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

US regulators have approved the emergency use the Pfizer and BioNTech vaccine. Will it reach India?

Updated

In big news on the vaccine front, US regulators have approved the emergency use of the country's first Covid-19 vaccine from Pfizer and its German partner BioNTech for people aged 16 years and older, reported IANS on 12 December. Earlier, the United Kingdom had approved the Pfizer-BioNTech vaccine for rollout from 'next week’, AFP reported on Wednesday, 2 December.

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.

Earlier in November, Pfizer and BioNTech had announced that their coronavirus vaccine was more than 90% effective in preventing COVID-19. To understand the results better and what they meant for India, FIT had spoken to Dr Shahid Jameel, Virologist and Director, Trivedi School of Biosciences at Ashoka University.

Will India be getting it anytime soon?

Dr Jameel: A word of caution here. 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.

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.

The development is, nevertheless, good from the point of view that it has proven a concept. India is in a fairly good position. In the coming months, we are likely to have at least 3 or 4 candidates that are working on the same principle essentially - not mRNA, but the same part of the virus, and hopefully, they will also show efficacy.

How do we make sense of the preliminary results? Is this good news?

Dr Jameel: Although these are interim phase three results, they are very encouraging from a few different perspectives.

These are the first initial results from a late-stage human trial of any COVID vaccine which have been shared. Secondly, this is the first mRNA vaccine platform that has shown to be efficacious. Till date, there has been no RNA based vaccines that have been licensed for use. This bodes really well for the future because it’s fairly simple to make RNA vaccines once you have the platform available. This also proves that you can take a small part of the virus structure, immunise with it and get protection. In this case, they didn’t even have to use the entire spike protein, but only a part of the spike protein.

So yes, it is optimistic from many different angles. We can hope that by the end of this year, we would know for sure whether this vaccine receives emergency use authorisation from the Food and Drug Association or not.

The FDA’s threshold for emergency use authorisation is 50% efficacy. Is 90% a realistic number? Did we expect it?

Dr Jameel: No, nobody was expecting that. In fact, I don’t think even the company was expecting it.

They were expecting the vaccine to be about 70 percent efficacious. It turned out to be more than 90 percent. For now, you have to go by the data. Its possible that when the analysis is done at a later time point, the efficacy may drop from 90 percent to, maybe, 85 or 80 percent. It would still be a good vaccine.

These early results are extremely encouraging and positive, but let’s wait for the final data to come out.

How is India’s COVAXIN different from Pfizer’s vaccine?

They are very different. COVAXIN is the whole virus. The procedure for such inactivated vaccines is that you grow a lot of the virus, purify it and then kill it with a chemical. This killed virus is then injected.

On the other hand, the mRNA vaccine and even the Oxford-Astrazeneca vaccine are based on a single component from the virus- the spike protein. COVAXIN contains all the proteins that are present in the virus.

(Subscribe to FIT on Telegram)

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