When the world faced a incurable pandemic, Big Pharma delivered. Moderna has joined Pfizer in successfully creating a COVID-19 vaccine with breathtaking speed, only to encounter the glacial pace of the government’s “expedited” approval process.
Moderna actually developed a cure that is 95% effective, mRNA-1273, in just two days this January as part of the Trump administration’s Operation Warp Speed. At a time when few people – reportedly even members of the research team – had heard of the novel coronavirus, scientists began looking for a cure. Messenger RNA technology meant that, instead of having to grow cultures of the virus in a laboratory, researchers merely needed its genetic sequence, supercharging the R&D process. And Moderna became one of the private firms to succeed (so far).
The two-day creation (hopefully temporarily) represents the summit of our history of speeding up vaccine introduction. A series of influenza vaccines rolled out over the course of 14 years; it took three years for Jonas Salk’s polio vaccine, nine years for Thomas Peebles’ measles vaccine, six years for the Yellow Fever vaccine, four years for the Hepatitis B vaccine, and five months for the H1N1 (Swine flu) vaccine. While Moderna accepted federal funding for its research phase, Pfizer – which received the world’s first authorization for a COVID-19 vaccine – confirmed that “all the investment for R&D was made by Pfizer at risk.”
But the R&D phase does not bring the tale to an end. There’s the rub. The FDA may approve both companies’ vaccines on December 10, and as many as 40 million doses may be distributed by year’s end. HHS Secretary Alex Azar has said, once approved, the vaccines could be delivered within 24 hours, and CVS Health announced it is ready to vaccine nursing home patients 24 hours after that.
The world now waits impatiently for the FDA to give its approval. The wait seems unbearable to a COVID-weary public – even in “Operation Warp Speed.” Even Republican allies of the president have had to publicly shame the FDA for dragging its feet on potentially life-saving breakthroughs. But compare this to the average FDA approval time of 10 months for “standard review” or six months for “priority review.” The full drug development usually drags on much longer:
New drug and device approval in the United States take an average of 12 and 7 years, respectively, from pre-clinical testing to approval. Costs for development of medical devices run into millions of dollars, and a recent study suggests that the entire cost for a new drug is in excess of $1 billion. For investigators seeking approval for new drugs and devices, FDA processes can be formidable.
That raises the question: What other cures may be trapped in the government’s Byzantine inspection regimen?
The question remains salient, because people across the political spectrum want to eradicate infectious diseases, yet all the public’s focus remains on the development, not the final approval. Joe Biden pledged in his Thanksgiving address, “We’re gonna find cures for cancer and Alzheimers and diabetes, I promise you.” However, his drug pricing plan would bleed an estimated $300 billion out of the drug industry over the next nine years.
The liberal-leaning Public Citizen group has already alleged that the COVID-19 vaccine producers “overcharged taxpayers.” While everyone wants to lower drug prices, “A 1999 Boston Consulting Group study found that pharmaceutical price controls in Greece, Belgium, and France delayed the drug development-to-market timeline by up to a year.” Profits matter, because they offer companies incentives.
As Moderna’s latest miracle shows, truly live in a time when “knowledge shall increase” (Daniel 12:4), or as a more accurate translation states, “knowledge shall be multiplied.” But knowledge does not fall out of Heaven like manna; it comes by deliberate cultivation. The Bible expositor Matthew Henry wrote in his commentary on Daniel, “Those that would have their knowledge increased must take pains, must not sit still in slothfulness and bare wishes but run to and fro, must make use of all the means of knowledge and improve all opportunities of getting their mistakes rectified, their doubts resolved, and their acquaintance with the things of God improved, to know more and to know better what they do know.” (Emphasis in original.)
The human race has proved it can learn how to stamp out global pandemics on an exponentially quicker timeline. But government has not yet demonstrated the innovation, dexterity, and efficiency to approve those cures in an equally safe but more expeditious manner. This status quo holds even though delays mean deaths increase as sickness persists and spreads. The pressing need is for our public leaders to learn how to decrease red tape without sacrificing patient health. Unfortunately, few seem interested in discovering how to bring the market’s speed into the public sector.