The most promising of the vaccines was fully designed before the first confirmed American case and was manufactured for testing before the first American death. How much faster could we have moved to deliver it? How many lives might've been saved? (1/x) https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html

"To start, this is—as the country and the world are rightly celebrating—the fastest timeline of development in the history of vaccines. It also means that for the entire span of the pandemic, which has killed more than 250,000 Americans, we had the tools we needed to prevent it."

"That a vaccine was available for the entire brutal duration may be, to future generations trying to draw lessons from our death and suffering, the most tragic, and ironic, feature of this plague."

"In weighing other risks and uncertainties, Americans have been much less cautious. On March 28, on what would normally be considered very thin evidentiary ground, the FDA issued an emergency-use authorization for the drug hydroxychloroquine."

"On May 1, it issued an EUA for remdesevir. On August 23, it issued another for convalescent plasma (the practice of injecting antibodies from the blood of recovered patients into those sick with the disease)."

"These were all speculative authorizations — gambles, without concrete evidence, that existing treatments which scientists and doctors had some reason to suspect might help with the treatment of COVID-19 would be both safe and effective. All of these bets were lost."

"None of them, in the end, proved effective. Hydroxychloroquine, famously, proved dangerous, too, increasing risk of death in patients receiving it."

"Just one drug, the steroid dexamethasone, has proven to be a worthwhile treatment for COVID-19 in a randomized control trial — though given too early, it too can be dangerous."

"The treatment dilemmas facing physicians and patients in the early stages of a novel pandemic are, as most public health officials would caution not the same as the dilemma of rushing a new vaccine to a still-healthy population."

"We defer to the judgment of desperate patients, with physicians inclined to try to help them, but not to the desires of vaccine candidates, no matter how desperate."

"An unsafe vaccine could cause medical disaster and public-health backlash."

"An ineffective vaccine could also give false security to those receiving it, thereby helping spread the disease by providing population-scale license to irresponsible behavior (indoor parties, say, or masklessness)."

"But on other matters of population-level guidance, our messaging about risk has been erratic all year, too."

"In February and March, we were warned against the use of masks, in part on the grounds that a false sense of security would lead to irresponsible behavior — on balance, perhaps the most consequential public-health mistake in the whole horrid pandemic."

"In April, with schools already shut, we closed playgrounds. In May, beaches — unable or unwilling to live with even the very-close-to-zero risk of socializing outside (often shaming those who gathered there anyway)."

"But in September, we opened bars and restaurants and gyms, inviting pandemic spread even as we knew the seasonality of the disease would make everything much riskier in the fall."

"The whole time, we also knew that the Moderna vaccine was essentially safe. We were just waiting to know for sure that it worked, too."

"None of the scientists I spoke to for this story were at all surprised by either outcome—all said they expected the vaccines were safe and effective all along. Which has made a number of them wonder whether, in the future, at least, we might find a way to do things differently."

"A layperson might look at the 2020 timelines and question whether, in the case of an onrushing pandemic, a lengthy Phase III trial — which tests for efficacy — is necessary."

"But the scientists I spoke to about the way this pandemic may reshape future vaccine development were more focused on how to accelerate or skip Phase I, which tests for safety."

"More precisely, they thought it would be possible to do all the research, development, preclinical testing, and Phase I trials for new viral pandemics before those new viruses had even emerged — to have those vaccines sitting on the shelf and ready to go when they did."

"They also thought it was possible to do this for nearly the entire universe of potential future viral pandemics — at least 90 percent of them, one of them told me, and likely more."

"According to vaccine scientist Florian Krammer, you could do all of this at a cost of about $20m to $30m per vaccine and, ideally, would do so for between 50 and 100 different viruses—enough, he says, to functionally cover all the phylogenies that could give rise pandemics."

"In total, he estimates, the research and clinical trials necessary to do this would cost between $1 billion and $3 billion."

"In a just-published paper, Krammer suggests it isn’t just that Phase I clinical work or Phase II safety trials which could be done preemptively, entirely before the arrival of new pandemics. Some Phase III efficacy testing, he says, could be done then, as well."

"If we do all that, he says, the entire timeline could be compressed to as few as three months. Three months from the design of the Moderna vaccine was April 13. The second and third surges, the long-dreaded fall and 225,000 more deaths— all of that still lay ahead."

"Shave another month off somehow and you’re at March 13, the day the very first person in New York City died." (x/x)