germany.

Although you would not know this from reading the NZ datasheet, deaths following the administration of the Pfizer mRNA vaccine (and the Moderna rRNA vaccine) have been reported in a number of countries where these vaccines are now in use.

In fact, according to an article published online on February 5, 2021, 653 deaths following receipt of these vaccines were reported from December 14, 2020, to February 4, 2021.  Of these 653 deaths, 58% were in Pfizer vaccine recipients and 41% were in recipients of the Moderna vaccine. [17] This information comes from the US VAERS database; this is a passive system so it is not compulsory for all all injuries to be reported to this database.  Deaths may also be reported to VAERS prior to formal ascertainment that the vaccine was the cause of death.  Passive reporting systems such as VAERS have been criticised for massive under-reporting. [18]  

The figures that are already available on the VAERS website are concerning.

Below are a few examples of people who are known to have died after receiving COMIRNATY:

• Dr. Gregory Michael, a Miami obstetrician/gynaecologist and vaccine advocate received the Pfizer shot on December 18, 2020. 

Three days later he admitted himself to the emergency room because he noticed petechiae (spots of blood beneath the skin) on his hands and feet.  A full blood count showed he had zero platelets.  (Platelets are cell fragments that play an important role in blood clotting and the normal count is between 150,000 – 400,000 per microlitre of blood.) According to a FB post by his widow, the best doctors in the country worked for two weeks to try to save Dr. Michael’s life but he suffered a haemorrhagic stroke that “took his life in a matter of minutes” on January 4, 2021. (https://m.facebook.com/story.php?story_fbid=10157817790183977&id=648648976)

Dr. Michael’s death is the subject of a formal investigation.  Pfizer was quoted as saying:  “We are actively investigating this case, but we don’t believe at this time that there is any direct connection to the vaccine.” [19]

A contrary opinion was offered by Dr. Jerry L. Spivak from Johns Hopkins University who said that it was a “medical certainty” that the vaccine caused Dr. Michael’s death. [20]

Dr. Michael is only one a number of health professionals and healthcare workers who have died within a short time of being vaccinated with the Pfizer mRNA vaccine.

A few of the other deaths in health professionals that have been reported are as follows:

  • 45-year-old Italian medical doctor Mauro Valeriano D’Auria who died while playing tennis on 24 January 2021.  His FB page states he was vaccinated against Covid-19. He was described as previously having been in “perfect health”.
  • 42-year-old nurse Luigi Buttazzo a surgical equipment technician was found dead in bed shortly after receiving his second dose of the Pfizer vaccine.  A heart attack is suspected as the cause of death.
  • 39 year old Elisabeth Durazzo, a nurse died suddenly in her sleep from cardiac arrest.  She was vaccinated on January 13, 2021 and was found dead ten days later.

(For a discussion of possible mechanisms by which vaccination against SARS-CoV-2 may cause cardiovascular complications, including deaths, please see the references and notes under the section “Further notes on cardiovascular complications”.)

Elderly

What the NZ datasheet says about COMIRNATY and the elderly

In relation to the elderly, the NZ datasheet simply states: 

“No dosage adjustment is required in elderly individuals ≥ 65 years of age.”

This statement may be based upon the fact that the clinical trials data did generally show that younger people had a higher rate of systemic adverse events than older people. 

What the NZ datasheet does not say about COMIRNATY and the elderly

Since COMIRNATY has been authorised for emergency or temporary use in other countries, the average age of the recipients who have been reported to have died following receipt of the vaccine has reported to be 77 years old.  

The higher average age of death of people reported to have died after receiving COMIRNATY may reflect the fact that in addition to healthcare workers, elderly people are being offered vaccination on a prioritised basis. (Significant work would be needed to prove or disprove a hypothesis that elderly people are dying at a disproportionate rate relative to younger vaccine recipients.)

It is worth noting that following deaths in elderly people residing in care homes in Norway who had died after being vaccinated with COMIRNATY, the Norwegian Medicines Agency (NOMA) “investigated 13 of the deaths so far and concluded that common adverse reactions of mRNA vaccines, such as fever, nausea, and diarrhoea, may have contributed to fatal outcomes in some of the frail patients”. https://www.bmj.com/content/372/bmj.n149

Children

What the NZ datasheet says about COMIRNATY and children

In relation to children the NZ datasheet states: The safety and efficacy of COMIRNATY in children and adolescents aged less than 16 years of age have not yet been established. Limited data are available.”

What the NZ datasheet does not say about COMIRNATY and children

The infection fatality rate for children and teenagers under is 0.003 percent IFR for children and adolescents according to the US Centers for Disease Control (CDC).  [21] In Sweden, despite preschools and schools remaining open, no children have died from Covid-19 and the rate of severe illness from  SARS-CoV-2 in children have been very low.  https://www.nejm.org/doi/full/10.1056/NEJMc2026670  In light of these facts it is highly questionable why the anyone would consider vaccinating children with any of the Covid-19 vaccines that have been rushed onto the market before the clinical trials have been completed.

Pregnant and breastfeeding women

What the NZ datasheet says about COMIRNATY and pregnant and breastfeeding women

In relation to pregnant women and breastfeeding mothers (no pregnant or breastfeeding women participated in the clinical trials) the NZ datasheet states:

“There is limited experience with use of COMIRNATY in pregnant women… Administration of COMIRNATY in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.”

What the NZ datasheet does not say about COMIRNATY and the pregnant and breastfeeding women

It is interesting to note that this part of the datasheet differs from information provided to British health professionals in December 2020, when that country began its mass vaccination campaign. Quoting from “REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS” [22]: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.”

In relation to breastfeeding British health professionals are advised: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.”

(For a discussion as to possible reasons for the differences in the advice given to UK and NZ health professionals on the topic of pregnancy and breastfeeding, please see the references and notes at the end of this article. You may also like to read an article on the topic of Covid-19 vaccination and pregnancy that is now available at this link: https://therealnews.nz/2021/02/28/are-covid-10-vaccines-safe-for-pregnant-women/ )

The NZ datasheet does not disclose that there have been reports of foetal death (including in the second trimester) made to the United States VAERS system after pregnant women have been vaccinated with the Pfizer/BioNTech Covid-19 vaccine (aka COMIRNATY).

(See: https://healthimpactnews.com/2021/wisconsin-resident-doctor-has-miscarriage-3-days-after-being-injected-with-experimental-covid-mrna-shot/ NB: At the reference above it is possible to go to the VAERS site and read the VAERS entry for each case by clicking on the VAERS reference number which is in blue.)

Also in relation to the health of mothers and babies and the use of COMIRNATY in pregnancy, the limited blood testing that was done in the trials showed that volunteers receiving the Pfizer/BioNTech vaccine experienced a transient elevation in their CRP (see below). This may have implications for the development of the baby’s brain during pregnancy as research dating back to 2013 shows an association between higher CRP in pregnancy and an increased risk of autism for the baby. See: https://www.nature.com/articles/mp2012197

Laboratory Tests

What the NZ datasheet says about COMIRNATY and effects on laboratory tests

Beneath the category “Effects on laboratory tests” the NZ datasheet states: “No data available”.

What the NZ datasheet does NOT say about COMIRNATY and effects on laboratory tests

The statement that there is “no data available” about COMIRNATY and laboratory tests appears to be untrue based on pages 43-44 of the UK “Public Assessment Report” [11] which state: Transient increases in C-reactive protein and transient decreases in lymphocyte count were observed in a dose dependant [sic] manner”. (Pages 43-44)  [Emphasis added]

The “Public Assessment Report” states that “no clinical impact was observed” in relation to these changes.

NB: C-reactive protein (CRP) is blood test used to assess inflammation – it may become elevated due to inflammation associated with infection and/or malignancy and/or obesity, among other conditions.

Lymphocytes (a type of white blood cell) assist with protection from infection and also from cancer; a transient decrease may have little long term significance.  If a transient decrease were sufficiently serious it might temporarily increase vulnerability to a virus (such as one that causes the common cold or influenza, for example) until lymphocyte levels return to normal.  

The “Public Assessment Report” also states that “Routine laboratory testing of haematology and clinical chemistry parameters was only conducted for Study BNT162-01 and Phase 1 of study c4591001”. (Pages 43-44)  

What the datasheet omits

There is a paucity of important information in many sections of the NZ datasheet.   

In addition to this there is another significant omission.  Perhaps one of the most important of these is pathogenic priming, also known as antibody-dependent enhancement (ADE).

This is a condition in which the presence of antibodies to a virus actually results in a more severe illness when exposed to the virus.

Attempts to create successful vaccines against the virus that causes SARS (SARS-CoV)  were not successful and in some cases this has been due to problems with dysregulated immune responses. [23]

Antibody-dependent enhancement (ADE) is a potential risk of vaccination against SARS-CoV-2, as discussed in the October 28, 2020 article in the International Journal of Clinical Practice in which the authors express concern that the informed consent forms being used in trials of Covid-19 vaccines may not have been adequate in advising trial participants of this possible risk. [24]

Informed consent in relation to this issue is important given that for many people, a SARS-CoV-2 infection could be asymptomatic or mild. [25]   Therefore a risk of potentially enhanced disease from SARS-CoV-2 as a consequence of choosing to be vaccinated is significant. 

This useful article, by a writer who has a PhD in molecular biology, makes the sobering point that if vaccination against SARS-CoV-2 does turn out to cause ADE, this risk may not be apparent until several years after vaccination. https://sciencewithdrdoug.com/2020/11/27/will-an-rna-vaccine-permanently-alter-my-dna/

Conditions imposed by Medafe in relation to the provisional consent for COMIRNATY

A large number of conditions have been imposed on Pfizer  under section 23(1) of the Medicines Act 1981 in relation to the provisional consent to market and distribute its mRNA vaccine Covid-19 vaccine COMIRNATY.  These were published in the NZ Gazette at the following link on February 3, 2021:

https://www.gazette.govt.nz/notice/id/2021-go338

Some of these conditions seem fair and timely. Others raise concerns that the provisional approval of the vaccine has preceded the supply of important information by Pfizer that has implications for the safety of COMIRALTY recipients.  

They are of especial significance now that the government plans to begin vaccinating people who work in border-related occupations on February 20, 2021. [26] 

Below are a few of the conditions from the relevant notice in the Gazette with some comments:

Condition #5:

“Any homology between translated proteins (other than the intended spike protein) and human proteins that may, due to molecular mimicry, potentially cause an autoimmune process should be evaluated. Due date: July 2021. Interim report: March 2021.”

Comments in relation to Condition #5:

Dr. Gregory Michael is dead and the most likely explanation for the premature demise of this previously “very healthy” man is that the Pfizer shot that he received triggered an autoimmune condition that caused his body to destroy his platelets which led to his fatal haemorrhagic stroke.

The previously healthy 19 year old Israeli man who developed myocarditis (inflammation of the heart muscle) several days after his second injection may be suffering from a similar autoimmune phenomena, albeit one that has targeted his heart muscle.

Given these and the other reports of severe adverse events in some COMIRNATY recipients overseas, why has this vaccine been given provisional approval BEFORE Pfizer has supplied information that shows that the vaccine does not have the potential to cause the body to produce proteins that can trigger devastating autoimmune diseases?

(As of this writing, this vaccine is expected to be in use in NZ beginning on February 20, 2021 and the interim report on this issue is not due until March 2021 and the full report is due in July 2021.) [26]

Condition #7:

“Provide the reassessment of the active substance specification for the DNA template purity and impurities. Due date: July 2021.”

Comments in relation to Condition #7:

In order for an mRNA vaccine to include the target mRNA sequence, the DNA template used to manufacture the mRNA  must be correct. 

If there are quality concerns about the DNA template why has this vaccine been given provisional approval? (As of this writing, this vaccine is expected to be in use in NZ beginning on February 20, 2021.) [26]

Condition #9:

“Comprehensively describe the capability of the next generation sequencing technology platform to detect lower amounts of RNA species of alternative sequence in the presence of the correct, more abundant RNA for the active substance. Due date: July 2021.”

Comments in relation to Condition #9:

COMIRNATY is an mRNA vaccine. Potential vaccine recipients (and most health professionals) who have read about mRNA vaccines in the popular press (and who have read the NZ datasheet for COMIRNATY) will be under the impression that COMIRNATY will contain mRNA that codes for the spike protein of SARS-CoV-2 (and only that mRNA).

If any batch of COMIRNATY has contained RNA other than the mRNA that codes for the spike protein of SARS-CoV-2 this could potentially explain some of the extreme adverse events reported in some recipients.

If Medsafe has not been provided with documentation that provides assurance that Pfizer has the capability of testing its mRNA vaccine to detect non-target RNA sequences (presumably so that batches that are contaminated with undesirable RNA can be destroyed, rather injected into people) then why has the vaccine been given provisional consent to be marketed in NZ?

Condition #12:

Provide a summary of the validation/verification status of the immunoblot analytical procedure used to detect double stranded RNA (dsRNA) in the active substance. Due date: July 2021.”

Comments in relation to Condition #12:

COMIRNATY is an mRNA vaccine. By definition, mRNA is a single stranded molecule. Therefore double stranded RNA (dsRNA) should NOT form any part of the “active substance” of COMIRNATY. 

Any dsRNA that may be present in COMIRNATY may pose a safety concern since according to a 2007 article, dsRNA is “pro-inflammatory” and “mimics an RNA-virus infection of host cells”. See: https://pubmed.ncbi.nlm.nih.gov/10580187/ or full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1986720/ )

If Medsafe has not been provided with documentation that provides assurance that Pfizer has developed a reliable testing method that can detect dsRNA sequences (presumably so that batches that contain dsRNA can be destroyed, rather injected into people) then why has the vaccine been given provisional consent to be marketed in NZ?

(As of this writing, this vaccine is expected to be in use in NZ beginning on February 20, 2021 yet Pfizer is not required to supply the information sought in condition #12 until July 2021.)

Comments in relation to Conditions #26-#51:

COMIRNATY contains four lipids including ALC-0315; ((4- hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) and

ALC-0159; 2- [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide.

Conditions #26-#51 in The Gazette entry relate to ALC-0315 and ALC-0159.

In relation to these compounds, it is worth noting the UK “Public Assessment Report” states that ALC-0315 and ALC-0159 “are considered novel in that they have not been used in an authorised medicinal product in the UK”.

To the best of my knowledge they have not been used in any other “medicinal product” in NZ, either.

Based on the extensive list of questions in relation to ALC-0315 and ALC-0159 it appears that Medsafe would like to know a great deal more about these compounds than it does at present. Questions of concern relate to the raw materials and manufacturing process of these novel lipids including questions #28 and #40 that seek information about “control of any potentially genotoxic contaminants”. 

In relation to the possibility of genotoxic contaminants making their way into ALC-0159 or ALC-0315 during their manufacture (and potentially thereby being included in COMIRNATY) it would seem disingenuous for the NZ datasheet on Medsafe’s website to include the phrase:  “The components of COMIRNATY (lipids and mRNA) are not expected to have genotoxic potential”  – unless Pfizer has already supplied Medsafe with data that shows that manufacturing processes are adequate to ensure that ALC-0159 and ALC-0315 do not contain genotoxic contaminants. 

(The relevant page of The Gazette specifies July 2021 as the due date for questions #28 and #41 with February 2021 as the month for the “interim report”.)

Conclusion

Doctors and nurses working in general practice and  pharmacists who are also licensed vaccinators are busy people who do not have time to read over a large number of peer-reviewed (or pre-print) papers to learn about new prescription medicines or vaccines. They rely on the datasheets on Medsafe’s website to provide an accurate picture of the benefits and risks of a vaccine or prescription medication so that they can advise patients about the suitability of a particular treatment. 

Health professionals are generally conscientious people who do their best for their patients – and expect that other people who are working in the health sector would be similarly dedicated. Health professionals generally expect that datasheets on Medsafe’s website contain reliable information.

The omission from the NZ datasheet of the fact that two people who received COMIRNATY during the clinical trial (Study C4591001) died and that many more people have died following the use of COMIRNATY in the countries where this product is already in use provides a false impression of the safety of the vaccine.

With the exception of anaphylaxis, the NZ datasheet on Medsafe’s website also fails to mention the alarming reactions that have been reported in some recipients of  COMIRNATY in countries where this vaccine is already in use.  This omission further provides a false impression of the safety of the vaccine.

The first doses of COMIRNATY are expected to injected into people in NZ beginning on 20 February 2021 thanks to the fact that Medsafe has chosen to give the vaccine provisional approval.

This is a troubling possibility given that many of the conditions relating to the provisional approval of COMIRNATY published in The Gazette show that Medsafe is still waiting for Pfizer to supply important information relating to the safety of the vaccine – and that the published date for the supply of most of this information post-dates the date on which COMIRNATY will begin to be injected into people in NZ.

Pfizer is a company that exists to make a profit. In fact, a cynical reading of some of the text of a Pfizer document on the FDA website [14] provides the impression that the major clinical trial (Study C4591001) was designed to support the company’s aim of developing a commercially successful vaccine:

“The Phase 2/3 portion of the study evaluated the safety, immunogenicity, and efficacy of the selected vaccine candidate, BNT162b2, and is intended to support licensure in the US and globally.” (Page 14) [Emphasis added]

According to one report, Pfizer expects to earn $US15 billion from COMIRNATY in 2021 – about a quarter of its entire projected revenue for this year.  [27]

Another report pegs the company’s projected earnings in 2021 from its coronavirus vaccine COMIRNATY at $US 19 billion – although this larger sum will reportedly need to be shared with BioNTech (the company that developed the vaccine). [28]

In any event, the projected earnings from COMIRNATY dwarf Pfizer’s 2020 vaccine profits which were reportedly $US 975 million.) [29]

The NZ government has given Pfizer indemnity so the company cannot be sued if COMIRNATY kills or injures New Zealanders (or people living in NZ). [30]

Medsafe’s is a “business unit” of The NZ Ministry of Health and its “mission” is supposedly to “To enhance the health of New Zealanders by regulating medicines and medical devices to maximise safety and benefit.” [31]

There are a number of prevention and treatment options for Covid-19 – including medications that have been in use for decades with well-characterised safety/risk profiles [32].  NZ also has currently very few cases of Covid-19 and no community transmission of the virus. Under these circumstances, it is difficult to see how a decision to give provisional approval to a vaccine before a major clinical trial has been completed [6] and before the manufacturer has supplied important information in relation to the vaccine’s safety meets Medsafe’s supposed goal of “regulating medicines…to maximise safety and benefit”.

Medsafe has recently refused to answer a request for information about Covid-19 vaccines that was made under the Official Information Act. [33]

The very reasonable questions that Medsafe refused to answer were: 

1) Was the SARS-CoV-2 vaccine tested against a saline placebo or was another vaccine used as a “placebo” in the clinical trials of the vaccine?  (If another vaccine was used as a “placebo” please state the name and manufacturer of the vaccine.)

2) What information has the manufacturer/distributor supplied in relation to the ability of the vaccine to:

• prevent infection with or carriage of SARS-CoV-2?

• prevent people who are exposed to SARS-CoV-2 from developing symptoms?  (Please specify which symptoms of a SARS-CoV-2 infection that the vaccine has been shown to prevent.)

• prevent people who are exposed to SARS-CoV-2 from developing an infection that is sufficiently severe that they require i) hospitalisation and ii) treatment in the intensive care ward of a hospital?

• prevent people who are exposed to SARS-CoV-2 from dying from the complications of a SARS-CoV-2 infection? (For example, from viral pneumonia, secondary bacterial pneumonia, sepsis, thromboembolic complications etc. – please specify which type of fatal complications of a SARS-CoV-2 infection the vaccine has been shown to prevent.)

The person who placed the OIA request asked Medsafe to “Please support each answer with appropriate documentation, such as a relevant peer reviewed paper and/or information supplied by the vaccine’s manufacturer/distributor etc.”

Here’s the answer from Medsafe to this reasonable list of questions, which would, I believe, be of interest to everyone in NZ:

“Information submitted to and held by Medsafe regarding COVID-19 vaccines that is in the scope of your request is confidential to the respective companies. As such, this information is withheld under section 9(2)(b)(ii), to protect information where the making available would be likely unreasonably to prejudice the commercial position of the person who supplied the information.”  [33] [Emphasis added]

The response from Medsafe also included following sentence:

“If and when any of the COVID-19 vaccines are approved for use in New Zealand, Medsafe will publish information such as the medicine data sheet, describing the known information about the vaccine, including ingredients, clinical study information and possible side effects.” [33]

It seems pretty clear whose side Medsafe is on.

It’s not on the side of the hardworking health professionals who rely on datasheets on Medsafe’s website to provide information about the benefits and risks of medicines that they may be considering for their patients – or for themselves.

It’s a sad day when an organisation that is supposed to look after the interests of the public instead appears to be looking to “maximise safety and benefit” … for a global pharmaceutical company.  

Is the datasheet for the Pfizer/BioNTech Covid-19 vaccine COMIRNATY the most data-deficient datasheet in the world?

I couldn’t accurately answer that question without reading the datasheets for the many different countries in which this vaccine is in use  …

I do know that we deserve better from Medsafe and the Ministry of Health than for a vaccine that uses experimental mRNA technology to be given provisional approval to be injected into people in NZ when there are still so many outstanding questions about its safety.

(Please share this article with your doctor, practice nurse and pharmacist who may otherwise take the COMIRNATY datasheet at face value.)

References and Notes

NB: References are below in numerical order; the extensive notes relating to anaphylaxis, other adverse events reported in clinical trial participants and cardiovascular complications may be found below the numbered references under the relevant heading.

References

[1] The link on the NZ Herald website is no longer active: https://www.nzherald.co.nz/nz/focus-live-pm-jacinda-ardern-announced-that-medsafe-have-approved-the-pfizer-covid-19-vaccine/UTO7OQ7BLRWLM7BYSIZWOL6HS4/

[2] https://www.newshub.co.nz/home/politics/2021/02/covid-19-pfizer-biontech-vaccine-approved-in-new-zealand-but-still-no-arrival-date-as-government-reveals-who-gets-first-jabs.html

[3] https://www.nzdoctor.co.nz/article/first-covid-19-vaccine-approved

[4]  https://www.msn.com/en-nz/news/national/pfizer-biontech-covid-19-vaccine-granted-provisional-approval-by-medsafe/ar-BB1dkQLm

[5] https://www.medsafe.govt.nz/profs/Datasheet/c/comirnatyinj.pdf

[6] The final data collection date for the primary outcome measure for the trial of this vaccine is August 3, 2021.   Some of the study the participants are planned to be followed for up to two years after their second dose. The trial began on April 29, 2020. https://clinicaltrials.gov/ct2/show/record/NCT04368728 (Accessed February 4, 2020)

[7] https://gazette.govt.nz/notice/id/2021-go338

[8] https://www.reuters.com/article/idUSKBN28J1D1 [8b] https://www.gov.uk/drug-safety-update/covid-19-vaccines-pfizer-slash-biontech-and-covid-19-vaccine-astrazeneca-current-advice#further-advice-for-the-pfizerbiontech-vaccine

[9] The abstract for this study is here:  https://pubmed.ncbi.nlm.nih.gov/33301246/

[10]  https://clinicaltrials.gov/ct2/show/NCT04436276

11]  https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/944544/COVID-19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH__15Dec2020.pdf

[12] https://www.biorxiv.org/content/10.1101/2020.06.15.150912v1

[13] https://english.alarabiya.net/coronavirus/2021/01/02/Coronavirus-Mexican-doctor-hospitalized-after-receiving-Pfizer-COVID-19-vaccine-

[14]  https://www.fda.gov/media/144246/download

[15] https://www.israelnationalnews.com/News/News.aspx/296028

[16] https://www.jpost.com/breaking-news/17-year-old-in-icu-after-receiving-second-coronavirus-dose-656527

[17] https://childrenshealthdefense.org/defender/deaths-injuries-following-covid-vaccine-cdc/

[18]   https://www.bmj.com/content/357/bmj.j2449/rr-0

[19] https://www.ibtimes.sg/florida-doctor-dies-weeks-after-receiving-pfizer-covid-19-vaccine-wife-blames-side-effects-54728

20] https://childrenshealthdefense.org/defender/johns-hopkins-scientist-medical-certainty-pfizer-vaccine-caused-death-florida-doctor/

[21] https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html

[22] https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/955899/Temporary_Authorisation_HCP_Information_BNT162_6_0_UK_editclean.pdf

[23] https://www.nature.com/articles/s41564-020-00789-5

[24] Full text is here: https://cloudup.com/cvlehB01053  (Abstract is here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645850/)

[25]  https://www.cebm.net/covid-19/covid-19-what-proportion-are-asymptomatic/

[26] https://www.nzherald.co.nz/nz/covid-19-coronavirus-vaccine-prime-minister-jacinda-ardern-jabs-begin-for-border-staff-next-week/FNNXTDYC777REAB226CRNXGKG4/

[27] https://www.news.com.au/finance/business/manufacturing/pfizer-expects-20-billion-in-covid19-vaccine-sales-in-2021/news-story/eb0280052d5e479c56a4d4376d74568e

[28] https://edition.cnn.com/2020/12/11/business/pfizer-vaccine-covid-moderna-revenue/index.html

[29] https://edition.cnn.com/2020/12/11/business/pfizer-vaccine-covid-moderna-revenue/index.html

[30] https://www.rnz.co.nz/news/national/435107/government-grants-vaccine-suppliers-indemnity-against-claims

[31] https://www.medsafe.govt.nz/other/about.asp

[32]  https://therealnews.nz/wp-content/uploads/2020/12/Fact-Sheet-on-TREATMENT-OPTIONS-FOR-COVID-19-including-references-and-notes-1-1.pdf

[33] https://voicesforfreedom.co.nz/tell-us-the-truth-an-open-letter-to-the-ministry-of-health-on-transparency/

Further notes on anaphylaxis:

To put the information on the NZ datasheet into perspective, a document  on the website of a British government agency “Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection” (available at this link https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/944544/COVID-19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH__15Dec2020.pdf ) and henceforth to be referred to as the “Public Assessment Report”, updated on 11 December 2020 states in relation to anaphylaxis:  “At present, there is no evidence that BNT162b2 is associated withhypersensitivity or anaphylaxis, but post-authorisation monitoring for these events will be conducted.” 

One possible reason that this British document stated that there was “no evidence” of anaphylaxis in the trials could have been due to the fact that people who had a history of anaphylaxis to vaccines were excluded from a major trial of the vaccine. https://clinicaltrials.gov/ct2/show/record/NCT04368728?view=record )

On December 1, 2021 the Pfizer/BioNTech vaccine gained “authorisation for temporary supply” in the UK and a mass vaccination programme began on Tuesday, December 8, 2020. By December 10, two people had reportedly experienced anaphylaxis and there was also another allergic reaction reported. In response, Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) put out a statement saying: “Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine.” Paul Turner of theImperial College London stated that the inclusion of PEG (the main ingredient in antifreeze) in the Pfizer/BioNTech MRNA vaccine was a possible cause of the allergic reactions. https://www.reuters.com/article/idUSKBN28J1D1

There has now, sadly, been the first reported death from anaphylaxis following the Pfizer vaccine. Drene Keyes of Virginnia was 58 years old and her job meant that she was eligible for the Pfizer shot. She stayed in the clinic for the recommended 15 minutes after receiving the vaccination but subsequently began to feel ill.  Despite receiving emergency treatment in hospital, she died.  Her family was told that she suffered fromflash pulmonary edema” as a consequence of the allergic reaction.  https://healthimpactnews.com/2021/58-year-old-mother-and-grandmother-of-six-in-virginia-dies-within-hours-of-receiving-experimental-pfizer-mrna-injection/

Further notes on adverse events:

Study C4591001 on the NZ datasheet on NZ’s website is quite truncated compared to the chart in the British MHRA’sPublic Assessment Report Authorisation for Temporary Supply Public Assessment Report Authorisation for Temporary Supply COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injection” (henceforth to be abbreviated as the “Public Assessment Report”). https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/944544/COVID-19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH__15Dec2020.pdf

Pages 40 and 41 of the UK “Public Assessment Report” document tabulate varying adverse events as reported by recipients of BNT162b2 and the placebo in the Phase 2/3 trials.  For most categories there were predictably more adverse events in the vaccine group than the placebo group.

The table on Page 40 reports that 5770 (26.7%) of the 21,621 people who received the Pfizer/BioNTech vaccine compared to 2638 (12.2%) of the 21,631 people who received the placebo (a saline solution) reported an “adverse event”.

(The “Public Assessment Report” document defines “adverse event (AE)” as “any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.”)

One category that stood out in the data tabulated on Page 41 of the UK “Public Assessment Report” is “Nervous system disorders” which are reported to have occurred at 6.9% of the vaccine group versus 2.3% of the placebo group.  Headaches are categorised under the term “nervous system disorders” but in relation to this adverse event category it is interesting to note this new paper that shows that the spike protein of SARS-CoV-2 may adversely affect the blood brain barrier.  https://www.biorxiv.org/content/10.1101/2020.06.15.150912v1

(While “nervous system disorders” could potentially include more serious adverse effects such as seizures or transverse myelitis or Gullain-Barre Syndrome, a search of the document for these terms did not reveal any mention of these terms.)

Curiously, the UK government document  “REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS” describes the risk of headache after vaccination as “very common”.  (The document defines “very common” as ≥ 1/10 which is significantly higher than 6.9% for all “Nervous system disorders” reported in the “Public Assessment Report”.)

This discrepancy may possibly be due to conflating of results from Study C4591001 with that of the results from the First-in-Human Phase 1/2 Study BNT162-01, about which there is a report at this link: https://www.fda.gov/media/144246/download

Headaches affected a lot of the higher dose recipients in the First-in-Human Phase 1/2 Study BNT162-01s trial.  The reported frequency of headaches ranged from “0% to 67%” in volunteers “across number of doses and dose levels”. (Page 28) The trial was apparently designed to test versions of the candidate vaccine formulated to contain 1, 3, 10, 20 or 30 micrograms of the mRNA (Page 13) but data are reported for only 1, 10, 20 and 30 micrograms dosages on Page 22.  

The highest dose used in the First-in-Human Phase 1/2 Study BNT162-01 (30 micrograms of mRNA) was the mRNA dose chosen for the vaccine formulation that has been given provisional approval by Medsafe.

Younger people were reported to be more likely to experience systemic side effects such as headaches, chills and muscle pain than older adults in this study. (Page 28) https://www.fda.gov/media/144246/download 

Table 23 beginning on Page 87 of the document at this link  https://www.fda.gov/media/144246/download lists the various serious adverse events reported in both vaccine and placebo recipients.

Further notes on cardiovascular complications:

The following facts may be pertinent to the cardiac-related  deaths of vaccine recipients during Study C4591001 and to the sudden cardiac-related deaths of previously healthy people following vaccination with the Pfizer/BioNTech vaccine in countries in which this product is already in use.

  1. A recent study suggests that the spike protein of SARS-CoV-2 is potentially capable of causing injury to the cardiovascular system; therefore any other Covid vaccine that contains the spike protein or forces the body to manufacture this protein) may carry the risk of causing injury to the cardiovascular system of recipients. https://www.mdpi.com/2076-393X/9/1/36/htm.

2.  An article published in 2018 on mRNA vaccines noted that naked RNA in the bloodstream has the potential to cause blood clots. https://www.nature.com/articles/nrd.2017.243

Blood clots have the potential to cause a fatal cardiac event especially in someone whose blood vessels are narrowed due to coronary artery disease. While the Pfizer vaccine should not contain naked mRNA (because the mRNA is coated in lipid nanoparticles) it would be difficult to rule out the accidental presence of naked mRNA in the vaccine – or in the bloodstream after injection.

The following article discusses SARS-CoV-2 infection and vaccines with respect to potential thromboembolic complications: https://childrenshealthdefense.org/defender/moderna-pfizer-vaccines-blood-clots-inflammation-brain-heart/.

3. Rodent studies conducted using Pfizer’s Covid vaccine candidate suggest other possible mechanisms by which the vaccine may cause thrombosis. According to the UK “Public Assessment Report” rat studies showed that the rats vaccinated with Pfizer’s Covid vaccine candidate had elevated fibrinogen “on day 17 (up to 2.49x) compared to controls, consistent with an acute phase response.”  (Fibrinogen (also known as Factor 1) is a glycoprotein complex made in the liver which circulates in the blood and is converted to fibrin and participate in blood clotting in the event of tissue or vascular injury.)

The rats in the study were vaccinated on Day 1, Day 8 and Day 15 and received a 30 microgram dose of the mRNA as an intramuscular injection so they received a more intensive and higher dose vaccination schedule than people in the clinical trials. Some types of white blood cells, notably neutrophils were elevated. Neutrophils “were up to 6.80x controls), monocytes (up to 3.30x controls), and large unstained cells, LUC, (up to 13.2x controls)”.  White blood cells were higher on day 17 as compared with day 4. (Pages 19-20)

Neutrophils can produce neutrophil extracellular traps (NETs) which have been described as “sticky, pathogen-trapping webs”. (See  https://www.news-medical.net/news/20200629/Overactive-neutrophils-may-drive-life-threatening-blood-clots-in-some-COVID-19-patients.aspx ) If some people who are vaccinated with COMIRNATY develop blood parameter abnormalities that are similar to those of the vaccinated rats, namely, increased neutrophils and increased fibrinogen, this could raise the risk of their developing blood clots. 

Unfortunately, very limited information is publicly available about possible changes to blood test parameters in humans after vaccination with COMIRNATY as routine blood testing was not done in most study volunteers.  (The “Public Assessment Report” [12] states that “Routine laboratory testing of haematology and clinical chemistry parameters was only conducted for Study BNT162-01 and Phase 1 of study c4591001”. (Pages 43-44))  

What is acknowledged in the “Public Assessment Report” (but omitted from the NZ datasheet on Medsafe’s website) is a transient increase in CRP and transient decrease in lymphocytes in human volunteers:

“Transient increases in C-reactive protein [CRP] and transient decreases in lymphocyte count were observed in a dose dependant [sic] manner”. (Page 43-44)  [12]

It was not stated whether there was any change in neutrophil numbers or whether the decrease in lymphocytes had any significant impact on the neutrophil to lymphocyte ratio (NLR).  Like increased CRP, an increased NLR has been found to be a marker of inflammation. https://clinical-experimental-nephrology.imedpub.com/neutrophils-to-lymphocytes-ratio-is-an-easy-non-expensive-marker-of-inflammation-in-hemodialysis-patients.php?aid=23886#3

4. A cardiothoracic surgeon has written to the FDA advising that people who have recently recovered from Covid-19 or who may be asymptomatic carriers may have an increased risk of vascular complications following vaccination.

https://noorchashm.medium.com/a-letter-of-warning-to-fda-and-pfizer-on-the-immunological-danger-of-covid-19-vaccination-in-the-7d17d037982d

  • As noted in this article, adverse cardiac events after vaccination with COMIRNATY do not seem to be limited to middle aged or elderly people (who may have previously diagnosed or unsuspected cardiovascular disease).   An Israeli teenager was recently reported to have developed chest pain, an accelerated pulse and shortness of breath and was diagnosed as having myocarditis (inflammation of the heart muscle).  A news report dated on February 1, 2021 stated that the previously healthy young man (aged 19) was admitted to the Intensive Care unit of Assaf Hospital.  He was hospitalised five days after his second dose of the Pfizer vaccine.

https://www.israelnationalnews.com/News/News.aspx/296028

This may be the second such case of myocarditis in an Israeli teenager who has received the Pfizer vaccine as it was reported on January 24, 2021 that a 17 year old boy had been admitted to  the ICU department of Safra Children’s Hospital after feeling intense pains in his chest a few days after receiving the second dose of the coronavirus vaccine”. 

https://www.jpost.com/breaking-news/17-year-old-in-icu-after-receiving-second-coronavirus-dose-656527

In relation to these cases, it is worth noting that myocarditis can have an autoimmune aetiology and is a serious condition that may lead to cardiomyopathy and subsequent heart failure. https://pubmed.ncbi.nlm.nih.gov/19357408/

Further notes relating to vaccination and pregnancy and breastfeeding women

One possible reason for the different advice to UK and NZ health professionals is that the document for British health professionals (“REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS”) states that animal fertility studies have not been completed. 

By contrast, the NZ datasheet states that there has been a study of rats administered four doses of the vaccine over the period of 21 days before mating and up until 20 days of gestation.  The datasheet states that the rats were followed up until their offspring were 21 days old.  Antibodies were present in both the mother rats, the rat foetuses and the baby rats.  In relation to this research, the datasheet includes this curiously worded sentence: “There were no vaccine related effects on female fertility and pregnancy rate.” [Emphasis added.]  

In terms of the antibodies in the rat foetuses, no information is given that allows any conclusions to be drawn about whether the synthetic mRNA in COMIRNATY passed through the placenta and into the foetal rats, causing the rat foetuses to generate an antibody response themselves – or whether antibodies generated in the mother were transferred across the placenta to the foetuses.*

The datasheet further states: “Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal development, parturition or post-natal development.”

There is no study number cited with the brief description of these animal studies in the NZ datasheet so it appears that the animal fertility studies may have been purely in-house research that has not been peer reviewed. 

Also, nowhere in datasheet is it described what criteria were used to determine whether or not any adverse outcomes experienced by any mother or any baby rats were related to the vaccine.

The datasheet also omits any discussion of whether the vaccine was tested on male rats to see if their fertility was affected.

In relation to the very superficial reporting on these apparently non peer reviewed animal studies it is worth noting the concerns of Michael Yeadon, PhD, a former Pfizer scientist who, with German medical doctor, Dr. Wodarg, wrote to the European Medicines Agency in December 2020 and warned that animal studies were crucial to rule out possible adverse impacts on fertility.  

The basis for the concerns of Drs. Yeadon and Wodarg that Cpvid-19 vaccines could have adverse impacts on fertility is that a protein that is needed for successful development of the placenta in mammals (known as Syncytin-1) is present in “homologous form in the spike proteins of SARS viruses”.  According to the petition of Drs. Yeadon and Wodarg, if antibodies against the spike proteins from SARS viruses were also to act like anti-Syncytin-1 antibodies “this would then also prevent the formation of a placenta which would result in vaccinated women essentially becoming infertile”.  An article outlining the concerns of Drs. Yeadon and Wodarg may be read at this link: https://www.globalresearch.ca/dr-wodarg-dr-yeadon-request-stop-all-corona-vaccination-studies-call-co-signing-petition/5731458

A PDF of Drs. Yeadon and Wodarg petition to the European Medicines Agency (which also included its authors’ concerns that the vaccine could cause severe allergic reactions due to PEG being included in its formulation – concerns which have been found to be accurate) may be downloaded from the link below:

Dr-Yeadon-and-Dr-Wodarg-petition-to-Europeans-Medicines-Agency-Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_ExhibitsDownload

In relation to whether there may be any male fertility concerns in relation to vaccination with the Covid-19 vaccines, a study to evaluate possible effects on the fertility (sperm concentration and motility) of vaccinated men began in mid-December 2020. This study is not expected to be completed until June 2021. See: https://www.clinicaltrials.gov/ct2/show/NCT04665258)

(It is not clear from the information above whether the study will examine only the Pfizer/BioNTech mRNA vaccine or whether men vaccinated with the Moderna mRNA vaccine will also be recruited for the trial.)

*In regards to the lack of information as to whether or not the synthetic mRNA passes across the placenta, the following article by a writer who has a PhD in molecular biology is worth reading since it suggests possible mechanisms by which synthetic mRNA from Covid-19 vaccines may potentially become integrated into a vaccine recipient’s nuclear DNA. https://sciencewithdrdoug.com/2020/11/27/will-an-rna-vaccine-permanently-alter-my-dna/ This follow up article is also well worth reading: https://sciencewithdrdoug.com/2021/02/15/breaking-study-sheds-more-light-on-whether-an-rna-vaccine-can-permanently-alter-dna/

If the synthetic mRNA from the Pfizer/BioNTech vaccine (or any other mRNA vaccine, for that matter) can pass through the placenta, into an embryo/foetus and interact with the nuclear DNA in the developing embryo/foetus, receiving such a vaccine in pregnancy could be considered to be a form of pre-natal genetic engineering.

Ed note: Since this article was written, an article on specifically about Covid vaccination and pregnancy has been posted on our website and you can read it at the link below: https://therealnews.nz/2021/02/28/are-covid-10-vaccines-safe-for-pregnant-women/