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.
“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 said in a statement.
Besides the Pfizer-BioNTech vaccine, two others had applied for an EUA in India: Covishield, the Covid-19 vaccine developed jointly by AstraZeneca and Oxford University, which is manufactured in India by Adar Poonawalla’s Pune-based Serum Institute of India; and Covaxin, the indigenous vaccine developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune. The DCGI approved the applications of both Covishield and Covaxin in early January and the two vaccines are being used in the first phase of India's inoculation drive as part of which 30 million healthcare workers are being vaccinated.
India is a significant market for the pharma giant, but the demand from the West is so high that an India launch for its vaccine seems to be on the slow track, till Pfizer initiates and submits data of a ‘bridging trial’.
“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,” Pfizer said in the statement.
The Pfizer-BioNTech vaccine, based on messenger RNA (mRNA), delivers a message to the body’s cells via a lipid nanoparticle envelope that instructs the cells to generate the spike protein found on the surface of a Coronavirus that initiates infection. Instructing cells to generate the spike protein spurs an immune response. But the vaccine is much more expensive than the two being used in the vaccination campaign in India. Besides, the vaccine needs to be stored at -70° C, which would require special infrastructure, especially in tropical countries such as India. In an email interview with Fortune India, a Pfizer spokesperson spoke about how to distribute the vaccine at such low temperatures, the company's supply strategy, and the vaccine platform, among other things. Edited excerpts:
What is Pfizer's strategy to supply its vaccine across the world?
Governments globally are developing comprehensive and strategic pandemic response plans. At this time, it is most appropriate that any vaccine that receives regulatory approval is made available to governments for use as per their plan. Therefore, at this stage, our priority is to ensure the availability of this vaccine for use by governments across the world. During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval.
The Pfizer vaccine needs to be kept at -70° C. This will require special infrastructure, which most countries don't have. So how will Pfizer distribute its vaccine?
Pfizer has built a capability to deliver this vaccine to the last mile vaccination centres using our specially designed, temperature-controlled thermal shippers. The shipper can maintain the recommended storage condition -70°C±10°C for 10 days unopened which allows for transportation globally to ensure all patients have access. Once opened, and if being used as temporary storage by a vaccination centre, then it can be used for a total of 30 days with re-icing every five days. It can also be stored in refrigeration units that are commonly available in hospitals. The vaccine can be stored for five days at refrigerated 2°C-8°C conditions. The minimum requirement for these shippers to be fully utilised is 5,000 doses.
Where have you rolled out your vaccine under EUA?
The Pfizer-BioNTech Covid-19 vaccine is already being administered in several countries across the world. Till date, Pfizer has received emergency use authorisations in a number of countries including the U.K., EU, the U.S., Canada, Mexico, Saudi Arabia, and Singapore.
Can you describe your vaccine platform technology?
The Pfizer BioNTech Covid-19 vaccine is a messenger RNA (mRNA) vaccine that has both synthetic, or chemically produced, components and enzymatically produced components from naturally occurring substances such as proteins. Unlike a traditional vaccine that uses inactivated, dead, or portions of actual virus to spur an immune response, mRNA delivers a message to your body’s cells via a lipid nanoparticle envelope that instructs the cells to generate the spike protein found on the surface of a Coronavirus that initiates infection. Instructing cells to generate the spike protein spurs an immune response, including generation of antibodies specific to the SARS-CoV-2 spike protein.
How are adverse effects monitored and dealt with?
We closely monitor all reports following vaccination, including any adverse events, including side effects we observed in the trial. As with all medicines, the process of monitoring for events is ongoing. The trial will continue for two years and participants will continue to be monitored for potential longer-term protection and to collect safety data for two years after they receive their second immunisation.