Cervarix is ​​a non-infectious adjuvanted recombinant vaccine prepared from virus-like particles (VLPs) of the major L1 capsid protein of the oncogenic HPV types 16 and 18 and developed to protect against diseases caused by human papillomavirus infection [Types 16, 18] from the age of 9.

Dosage declared by the manufacturer

Ages 9 to 14 including two doses with the second dose given between 5 and 13 months after the first dose.
From 15 years and over three doses, each at 0, 1, 6 months.

Italian National Vaccination Prevention Plan (PNPV).

Two or three doses according to age (two doses up to fourteen years, three doses over fifteen years of age).

Reported adverse events

• Upper respiratory tract infection
• Headache
• Dizziness
• Gastrointestinal symptoms including nausea, vomiting, diarrhea and abdominal pain
• Itching, rash, urticaria
• Myalgia
• Arthralgia
• Injection site reactions, including pain, redness, swelling, fatigue
• Fever (≥38°C)
• Lymphadenopathy
• Allergic reactions (including reactions anaphylactic and anaphylactoid), angioedema
• Syncope or vasovagal responses to injection, sometimes associated with tonic-clonic movements

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Declared qualitative composition

1. Human Papillomavirus1 type 1 L16 protein
2. Papillomavirus L1 protein1 human type 18
3. adjuvant AS04
   
   1. 3-O-desacyl-4'-monophosphoryl lipid A (MPL)
   2. aluminum hydroxide, hydrate (Al(OH) 3)
4. L1 protein in the form of non-infectious virus-like particles (VLPs) produced by technology of recombinant DNA using a Baculovirus expression system using Hi-5 Rix cells 4446 derived from Trichoplusia ni.
5. Sodium chloride (NaCl)
6. Sodium dihydrogen phosphate dihydrate (NaH₂ PO4.2H₂ O)
7. Water for injections

Curiosity

Cervarix received US Food and Drug Administration (FDA) approval in October 2009 and contained a new adjuvant called AS04, composed of a lipid (MPL) and aluminum, which had not previously been used in vaccines licensed in the United States. In preclinical studies, the safety of Cervarix was evaluated by comparing it to a licensed vaccine assumed to be safe, hepatitis A vaccine, which contained up to 500 mcg aluminum hydroxide (AL(0H)3).

Serious adverse reactions following HPV vaccination continued to be reported in the United States and abroad. In June 2013, the Japanese government withdrew its support for HPV vaccination, citing safety concerns related to the high number of serious adverse reactions reported following vaccination. Three years later, in July 2016, Japanese victims of the HPV vaccination filed a class action lawsuit against the Japanese government, Merck, the maker of Gardasil, and GlaxoSmithKline, the maker of Cervarix, for damages related to the numerous health problems suffered after vaccination.

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Gardasil 9 is a vaccine 9-valrecombinant you adjuvant nnot infecting indicated for children and adolescents from 9 years of age and for adults. Vaccination with Gardasil 9 is indicated for protection against diseases caused by the 9 types of Human Papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58.

Dosage declared by the manufacturer

Individuals 9 to 14 years of age (inclusive) with two doses. The second dose can be given between 5 and 13 months after the first and if the second dose of vaccine is given earlier than 5 months after the first dose, a third dose should always be given.

Individuals 15 years of age and older at the time of the first injection, Gardasil 9 can be administered according to a 3-dose vaccination schedule.

Italian National Vaccination Prevention Plan (PNPV).

Two or three doses according to age (two doses up to fourteen years, three doses over fifteen years of age).

Reported adverse events

• Lymphadenopathy
• immune system disorders,
• hypersensitivity,
• anaphylactic reactions,
• pathologies of the nervous system,
• Headache, dizziness,
• Syncope sometimes accompanied by tonic-clonic movements,
• gastrointestinal pathologies,
• nausea, vomiting
• pathologies of the skin and subcutaneous tissue, urticaria,
• pathologies of the musculoskeletal system and connective tissue
• arthralgia
• myalgia
• general disorders and injection site conditions, pain, swelling, itching, injection site erythema,
• pyrexia, fatigue, bruising, asthenia, chills and malaise,
• cellulitis at the injection site
• idiopathic thrombocytopenic purpura
• immune system disorders
• anaphylactoid reactions
• bronchospasm
• acute disseminated encephalomyelitis
• Guillain-Barré syndrome.

There are no data on the effects of Gardasil 9 on human fertility.

Insights on "Can the human papillomavirus (HPV) vaccine cause injury and death?"

Declared qualitative composition

1. Human papillomavirus type 1 L6 protein
2. Human papillomavirus type 1 L11 protein
3. Human papillomavirus type 1 L16 protein
4. Human papillomavirus type 1 L18 protein
5. Human papillomavirus type 1 L31 protein
6. Human papillomavirus type 1 L33 protein
7. Human papillomavirus type 1 L45 protein
8. Human papillomavirus type 1 L52 protein
9. Human papillomavirus type 1 L58 protein
10. L1 protein in the form of virus-like particles produced by yeast cells (saccharomyces
    cerevisiae CANAD 3C -5 (Strain 1895)) by recombinant DNA technology.
11. Amorphous aluminum hydroxyphosphate sulphate adjuvant
12. Sodium chloride
    
13. Histidine
    
14. Polysorbate 80
    
15. Borax
    
16. Ackua for injections

Curiosity

Most of the pre-approval clinical trials compared Gardasil 9 to Merck's original Gardasil vaccine. In pre-clearance studies of the original Gardasil vaccine, Merck obtained FDA approval to use amorphous aluminum hydroxyphosphate sulfate (AAHS), an aluminum adjuvant, in place of a saline placebo, as a control for nearly all study participants. A responsive placebo, such as AAHS, has the ability to artificially enhance the appearance of safety when used as a control in a clinical study, and neither the FDA nor Merck have disclosed the amount of aluminum contained in the placebo. Human and animal studies have shown that aluminum can penetrate the brain, and aluminum adjuvants in vaccines can cause nerve cell death, as well as inflammation at the injection site leading to chronic muscle and joint pain and fatigue .

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