UK Approves Pfizer’s COVID Vaccine; What Does it Mean for India?

Pfizer and BioNTech had earlier applied to the European drugs regulator for conditional authorisation of their shot.

Pfizer had said that a final analysis of clinical-trial data from its COVID-19 vaccine trial shows that the shot is 95 percent effective.

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The United Kingdom has approved the Pfizer-BioNTech vaccine for rollout from 'next week’, AFP reported on Wednesday, 2 December. With this, the UK becomes the first country to approve the Pfizer vaccine as well as the first western country to approve a vaccine against COVID-19.

Pfizer CEO Dr. Albert Bourla called the UK’s approval of the vaccine a ‘historic moment’ in the battle against COVID-19, AFP further reported.

Britain's Prime Minister Boris Johnson hailed the development as "fantastic" news that would help life get back to normal, according to Reuters.

"It's the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again," he said.

Pfizer Inc and BioNTech on Tuesday, had informed that they have applied to the European drugs regulator for conditional authorisation of their COVID-19 vaccine, following similar steps in the United States and Britain, according to Reuters.

The companies had applied in the United States for approval on 20 November.

Vaccine 95% Effective in Final Trials, No Safety Concerns: Pfizer

United States’ Pfizer and Germany’s BioNTech, according to Reuters, reported final trial results on 18 November that showed that their vaccine candidate was 95 percent effective in preventing COVID-19.

The company also said that there had been no significant safety problems so far in a trial which included almost 44,000 participants.

“The Phase 3 study of our COVID-19 vaccine candidate has met all primary efficacy endpoints. The study reached 170 confirmed cases of COVID19, with the vaccine candidate BNT162b2 demonstrating 95 percent efficacy beginning 28 days after the first dose,” a statement from the company read, according to ANI.

The Pfizer-BioNTech data said that the vaccine’s efficacy in people older than 65 was more than 94 percent, according to Bloomberg.

An earlier preliminary analysis, results of which were announced on 9 November, had shown that the COVID-19 vaccine being developed by Pfizer Inc. and BioNTech SE prevented more than 90 percent of infections. Those findings were based on a preliminary analysis and Phase 3 trials of the vaccine were still underway at the time.

What Does the Pfizer Announcement Mean for India?

While UK’s approval of Pfizer is certainly encouraging news, what does it mean for India?

The Pfizer vaccine requires minus 70 degree Celsius (minus 94 degrees Fahrenheit) or even lower – one of the coldest temperatures ever seen in a vaccine.

Dr Shahid Jameel, Virologist and Director, Trivedi School of Biosciences at Ashoka University, had spoken about the cold chain requirement in India and had said that the Pfizer vaccine may not be a practical choice or option.

“This vaccine requires ultra-cold temperatures to be stored in - near -94 degree F in supercooled containers. This creates immense challenges as far as the distribution and cold chain for the vaccine is concerned,” Dr Jameel said, speaking to FIT.

“Therefore, it is certainly not a vaccine with which you can think of immunising a lot of people in India, because India just doesn’t have the infrastructure for this kind of a cold chain. Perhaps, some very rich people who can afford to pay a lot of money may be able to afford it, that too if the vaccine finally becomes available in India. But the fact of the matter is, don’t get too happy that this vaccine will reach us In India in the near future. It won’t.”

Dr Shahid Jameel

Pfizer and Biotech, along with other companies, are reportedly working on this challenge, investing in cold storage, freezers, transportation and temperature tracking devices. But the prospect of these reaching other countries, especially those without the required infrastructure, remains low.

(With inputs from AFP.)