New Pneumococcal Vaccine Available in Europe

LONDON (Reuters Health) Apr 06 - Wyeth began to market Prevenar, their vaccine against invasive pneumococcal disease, in Europe this week before national health services announced their policy on how the potentially life-saving but expensive vaccine will be used.

Prevenar, the first conjugate vaccine for pneumococcal disease, received EU approval on February 5 for use in children 2 months to 2 years old. The vaccine is protective against invasive pneumococcal disease caused by seven serotypes of Streptococcus pneumoniae.

In a news release this week, the firm's UK subsidiary said that initially it anticipated the product will be prescribed only by paediatricians because the Department of Health is still considering its incorporation into the UK's routine childhood immunization program.

Three doses of the vaccine are required. The basic NHS price per single dose vial is 39.25 pounds.

A company spokeswoman told Reuters Health that the high price reflects the complicated manufacturing process. She said the Department of Health's joint committee on vaccination and immunization was expected to decide this spring whether Prevenar should be added to the list of vaccines routinely given to all children.

If it does, observers expect the price will fall significantly as the purchase of vaccines for immunization program is negotiated centrally through the NHS Purchasing and Supply Agency.

In the meantime, the spokeswoman explained that it will be up to individual National Health Service hospital trusts to decide whether to buy the vaccine.

Wyeth said the efficacy of Prevenar in preventing invasive pneumococcal disease had been demonstrated in clinical trials conducted in both the US and Europe. A clinical study involving more than 37,000 infants found that Prevenar was 97.4% effective in preventing serotype-specific invasive pneumococcal infections in fully vaccinated infants.

The vaccine's safety has also been demonstrated in clinical trials and confirmed by experience in the US where some 12 million doses of the vaccine had been distributed by the end of 2000.