TAG: GS 3: SCIENCE AND TECHNOLOGY
THE CONTEXT: Sanofi India Limited’s recent discontinuation of ShanIPV, its inactivated polio vaccine (IPV), in India has prompted concerns regarding vaccine availability.
EXPLANATION:
- However, the company assures that there will be no shortage, as it has obtained approval for an alternative IPV, IMOVAX-Polio.
- IMOVAX-Polio, the alternative IPV, has the same composition and formulation as ShanIPV.
- This similarity ensures continuity in the immunization program without compromising on vaccine efficacy.
- Polio remains a significant global health concern despite major strides towards eradication.
- India achieved polio-free certification in 2014, marking a significant milestone in global eradication efforts.
- Inactivated polio vaccines (IPVs) play a crucial role in maintaining immunity and preventing polio outbreaks.
Regulatory Approval
- Sanofi India initiated the closure of ShanIPV in 2023 and applied for regulatory approval for IMOVAX-Polio.
- The decision was influenced by the evolving healthcare sector, accelerated by the COVID-19 pandemic, which led to increased supply capacities and emergence of new pharmaceutical manufacturers.
- Despite discontinuing ShanIPV, Sanofi India reaffirmed its dedication to supporting India’s public health program for polio eradication.
- The company has been a longstanding contributor to India’s journey towards becoming polio-free and aims to align its efforts with the authorities.
Maintaining Polio-Free Status in India
- India achieved polio-free certification in 2014, but maintaining this status requires sustained efforts.
- High routine immunization coverage (>90%) and robust surveillance are essential to prevent polio resurgence. ShanIPV, launched in 2015, played a crucial role in India’s Universal Immunization Programme.
Future Considerations:
- Continued emphasis on routine immunization coverage, especially within the Universal Immunization Programme, is essential to prevent polio resurgence.
- Robust surveillance systems and rapid response plans are imperative to detect and contain any polio outbreaks promptly.
ShanIPV:
- ShanIPV is an inactivated polio vaccine (IPV) produced by Sanofi Pasteur Ltd.
- It is a trivalent inactivated injectable vaccine indicated for the prevention of poliomyelitis in infants, children, and adults for primary vaccination and as a booster.
- The vaccine contains inactivated poliovirus Type 1 (Mahoney strain 40 DU) and is administered in a series of three successive doses at intervals of one or two months, followed by a first booster 6 to 12 months after the last dose.
- Further boosters in childhood, adolescence, and adulthood should be administered according to national recommendations.
- ShanIPV is stored in a refrigerator between 2°C – 8°C and should be protected from light and not frozen.
- Once opened, the vaccine can be used for up to 28 days if stored correctly. It is essential to follow official recommendations for the proper use of ShanIPV to ensure its effectiveness in preventing polio.
IMOVAX-Polio:
- IMOVAX Polio is an inactivated polio vaccine (IPV) produced by Sanofi Pasteur Ltd.
- It is indicated for the prevention of poliomyelitis in infants, children, and adults, for primary and booster vaccination.
- IMOVAX POLIO must be used according to effective official recommendations.
- The vaccine contains inactivated poliovirus Type 1 (Mahoney strain), Type 2 (MEF-1 strain), and Type 3 (Saukett strain).
- It is administered in a series of three successive doses at intervals of one or two months, followed by a first booster 6 to 12 months after the last dose.
- Further boosters in childhood, adolescence, and adulthood should be administered according to national recommendations.
- IMOVAX POLIO is stored in a refrigerator between 2°C – 8°C and should be protected from light and not frozen.
- Once opened, the vaccine can be used for up to 28 days if stored correctly.
- It is essential to follow official recommendations for the proper use of IMOVAX POLIO to ensure its effectiveness in preventing polio.
- The vaccine may contain traces of neomycin, streptomycin, and polymyxin B, which should be taken into account when administering it to individuals with allergies to these substances.
- Polio:
- Polio is a crippling and potentially deadly viral infectious disease that affects the nervous system.
- There are three individual and immunologically distinct wild poliovirus strains:
- Wild Poliovirus type 1 (WPV1)
- Wild Poliovirus type 2 (WPV2)
- Wild Poliovirus type 3 (WPV3)
- Symptomatically, all three strains are identical, in that they cause irreversible paralysis or even death. However, there are genetic and virological differences, which make these three strains separate viruses which must each be eradicated individually.
- The virus is transmitted by person-to-person mainly through the faecal-oral route or, less frequently, by a common vehicle (for example, through contaminated water or food).
- It largely affects children under 5 years of age. The virus multiplies in the intestine, from where it can invade the nervous system and can cause paralysis.
- There is no cure, but it can be prevented through Immunisation.
India’s polio vaccination strategy:
- Pulse Polio Programme:
- It was started with an objective of achieving 100% coverage under Oral Polio Vaccine.
- Intensified Mission Indradhanush 2.0:
- It was a nationwide immunisation drive to mark the 25 years of Pulse polio programme (2019-20).
- Universal Immunization Programme (UIP):
- It was launched in 1985 with the modification to ‘Expanded Programme of Immunization (EPI). The objectives of the Programme include:
- Rapidly increasing immunization coverage
- Improving the quality of services
- Establishing a reliable cold chain system to the health facility level
- Introducing a district-wise system for monitoring of performance
- Achieving self-sufficiency in vaccine production.
- It was launched in 1985 with the modification to ‘Expanded Programme of Immunization (EPI). The objectives of the Programme include: