American pharmaceuticals company Pfizer’s efforts to market their Covid-19 vaccine to India have been beset with practical issues of storage temperature and distribution infrastructure.
The Subject Expert Committee (SEC) in India’s Central Drugs Standard Control Organisation (CDSCO) met on Wednesday to discuss the emergency use authorization of the Oxford-AstraZeneca vaccine. Pune-based Serum Institute of India (SII), who will manufacture their vaccine, applied for an approval in India soon after the vaccine was approved in Britain. The Committee considered emergency use authorization requests from Pfizer, SII, and Bharat Biotech Pvt Ltd.
Earlier this month, the expert committee on Covid-19 had requested the three companies to submit additional data. While SII and Bharath Biotech presented the data, Pfizer had requested more time.
The request for more time comes shortly after a 45-year-old nurse in California tested positive for Covid-19 a week after receiving the Pfizer vaccine.
The nurse, identified as Mathew W, stated in a Facebook post on December 18, that he had received the Pfizer vaccine. Six days later, on December 24, he fell sick. After working a shift in the Covid-19 unit, he later came down with chills, muscle ache, and fatigue. He went to the hospital the next day and tested positive.
“The company will review all available information on this case and all reports of any confirmed diagnosis following vaccination,” Pfizer said in a statement to Reuters. “Based on our Phase 3 safety and efficacy study, the vaccine provides some protection against Covid-19 within about 10 days of the first dose and substantially boosted after the second dose, supporting the need for a 2-dose vaccination series.”
Pfizer was the first pharmaceutical firm to seek emergency authorization for its Covid-19 vaccine in India, soon after it secured clearance in the United Kingdom and Bahrain. The application was submitted to Drug Controller General of India (DCGI) on December 4, seeking permission to import the vaccine for sale and distribution in India.