December 2, 2020

The God Vaccine? Is it the second coming?

Let us temper expectations about the immediate end of Covid.
Keywords: Pfizer | BioNTech | Vaccine | Covid-19 | Lockdown | RCT | mRNA | Technology | Science | Supply Chain | FDA | Drug | Health | Co-morbidities
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The announcement by US giant Pfizer and startup BioNTech about their candidate vaccine for Covid-19 has been greeted with understandable euphoria, as people are chafing under the ‘new normal’ of lockdowns and restrictions. Indeed, markets cheered: stock market indices hit new highs; airline stocks soared; Zoom’s (an online video conferencing system) took a hit.

This reminds me of the fuss in certain circles about the Higgs Boson, the so-called ‘God Particle’, which, when found, confirmed certain theories about fundamental particles. Now people are acting as though we have found the ‘God Vaccine’. 

But it is too soon to celebrate, as there are many concerns and considerations. 

Most intriguingly, there is no clarity about efficacy, though the phrase “90% effective” has been bandied about. Exactly what does this mean? 90% of those who were vaccinated remained immune when exposed to the virus? What about the ethics of the trial? How can you deliberately expose people to possible harm: what about the other 10% of the test subjects who actually caught the disease when exposed? Did they die? What if it had been 50%?

What was the composition of the alleged 43,000 test subjects in the, let us emphasize, incomplete and ongoing Phase 3 trial? How many were aged, how many had co-morbidities? What was the breakdown by gender, race, age, body mass index, blood sugar level, cholesterol, cardiac calcium score, blood pressure, etc, etc? In other words, how random a sample was it?

Why didn’t they do an RCT? I am personally sceptical about RCTs, but the medical establishment seems to consider it a ‘gold standard’, and so what is the result of the randomized controlled trials?

What about side-effects? Other vaccine trials have been dogged by ill-effects on study participants, so much that several have been halted (and then re-started). For instance, on Nov 9th, Brazil briefly stopped its trial of a Chinese vaccine .

Crucially, how long does the immunity conferred by this vaccine last? Researchers don’t know, as the trial has only been going for a short while. But lay people want to know: will I be immune for a year? Six months? Three months? A week? 

How much is the vaccine going to cost? Is Pfizer doing this pro bono, covering only its costs, or it is going to make a profit? I heard an interview with one of Pfizer’s senior people, who said it was likely to be only covering its costs, but I’ll believe it when I see it. Big Pharma is not famous for charity. 

Let us consider the science and the technology behind the vaccine. The technology is not new: it was first practised by Indian vaidyas in the 1700s in Bengal. They vaccinated healthy people with cowpox pus, so their own immune system would develop responses to the much more deadly, and related, smallpox. You inoculate with an attenuated or dead pathogen, and the immune system learns to recognize it, and will fend off a live infection.

The science, however, is newer, and rather alarming. Instead of the typical attenuated or dead pathogen, this vaccine is a live, so-called mRNA vaccine. Here’s a description of what mRNA vaccines are, from Statnews, the Boston Globe’s health publication:

“Both Pfizer’s vaccine and Moderna’s use messenger-RNA, or mRNA, technology, which uses genetic material to cause the body to create a protein from the virus; the immune system then recognizes the virus and learns to attack. Other vaccines in the late stages of development use genetically engineered viruses for a similar purpose, or pieces of protein that are directly injected. No mRNA product has ever been approved by regulators.”

That last sentence makes me really nervous. What if the mRNA goes rogue, and replicates in unforeseen ways? This science is going to be tried out on millions of people as guinea pigs? Pfizer expects to produce 50 million units by year-end, and 1.1 billion units in 2021. .

Of course, there will be vaccine haves and have-nots.

Even if the science is blameless, productization will have to proceed as always: engineering, manufacturing, distribution. Unfortunately, there are possible glitches. In terms of manufacturing, it is not clear whether there is enough supply of Bill of Materials items such as glass syringes, needles, rubber stoppers and all other items needed for a vast and quick ramp-up. 

Even if the supply chain can be managed, there is the gigantic problem of distribution. The vaccine has to be maintained at -80 degrees Celsius. That will be a problem. For instance, India’s ‘cold chain’ created for distribution of pulse polio drops can guarantee no more than -8 degrees Centigrade. It is possible that this means only urban people mostly in rich countries have a chance of getting the vaccine.

There was also the optics of the vaccine announcement with the US Food and Drug Administration (FDA) on board, just days after such a news could have made a huge difference in voter sentiment. An earlier story in the New York Times (“How the FDA stood up to the President”), suggests tensions between President Trump and the FDA:

“The F.D.A. wanted to require two months of follow-up data to make sure a vaccine was safe and effective, all but ensuring one would not be ready by Election Day as President Trump had promised.”

Naturally, a peeved Trump has claimed that the FDA in effect conspired to deny him a victory. But the FDA has made other peculiar decisions lately, for example it approved Remdesivir for Covid-19 within days of a WHO study that suggested that it had no effect whatsoever. 

All in all, for something that is practically the holy grail for many, this vaccine seems distinctly dicey.

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Rajeev Srinivasan

Rajeev Srinivasan

Rajeev Srinivasan is a management consultant and columnist. He focuses on strategy and innovation and has taught at several IIMs. He is an alumnus of IIT Madras and the Stanford Business School.

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