On December 4, Pfizer India became the first pharmaceutical organisation to apply to the Indian regulator for an emergency approval for its COVID-19 vaccine. The mRNA vaccine received an emergency approval in the UK earlier this week. However, in India, top officials monitoring the vaccine administration have said cold storage requirements in the country are inadequate for the Pfizer vaccine that requires storage temperature of -70 degrees.
Filing an application itself, however, doesn't imply that Indians would get the vaccine soon, experts say. According to Dr V.G. Somani, drugs controller general of India, in India, vaccines requiring marketing authorisation have to have undergone clinical trials on Indian population. "As far as vaccines are concerned, up till [sic] all marketing authorisations which are given in our country, are given only on the basis of clinical trials conducted on Indian populations," Somani said at a webinar on regulatory pathways for COVID-19 vaccines, organised by the health ministry on December 4. At the event, the drug controller highlighted the requirement for conducting a clinical trial in the Indian population as a prerequisite for getting an emergency approval in the country.
"For example, if some vaccines are coming from outside the country and they have generated a lot of data, they have already got the authorisation...they have already done Phase 1, 2,3 over there, in that case...we adopt the approach that we evaluate the data generated outside and if that data is found to be complying with requirement of our law that is relied upon and we allow the importer, or if the tech transfer is occurring in India, the tech transfer sponsor to conduct the trial from that stage onwards on the Indian population, on a small, reasonable population, that is called bridging trial data in Indian population. And that [trial data] is considered for authorisation purposes in emergency situations," Somani said.
In the past, though drugs have received approvals without having been tested on Indian population, in the case of vaccines, that has not been the case, a public health expert who did not wish to be identified, told THE WEEK. "Which is why it would be interesting to see how the DCGI responds."
The DCGI could ask for a bridging trial, that for instance, is being done in the case of other vaccines such as Oxford-AstraZeneca and Sputnik V. The Oxford vaccine candidate that is being tested on Indian people by Serum Institute, is likely to be submitted to the regulator in the coming weeks.
"India is a big market. And any company would want to start by applying for an approval. The details of supply chain and logistics of distribution notwithstanding, approval is a must,” the expert said.
The approval from the drug regulator doesn't mean that the vaccine would be part of the public health strategy of the government, either. "It may be sold in the private market for those who can afford," he said. Also, after the drug regulator’s approval, the National Technical Advisory Group on Immunisation takes a call on whether a vaccine should be part of the public health programme. “The two [regulator and NTAGI] need not be aligned,” NITI Aayog member Dr. V.K. Paul has said, citing the case of the flu vaccine where the product is not part of public health programme, but is available in the country.
In response to THE WEEK’s queries on Pfizer India’s plans for distribution in the country, a company spokesperson said, “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. We remain committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country.”
The spokesperson added that the company had developed “detailed logistical plans and tools to support effective vaccine transport, storage and temperature monitoring”. “Globally, we will be utilising road and air modes of transportation via our main carrier partners. We have also developed packaging and storage innovations to be fit for purpose for the range of locations around the globe where we believe vaccinations will take place.”
Elaborating on the storage plans, the spokesperson said, “We have three options for storage: Ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months. Second, Pfizer’s specially-designed, temperature-controlled thermal shippers, in which doses will arrive, that can be used as temporary storage units. 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 the vaccine can be used for a total of 30 days with re-icing every five days. “The third option for storage is the refrigeration units that are commonly available in hospitals. “The vaccine can be stored for five days at refrigerated 2-8°C conditions,” the spokesperson added.
The price of the vaccine has been reported to be around $40-50$ per patient.
