'Re-evaluate H1N1 vaccination'

Saturday, July 17, 2010 (The Mirror Pg 13)

By Rebecca Kwei
The Director of the World Health Organisation Collaborating Centre for Advocacy and Training in Pharmacovigilance, Dr Alex Dodoo, has called for a re-evaluation of the large-scale rollout of the HINI vaccine nationwide.
He said any such large-scale deployment of vaccines should be informed by proper assessment of the risk and a good and rigorous determination of those most vulnerable and hence requiring vaccination.
“There are several people who would benefit from H1N1 vaccination but there are millions more for whom vaccination would present very little benefits” he said in an interview with The Mirror.
Dr Dodoo said the rollout should have been accompanied by very intensive and active monitoring for the occurrence of side effects to ensure that the known benefits of vaccination far outweigh the risks posed by the vaccine itself.
“The fact that several people have complained of unacceptable side effects shows how important safety is to the public.Those likely to suffer severe consequences from H1N1 infection include pregnant women, people with serious pre-existing conditions like asthma and certain heart and lung conditions, as well as those with reduced immunity for instance cancer patients, HIV patients” he said.
Dr Dodoo explained that the benefits of vaccination to such people were expected to be higher than any side effects the vaccines might give.
However, for most normal adults, the H1N1 infection is likely to lead to mild symptoms. Hence, any severe side effects from the vaccine is not likely to be acceptable.
Since the nationwide H1N1 vaccination started, many people who have been vaccinated have complained of side effects such as dizziness, general weakness, reactions at the site of the injection such as hardening, swelling, pain and redness, fatigue and fever.
However, the Ghana Health Service (GHS) in a press statement, vouched for the safety of the H1NI vaccine, indicating that it was to provide beneficiaries with protection against the disease.
It said although those adverse reactions, even after any drug administration were not unusual, the health authorities would deal with the reports with all the seriousness they deserved.
Dr Dodoo said the rollout of H1N1 vaccination to travellers to the World Cup and also to at-risk groups and vulnerable people was a good idea except that the very close monitoring that should have accompanied the rollout appeared to have been absent.
In addition, there has not been published evaluation of those events reported and what the implications of those are to the continuation of the mass immunisation.
Some people also claim they were not given any information on what to expect and what side effects may occur.  
“The reported side effects and associated media coverage of them following the large-scale rollout of the H1N1 vaccine to the public, however, raises serious concerns which call for an immediate re-evaluation of the decision to vaccinate everyone.
Apart from the identified vulnerable populations, what are the expected benefits and how much risk is there of contracting H1N1 given that the pandemic appears to have abated and several countries have stayed away from mass immunisation?” he queried.
”If we don’t rollout public health initiatives with good education and appropriate safety monitoring, we risk alienating the public and compromising these laudable initiatives.
“Vaccination is good but only when targeted at the right people and carried out with good education and information provision accompanied with robust safety monitoring and communication systems” Dr Dodoo added.
He said the public needed to be continuously assured of the safety of vaccines and the small risk of adverse reactions that a minority of patients may suffer.
Dr Dodoo also called for a robust risk management plan to accompany the large-scale immunisation of the Ghanaian public with the H1N1 vaccine and regular publication of the adverse events associated with the vaccine as is currently being done in many countries.
In another development, there have been public concerns by several global experts who have questioned the whole management of the pandemic by the WHO, citing possible conflicts of interest and profiteering by the pharmaceutical industry.
In an editorial and investigative piece by the British Medical Journal on June 3, this year, the authors mentioned the example of Poland which refused to be involved in stockpiling vaccines and anti-retrovirals, a decision which now appears very prudent since countries such as France and England which stockpiled these medicines are now finding ways to sell them to other countries.
Other serious issues were raised by the editorial which the WHO had since responded to officially.