H5N8 Bird Flu vaccine shipping to EU: up to 40 million doses of an untested vaccine designed for a disease that does not exist
The regulators really are criminals. Read their own marketing authorization.
SUMMARY OF PRODUCT CHARACTERISTICS (I cut and pasted from the label below except where I use my name)
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
A/Astrakhan/3212/2020 (H5N8)-like strain (CBER-RG8A) (clade 2.3.4.4b) 7.5 micrograms** per 0.5 ml dose
* propagated in fertilised hens’ eggs from healthy chicken flocks
** expressed in micrograms haemagglutinin (HA).
Adjuvant MF59C.1 containing per 0.5 ml dose: [can cause autoimmunity—Nass]
squalene (9.75 mg), polysorbate 80 (1.175 mg), sorbitan trioleate (1.175 mg), sodium citrate (0.66 mg) and citric acid (0.04 mg).
Zoonotic Influenza Vaccine Seqirus may contain trace residues of egg and chicken proteins, ovalbumin, kanamycin, neomycin sulphate, formaldehyde, hydrocortisone and cetyltrimethylammonium bromide which are used during the manufacturing process (see section 4.3).
For the full list of excipients see section 6.1.
Interchangeability
No data to support interchangeability of Zoonotic Influenza Vaccine Seqirus H5N8 with other H5 monovalent vaccines are available. [In other words, we have no clue how this works against the current bird flu strain H5N1—Nass]
Duration of protection
The duration of protection following the primary vaccination schedule is unknown. [Protection? We never established protection—Nass]
Limitations of vaccine effectiveness
There is no immune correlate of protection established for influenza A caused by H5 subtypes. Based on humoral immune responses to Zoonotic Influenza Vaccine H5N1, after two doses a protective immune response may not be elicited in all vaccinees. [We have no idea if it works, but the same people who bring you the COVID vaccines think it would be a very good idea for you to receive this.—Nass]
Cross-reactive immunity
There are no clinical cross reactivity data with the Zoonotic Influenza Vaccine Seqirus H5N8. The degree of immune response that may be elicited to influenza A(H5) viruses of subtypes or clades different to that of the vaccine strain Zoonotic Influenza Vaccine Seqirus H5N8, is unknown (see section 5.1 Information from nonclinical studies) [We have no idea what we are doing—Nass]
4.6 Fertility, pregnancy and lactation
Pregnancy
No data are available regarding the use of Zoonotic Influenza Vaccine Seqirus H5N8 during pregnancy.
Limited data were obtained from women who became pregnant during the course of clinical trials with Zoonotic Influenza Vaccine H5N1 or similar pandemic H1N1 vaccines adjuvanted with MF59C.1. [Aha! So they do have an H5N1 vaccine… but they are not using it… instead using a much worse match to the current circulating H5N1 bird flu. What problems did they encounter with the H5N1 vaccine??? Later the label describes how over 4,000 people received the H5N1 prototype, but the EU chose to buy the untested vaccine—Nass]
Fertility
There are no data concerning human fertility Zoonotic Influenza Vaccine Seqirus H5N8. A study in rabbits did not indicate reproductive or developmental toxicity of Zoonotic Influenza Vaccine H5N1 (see section 5.3).
4.7 Effects on ability to drive and use machines
Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or operate machinery. [A dangerous vaccine for a disease that does not exist. What did I tell you?—Nass]
4.8 Undesirable effects
Summary of the safety profile
No clinical data exist with Zoonotic Influenza Vaccine Seqirus A/Astrakhan/3212/2020 (H5N8)-like strain (CBER-RG8A) (clade 2.3.4.4b). [No clinical data means: We have not tested it in humans. Who will be stupid enough to take it?—Nass]
Clinical efficacy
No clinical data exist with Zoonotic Influenza Vaccine Seqirus A/Astrakhan/3212/2020 (H5N8)-like strain (CBER-RG8A) (clade 2.3.4.4b).
5.3 Preclinical safety data
No preclinical safety data are available with Zoonotic Influenza Vaccine Seqirus H5N8
Information for the user starts on page 26 and at best it would be called misleading. It says “ask your doctor or nurse” about various things—however the information provided to doctors and nurses, which I excerpted from above, fails to answer the questions.
Below I include the regulators’ risk management plan. It explains how the regulators will avoid risk to themselves for authorizing this product. They have 2 strategies:
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disclose possible side effects (purely through guesswork since they product has apparently never been given to humans or they would have clinical data) in the label
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fail to make any special efforts to collect data regarding any of these specific, named, feared side effects.
Beware the “health care system” as it has become the disease-inducing system. I wish I could say the inmates were running the asylum. But it has become worse than that.