Ladakh rolls out drive to vaccinate those in 18-45 age group
When in the first week of February this year, Pfizer decided to withdraw its application for Emergency Use Authorisation of its Covid-19 vaccine in India, many conjectured that Pfizer s India chapter was closed for good.
At this time, the Pfizer spokesperson said, 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.
Fast tracking of foreign vaccines: Too little, too late? Ankit Kumar
Falling short with the desi Covid jabs, the government has decided to fast track the approval for vaccines, already cleared by the drug regulators of the United States, United Kingdom, European Union, Japan and the World Health Organization (WHO), under emergency use authorisation (EUA) provisions. However, with rising global demands, disruptions in the supply chain of critical components and backlog of unfulfilled contract obligations with other countries, the wait for these foreign vaccines could stretch longer. The modern messenger RNA (mRNA) based Covid vaccines by pharma giant Pfizer and biotech firm Moderna has turned out to be extremely effective against the raging pandemic in some countries like the US, Israel and UK. But India s already delayed response in regulatory clearance and government-sponsored acquisitions of these mRNA vaccines could mean months of extended wait in Indian markets
Image: Alamy
Pfizer has decided to give India a miss with its Covid-19 vaccine at least for now. On Friday, the pharma giant decided to withdraw its application for emergency use authorisation (EUA) of its vaccine, which it developed in association with Germany s BioNTech.
Pfizer, which is believed to have spent more than $2 billion developing the vaccine, was one of the first pharma companies to have applied for EUA in India. The pharma major applied for an EU with the Drugs Controller General of India (DCGI) in December. Subsequently, its India officials did not appear for a meeting with the regulator as bridging trial studies (trials on the Indian population) a necessary step for receiving marketing approval in the Indian market had not been conducted by them.
"Pfizer will continue to engage with authority & resubmit its approval request with additional information as it becomes available in the near future", the company's spokesperson said in a statement.