The Irish Pharmaceutical Healthcare Association (IPHA) welcomes the announcement this morning by the Health Service Executive (HSE) that it has added an enhanced pneumococcal vaccine (PCV) to the childhood immunisation programme.

The addition of this new vaccine to the childhood immunisation programme means that Irish children are now less likely to get the life-threatening illness, meningitis. Irish children are now protected against a total of 12 infectious agents under the current national vaccination programme.

Advances are taking place every day and the industry calls on the State, through the Department of Health and Children and its agencies, to continue to make these advances available to the Irish population by:

- Ensuring that uptake rates for the various immunisation programmes meets WHO standards;

- Supporting healthcare professionals to improve uptake levels for all vaccines;

- Increasing confidence in vaccines and vaccination programmes by working with all relevant stakeholders to improve communication of the significant benefits of vaccines to the public, healthcare professionals and the media;

- Introducing a transparent consultative process for the review and recommendation of vaccines.

As biological sciences continue to advance rapidly, the vaccines industry is making significant investments to further extend the range of available vaccines. Scientists continue to work on preventing infectious diseases. A number of vaccines are now in development that are designed to treat diseases, such as cancer. Unlike more traditional vaccines, these aim to focus the immune system on attacking established disease, rather than offering protection against infections.

Notes

The Vaccine Development Process

The process of researching, testing, gaining regulatory approval and manufacturing vaccines is costly, complex and lengthy. Unlike traditional pharmaceuticals, vaccines are biological medicines based on living organisms and therefore must meet specific, extensive regulatory requirements throughout their development, production and distribution cycles. As a result, developing a new vaccine takes on average 18.5 years, costs over $500 million and can require testing in tens of thousands of subjects.

Its development cycle is also quite different from that of traditional pharmaceuticals:

- Exploratory stage: to understand the disease, its epidemiological data and the right proteins (antigens) to use in preventing or treating the disease;

- Pre-clinical stage: to assess antigen safety and select the best candidate vaccine;

- Clinical development: from 10 (Phase I) to 1,000 people (Phase III) are involved in clinical trials and the first batches are produced (clinical batches and industrial batches for compliance);

- Regulatory approval: all the data collected through the preceding stages are submitted to the relevant health authorities for approval;

- Manufacturing process: takes up to 22 months to produce a single batch of vaccine;

- Quality control: approximately 70% of production time is dedicated to quality control.

Source:
Irish Pharmaceutical Healthcare Association (IPHA)