India’s cold chain a challenge as Pfizer makes COVID vaccine breakthrough

If the company decides to approach Indian regulatory authorities, a key issue will be of cold chain. Pfizer’s vaccine candidate requires storage and shipping in sub-zero temperature conditions

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Representative photo: iStock

When will an antidote against COVID-19 finally become widely available – that’s a natural question a day after pharmaceutical company Pfizer announced that its COVID-19 vaccine candidate has been found to be more than 90 per cent effective in preventing the disease.

Pfizer chairman and CEO Albert Bourla said, “Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19.”

A report suggested that the announcement does not mean a vaccine is imminent. This interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the US and five other countries, the report said.

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On the positive side, the US pharma giant has decided to hold discussions with regulatory authorities worldwide.

In August, the Indian government had had an “initial meeting” with representatives of Pfizer’s Indian subsidiary days after Pfizer released the early phase-1 trial data of its vaccine candidate for the novel coronavirus, which, it said, demonstrated a strong immune response.

Also read:COVID vaccine likely by Feb, 30 crore Indians to be priority beneficiaries

Pfizer has so far identified five facilities across the globe, including in the United States and Germany, to manufacture its vaccine. Top officials had confirmed that while Pfizer did not “as of now” have an agreement with the government, and had not identified any manufacturing facility, it was possible that a “fill and finish” option might emerge.

Pfizer has said it would manufacture up to 100 million doses of the vaccine by the end of 2020, and potentially more than 1.2 billion doses by the end of 2021. It has so far announced agreements to supply the vaccine to countries, including the US, United Kingdom, Japan, and Canada.

Should the company (and its partner, the German biotech firm BioNTech) decide to approach Indian regulatory authorities, a key issue that will have to be addressed is that of the cold chain. Pfizer’s mRNA vaccine candidate requires storage and shipping in sub-zero temperature conditions.

A subgroup formed by India’s high-level expert group on vaccine administration has started to map cold storage facilities across the country, including those available with the food processing industry. The 28,000-unit cold storage network that the country’s universal immunisation programme uses currently handles temperates in the range of 2-8 degrees Celsius.

India raced ahead with work on its vaccine while Britain’s AstraZeneca said its deliveries were running “a little bit late.”

Australia is beefing up its prospective arsenal against the pandemic to 135 million doses of various vaccine candidates. “We aren’t putting all our eggs in one basket,” PM Scott Morrison said last week.

An Indian government-backed vaccine could be launched as early as February — months earlier than expected — as last-stage trials begin this month and studies have showed it is effective, a scientist said.

Also read:Bengal begins preparing for COVID-19 vaccine rollout

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