The COVID-19 vaccine candidate developed by US pharmaceutical giant Pfizer and German biotech firm BioNTech has brought hope since the announcement yesterday about its 90 per cent efficacy. But it looks unlikely that India would have it anytime soon, though both Pfizer and the Health Ministry have indicated they are open for talks.
The interim results released so far are of only 94 out of nearly 40,000 volunteers who were injected with the vaccine candidate. Pfizer will have to provide two months of safety follow-up data that will shed more light on how effective it is on elderly and severe patients. The current results have not given clarity about efficacy on these sub-groups. Pfizer will then have to seek approval for emergency authorisation from the US regulator. They may take up to third week of November to reach that point.
Only 50 million doses are expected to be available in 2020. These will be delivered proportionally by the end of this year to countries like the US, the UK and Japan, which have signed supply agreements with Pfizer.
India is yet to sign any agreement with Pfizer and as per India's regulatory requirements a vaccine would have to undergo local trials in India before it can receive an approval for a launch.
Vaccine experts in India have raised their concerns about the logistical issues including the fact that it requires storage at minus 70 degree Celsius and India lacks such cold chain infrastructure. Vaccine scientist and professor of microbiology at Christian Medical College in Vellore, Twitted , "This RNA vaccine needs ultracold storage. Not sure of BioNTech price, but Moderna is $37 a dose. Which makes these vaccines a stretch for less resourced countries that will find them hard to deliver and expensive."
The Health Ministry today indicated that they are open to a dialogue with Pfizer. "The National Expert Group on vaccines is in touch with both domestic and international manufacturers of all vaccines. We look at regulatory approvals for all vaccines. And also look at the resources they require for refrigeration. This is a continuously changing equation. As and when the approvals come and situation changes we will let you know," said Rajesh Bhushan, Health Secretary.
Pfizer in a statement to NDTV said, "Based on current projections we expect to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. If our vaccine candidate is successful, we would allocate the available 2020 doses proportionally across the countries where we have fully executed supply agreements that include delivery of a portion of doses in 2020. Pfizer is committed to ensure the availability of this vaccine for use by governments across the world. We seek to work with governments to support distribution to their defined priority groups. We remain committed to engaging with the government of India to advance our dialogue and explore opportunities to make this vaccine available for use in the country."
Presently, three other vaccine candidates Covaxin, ZyCoV-D and Covishield are in different phases of trials in India. Covaxin developed by Bharat Biotech and Covishield developed by the University of Oxford are in the final phase 3 of trials. ZyCoV-D developed by pharmaceutical firm Zydus Cadila is in phase 2 of the trial.
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