Pfizer Inc has withdrawn an application for emergency use approval of its Covid-19 vaccine following a meeting with Drugs controller General of India (DCGI). in a statement, the company said it participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India earlier this week. It said based on the deliberations and the company’s understanding of additional data that the drug regulator might be requiring, the company has withdrawn its application for the time being. Pfizer said it will resubmit its approval request once more data is available.
The US drugmaker said it was committed to making the vaccine available in India and pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment.
Pfizer was the first drugmaker to apply for emergency use authorisation in India. However, it was asked by the drug regulator to submit more data. DCGI had later approved two indigenous vaccines – Covishield and Covaxin for emergency use. The vaccination drive is currently underway in the country with these two vaccines. In the first phase, frontline and healthcare workers are being vaccinated.
The country has so far vaccinated around 40 lakh healthcare workers within 18 days of vaccine roll-out. According to data shared by health ministry, 44,49,552 healthcare workers have received their first vaccine shot. According to Union Health Minister Dr Harshvarrdhan, this is the fastest vaccination done across the world.
The health ministry has said that the hesitation in getting vaccinated is also decreasing. It said number of beneficiaries being vaccinated every day has shown a progressive increase. Uttar Pradesh has vaccinated most number of healthcare workers so far with number of beneficiaries crossing 4.63 lakh, while Maharashtra, Karnataka and Rajasthan have vaccinated more than 3 lakh beneficiaries.