Impfung
AfH_Logo_Komplett_CH.png

 What are the concerns of 

 Airliners for Humanity Switzerland? 

 
 

2008

BioNTech wurde von Prof. Dr. Ugur Sahin, Prof. Dr. Özlem Türeci und Prof. Dr. Christoph Huber gegründet, um Behandlungen für die individualisierte Krebsimmuntherapie zu entwickeln und herzustellen.

2020

Eröffnung der BioNTech Produktionsstätte in Marburg zur Herstellung des COVID-19-Impfstoffs. Das Werk entwickelte sich im Jahr 2021 zu einer der größten mRNA-Produktionsstätten.

2020

Beginn von “Projekt Lightspeed” zur raschen Entwicklung eines sicheren und wirksamen Impfstoffs zur Eindämmung der SARS-CoV-2-Pandemie. Der Pfizer-BioNTech COVID-19-Impfstoff ist der erste Impfstoff, der nach einer weltweiten Phase-3-Studie eine Notfallzulassung erhält

2020

"Im Jahr 2020 konnten wir unser Know-how im Bereich der mRNA-Technologie für die Entwicklung eines COVID-19-Impfstoffs nutzen – das erste für den Einsatz am Menschen (befristet) zugelassene mRNA-basierte Arzneimittel und der am schnellsten zugelassene Impfstoff gegen einen neuen Erreger in der Geschichte der Medizin"

2008
BioNTech was founded by Prof. Dr. Ugur Sahin, Prof. Dr. Özlem Türeci and Prof. Dr. Christoph Huber to develop and manufacture treatments for individualized cancer immunotherapy

2020
Opening of the BioNTech production facility in Marburg for the production of the COVID-19 vaccine. The plant developed into one of the largest mRNA production sites in 2021

2020
Launch of “Project Lightspeed” to rapidly develop a safe and effective vaccine to contain the SARS-CoV-2 pandemic. The Pfizer-BioNTech COVID-19 vaccine is thefirst vaccine to receive emergency use approval after a global phase 3 trialreceives

2020
"In 2020 we were able to leverage our expertise in mRNA technology to develop a COVID-19 vaccine -the first mRNA-based drug approved for human use (temporarily) and the fastest approved vaccine against a new pathogen in the history of medicine"

Remark:
BioNTech looked back on a company history of only 12 years with the production of their first "marketable" product. Comirnaty, resp. BNT162b2 was the first product ever to receive conditional approval and clinical trials are still ongoing.
BioNTech has focused its products on products in the field of oncology. More than 20 products are currently in the clinical phases for use in the treatment of cancer and tumors. Vaccines are also currently being developed for the treatment of HIV, herpes zoster and tuberculosis, among others.

Biontech 1.png
Biontech 2.png

Status of these documents: August 2022. The original files can be found atswissmedic.ch
orswissmedicinfo.ch  (enter "Comirnaty").

Arzneimittelinformation.png
Patienteninformation.png

Permit

Comirnaty istemporaryauthorized

 

excipients
ALC-0315, ALC-0159

Remark:
Both ingredients are novel and are being used for the first time in therapy to prevent respiratory disease. Not only the vaccine, but also the ingredients it contains are in a trial phase. According to product data sheets, these ingredients may only be used for research and are "not for human use". This fact has often been discussed, but to date no one has been able to prove that these ingredients have been properly tested and that they are approved for use on humans. If someone is in possession of such a confirmation of admission, please forward it to us so that we can present this fact correctly.

duration of protection

The duration of protection induced by the vaccine isnot known, since they're still inrunning clinical trialsis determined.

authorization purpose
"
The vaccine is forprevention of COVID-19,which is caused by the SARS-CoV-2 virus."
Note: Covid-19 cannot knowingly be prevented in the meantime.

duration of protection
"As with any vaccine, Comirnaty may not protect all vaccinated individuals and it is 
not known how long you are protected."

side effects

Very common (affects more than 1 in 10 people)

Pain and swelling at the injection site, redness at the injection site, tiredness, headache, muscle pain, joint pain, chills, increase in body temperature including fever, diarrhoea.
 

Common (affects 1 to 10 users in 100)

nausea, vomiting.
 

Rare (affects 1 to 10 users in 10,000)

Temporary, unilateral paralysis of the face, allergic reactions such as swelling of the face.
 

frequencynot known(canfrom the available datanot estimatedwill)

Severe allergic reactions [.........] Inflammation of the heart muscle (myocarditis) or inflammation of the sac around the heart (pericarditis) which can cause breathlessness, palpitations or chest pain. [...] swelling of the face. [...] Decreased feeling or sensitivity, particularly of the skin (hypoaesthesia).

Prevention of Covid-19 cannot be achieved. The duration of protection is not known. Certain side effects are very common and may often exceed the symptoms that would have been caused by Covid-19 in healthy, non-risk patients.

According to the manufacturer, an officially unknown risk has been published for consequences for heart functions. It cannot be estimated. What does this mean for the use of these substances, for example by pilots?

To make matters worse, BioNTech is still a young company without many years of experience in the market. The core business is the therapy of cancer and tumors, which, however, have not yet been approved for use.

The approval is still limited, the studies are still ongoing. Other vaccine variants will soon be used, which most likely will not have to undergo extensive clinical trials.

We consider the risk to be "unpredictable" and consequently this vaccine should no longer be used until the risk can be ruled out.

A notice:

Particular attention should be paid to people who have received primary immunization from an mRNA manufacturer another mRNA manufacturer switch. This change within the same technology with different providers takes place in the so-called off-label-use application. You can find out what the problem could be in the "Legal" section.

 

2010

Firmengründung moderna

2011

moderna beginnt mit der Forschung von mRNA Impfstoffen.

2020

Am 18. Dezember 2020 teilte die FDA mit, dass sie dem Impfstoff (Spikevax mRNA-1273) eine Notfallzulassung erteilt habe.

2022

Moderna erhält die Zulassung für den ersten bivalenten Impfstoff (Spikevax mRNA1273.214).Für diese erneut befristete Zulassung musste diese Impfstoffvariante musste keine umfassenden klinischen Studien Durchlaufen.

2010
Company foundation moderna

2011
moderna starts research into mRNA vaccines.

2020
On December 18, 2020, the FDA said it had granted emergency use authorization for the vaccine (Spikevax mRNA-1273).

Remark:
In the production of its first "marketable" product, moderna looked back on a company history of just 12 years. Spikevax, resp. mRNA-1273 was the first product ever to receive conditional approval and clinical trials are still ongoing.

modernapro.png

Status of these documents: August 2022. The original files can be found atswissmedic.ch
orswissmedicinfo.ch  (enter "Comirnaty").

Bivalent F.png

Bivalent

Bivalent P.png

Bivalent

Patienteninformationen M.png

Original

Arzneimittelinformationen M.png

Original

Permit
The approval for Spikevax istemporary.

excipients

Lipid nanoparticles SM-102Remark: This ingredient is novel and is being used for the first time in therapy to prevent respiratory disease. Not only the vaccine, but also the ingredient it contains is in a trial phase. According to product data sheets, this ingredient may only be used for research and is "not for human use". This fact has often been discussed, but to date no one has been able to prove that this ingredient has been properly tested and that it is approved for use in humans. If someone is in possession of such a confirmation of admission, please forward it to us so that we can present this fact correctly.


Purpose / Application
Spikevax is intended for active immunizationpreventioncaused by the SARS-CoV-2 virusCoronavirus 2019 disease(COVID-19) indicated in individuals from 6 years of age. The use of this vaccinemust be done according to the official recommendations.


booster vaccination
"The decision on when and to whom to give a booster (booster) dose of Spikevax should be based on the available data on vaccine efficacy, atConsideration of the 
limited security data.The assessment also includes the risk of severe unwanted Vaccination symptoms (UIE), especially myocarditis and pericarditis in people up to 40 years of age, wherebyumales appear to be predominantly affected. The risk-benefit ratio of a boosterVaccination with Spikevax to prevent symptomatic Covid-19 cases in people up to a Age up to 30 years is currently not proven."

myocarditis and pericarditis

Very rare cases of myocarditis and pericarditis have been observed after vaccination with Spikevax. These cases occurred mainly within 14 days after vaccination, more frequently after the second vaccination and more frequently in younger men. In astudy, in which167 Attendeesonebooster vaccination(booster, 0.25 ml, 50 μg of the 0.20 mg/ml dispersion) with Spikevax,were 2 cases of pericarditisobserved in temporal relation to the administration of the booster.
 

duration of protection

The duration of protection provided by the vaccine isunknown, since they're still inrunning clinical trialsis examined.
Note: Update of this statement: August 2022!

pregnancy

There wereno adequate and well-controlled studiesfor application ofSpikevax bei pregnant womencarried out.The available data on the use of Spikevax bei pregnant women are not sufficientto over the with theVaccine related risksduring pregnancy tooinform.

Note: Update of this statement: August 2022!

lactation

It isnot known if Spikevax is excreted in human milk. There are no data to assess the effect of Spikevax on the breastfed infant or on milk production or secretion. Therefore, the use of Spikevax in nursing mothers is not recommended.

Note: Update of this statement: August 2022!

 

Effect on the ability to drive and use machines

There wereno studiesto theeffectsfrom Spikevax to theability to driveand theAbility carried out to operate machines.Some of the in the «unwanted effects» mentioned effectscan drive abilityor the ability to operate machines influence.

Note: Update of this statement: August 2022!

authorization purpose
Spikevax is a vaccine forpreventionof COVID-19 caused by SARS-CoV-2.

Note: Covid-19 cannot knowingly be prevented in the meantime.

Driving and using machines

Do not drive or use machines if you feel unwell after the vaccination. Wait until the side effects of the vaccine have worn off before driving or using machines.



side effects

Let yourselfurgentlySeek medical attention if you notice any of the following signs and symptoms of an allergic reaction:

...

...

hives or rash

nausea / vomiting

...
 

Very common (may affect more than 1 in 10 people)

...

nausea

Vomit

Severe tiredness

...

Common (may affect up to 1 in 10 people)

...

rash or hivesat the injection site (some of which may appear about 9 to 11 days after the injection.
 

Uncommon (may affect up to 1 in 100 people)

...

dizziness

...
 

Frequency not known (cannot be estimated from the available data)

...

Inflammation of the heart muscle (myocarditis) or inflammation of the sac around the heart (pericarditis),

which can cause shortness of breath, palpitations or chest pain.

..

remark

This leaflet was last revised by the drug agency in August 2022

(Swissmedic) tested.

Prevention of Covid-19 cannot be achieved. The duration of protection is not known. Certain side effects are very common and may often exceed the symptoms that would have been caused by Covid-19 in healthy, non-risk patients.

According to the manufacturer, an officially unknown risk has been published for consequences for heart functions. It cannot be estimated. What does this mean for the use of these substances, for example by pilots?

To make matters worse, moderna is still a young company without many years of experience in the market. 

The approval is still temporary, the studies are still ongoing. Other vaccine variants will soon be used, which most likely will not have to undergo extensive clinical trials.

We consider the risk to be "unpredictable" and consequently this vaccine should no longer be used until the risk can be ruled out.

A notice:

Particular attention should be paid to people who switch from one mRNA manufacturer to another mRNA manufacturer after primary immunization. This change within the same technology with different providers takes place in the so-called off-label-use application. You can find out what the problem could be in the "Legal" section.

 

The company was founded in 1936 as Cilag Chemie by the chemist Bernhard Joos in Schaffhausen (Switzerland). In 1952 a German branch was established. In 1953, the chemist and physician Paul Janssen founded Janssen Pharmaceutica NV in Turnhout (Belgium). In the same year, the American healthcare group Johnson & Johnson took over Cilag Chemie. In 1961, Johnson & Johnson also acquired drugmaker Janssen.

Status of these documents: August 2022. The original files can be found atswissmedic.ch 
be downloaded.

Arzneimittelinformationen J.png
Patienteninformationen J.png

Permit

Vaccine Janssen istemporaryauthorized

indications

COVID-19 Vaccine Janssen is indicated for the active immunization of persons aged

18 years and older topreventionthose caused by SARS-CoV-2COVID-19 disease.

Duration of vaccination protection

theduration of protectionof the vaccine isnot yet known, since they are still in the frameongoing clinical studiesis examined.


List of undesirable effects

...

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000

up to <1/1'000); very rare (<1/10'000); not known (cannot be determined from the available data

be estimated).

diseases of the immune system

Rare: Hypersensitivitya,urticaria.

Not known: anaphylaxisb.
 

Diseases of the nervous system

Very common: Headache (38.9%).

Uncommon: tremor.
 

Respiratory, thoracic and mediastinal disorders

Frequently:Cough.

Uncommon: sneezing, oropharyngeal pain.
 

Diseases of the gastrointestinal tract

Very common: nausea (14.2%).
 

Diseases of the skin and subcutaneous tissue

Uncommon: Rash, hyperhidrosis.

Musculoskeletal, connective tissue and bone disorders

Very common: myalgia (33.2%).

Common: arthralgia.

Uncommon: Muscular weakness, pain in extremity, back pain.
 

General disorders and administration site conditions

Very common: fatigue (38.2%), injection site pain (48.6%).

Frequently:Fever, Injection site erythema, Injection site swelling, Chills.

Remark:
With all of these side effects experienced in previous studies, the question must be asked: Which event occurs more frequently in flight personnel: an illness from Covid-19 with severe symptoms that are more intense than with a conventional illness, or the consequences of one of the side effects listed in this listed frequency? We question the supposedly "positive" benefit-risk ratio in healthy people whose state of health is regularly checked and whose work requires the highest standards of physical fitness.

authorization purpose

COVID-19 Vaccine Janssen is a vaccine forProtection against COVID-19(Coronavirus Disease 2019), caused by the SARS-Coronavirus-2.
 

Frequency not known (cannot be estimated from the available data)

Severe allergic reaction, capillary leak syndrome (a condition in which fluid leaks from small

blood vessels), inflammation of the spinal cord.


Remark:

In addition to the well-known side effects, the topic of capillary leak syndrome was often discussed with the Janssen vaccine. Without wanting to assume an increased risk, this must also be able to be checked and ruled out in aviation. The same applies to the risk of thrombosis, which has also already been discussed in connection with the Janssen vaccines.

 

Even with the mRNA vaccines, many questions regarding the mode of action and the medium and long-term consequences are still unknown. Therefore, when using this technology, every risk must be evaluated and ruled out.

A notice:
Particular attention should be paid to people who switch from a vector vaccine to an mRNA vaccine after primary immunization. This change in vaccination technology takes place in the so-called off-label-use application. You can find out what the problem could be in the "Legal" section