As part of the 3S programme, India is evaluating the safety of the recently-introduced rotavirus vaccines
The 3S project was recommended by WHO, considering the limited safety data on vaccines introduced in India
NEW DELHI :
The central government will expand the reach of the Smart Safety Surveillance, or 3S, programme, to optimize post-marketing surveillance of priority drugs and vaccines, and ensure the vaccines distributed under the universal immunization programme are safe.
The 3S project was recommended by the World Health Organization (WHO), considering the limited safety data on vaccines introduced in India.
According to the ministry of health and family welfare, new medical products often enter the market with limited safety data from clinical trials, which evaluate small controlled populations. Therefore, for immunization programmes, post-marketing safety surveillance is essential to monitor the risk-benefit profile of a product in the wider population, it added.
As part of the 3S project, India is evaluating the recently-introduced rotavirus vaccines. It is also trying to strengthen the collaboration among key stakeholders, such as ministry of health and Central Drugs Standard Control Organisation (CDSCO), to ensure high levels of vigilance.
The government on Tuesday also released a white paper on the safety of rotavirus vaccine, which was introduced in 2016 in a phased manner, as part of its nationwide immunisation programme. The project achieved countrywide coverage in September 2019. The rotavirus vaccines used in the project are manufactured by two Indian companies.
“There were several learnings from the 3S activities implemented in India, which directly led to required next steps. One of these is the need for collating safety data from all sources for the safety assessment of the vaccines in the post-marketing period, including routine data collection and special studies," the white paper said.
“The 3S priorities in India were to link pharmacovigilance activities between different stakeholders, for data sharing, signal detection, risk assessment, risk management, risk communication, and benefit harm evaluation for regulatory decision-making. The 3S project implemented in India allowed synthesis of multiple data sets, with high data quality from the sentinel surveillance systems, which provide reassurance regarding the safety of the Rotavac vaccine," it said.
WHO has been prodding countries to adopt the 3S programme, with the support of the Bill and Melinda Gates Foundation, to strengthen pharmacovigilance systems in developing nations. “Efficient healthcare delivery systems providing equitable, affordable and easily accessible healthcare is at the heart of all our efforts," said Harsh Vardhan, Union health minister.
“Most of the vaccines have been introduced in India’s universal immunization programme. There are plans of scaling up pneumococcal conjugate vaccine (PCV) and introduction of human papilloma virus (HPV) vaccine and typhoid vaccines," said Naveen Thacker, co-chair, International Pediatrics Association (IPA), a strategic advisory group on immunization.
The government is also planning to expand coverage of PCV that prevents pneumonia among children to all states by 2022. However, even after two years of the roll out of the PCV, the Union health ministry is yet to start the vaccine’s impact study. The only evaluation, which was supposed to start in November 2018 and finish by July 2022, could not take off due to technical reasons, said ministry officials, requesting anonymity.
According to WHO, access to medicines and vaccines in low- and middle-income countries has improved in the past two decades. However, there has not been a proportionate improvement in pharmacovigilance infrastructure and activities to monitor adverse events and address safety issues.
“As far as the capacity for surveillance is concerned, India has the legacy of eradicating polio. The National Polio Surveillance Project is one of the best in the world. We are carrying out surveillance for Rubella, measles, diphtheria, pertussis (whooping cough), and tetanus vaccine. India has a strong laboratory network and experienced manpower. It is fully capable of ensuring vaccine safety provided we continue to invest and strengthen our resources," Thacker said. “It is very important to have impact evaluation of any newly launched vaccine in population for better understanding and further policy decisions."
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