Pfizer has decided to withdraw the application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in India. Pfizer was amongst the other industries like Dr. Reddy's Lab and Zydus Cadila which was seeking DCGI approval for their COVID-19 vaccine for EUA.
Pfizer India was the first company to apply for EUA in India on 4th December 2020 for it's mRNA Covid-19 vaccine just after it had received an emergency approval in the United Kingdom.
A company spokesperson said in a statement, "In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3. Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time."
“Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future. Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment.”
It seems like Pfizer may have considered a number of factors before making this decision to withdraw EAU from the second largest populated country.
India has already approved COVAXIN and COVISHIELD for EUA in the country and the central government tied up with manufacturers of these vaccines and supplied it to various states of India. As on 5th February, 2021, till 8:00 AM, nearly 50 lakh beneficiaries have received the vaccination under the countrywide COVID19 vaccination exercise.
Besides, Number of COVID-19 cases are declining in India day by day. India’s cases per million population (7,828) are amongst the lowest in the world. This count is much higher for countries like Russia, Germany, Italy, Brazil, France, UK and USA. A total of 1.04 Cr (1,04,96,308) people have recovered so far. 15,853 patients have recovered and got discharged in the last 24 hours. The Recovery Rate has reached 97.16%.
Also, there are few chances that Dr. Reddy's Lab COVID-19 vaccine Sputnic V and Zydus cadila's COVID-19 vaccine may get approval in a couple of months.
Pricing is matter in India and Pfizer's COVID-19 vaccine estimated pricings are assumed to way higher than COVISHIELD and COVAXIN. Also, there are stringent criterias for handing of the Pfizer vaccine.
Pfizer is also having prior commitment to supply vaccines in various parts of the world, specially the USA which is a big market for any pharmaceutical industry.