ELC’s Dr Parvinder Punia and Dr Siddharth Chachad discuss global and regional vaccine programmes
ELC’s Dr Parvinder Punia and Dr Siddharth Chachad
Global and regional programmes exist for vaccines. Each region has its own mandate of how and when vaccines are administered, especially in the paediatric population.
Apart from the regional programmes run by the FDA, EMA (and its local authorities), TGA and other such large health agencies, the WHO is additionally running the Global Vaccine Action Plan (GVAP) endorsed by the 194 member states of the World Health Assembly. It is a framework targeted to prevent millions of deaths by 2020 through better access to vaccines.
Immunisation is one of the most successful and cost-effective health interventions known.
Over the past few decades, immunisation has achieved many things, including the eradication of smallpox, an accomplishment that has been called one of humanity’s greatest triumphs.
Vaccines have saved countless lives, lowered the global incidence of polio by 99% and reduced illness, disability and death from diphtheria, tetanus, whooping cough, measles, Haemophilus influenzae type b disease and epidemic meningococcal A meningitis.
The GVAP is the catalyst for health agencies and regulators worldwide to consolidate the regulations for vaccines.
At the moment, regulations are agency (or regional agency)-dependent or from the pre-qualification of the WHO.
By law, regulators are restricted to access or use information from other regions to determine the safety, efficacy and quality of a vaccine based on evaluation from other regulators. Moreover, there is a limited pool of regulators worldwide that are able to assess vaccines based on these parameters as well as compliance to GMP and manufacturing standards.
However, it is well-accepted that the regulators pre-qualifying vaccines for the WHO are drawn from national regulatory authorities (NRAs), for example, the TGA, FDA and so on.
Therefore, it would only stand to reason that a pre-qualified WHO vaccine should be widely accepted by other regulatory authorities.
In cases where distribution of pre-qualified vaccines has been extremely broad (millions of doses administered, effective immunisation achieved), it may be justified that further regulatory scrutiny could be minimised.
Safety is well-established from wide usage in the population without any significant concerns or adverse events; although still questioned under the remit of a controlled clinical trial with a non-inferiority study design.
Moreover, the vaccination programmes remain unharmonised. Dosing schedules of the vaccines in infants may differ significantly, as mandated by different immunisation programmes in different countries, which can lead to confusion in clinical study planning and its future acceptability by regulators.
For instance, while 22 out of 29 EU/EEA countries have implemented a universal vaccination programme for hepatitis B vaccine in infants and adolescents as per WHO recommendation, seven countries (Denmark, Finland, Iceland, the Netherlands, Norway, Sweden and the UK) have opted for only selective vaccination programmes targeting risk groups such as neonates born to HBsAg-positive mothers (21/29), haemodialysis patients (22/29) and household contacts of HBsAg-positive patients.
Inputs have arrived from a wide range of regulators, and the scientific opinion is changing now on a global scale.
Current regulatory science is improving methods to measure vaccine potency to minimise trials and maximise assay outcomes. Moreover, post-marketing surveillance is being similarly enhanced to evaluate the risk/benefit of a vaccine at registration and throughout its global lifecycle.