Vaccine experts in India raised concerns over logistical issues
New Delhi:
The COVID-19 vaccine candidate developed by the American pharmaceutical giant Pfizer and the German biotechnology company BioNTech has raised hopes since the announcement yesterday of its 90% effectiveness. But it seems unlikely India will have it anytime soon, although Pfizer and the Health Ministry have both indicated they are open to discussions.
The interim results published to date concern only 94 of the nearly 40,000 volunteers who received an injection of the vaccine candidate. Pfizer will need to provide two months of follow-up safety data to better understand its efficacy in elderly and severe patients. The current results have not clarified the efficacy on these subgroups. Pfizer will then need to seek approval from the US regulator for an emergency clearance. They can take up to the third week of November to reach this 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, UK and Japan, which have signed supply agreements. with Pfizer.
India has yet to sign a deal with Pfizer, and according to India’s regulatory requirements, a vaccine is expected to undergo local testing in India before it can receive approval for a launch.
Vaccine experts in India have raised concerns about logistics issues, including that it requires storage at minus 70 degrees Celsius and that India does not have such cold chain infrastructure. Vaccine scientist and professor of microbiology at Christian Medical College in Vellore, Twitted, “This RNA vaccine requires ultra-cold storage. I’m not sure how much BioNTech costs, but Moderna costs $ 37 a dose. these vaccines a stretch for less wealthy countries who will find them difficult to deliver and expensive. “
The Department of Health said today it was open to a dialogue with Pfizer. “The National Vaccine Expert Group is in contact with national and international manufacturers of all vaccines. We are reviewing regulatory approvals for all vaccines. And we also look at the resources they need for refrigeration. This is an ever-changing equation. As the approvals come in and the situation changes, we will keep you posted, ”said Rajesh Bhushan, Secretary of Health.
Pfizer in a statement to GalacticGaming said, “Based on current projections, we plan to produce up to 50 million doses of vaccine in 2020 and up to 1.3 billion doses in 2021. If our vaccine candidate is successful , we will allocate the available doses for 2020 proportionately among countries where we have fully executed supply agreements that include delivery of a portion of the doses in 2020. Pfizer is committed to ensuring the availability of this vaccine for use by governments around the world. We seek to work with governments to support distribution in the country. We remain committed to working with the Indian government to advance our dialogue and explore possibilities of making this vaccine available for use in the country. “
Currently, three other candidate vaccine candidates Covaxin, ZyCoV-D and Covishield are at different stages of testing in India. Covaxin developed by Bharat Biotech and Covishield developed by the University of Oxford are in final phase 3 trials. ZyCoV-D developed by pharmaceutical company Zydus Cadila is in phase 2 of the trial.
