The Capital Note: COVID-19 Vaccine Developed at Historic Speed

Moderna Therapeutics headquarters in Cambridge, Mass., May 18, 2020. (Brian Snyder/Reuters)

Welcome to the Capital Note, a newsletter about business, finance and economics. On the menu today: how we got a vaccine, how it works, how it will be transported, and how our forebears distributed a smallpox vaccine.

COVID-19 Vaccine Developed at Historic Speed
In just eight months, two American companies have developed vaccines that appear to be safe and effective in preventing COVID-19. Following Pfizer’s blockbuster results last week, Moderna released early results showing its vaccine prevented infection in 94 percent of patients in clinical trials, and, unlike Pfizer’s candidate, demonstrated effectiveness in preventing severe infection. And whereas the Pfizer vaccine must be stored in industrial freezers, the Moderna vaccine can last up to 30 days in a regular refrigerator, making it easier to distribute.

If the early data from Pfizer and Moderna hold up, a COVID-19 vaccine will have been developed in roughly 10 percent of the typical eight-year vaccine-development timeframe, according to a paper from the Yale School of Medicine:

Between January 2010 and June 2020, the FDA approved 21 vaccines, most commonly for influenza (5 [23.8%]) and meningococcus (5 [23.8%]). Of these, 4 (19.0%) received Accelerated Approval. The median premarket clinical development period (investigational new drug submission to FDA approval) was 8.1 (interquartile range [IQR], 6.1-10.5) years, including a median FDA review period (BLA submission to FDA approval) of 12.0 (10.8-21.0) months.

The speed with which vaccines have come to fruition is a testament to the scale of the development effort: Each trial has included more than 30,000 patients, well above the median number of 5,000 patients in the usual vaccine trial. Somewhat perversely, the severity of the domestic coronavirus outbreak facilitated these trials, because the number of infections increased the amount of data available to pharmaceutical companies.

Vaccine developers were also helped along by the federal government’s Operation Warp Speed program, which provided research funds and guaranteed large purchase orders. Absent the financial considerations that can stall drug development, companies committed enormous amounts of capital and labor to the vaccines. Both Pfizer and Moderna received advance vaccine orders of $2 billion and $1.5 billion, respectively, and Moderna received an additional $1 billion in development funding from the government.

The medical feat is all the more stunning because it’s based on an entirely new technology. Whereas vaccines traditionally use dead viral material to spur antibody production, current COVID-19 candidates inject patients with messenger RNA that encode the coronavirus spike protein in patients’ cells. The new technology sped up development, as an Economist article explains:

It is no accident that the vaccines that have come along fastest are based on these novel strategies. Before the coronavirus struck these technologies were already being developed as platforms on which a rapid response to a new viral disease could be built, work supported in part by the Coalition for Epidemic Preparedness Innovations (cepi). Vaccines which are built on such platforms are quick to engineer and comparatively easy to make.

The government’s orders of several hundred million doses of each vaccine should be enough to suppress COVID-19 by mid 2021. A recent paper found that “If face mask use is reduced by 50% . . . a vaccine that is 80% effective (moderate vaccine) would only require 32-57% coverage to suppress the epidemic.” Given that current vaccine efficacy has exceeded 90 percent, roughly 130 million Americans will need to be vaccinated to suppress the coronavirus domestically.

At long last, a light at the end of the tunnel.

Around the Web
Vaccines are ready. Now they must be securely transported (Wall Street Journal):

Drugmakers and health authorities are counting on Corning’s new medical glass container, named Valor, to protect Covid-19 vaccines better than conventional ones, especially during initial months when supplies will be limited and little can afford to be lost.

Thanks to their special recipe, Valor vials can be filled faster than conventional counterparts, and then withstand the subzero temperatures required to store the leading vaccine candidates. The vials are also embedded with identifiers visible under black light to prevent counterfeiting.

In a week of good news, more good news: SpaceX launched four astronauts to the International Space Station on Sunday: “Lighting up the night sky, four astronauts shot into orbit atop a SpaceX Falcon 9 rocket Sunday for a 27-hour voyage to the International Space Station in the first operational flight of a commercially developed Crew Dragon capsule.”

For the scientifically minded, how COVID-19 vaccines could usher in a new age of nanomedicine. Physicist Richard Jones explains that the vaccines rely “on packaging the mRNA molecules inside nanoscale delivery devices.”

These packages protect the mRNA from the body’s defense mechanisms, carry it undamaged into the interior of a target cell through the cell’s protective membrane, and then open up to release the bare mRNA molecules to do their job. This isn’t the first application of this kind of nanomedicine in the clinic – but if the vaccine lives up to expectations, it will make unquestionably the biggest impact. In this sense, it marks the coming of age of nanomedicine.

Random Walk
Now that a COVID-19 vaccine appears to be in the offing, public-health officials are gearing up for the logistical challenge of distributing hundreds of millions of doses across the country. We’ve done this before: In the 19th century, vaccine couriers raced across the world to deliver smallpox vaccines.

From Wikipedia, via Alex Tabarrok:

In 1803, the [Spanish] king, convinced of the benefits of the vaccine, ordered his personal physician Francis Xavier de Balmis, to deliver it to the Spanish dominions in North and South America. To maintain the vaccine in an available state during the voyage, the physician recruited 22 young boys who had never had cowpox or smallpox before, aged three to nine years, from the orphanages of Spain. During the trip across the Atlantic, de Balmis vaccinated the orphans in a living chain. Two children were vaccinated immediately before departure, and when cowpox pustules had appeared on their arms, material from these lesions was used to vaccinate two more children.

There was even a vaccination program on the American frontier:

[Later] President Thomas Jefferson gave some cow lymph to Meriwether Lewis and William Clark to take on their explorations west of the Mississippi River. Antoine Saugrain, the only practicing physician in St. Louis when Louisiana was purchased by the United States from France in 1803, received some cowpox lymph from Lewis and Clark and began to vaccinate individuals free of charge, including Native Americans. Saugrain’s free vaccination program established cowpox in the Mississippi valley roughly a decade after Jenner published his inquiry.

— D.T.

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