The French Masala: Have you read the Product Information documents of the Covid-19 vaccines?

1. Introduction

The Vaccines against the Covid-19 virus are available and administered in Europe and all over the world since more than a year now. In keeping with its desire for utmost transparency (most of the information is available in 24 European languages), the European Medical Agency (EMA) has done a commendable job in availing all Covid-19 vaccines related information on its website. For all the authorized Covid-19 vaccines (Pfizer, Moderna, Astra Zeneca, Janssen and Novavax), it offers vital information such as authorization details, product information, assessment history, regular safety updates and a FAQ (Frequently Asked Questions) section. This exhaustive information should be critical and vital not just for the medical experts and the European Union member state governments but importantly also for the common population, vaccinated or not, in order to make informed/judicious choices. Since one can safely assume that most of the European population is educated, rational and responsible, it is certain that they already have had access to this information through this website, through their national governments and/or the media. And yet, I would like to invite you to have a quick look at some of the details regarding these vaccines, referenced from the European Medical Agency (EMA) website.

Here is the link to the Covid-19 vaccines section of the EMA website [1].

1.1 COVID-19 vaccines in European Union

1.1.1. Currently under rolling review

Sputnik V, Gam-COVID-Vac (Gamaleya Institute), COVID-19 Vaccine (Vero Cell) Inactivated (Sinovac), Vidprevtyn (Sanofi Pasteur), VLA2001 (Valneva)

1.1.2 Marketing authorization application submitted

No applications currently under evaluation.

1.1.3 Authorised for use in the European Union

2. Comirnaty (Pfizer)

2.1 Product information

Comirnaty is a vaccine that was authorised in the EU on 21 December 2020 to prevent COVID-19 when infected with the coronavirus SARS-CoV2. The referenced product information document [2] was first published on 12/01/2021 and was last updated on 20/01/2022.

In order to confirm the efficacy and safety of Comirnaty, the marketing authorisation holder (Pfizer) should submit the final Clinical Study Report for the randomized, placebo-controlled, observer-blind study C4591007 by July 2024.

2.2 FAQs (Frequently Asked Questions)

2.2.1 How does Comirnaty work?

Comirnaty works by preparing the body to defend itself against COVID-19. It contains a molecule called mRNA which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells [3].

When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.

If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it.

The mRNA from the vaccine does not stay in the body but is broken down shortly after vaccination.

Unlike what is claimed above, several reports have now made it clear that the vaccinated people could not defend themselves from getting infected by the Delta, Omicron and other variants [4] [5] [6] [7].

2.2.2 Can Comirnaty reduce transmission of the virus from one person to another?

The impact of vaccination with Comirnaty on the spread of the SARS-CoV-2 virus in the community is not yet known [3]. It is not yet known how much vaccinated people may still be able to carry and spread the virus.

However, the French Health Minister, Olivier Véran, in a declaration on 14^th January 2021, claimed that there are “good reasons to hope” that the vaccine prohibits transmission of the virus [8]. Further, on Wednesday 28^th July 2021, the Education Minister Jean-Michel Blanquer declared on FranceInfo that those who are vaccinated do not transmit the virus to others [9]! In contrast, until this date, the product notice of Pfizer does not make any such claims.

2.2.3 Can people who have already had COVID-19 be vaccinated with Comirnaty?

There were not enough data from the trial to conclude on how well Comirnaty works for people who have already had COVID-19 [3].

And yet, the Direction Générale de la Santé (DGS) in France, on 12^th January 2022 declared that the booster dose is required for all those who are 18 years and above and who already had their 2 vaccine doses [10]. So, in essence, it makes no difference for the booster dose if one had or not the Covid-19 infection after the two doses. It is intriguing to notice why Pfizer remains elusive on this subject in their product notice while authorities such as DGS give assurances and guidelines on BigPharma’s behalf.

2.2.4 Conditional marketing authorisation

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future [3].

As Comirnaty received a conditional marketing authorisation, the company that markets Comirnaty will continue to provide results from the main trial in adults, which is ongoing for 2 years, as well as from the trials in children. This trial and additional studies will provide information on how long the protection lasts, how well the vaccine prevents severe COVID-19, how well it protects immunocompromised people, pregnant women, and whether it prevents asymptomatic cases.

Comirnaty has been granted a conditional marketing authorisation. This means that there is more evidence to come about the vaccine, which the company is required to provide. The Agency will review any new information that becomes available and this overview will be updated as necessary.

In addition, independent studies of COVID-19 vaccines coordinated by EU authorities will also give more information on the vaccine’s long-term safety and benefit in the general population.

The company will also carry out studies to provide additional assurance on the pharmaceutical quality of the vaccine as the manufacturing continues to be scaled up.

2.3 Missing information/data/trials

2.3.1 Interchangeability

The interchangeability of Comirnaty with COVID-19 vaccines from other manufacturers to complete the primary vaccination course or the booster dose (third dose) has not been established.

Further, the concomitant administration of Comirnaty with other vaccines has not been studied.

Strangely, ignoring this vital detail regarding the interchangeability of the Covid-19 vaccines, for the booster dose, the “Conseil d’Orientation de la Stratégie Vaccinale” and the “Haute Autorité de Santé (HAS)” gave an unequivocal go [11] [12] [13] [14].
Further, the French government recommended that it would be possible to take both the annual vaccine against the Flu as well as the vaccine against Covid-19 on the same day [15] [16] [17]!

2.3.2 Interaction with other medicinal products and other forms of interactions

No interaction studies have been performed.

Yet the French government’s consistent official position has been to vaccinate on priority aged people or those with comorbidity [18] [19]. And it is the aged, or the vulnerable population that is usually taking at least some medication to respond to their comorbidities.

2.3.3 Fertility, pregnancy and lactation Pregnancy

2.3.3.1 Fertility

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Knowing that the study of the fertility of a species is conducted over several generations, it is obvious that the data will not be available anytime soon; and that it is therefore very risky to embark on mass vaccination.

2.3.3.2 Pregnancy

There is limited experience with use of Comirnaty in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. Administration of Comirnaty in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.

Consider now the much hyped and televised vaccination on 27^th July 2021 by the French Health Minister, Olivier Véran of his pregnant colleague, Olivia Grégoire, secretary of State at Bercy [20]. The justifications cited by them behind their decision were that there was no link between vaccination and the miscarriage. Also that the “recommendations” of prudence had evolved and that it was safe to vaccinate pregnant women, irrespective of the duration of pregnancy and finally, the fact that hundreds of pregnant women in certain countries were vaccinated.

Strangely, none of these assurances or clarifications appears (until this date) in the product information notice of Pfizer. Thus, was this a media hyped and a deliberate exercise meant to mislead the French population?

2.3.3.3 Breast-feeding

It is unknown whether Comirnaty is excreted in human milk.

Meanwhile, several emerging studies alleviated any apprehensions of vaccine side effects on breast feeding mothers and their babies [21] [22] [23] [24] and tried to reassure the citizens. It is however quite surprising that Pfizer is (till this date) unable to give any assurance through clinical tests of its own product to Food and Drug Administration (FDA) / European Medical Agency (EMA) but parallel medical institutes confirm its safety and that it is accepted as a proof by the governments to promote vaccination!

2.3.4 Duration of protection

The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. It is recommended to receive the second dose of the same vaccine 3 weeks after the first dose to complete the vaccination course. A booster dose (third dose) of Comirnaty may be administered intramuscularly at least 6 months after the second dose in individuals 18 years of age and older. The decision when and for whom to implement a third dose of Comirnaty should be made based on available vaccine effectiveness data, taking into account limited safety data. If you are immunocompromised, you may receive a third dose of Comirnaty at least 28 days after the second dose.

2.4 Side Effects

Hypersensitivity and anaphylaxis

Events of anaphylaxis (Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death) have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.

Myocarditis and pericarditis

There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty : myocarditis is an inflammation of the heart muscle (myocardium) that can reduce the heart's ability to pump and cause rapid or irregular heart rhythms (arrhythmias); and the pericarditis is the swelling and irritation of the thin, saclike tissue surrounding the heart (pericardium) that often causes sharp chest pain and sometimes other symptoms. These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males. The risk of myocarditis after a third dose of Comirnaty has not yet been characterised.

Anxiety-related reactions

Anxiety-related reactions, including vasovagal (syncope) reactions (Vasovagal syncope occurs when you faint because your body overreacts to certain triggers, such as the sight of blood or extreme emotional distress causing your heart rate and blood pressure to drop suddenly.), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, tingling sensations and sweating) may occur in association with the vaccination process itself.

Thrombocytopenia and coagulation disorders

As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia (Thrombocytopenia is a condition in which you have a low blood platelet count. Platelets stop bleeding by clumping and forming plugs in blood vessel injuries.) or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

2.5 Deaths

As of 2 January 2022, EudraVigilance contained:

- for Comirnaty: a total of 522,530 cases of suspected side effects spontaneously reported from EU/EEA countries; 6,490 of these reported a fatal outcome (by the same date about 545 million doses of Comirnaty had been given to people in the EU/EEA) [25].

In spite of officially recognizing Covid-19 vaccine inflicted 6,490 casualties by 2 January 2022, the EMA so innocently tries to exonerate the Covid-19 vaccines by diverting attention to health problems not related to the vaccination! This is both highly inconsistent and shocking since there are numerous (self-admitted by the vaccine companies) loopholes and deficiencies in these Covid-19 vaccines.

3. Vaxzevria (Astra Zeneca)

3.1 Product information

Vaxzevria has been given ‘conditional authorisation’ valid throughout the EU on 29 January 2021. The product information document was first published on 18/02/2021 and was last updated on 18/01/2022 [26].

In order to ensure that all reported thrombotic events with thrombocytopenia and/or bleeding events are investigated by performing an in-depth exploration of platelet function in the interventional study in immunocompromised subjects, the Marketing Authorisation Holder (MAH) should submit the clinical study report, in accordance with a revised and agreed study protocol by 30 November 2023.

In order to confirm the efficacy and safety of Vaxzevria in the elderly and subjects with underlying disease, the MAH should submit the overview and summaries of the final clinical study report for study D8110C00001 by 31 March 2024.

3.2 FAQs (Frequently Asked Questions)

3.2.1 How does Vaxzevria work?

This product contains genetically modified organisms (GMOs).

Vaxzevria works by preparing the body to defend itself against COVID-19. It is made up of another virus (adenovirus) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells [27].

Once it has been given, the vaccine delivers the SARS-CoV-2 gene into cells in the body. The cells will use the gene to produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.

If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it.

The adenovirus in the vaccine cannot reproduce and does not cause disease.

3.2.2 Can Vaxzevria reduce transmission of the virus from one person to another?

The impact of vaccination with Vaxzevria on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known how much vaccinated people may still be able to carry and spread the virus [27].

3.2.3 Can people who have already had COVID-19 be vaccinated with Vaxzevria?

There were no additional side effects in the 345 people who received Vaxzevria in the trial and had previously had COVID-19.

There were not enough data from the trial to conclude on how well Vaxzevria works for people who have already had COVID-19 [27].

3.2.4 Conditional marketing authorization

Vaxzevria received a conditional marketing authorisation valid throughout the EU on 29 January 2021.

3.3 Missing information/data/trials

3.3.1 Interchangeability

There are no data available on the interchangeability of Vaxzevria with other COVID-19 vaccines to complete the vaccination course.

Concomitant administration of Vaxzevria with other vaccines has not been studied.

3.3.2 Interaction with other medicinal products and other forms of interactions

No interaction studies have been performed.

3.3.3 Fertility, pregnancy and lactation Pregnancy

3.3.3.1 Fertility

Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

3.3.3.2 Pregnancy

There is limited experience with use of Vaxzevria in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. Administration of Vaxzevria in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.

3.3.3.3 Breast-feeding

It is unknown whether Vaxzevria is excreted in human milk.

In animal studies, lactational transfer of anti-SARS-CoV-2 S antibodies from maternal female mice to pups was observed.

3.3.4 Duration of protection

The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.

3.4 Side Effects

Coagulation disorders

Thrombosis with thrombocytopenia syndrome
Cerebrovascular venous and sinus thrombosis
Thrombocytopenia

Capillary leak syndrome

Neurological events

Guillain-Barré syndrome (GBS) has been reported very rarely following vaccination with Vaxzevria.

3.5 Deaths

As of 2 January 2022, EudraVigilance contained:

- for Vaxzevria: a total of 231,363 cases of suspected side effects spontaneously reported from EU/EEA countries; 1,378 of these reported a fatal outcome (by the same date, about 69 million doses of Vaxzevria had been given to people in the EU/EEA) [25].

4. Conclusion

Similar information could be fetched from the EMA’s website [1] regarding the other authorized vaccines Spikevax (Moderna), COVID-19 Vaccine Janssen (Johnson & Johnson) and Nuvaxovid.

Here are some of the reasons to be doubtful about these Covid-19 vaccines: the inconsistencies/deficiencies in the available clinical results (self-admitted by these pharmaceutical companies through their product information documents), the unsubstantiated and yet initially advertised tall claims of vaccine efficiency (proven wrong now by the present Omicron outbreak of high Covid infections even among massively vaccinated populations), the reports of vaccine related side effects (both mild and serious) coming from all around the world (not to forget that Astra Zenca, Moderna and Johnson & Johnson vaccines were halted in many European Countries [28] [29] [30] [31] [32]), the aggressive pro-vaccine propaganda by the governments and the mainstream media, the ever restrictive and punishing measures employed by State governments against its non-vaccinated population, the incessant state sponsored vilification of non-vaccinated citizens, the introduction of vaccination for children in many countries, etc. And importantly, all this in the background of a disease that has a world infection fatality rate of just 1.4% [33] or a case fatality rate of a mere 1.26% [34] for the European Union.

A careful reading of these documents by medical experts or even by common citizens leaves us with more unanswered questions than any convincing answers. Science certainly does not teach us to merely “believe in science” and to desperately inject something in our bodies because we so much wish to go to a restaurant or to a museum (a non-medical reason, for that matter). Instead, what it teaches us is to be skeptical, prudent and reasonable.

Do you still think the dictate of vaccination by the executive is justified?