Pharmaceutical company Pfizer is in talks with the government for ‘early approval’ for its COVID-19 vaccine in India. Pfizer CEO Albert Burla gave this information on Monday. He said, “Unfortunately, our vaccine is not registered in India, although our application was submitted months ago.”
He said, “We are currently discussing with the Government of India about an early approval route to make our Pfizer-Bioentech vaccine available for use in the country.”
Pfizer withdrew its application, this was the reason
Pfizer sought permission from the Drug Regulator of India (DCGI) in December for its vaccine. Subsequently, Pfizer’s application was considered by the Subject Expert Committee (SEC) of the Central Drug Standards Control Organization and recommended against approving the vaccine.
The SEC’s February recommendation stated, “The company also did not offer to prepare safety and immunity data according to the Indian population. After detailed deliberations, the committee did not recommend the emergency use of ( COVID vaccine) in the country in this phase. “
About 2 days later, Pfizer announced the withdrawal of its application.
Now government intensifies the approval process for foreign vaccines
The Government of India has expedited the process of approving foreign vaccines to increase the availability of COVID vaccines in the country. According to the Union Health Ministry, eligible manufacturers of major foreign vaccines will no longer need to conduct separate local clinical trials in India.
Recently, the Ministry of Health’s statement said that the government has decided that the COVID-19 vaccines can be approved for emergency use in India, which are developed and manufactured abroad and which can be used in the US, Europe, UK or Japan. It has received emergency approval from regulators for limited use or has been included in the Emergency Use List of the World Health Organization (WHO).
The government had said that due to security reasons, the health of the first 100 beneficiaries of such vaccines made abroad will be monitored for seven days, after which these vaccines will be used in the country’s immunization program.