What Pfizer Said On Key Challenge In Coronavirus Vaccine Storage In India

American pharmaceutical firm Pfizer, which has asked the DCGI (Drugs Controller General of India) for emergency approval of its coronavirus vaccine, has said it is prepared to address a key challenge in the distribution of its vaccine - ultra-cold storage.

The US firm, which has developed Covid vaccine jointly with German partner BioNTech has sought India's approval as the United Kingdom and Bahrain prepare for the vaccine rollout.

The vaccine, however, needs to be stored and transported at - 70 degrees Celsius. Experts in India have raised concern about the logistics as most vaccines in the country are stored between 2 and 8 degrees.

In a statement to NDTV, the firm said: "We have experience working with customers in all markets to help ensure success. We have 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," the statement added.

The DCGI may give emergency approval if it is satisfied by the results of the trials conducted outside India, sources say. The regulator has "discretionary power to waive localised clinical trials for a vaccine," as per officials. 

Pfizer has given three options for storage. The first one is ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months. 

The second option, according to the firm, are "the specially designed, temperature-controlled thermal shippers, in which doses will arrive, which can be used as temporary storage units". 

"The shipper can maintain the recommended storage condition -70 Degrees C plus/ minus 10 Degrees 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," reads the statement. 

Refrigeration units that are commonly available in hospitals can be used as the third option. The vaccine refrigerated at refrigerated 2 to 8 degrees - can be stored for five days.

Serum Institute, the world's largest vaccine maker by number of doses produced, has also sought government approval for the vaccine it has developed with British firm - Astrazenaca and the University of Oxford, according to officials familiar with the matter.

Pricing may be another issue for Pfizer as Adar Poonawala of the Pune-based institute had earlier suggested they may offer vaccine at reasonable prices after talks with the government agencies. 

In its statement on Sunday, Pfizer said the pricing of the vaccine will depend on the doses ordered and the advance commitments with the government. 

"Our vaccine approach is based on the principles of ensuring broad access and supplies to governments. This is reflected in all aspects of our agreements with various Governments with the pricing strategy being an outcome of volume, advanced commitment, equity and affordability principles," it said. 

While Pfizer has said its vaccine is 95 per cent effective in stage-3 of trials, AstraZeneca last month had said an interim analysis of clinical trials of its COVID-19 vaccine in the UK and Brazil showed that it was 70 per cent effective on average, adding it can be up to 90 per cent effective.