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Was Vaccine Production Actually Delayed?

… for the entire span of the pandemic in this country, which has already killed more than 250,000 Americans, we had the tools we needed to prevent it .

– David Wallace-Wells, We Had the Vaccine the Whole Time

In the weeks since the article’s publication, libertarians have lamented the failures of the FDA, our unwillingness to experiment with human-challenge trials, and the bureaucratic nightmare that is seemingly to blame for the entire pandemic.

According to Moderna’s own timeline, the first clinical batch was shipping February 24th, but didn’t receive emergency use authorization until December 18th. That’s a 10 month gap, and so the righteous indignation seems justified, if not outright required.

But how much faster could production have actually gone?

Take a closer look at the timeline, and you’ll see that by August 11th, the US government had already awarded Moderna $1.5 billion for the manufacture of 100 million doses. So whether or not the vaccine had received approval, Moderna was already ramping up production in parallel, just 6 months after the first clinical batch.

Is 6 months still too long? Look back and you’ll see that by May, Moderna had already planned to produce 1 billion doses. Even earlier in April, the US Biomedical Advanced Research and Development Authority awarded Moderna another $500 million “to enable large-scale production”.

We can go even further and consider this update from March 23:

While a commercially-available vaccine is not likely to be available for at least 12-18 months, Moderna reported it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020.

Moderna confirmed that it is scaling up manufacturing capacity toward the production of millions of doses per month, in the potential form of individual or multi-dose vials. [emphasis mine]

So were the delays primarily bureaucratic? From what I can tell, Moderna had the institutional support it required, and began working in March to scale up production, less than a month after shipping the first clinical batch.

Furthermore, regulatory approval aside, Moderna never believed a vaccine could be made available, even for emergency non-commercial use, until fall.

So how much of the delay can be directly attributed to government bureaucracy? I’m not sure, but neither are you.

I accept that there were certainly some needless delays, and these are aggravating to read about, but it matters very much if it is a matter of a couple weeks or of several months.

Appendix: Trust in Vaccines

So long as I am expressing skepticism of bureaucracy as the root of all evil, consider the analogous debate over vaccine rollout.

While some have lamented the bureaucracy entailed in getting the vaccine, I worry this is not as serious an issue as the incredibly high levels of outright rejection.

How high are rejection rates? It depends on who you ask. In ascending order:

  • Kaiser Family Foundation reports a rejection rate of 27%, and 29% for healthcare workers.
  • A global survey published in Nature reports 28% of people do not agree they would get a vaccine.
  • The Public Policy Institute of California reports that 40% of adults and 69% of African Americans “probably or definitely” would not get the vaccine,
  • The Wall Street Journal reports a National Association of Health Care Assistants survey claiming “nearly 72% of certified nursing assistants didn’t want to receive the vaccine”.
  • The AP reports nurses have a rejection rate as high as 80% at some nursing homes.

It is easy to make fun of anti-vaxxers when they are a niche minority, much harder when they are the majority of healthcare workers. It is worth taking their concerns seriously, and at least attempting to understand why some people may be hesitant.

Remember, for example, when the CDC pretended to treat black Americans with syphilis, but secretly denied them care for 40 years. Or much more recently, when the CIA pretended to vaccine people for hepatitis, but was actually taking DNA for surveillance.

Where is the discussion of these historical ills in all the recent complaints?

My point is not that we ought to be suspicious of vaccines, merely that my current levels of confidence are predicated on the clinical trials. There is a long-game to play with regards to establishing trust, and attempting to play fast and loose with established procedures is not the way to win it.

The same PPIC survey also reports that 68% of Californians are “more concerned about approval of a vaccine moving too fast” while merely 26% are “more concerned about approval moving too slowly, delaying access to a vaccine”. Note that this skews liberal, so other states may be less extreme, but even among Republicans, 51% were “more concerned about approval moving too fast.”

None of this is to say that I am against accelerating future development! A recent proposal in Cell to conduct phase I/II trials for the 100 most likely pandemics is a great idea, and well worth the estimated $3 billion investment. I am certainly not advocating in favor of complacency.

And yet, I am not so confident that our behavior over the last 10 months has been such a disaster, nor am I confident that FDA bureaucracy is primarily to blame.