Hepatitis B vaccination: safety issues (2003)

 

The scientifically proven benefits of vaccination in general and more specifically those of hepatitis B vaccination are overwhelming and outweigh by far any suggested risk. Currently, 168 countries have implemented universal infant and / or adolescent vaccination against hepatitis B, and there is no reason to change these policies based on fears of an alleged and unsubstantiated link with multiple sclerosis or other disorders.

 

1. The VHPB remains fully committed to the current recommendations for continued universal as well as risk-group hepatitis B vaccination programmes, and sees no evidence for establishing any links between the hepatitis B vaccine and certain diseases. Hepatitis B vaccine remains one of the safest and most effective vaccines. It protects people of all ages against hepatitis B virus infection and the wide spectrum of liver diseases that the infection can cause.

 

2. No hard scientific data support the existence of a causal link between hepatitis B vaccination and the development of multiple sclerosis (MS). There is also no evidence to support any biological plausibility of a link: molecular mimicry would need to be based on an homology between the hepatitis B surface antigen and the human myelin protein, and no such homology can be found. Any temporal association appears to be a coincidental one. WHO’s Global Advisory Committee on Vaccine Safety (GACVS), the Institute of Medicine (IOM), and the VHPB support this point of view.

 

3. The only evidence of potential adverse events that may result from administration of thiomersal-containing vaccines is a small risk of hypersensitivity, such as skin rash and swelling, at the injection site. There is no stringent reason, therefore, to stop the use of thiomersal-containing vaccines in current immunisation programmes, with the balance of benefits over risks of such vaccines being overwhelmingly positive.

 

4. No causality between the administration of aluminiumcontaining vaccines and general systemic complaints has been demonstrated. The general public needs to know and understand that although this type of histological muscle lesion is caused by vaccination, the lesions are not linked to the generalised clinical symptoms. This issue is relevant as a communications challenge having considerable potential for affecting public confidence in vaccination.

 

5. A hypothetical link between vaccination and acute lymphoblastic leukaemia (ALL) in children has been investigated in a number of studies. The results of the only study that suggested a link between hepatitis B vaccination and ALL, hypothetically attributed to thiomersal, were not convincing, based only on a small number of cases, and other thiomersal-containing vaccines not implicated. At this moment, there are no other scientific data supporting such an association and no need to change current immunisation recommendations.

 

6. There is currently enough evidence to conclude that people suffering from autoimmune diseases can be vaccinated.

 

7. Hepatitis B immunisation programmes: selected countries

 

France

As a consequence of France’s temporary suspension in 1998 of school-based adolescent hepatitis B immunisation programmes, following allegations of an association between the hepatitis B vaccine and multiple sclerosis, immunisation rates dropped dramatically, in infants as well as in adolescents. Although these safety allegations have since been refuted and communicated to the general public and medical practitioners, hepatitis B immunisation coverage has not yet recovered to its previous higher level. One measure that is expected to help increase hepatitis B immunisation in France is the use of hexavalent vaccines for infants. These new vaccines are recommended in France but are not yet on the market.

 

Germany

Vaccine safety issues in Germany are not of major concern to the general public or to health care practitioners. Universal infant and adolescent hepatitis B immunisation have been recommended in Germany since 1995, and there is now wide acceptance of infant hepatitis B vaccination with the recently licensed hexavalent vaccines. The high uptake of these new vaccines by paediatricians in Germany may be attributed, in part, to the fact that fewer injections and less office visits are required, and are regarded as major advantages among parents for their children’s immunisations.

 

Scotland

A pilot study in Glasgow demonstrated that through promotion of proactive and objective health education and vaccine-related materials, it is possible to achieve high uptake of hepatitis B vaccine in young adolescents, similar to uptake of other routine school immunisations. In the UnitedKingdom, the current policy (2003) of selective hepatitis B immunisation of risk groups, based on the low incidence of hepatitis B, is under review by the UK Joint Committee of Vaccination and Immunisation (JCVI).

 

Israel

The overall compliance rate for all vaccines in Israel’s infant immunisation schedule, including hepatitis B, is 95%. Adverse events following hepatitis B immunisation are rarely seen in Israel, and only one case of litigation concerning the hepatitis B vaccine has occurred in thirty years. The high uptake rates in Israel attest to its success in reducing vaccinepreventable diseases.

 

8. Changes in immunisation policy should be evidence-based. Rapid changes in vaccination recommendations, such as those based on vaccine ‘scares,’ should not be encouraged. All changes in vaccination recommendations should be accompanied by effective communication strategies. This communication must come from organisations that are recognised as a reliable source of information by medical practitioners.

 

9. A rapidly changing global environment has led to basic changes in perception of immunisation that require a reassessment of issues concerning:

• The divide between industrialised, transitional-economy, and developing countries, and their degree of access to vaccines, basic health care, and evidence-based information;
• The challenge of appropriate response by the scientific / health care, regulatory, and vaccine industry sectors to increasing demands by the general public for consistent, reliable, and readily understandable information relating to vaccine safety, quality, and efficacy, and to the vaccine preventable-disease itself;
• The need for better understanding and increased public awareness of the level of regulations and quality control for vaccines, in order to appreciate better the quality of the currently available vaccines and to make informed decisions.

 

10. Creating a positive environment for immunisation can be achieved by repositioning the value of vaccines and vaccination. This new environment will need to be supported by evidence-based information that will ease the task of health care decision-makers in developing proactive communication strategies to deal with crises that have the potential to have a negative impact on vaccine coverage, and on the consequent health status of children.

 

11. While the scientific community needs to deal rapidly with vaccine safety issues as soon as they arise, there also needs to be rapid follow-up communication to health care professionals and the general public regarding the outcome of such investigations. As research is carried out to investigate hypotheses of vaccine safety concerns, delays in communicating the results of these investi-gations may have a negative impact on immunisation programmes, and may delay the introduction of certain vaccines in certain countries. The VHPB, therefore, encourages publication of the results of such studies, as well as those of clinical trials, to make this information accessible to many different audiences.

 

12. A wide range of issues concerning vaccine safety is being taken up by anti-vaccination groups as well as by other groups whose concerns may reflect local customs, religious, political, or other beliefs. Responding to media / anti-vaccination allegations thus requires:

Familiarity with issues that may reflect unique or local beliefs and attitudes;

Cultivating relations with the media by responding to vaccine safety issues in a timely and appropriate way, and being seen as a reliable, trustworthy partner in communication;

Learning where to go for reliable, helpful information and where to seek help in investigating local incidents.

 

13. Trends have been observed in immunisation coverage following vaccine injury compensation lawsuits, which show dramatic drops in coverage for the relevant vaccine and corresponding geographical area. Previous higher coverage levels are sometimes not attained even after safety allegations have been refuted.

 

14. To provide a basic framework for vaccine litigation issues, United Nations-developed regulations, while having no legal basis, could provide a model to be followed by the European

countries and to provide an impetus for implementation at national level.

 

15. Vaccine ‘scares’ continue to have an impact on immunisation coverage. In order to respond to this challenge, there is a need to develop vaccine communication strategies that provide a balance between evidence-based information and advocacy / lobbying activities. Improving communications at international level requires:

• Consensus among authorities on key issues;
• Ability to provide credible, scientific data, either proactively or in timely response to a crisis situation;
• Compiling independent, international reviews of vaccine safety issues, together with relevant statements from authoritative neutral organisations;
• Strong inàternational collaboration, with direct, early and clear statements agreed by authorities and other key parties, prior to public communications.

 

16. The vaccine industry recognises that vaccine issues (including safety and supply) need to be dealt with through partnerships forged at different levels:

• At company level, recognising the importance of internal stakeholders;
• Through vaccine industry associations;
• With health authorities and expert groups.

 

17. The vaccine industry needs to be proactive in identifying resources and in adapting information to different types of audiences. Lobbying activities will also have their place in vaccine communications, as legislators often do not have the time to read to be kept informed of ongoing developments in the vaccine community.

 

18. A new environment surrounding vaccine issues includes not only traditional players (health authorities, scientific media, patients, health professionals and the industry) but also newer players who must be taken into account in vaccine communications. Patient action groups, the legal profession, the lay media who will be as crucial in crisis management as the specialised press, and the Internet. It is important for the industry to act on the precept that understanding issues does not necessarily bring support to an issue, but that support must also be gained through trust.

 

19. International collaborative working groups, such as the Brighton Collaboration, are developing standardised definitions for adverse events following immunisation, in order to allow comparability of data in developing guidelines for clinical trials and surveillance systems.

 

20. Loss of public confidence in vaccination is one of the greatest threats to public health, and needs to be addressed by local, national and international bodies, pooling resources, to prepare for possible causes that might be taken up by antivaccination groups or the media. The health care community needs to actively promote and personally recommend the benefits and safety of vaccination in language that is readily and easily understood by the intended audience.

 

21. Previous vaccine ‘scares’ should provide a model for dealing with possible future crises, with the scientific community and health departments providing information to the public of any new, credible evidence of adverse events.Vaccine ‘scares’ should be dealt with through encouraging open debate and undertaking further studies, if necessary.

 

22. The vaccine community needs the media and must, therefore, be willing to communicate in a responsible, professional, and timely manner to allegations of adverse events. Journalists, as one of the main communication links with the general public, will need to be informed and convinced of the safety, effectiveness, and benefits of vaccination.

 

References 

Viral Hepatitis Prevention Board. Hepatitis B vaccination: safety issues. Viral Hepatitis Prevention Board meeting, Geneva, Switzerland, March 13-14, 2003. Viral Hepatitis 2003; 12.1.