As a big breakthrough, drugmakers- Pfizer and their German partner BioNTech SE have announced that their COVID-19 vaccine is 90% effective, giving us hope that we may have finally won the battle against SARS-CoV-2. Here, Prof. Dr. Sundeep Mishra systematically breaks down the announcement and what we can expect from the new vaccine in India.

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Pfizer Inc in a breaking news on Monday announced the interim data on their vaccine (Phase III clinical trial) against COVID-19, involving 44.000 participants, finding that it was more than 90% effective (for an effective vaccine only 50% efficacy is enough) with no major side-effects (some minor side-effects were aches and fever). This they claimed was a major victory in the fight against a pandemic that has killed more than 10 lakh people and has turned literally turned the global economy and people’s daily life-style upside down. This indeed is remarkable because among the a million people, battered the world's economy and upended daily life. Each participant got two injections spaced 21 days apart and high effectiveness was noted 7 days after 2nd dose.

While more than 10 companies are in fray (notably Astra Zeneca, Johnson & Johnson and Moderna), Pfizer and German partner BioNTech SE are the first drug makers to release highly successful data (90%) from a large-scale clinical trial of a coronavirus vaccine (earlier vaccine had approached only 50% success with concerns of serious side-effects in some of them). Based on this early success they expect to receive U.S. authorization by the end of November for emergency use of the vaccine.

Is this vaccine applicable to India?

While Pfizer vaccine may be good news for some, it may not provide cheer to India because of 2 reasons;

1. It is likely to produce 5 crore doses (2.5 crore individuals), but the whole lot of vaccine has already been bought by richer nations from Europe and USA, leaving the developing world in a lurch.
2. Even if available, the vaccine is required to be kept at ultra-cold storage (at least (-68°C) and it rapidly deactivates at 2°C. This kind of cold-chain is non-existent in India (and other developing countries) at the moment.

Are the results reliable?

The results are as reported by the company spokesperson. They have not been peer-reviewed by scientists outside the company or published in a medical journal. Even details of vaccine performance are not available by the independent monitors overseeing the study. The company has reported no major side-effects but the duration of the study for which results are available is only 2 months. No long-term data is available.

Are there any downsides?

While an important downside is that as yet no long term data is available either for efficacy or side-effect, anything said about the results is premature. However, some researchers worry that being a genetic vaccine, it could interact with host DNA material.

On the face of it, this worry seems unfounded because the vaccine is mRNA which acts by synthesising only some non-pathogenic viral proteins (against whom host antibodies can develop) but because long-term data is not available, nobody knows what may happen. Thus, at the moment it may be prudent to wait for long-term data before using it very widely.

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author, Dr. Sundeep Mishra is a Professor of Cardiology.