Recombinant nine-valent human papillomavirus(6/11/16/18/31/33/45/52/58)vaccine(Beijing Health Guard Biotechnology)

Vaccines stimulate a person's immune system to produce an adequate reaction against a specific infectious agent; i.e. the person is protected from that disease without having to get it first. As vaccines are administrated to healthy subjects, they are held to the highest standards of safety. Regarding human papillomavirus (HPV) vaccines, at present three prophylactic vaccines are licensed (bivalent HPV 16/18, quadrivalent HPV 6/11/16/18 and the nonovalent HPV 6/11/16/18/31/33/45/52/58 vaccine). Pre- and post-licensure studies (i.e. not yet for nonovalent HPV vaccine) confirm that HPV vaccines are generally safe and well-tolerated, site injections symptoms are the most common adverse events (AEs) reported, and pain is the most frequently referred local symptom. Serious AEs are rare and not associated with severe sequelae, at least no vaccine-related deaths have occurred. Despite these scientific evidences, it is still difficult to explain to the population the importance of a good vaccination programme. There are many determinants for HPV vaccines hesitancy which represent a barrier that must be overcome in order to increase vaccine coverage, including psychological reactions, religious or cultural aspects, and fear of possible AEs (demyelinating diseases, Complex Regional Pain Syndrome - CRPS, or Postural Orthostatic Tachycardia Syndrome - POTS). A weak communication strategy which frequently suffers due to spread of unverified news by media and websites may lead to the failure of a vaccination programme. Such a situation happened in Japan (2013), due to which a great number of women remain vulnerable to HPV-related cancers. In order to resolve the issues around HPV vaccines acceptance, it is necessary to use good communication strategies. Multicomponent and dialogue-based interventions seem to be the most effective, especially if an adequate language is used, customized according to the vaccination programme target.

Since 2006, three vaccines against infections and disease caused by human papillomavirus (HPV) became available in Europe-in 2006 a quadrivalent HPV 6/11/16/18 vaccine, in 2007 a bivalent HPV 16/18 vaccine and in 2015 a nonavalent HPV 6/11/16/18/31/33/45/52/58 vaccine. HPV 16 and 18 are the most oncogenic HPV strains, causing about 70% of cervical and other HPV-related cancers, HPV 6 and 11 cause 85% of all genital warts. The additional types of the polyvalent vaccine account for about 20% of invasive cervical cancer and >35% of pre-cancer. The potential differences between these vaccines caused some debate. All three vaccines give a robust and long-lasting protection against the strains in the various vaccines. The promise of cross-protection against other types (i.e. HPV 31/33/45) and hence a broader cancer protection was not fulfilled because these observations were confounded by the vaccine efficacy against the vaccine types. Furthermore, cross-protection was not consistent over various studies, not durable and not consistently seen in the real world experience. The protection against disease caused by oncogenic HPV strains was not compromised by the protection against low-risk types causing genital warts. The most effective cancer protection to date can be expected by the nonavalent vaccine, data indicate a 97% efficacy against cervical and vulvovaginal pre-cancer caused by these nine HPV types.