E-DRUG: Pneumococcal vaccines effective and safe
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[In response to the E-drug message entitled "Dangerous pneumococcal child vaccine?", here is the WHO press release of some 6 months ago refuting the allegations. Thanks to Leela for bringing this to our attention. WB]
World Health Organization
Country Office for India
3 October 2008
Press Release
PNEUMOCOCCAL VACCINES EFFECTIVE AND SAFE
New Delhi: The pneumococcal conjugate vaccines are effective in preventing serious and fatal pneumonia in young children under 5 years of age, these vaccines are safe and cost-effective.
Recently, there were articles in the media expressing concerns about the risks and benefits of pneumococcal conjugate vaccines. The pneumococcal conjugate vaccines are an important tool to reduce mortality due to childhood pneumonia which causes over two million deaths each year, mostly in the developing countries. Protection against invasive pneumococcal disease by vaccine serotypes is close to 90%.
The media concerns were generated from incorrect interpretations of a discussion about �clinical pneumonia� versus X-ray confirmed pneumonia. The main goal for pneumonia vaccines in India and other developing countries is to prevent pneumonia deaths in children. For this purpose, X-ray proven pneumonia is a better marker for vaccine effectiveness. The WHO clinical pneumonia definition was primarily meant for community case management of pneumonia by primary health care workers; a large proportion of such cases are either not pneumonia or milder forms of pneumonia that do not result in death. Therefore, it was erroneous to make conclusions about the effectiveness of the pneumococcal vaccines by interpreting their effect on non-specific and mild cases of respiratory illness.
In India, pneumonia is responsible for about 400,000 deaths in children under five and a substantial proportion of these pneumonia deaths are pneumococcal. While treatment with antibiotics reduces mortality, lack of access to care and delay in provision of antibiotics, especially among the poor and most vulnerable children result in high case fatality from pneumonia. Up to 19% of children hospitalized with pneumonia die in India, studies have shown. Another consideration is the rising resistance to commonly used antibiotics worldwide associated with increasing rates of treatment failures.
The pneumococcal conjugate vaccines also prevent meningitis caused by pneumococcus, one of the most common causes of bacterial meningitis, which is associated with high fatality rate (over 30% in India) and long term disabilities like deafness, seizures, paralysis and learning disorders among survivors. Prevention of severe pneumonia and invasive pneumococcal diseases through vaccination is therefore an important advance in public health.
Severe pneumonia being the single biggest killer of children under-five globally, WHO recommends prioritizing use of vaccines such as the pneumococcal conjugate as millions of children, specially the poor, remain at high risk of getting the disease and dying. The WHO recommendations were made after a thorough review of all available data on the disease and potential vaccine impact by duly constituted expert committees and the WHO Strategic Advisory Group of Experts (SAGE).
(http://www.who.int/immunization/wer8212pneumococcus_child_Mar07_position_paper.pdf)
Introduction of pneumococcal conjugate vaccines into the childhood immunization programs, especially in developing countries, will contribute effectively to achieving the Millennium Development Goal of globally reducing childhood deaths by two-thirds by 2015.
A comprehensive review of all the safety data related to this vaccine was conducted by the WHO Global Advisory Committee of Vaccine Safety who concluded that �the evidence did not identify any major safety problems with PCV7 or any other pneumococcal conjugate vaccine, with the possible exception of reactive airway disease (wheezing), which may bear further scrutiny as additional data become available.� While data from the clinical trial in South Africa showed a higher rate of wheezing in vaccinated children, which did not persist on longer term follow up, another study in The Gambia showed no such association. The advisory committee concluded that the risk-benefit ratio for the vaccine strongly supports the use of the vaccine in routine immunization programmes. (http://www.who.int/vaccine_safety/topics/pneumococcal/en/index.html).
The vaccine is currently being used in the national immunization programmes of over 25 industrialized countries with no evidence of increase in the occurrence of wheezing. A post-marketing surveillance review in the U.S.A. estimated a less than 1 case report of asthma per 1 million doses of PCV distributed. However, like with any vaccine, ongoing safety evaluations will further monitor this issue and overall safety of these vaccines.
Finally, regarding the vaccine cost, it is recognized that the price in the private market and in industrialized countries is relatively high at present, but past experience, for example with the hepatitis B vaccines, shows that the cost of vaccines do decline after the initial phases of introduction and implementation. Global initiatives such as the Advanced Market Commitment for pneumococcal vaccines have been launched to facilitate the supply of affordable vaccines for developing countries. At the projected public sector prices for the vaccine in developing countries, the vaccine is considered highly cost-effective even if a country were to self-finance the procurement and delivery of the vaccine.
The above pattern of ultimate reduction in vaccine cost is also true for the cost of life-saving treatments such as for AIDS, and which have substantially declined over time. Saving lives, especially the lives of so many children, is the right thing to do.
For further information please contact; Ms Shamila Sharma, Public Information & Advocacy Officer, Tel: 09818595937