Re: Mandatory childhood vaccination could cause “irreparable damage,” says expert panel
Before considering implementing mandatory vaccination to remedy the falling rates of vaccine uptake and confidence in vaccine safety it may be prudent to consider all the practical issues associated with vaccines which are perhaps, contributing to the overall reticence of the public to embrace vaccination.
The role of the MHRA is used time and time again to reassure a concerned public as to vaccine safety. The public need to be reassured that the highest possible standards are employed in both collating data and responding to ADR’s. Establishing that is pivotal to the overall levels of vaccine uptake.
The public have the rightful expectation that the MHRA will respond immediately and effectively to any safety issues flagged up. Collating the information alone doesn’t satisfy the public’s expectations. With daily coverage of falling vaccine rates and loss of vaccine confidence it is vital that the standard of post marketing surveillance and resultant action in respect of unsafe products is swift and consistent.
Apparent inconsistencies in what constitutes a problematic, unsafe product with subsequent removal from the market will not reassure the public and instil confidence.
Two relatively recent FOIA disclosures appear to display very different standards between the criteria employed in medicines and vaccines triggering their removal from the market.
Under FOIA, the MHRA confirmed 1076 suspected ADR reports in the under 5’s between 1st January 2005 and 31st December 2015, following administration of the MMR vaccine. (1)
Reports are categorised as to their seriousness under criteria from the “working group of the Council for International Organizations of Medical Sciences (CIOMS) and are defined as 6 possible categories which are documented on the Yellow Card”
The criteria are: “(1) patient died due to reaction (2) life threatening (3) resulted in hospitalisation or prolonged inpatient hospitalisation (4) congenital abnormality and (5) involved persistent or significant disability or incapacity or (6) if the reaction was deemed medically significant.” (1)
Breakdown of the “serious” ADR’s (626) from the 1076 are……….
Patient Died 8
Hospitalised Due To Reaction 143
Life Threatening 27
Congenital Abnormality 0
Other Medically Significant 381
However, a 2017 FOIA (17/460) from the MHRA confirmed that since it came into being in 2003, only 12 medicinal products and no vaccines have been removed from the UK market due to “safety concerns”.(2)
Three of the 12 products listed were removed because of “increased risk of cardiovascular side effects”, two for “liver toxicity”, one for MI/stroke, one for serious skin reactions, one for psychiatric reactions, one for toxicity in overdose, one for risk of abuse/addiction, one for PML and one for “increased incidence of non-fatal serious adverse events and lack of efficacy”.
Risks of abuse and or addiction to any medicine are themselves a matter of concern and a very good reason for removing it from the market but it is understandable that an uneasy public might question why 8 deaths and 67 cases of disability following the administration of the MMR vaccine in under 5’s did not result in it too, being removed from the market.
How can the public be expected to have confidence in a system which appears inconsistent in its approach to what constitutes an actionable safety risk?
Is there a different standard employed by the MHRA with regard to product safety between other medicinal products and vaccines?
Before employing draconian measures of enforced vaccination it may be worth addressing how much of an impact a lack of confidence in the post marketing surveillance is contributing to the overall problem. It seems very unfair to foist the entire burden of the perceived remedy to the problem on to the children and their families if one of the causes of the problem lies elsewhere and a different remedy is called for.
Competing interests: No competing interests