“An eleven-month-old boy from Maharashtra's Beed district has been found infected with the vaccine derived polio virus (VDPV)”. This recent newspaper report raised serious concern in the minds of people and the health professionals about the safety of vaccines used in public health. This seems to be the first such case in the state and the third in the country since March 2012. There have been reports that the parents failed to get the required dosing on time. Though complete investigation is not yet over, irrespective of the reasons for this paralytic polio attack, vaccine derived polio infection is not acceptable. This is not the first issue of vaccine safety in this country. In another recent incident, following the death of an infant in Chandigarh after administration of recently introduced pentavalent vaccine, the company has recalled the batch of the vaccines from the market.
Instances of vaccine disasters
There are many instances of vaccine disasters. Some of them are: fiasco in the US military in 1942, when yellow fever vaccine contaminated with hepatitis B caused 100 deaths; the mass vaccination against smallpox in New York in 1947 that caused six deaths (four more than the outbreak itself); in the Cutter incident in the 1950s, inadequately inactivated polio vaccine caused 164 cases of paralysis and 10 deaths.
The vaccines and the vaccinations are one of the best medical interventions in medical science promoting public health. Ever since the discovery and success of small pox vaccine in eradicating small pox from the world, the immunization (vaccination) programmes have been strengthened worldwide including India to prevent preventable diseases. The country has been successful in eradicating small pox and the last two years have no reported cases of polio. The absence of polio cases in last two years is the result of sustainable campaign and implementation of pulse polio immunization programme. While achieving the incident free two years, the country marches forward for third incident free year. The certificate is issued on achieving three successive years free of incidences. Though technically it does not affect the India’s goal of achieving World Health Organization (WHO)’s polio eradication certificate, but it definitely causes concern and loss of public trust on vaccination.
All India Drug Action Network (AIDAN), a non-profit civil society, has expressed serious reservation over the introduction of pentavalent vaccine in the immunization programme on safety issues. The organization urged the director general, World Health Organization against the introduction of pentavalent vaccine into India’s universal immunization programme. The Government of India introduced the addition of two more vaccines (Haemophilius influenza b and hepatitis B) to the DPT (Diphtheria, Whooping Cough and Tetanus) vaccines making five vaccines under universal immunization programme to begin with in two states: Kerala and Tamil Nadu in 2011. In Kerala itself four deaths were reported in less than two months of its introduction. All these deaths were attributed to hypersensitive reactions. Now the death of infant at Chandigarh is reported. Vaccines that frequently and unpredictably cause deaths of children cannot be recommended.
There are quality issues with the vaccines too. Finding deficiency in the implementation of Good Manufacturing Practices and Quality Management System, the WHO has cancelled the prequalification of products from three private vaccine manufacturers. Ironically, with reported pressure from WHO, citing non-compliance of GMP, in 2007 the Government of India cancelled the license of three public sector vaccine manufacturers. No substantial efforts have been made to revive them to supply vaccines for national immunization programme. The Government continues relying on private sectors. The country’s regulatory authority, CDSCO, has passed the stringent litmus test of WHO and WHO declared the CDSCO as functional national vaccine regulatory body. Unfortunately the issues of quality and safety of vaccines continue to be threat.
There has been a national surveillance programme for monitoring Adverse Events Following Immunization (AEFI) is in place. The programme is meant to detect, report and monitor adverse events in a timely manner to enable preventing AEFI. The functioning of the programme is any body’s guess. Under a revised plan, the Adverse drug reaction Monitoring Centres (AMCs) established under National Pharmacovigilance Programme are involved in vaccine safety data collection process. A total of 581 individual case safety reports (ICSR) on vaccines were received by the National Coordinating Centre of National Pharmacovigilance Programme during April 2011 to December 2012. An analysis of these data showed the occurrence of 613 ADRs. 36 cases of serious vaccine ICSRs were reported during this period involving BCG, DPT, Hepatitis B, Haemophilus influenza type B, Pneumococcal, Rabies and and Polio Vaccine. But the Pharmacovigilance centres are located in Medical Colleges and immunization programmes are organized at various levels. Never the less, some beginning documenting AEFI is made.
The vaccines are different from other medicinal products. The other medicinal products are meant for patients while the vaccines are basically meant for healthy persons mostly children. Realizing the safety concern of vaccines, the Indian regulation keeps the vaccines as new drugs while all other medicinal products (drugs) are treated as new drugs only for four years of their introduction to market or entry into pharmacopoeia whichever is earlier. The death of even one child during immunization practice not only causes grave psychological issues in the mind of vaccinator, it also threatens the very foundation of basis of immunization. The community looses trust. The regulators, the vaccine makers, the supply chain managers and the field staff need to sensible and realize the importance of vaccine safety in the larger interest of public health. They together can ensure safer vaccines and vaccination system. The compensation and rehabilitation programme for children adversely affected by vaccines would further build the community’s trust and promote immunization programme.
(The authors are with Department of Pharmacy, Annamalai University, Annamalai Nagar, TN 608 002