Days after Pfizer received an Emergency Use Authorisation (EUA) for its Covid-19 vaccine in the UK, the multinational drugmaker is said to have approached the Indian regulator with a similar request.
The company has applied to the Drug Controller General of India (DCGI) for an EUA on its vaccine, a Health Ministry source confirmed to BusinessLine. It is not clear, though, how long the process will take, as a committee will review whether “bridging studies” will be required to assess how the vaccine works on the Indian population.
Pfizer has constantly maintained that its vaccine has the potential to be part of India’s response to tackling the novel coronavirus and that it is committed to engaging with the government to make the vaccine available in the country.
The hitch, however, is in its storage and distribution, as the next-gen mRNA vaccine will need temperatures of (minus) 70°C.
Responding to a query on the EUA filing in India, a Pfizer spokesperson said: “Pfizer is dedicated 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.”
Doctors following the vaccine developments had indicated that Pfizer would support the storage and distribution in countries like India, and possibly even work on stabler versions that can be transported at less extreme temperatures.
In a note to BusinessLine, the company outlined its storage options.
Storage options
It said there are ultra-low-temperature freezers, which are commercially available and can extend the shelf life for up to six months. Then, there are “Pfizer specially designed, temperature-controlled thermal shippers in which doses will arrive, and can be used as storage units. They can maintain the recommended storage condition -70°C±10°C for 10 days unopened. Once opened, and if being used as temporary storage by a vaccination centre, it can be used for 30 days with re-icing every five days,” it explained. And since refrigeration units are commonly available in hospitals, “the vaccine can be stored for five days, refrigerated at -2-8°C,” it said.