China Approves SINOVAC’s Sabin Strain Based Inactivated Polio Vaccine
SINOVAC Biotech Ltd. (SVA) said Monday it received a drug registration approval from the National Medical Product Administration of China or “NMPA” for its Sabin strain based inactivated polio vaccine or “sIPV”.
The company expects that the vaccine will be available on the market by the end of 2021.
In addition, the company said it submitted an application for prequalification to the World Health Organization or “WHO” in early 2020 and the WHO conducted its on-site inspection in February 2021.
SINOVAC’s sIPV is approved for use on infants and children aged 2 months and above to prevent poliomyelitis due to infection of types I, II and III polioviruses. The primary immunization requires 3 doses at least one month apart, beginning at 2 months of age. A booster shot will be given at 18 month of age.
According to the results of phase III clinical trial, no serious or rare adverse events were observed in relation to vaccinations, which indicates the good safety profile of SINOVAC’s sIPV vaccine.
Inactivated polio vaccine contains no live virus and, thus, carries no risk of emergence from vaccine-derived poliovirus or vaccine-associated paralytic polio.
Poliomyelitis, commonly shortened to polio, is an infectious disease caused by the poliovirus, which mainly affects children under 5 years of age. Poliovirus is usually spread from person to person through infected fecal matter entering the mouth. It may also be spread through food or water containing human feces and, less commonly, from infected saliva, causing damage to motor neurons in the anterior horn of the spinal.
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