US-based pharmaceutical firm Pfizer is seeking fast-track approval for its COVID-19 vaccine, informing Indian authorities that its vaccine has shown "high effectiveness" against the COVID-19 variant endemic in India, PTI quoted sources on Wednesday, 26 May.
Seeking expeditious distribution of the jab in India, the company told the Indian government that "the timely alignment and execution of the draft Heads of Terms will enable Pfizer to reserve the allocation of doses and pave the pathway for executing the Distribution and Supply Agreement,” PTI reported.
Further, the jab is also indicating efficacy on people of Indian ethnicity and nationality and is suitable for everyone aged 12 years or above.
Sources also informed that the vaccine can be stored for upto a month at 2-8 degrees.
What the Data Indicates
Pfizer has also provided the government with data and said that the UK’s Public Health England (PHE) has reported 87.9 percent, or high-vaccine effectiveness against the B.1.617.2 variant, most prevalent in India, in an observational study that concluded on 22 May, PTI said in its report.
Additionally, 26 percent of the participants in that study were of "Indian or British Indian" ethnicity.
The vaccine has also demonstrated effectiveness against the B.1.1.7 variant, first found in the United Kingdom and the B.1.351 variant, first recorded in South Africa.
The data shared with Indian authorities also includes "real-world evidence of BNT162b2 vaccine effectiveness and safety from national immunisation programmes".
The shared information includes trials showing nearly 95 percent effectiveness against COVID-19, 100 percent efficacy against critical illnesses, and 100 percent vaccine efficacy in 12-15-year-old adolescents, PTI reported.
Pfizer is ready to offer 5 crore shots to India in 2021 but has demanded significant regulatory relaxations, including indemnification in return, sources said on Tuesday.
The firm recently held a series of interactions with Indian government officials, during which it shared the data points regarding efficacy trials and approvals for its vaccine in various countries and by the World Health Organization (WHO).
It said, "The current situation in India, and across the world, is not ‘business as usual’ and we must not respond to it with processes as usual too," the PTI report quoted.
In the background of India launching its vaccine drive in January and administering over 20 crore doses, the country is still far from inoculating the majority of its citizens and is facing an acute vaccine shortage in many of its states.
Pfizer's Chairman and CEO Albert Bourla and the indian authorities have reportedly agreed to work together on three key issues to expedite the approval for the company's COVID-19 vaccine in India, namely procurement through a central government pathway; indemnity and liability; and the regulatory requirement for post-approval bridging studies, PTI reported.
Pfizer has urged the government to “rely on the 44 authorisations, including WHO’s approval, facilitate a EUA (Emergency Use Authorisation)/Restricted Use pathway for the Pfizer vaccine in India, and not seek a local PSA (Post Approval Commitment) study,” PTI reported.
However, the US-based manufacturer is open to negotiating safety surveillance of the first 100 subjects after understanding the process to be followed.
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