Project Lightspeed - Too fast to be true?

BioNTech Covid-19 Vaccine Development

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I am currently reviewing 80,000 pages of the newly released Pfizer documents, so please subscribe to give me some encouragement! Whilst doing so, I came across numerous references to advisory meetings between BioNTech and the Paul Ehrlich Institut (PEI) on 6th February 2020. The PEI is the German regulatory body and research institution for vaccines and biomedicines and as I’m sure you’re aware, Pfizer partnered with BioNTech, a German pharmaceutical company to produce their Covid vaccines.

This information is not new but it got me thinking about the speed of BioNTech’s vaccine development. Was this early development incredible foresight and a calculated risk by BioNTech or were they privy to information that was not being publicly shared?

BioNTech called their vaccine development “Project Lightspeed” and the early timeline, from their website, goes as follows:

January 12,2020: - SARS-CoV-2 genetic sequence

• Ugur Sahin read a publication in the Lancet about a new virus that emerged in the Chinese province of Wuhan.

• Immediately, Ugur realized that this virus had the potential to spread beyond Chinese borders. Not only was the virus novel and highly infectious, but treatments were also unavailable and several infected individuals did not show any symptoms. In addition, Wuhan is a heavily populated city with over one million inhabitants that is highly connected to the rest of the world.

• He discussed this with Özlem Türeci and the management team and, a few days later, BioNTech initiated “Project Lightspeed” in order to develop a potential vaccine against COVID-19.

Mid-January 2020: Start of global development program

• Subsequently, BioNTech selected potential vaccine candidates and conducted non-clinical studies.

• Shortly thereafter, the team initiated GMP production of its vaccine candidates (in Germany) for potential clinical studies.

March 16/17 2020: Collaborations

• BioNTech announced a development and commercialization collaboration with Fosun Pharma. Together, the companies aim to develop BioNTech’s mRNA vaccine candidate in China to prevent COVID-19 infections.

• BioNTech and Pfizer signed a letter of intent to develop and commercialize the mRNA-based vaccine against the coronavirus outside of China. The collaboration with Pfizer built on the existing influenza partnership.

Ugur Sahin (referenced above) co-founded BioNTech with his partner and spouse Ozlem Tureci. According to the timeline, on 12 January, Ugur read a publication in the Lancet and within the space of a few days, managed to convince the rest of the company to develop a new vaccine. Again, within a few days, they selected vaccine candidates. And finally, a couple of weeks later they were discussing vaccine trials with the German regulatory authority.

Photo by Anton Filatov on Unsplash

Now maybe it is quite possible for all that to happen so quickly, and if so, hats off to them. However, even if the timing wasn’t an issue, what about the risk?

In a 2018 study in The Lancet Global Health, the estimated cost of early development and initial clinical safety trials for a typical vaccine is between $31-$68 million. In an accelerated timetable with a new coronavirus, this cost might be higher.

Would a large pharmaceutical company really risk that much money on a virus that might fizzle out?

On 12th January, no new cases had been reported in China since 5 January, although Wuhan hospitals were beginning to fill up. The WHO said that there was no clear evidence that the virus passes easily from person to person. China had only reported one death by this point.

By 6th February, when BioNTech were already in detailed discussions with PEI, 545 people in China had died and there were only 31 cases in Europe.

It was only on 1 February 2020 that Jeremy Farrar of the Wellcome Trust and Anthony Fauci were discussing whether the virus came from a lab leak and how they should respond.

Furthermore, it was only on 30 January 2020 that the WHO declared a Public Health Emergency.

Without discussing how well the vaccines work etc, if Ugur took the massive risk to spend a lot of money developing a vaccine under “Project Lightspeed” that early on, then again, hats off to him.

But to me, risking tens of millions of dollars on an article read in the Lancet seems dubious. And convincing the whole company to go along with it seems far fetched without further information to back it up. This was a company that was primarily focused on cancer vaccines although they had started a R&D collaboration with Pfizer for a flu vaccine in 2018. They had no experience at all of coronaviruses.

I’ll say it again, maybe Ugur could sense what was coming, took a great financial risk and hit the jackpot. Again, without commenting on the actual vaccines themselves, if that is the case, I congratulate him for great entrepreneurship.

However, I suspect that Ugur knew more than just what he had read in the Lancet. And if Ugur knew enough to risk tens of millions of dollars then so did the WHO and other public health authorities. As I’ve explored before, there is mounting evidence suggesting that the virus was already spreading globally in 2019.

So, when did our governments really know about the spread of Covid? If it was already widespread then did the panic produced by the response in March/April 2020, cause many of the excess deaths, instead of the virus itself?

Was the early vaccine development a gamble or a calculated risk with knowledge that had not been released to the public? And why is Bill Gates always so great with his timing? BioNTech received a capital contribution of $55 million from the Bill & Melinda Gates Foundation in September 2019, just before Event 201, with an option of doubling that investment at a later date. To be fair, this was just before BioNTech’s Nasdaq IPO but still, great timing! Share prices rose 28 fold in 2 years after that.