It was more than a month back in April that India decided to open its doors to Covid-19 shots that are already in use in selected countries as a severe shortage of the domestically produced Covishield and Covaxin hit the pace of the vaccination drive at a time when India was grappling with a deadly surge of cases.
But despite feverish speculation on when these jabs will finally be available in India, there is little headway when it comes to actually securing supplies. One foreign vaccine, the Sputnik V made by Russia, has recently been rolled out in India, but with the country in a situation where every extra dose is welcome — given the task of inoculating a billion-plus people — all eyes are on the vaccines that have been made by the US-based Pfizer and Moderna to be quickly brought in.
Supply-side and logistical issues have been pointed out as big factors holding up the procurement of these two vaccines. While it is reported that their order books are full, reaching these vaccines when, and if, they arrive to the people who need them represents its own challenge as both have to be refrigerated at sub-zero temperatures and would require a robust cold chain system to be moved around the country.
However, regulatory and legal aspects of the efforts to bring them to India have emerged as a key sticking point. None of the three vaccines that have been cleared for use in the US, Johnson and Johnson’s single-dose vaccine being the third one, have sought permission to sell their vaccine in India although the Centre has said it would fast-track approvals for their launch here.
First, the numbers
According to a PTI report earlier this week, Moderna is only looking to launch in India next year with a single-dose vaccine that it is working on. That is because, due to prior commitments, it has no vaccines it can send to India this year. Although Indian drug-maker Cipla is reportedly pursuing five crore doses from Moderna for 2020, it is said to have “requested confirmation from the central government in respect of stability in regulatory requirements/policy regime”.
The Johnson and Johnson vaccine has had a chequered career since it received an emergency nod in the US in February this year. But few cases of blood clots and issues with a manufacturing facility in the US saw the country put a pause on the use of the vaccine that was later lifted. The Hyderabad-based Biological E is reported to have signed a deal to produce 1 billion doses of the vaccine under the Quad Vaccine Partnership, but not all doses will be for use in India.
That leaves us with the Pfizer-BioNTech vaccine. The US pharma giant has said it is ready to offer 5 crore doses to India between July and October this year, but there are factors of indemnity and exemption from trials in India that have come in the way of its becoming available here.
Legal protection for a jab that protects
Pfizer had sought emergency approval for launch in India, but withdrew from the process earlier this year with those in the know saying at the time that it was over the issue of indemnity that the pharma major was holding itself back.
Now, following the government’s decision to facilitate the launch of foreign vaccines to India, it is the same issue that has been flagged by the company as preventing it from catering to the Indian market.
What Pfizer is seeking is the signing of an indemnity bond that will exempt it from any action in case its vaccine causes side-effects among the people who receive it in India. It is a nod that Pfizer has secured from the other countries where it is sending its vaccine, including the UK and and the US.
However, India has not extended such an exemption to any of the vaccines that are currently in use in the country.
It is also reported that Pfizer also wants a waiver on local trials from the government. When India had extended an invite to any foreign vaccine that had received emergency approval in the US, Europe, UK and Japan or from the World Health Organisation (WHO), it had said that the “first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country”.
However, Reuters has quoted unnamed government sources to say that some form of legal protection would be included in any deal that Pfizer enters with India.
Covishield, Covaxin and the Russian Sputnik V had all completed small safety trials in India ahead of their roll-out in India.
Making a case for the indemnification clause, Pfizer is reported to have stated that millions of doses of its vaccine have by now been administered across the world with no serious side-effects being reported.
In a statement on May 27, the government said that it has held discussions with Pfizer, Moderna and Johnson & Johnson and “offered all assistance to have them supply and/or manufacture their vaccines in India”. But it added that “no application of any foreign manufacturer for approval is pending with the drugs controller.”
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