HPV - pakningsvedlegg
Fra og med høsten 2017 ble Cervarix tilbudt som HPV-vaksine i det norske barnevaksinasjonsprogrammet. Cervarix erstattet Gardasil, som hadde vært i bruk siden 2009.
Både Cervarix (GSK) og Gardasil (Merck) bruker aluminium i vaksinene.
CERVARIX (GSK):
Jeg anbefaler at pakningsvedleggene leses nøye. I studiene til Cervarix så ble kontrollgruppene gitt vaksinen Havrix (som inneholder aluminium) og aluminium (Al(OH)3).
Utdrag fra det amerikanske pakningsvedlegget til Cervarix (les nøye og forstå):
Punkt 6.1:
«The safety of CERVARIX was evaluated by pooling data from controlled and uncontrolled clinical trials involving 23,952 females 9 through 25 years of age in the pre-licensure clinical development program. In these studies, 13,024 females (9 through 25 years of age) received at least one dose of CERVARIX and 10,928 females received at least one dose of a control [Hepatitis A Vaccine containing 360 EL.U. (10 through 14 years of age), Hepatitis A Vaccine containing 720 EL.U. (15 through 25 years of age), or Al(OH)3 (500 mcg, 15 through 25 years of 72 age)]»
Punk 11:
«Each 0.5-mL dose is formulated to contain 20 mcg of HPV type 16 L1 protein, 20 mcg of HPV type 18 L1 protein, 50 mcg of the 307 3-O-desacyl-4’-monophosphoryl lipid A (MPL), and 0.5 mg of aluminum hydroxide.»
Punkt 13.1:
«CERVARIX has not been evaluated for its carcinogenic or mutagenic potential. Vaccination of 321 female rats with CERVARIX, at doses shown to be significantly immunogenic in the rat, had no 322 effect on fertility.»
GARDASIL (Merck) OG GARDASIL 9 (Merck):
Jeg anbefaler at pakningsvedleggene leses nøye. I studiene til Gardasil 9 så ble kontrollgruppene gitt vaksinen Gardasil. I studiene til Gardasil så ble kontrollgruppene gitt aluminiumsadjuvantet AAHS (500 mcg aluminium). Det var også en ekte kontrollgruppe i disse studiene, men den var veldig liten.
Utdrag fra det amerikanske pakningsvedlegget til Gardasil 9 (les nøye og forstå):
Punkt 6.1:
«The safety of GARDASIL 9 was evaluated in seven clinical studies that included 15,703 individuals who received at least one dose of GARDASIL 9 and had safety follow-up. Study 1 and Study 3 also included 7,378 individuals who received at least one dose of GARDASIL as a control and had safety follow-up.»
Punkt 11:
«Each 0.5-mL dose of the vaccine also contains approximately 500 mcg of aluminum (provided as AAHS), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodiumborate, <7 mcg yeast protein, and water for injection. «
Punkt 13.1:
«Gardasil 9 has not been evaluated for the potential to cause carcinogenicity, genotoxicity or impairment of male fertility. GARDASIL 9 administered to female rats had no effects on fertility [see Pregnancy (8.1)].»