The Biden administration has dropped the ball on vaccine development
Vaccines have saved tens of millions of lives. So why aren't we making better ones?
The development of Covid vaccines in 2020 is one of the most startling accomplishments in human history — in the same league as the moon landing or the Manhattan Project. In record time, scientists, corporations, and governments responded to the threat of a pandemic in real time by developing vaccines before the pandemic was even halfway through. Wide dissemination of these vaccines is estimated to have saved 20 million lives:
The United States, as a nation — along with Britain and Germany — played a central role in this triumph. It was U.S. government agencies — NIAID and DARPA — that funded much of the scientific research behind mRNA vaccines, decades before anyone knew they’d be needed in a global emergency. It was U.S. private capital that funded Moderna through long years of unprofitability. It was U.S. industry that solved the difficult supply chain issues that threatened to hold back mass production of those vaccines.
And it was bold U.S. government action that allowed rapid development, authorization, and dissemination of Covid vaccines. Operation Warp Speed, an interagency program established by the Trump administration, funded research and development of Covid vaccines, committed to prepurchase agreements, and secured supplies of critical raw materials for supply chains.. In addition, the Trump administration leaned heavily on the FDA to accelerate its approval of the vaccines, cutting precious months or years off of the timeline.
I admit that I was totally surprised at how amazingly successful Operation Warp Speed was, for several reasons. First, given the Trump administration’s incompetence with respect to restoring U.S. manufacturing, and its general attitude of belligerence and empty self-aggrandizement, I expected OWS to be a boondoggle. Never have I been happier to be proven wrong. Second, given the supply chain failures in mask and ventilator production early in the pandemic, I expected similar holdups in mRNA vaccine production — but instead, it was manufacturing powerhouse China that had difficulties while we sailed through. Third, given the extreme dysfunction of the CDC with regards to Covid testing and masking early in the pandemic, I expected the FDA to hold up release of even a fully safe and effective vaccine for far longer than it did. The early pandemic contributed to a narrative of American decline and dysfunction that I bought into, and fortunately my negative expectations proved unfounded.
But it has been over a year since that triumph, and in that time, the Biden administration has curiously dropped the ball on vaccine development. As a result, America and the world are not getting crucial new technologies that could create another big reduction in the risk of Covid.
Vaccine development failures under Biden
It’s helpful to list some of the vaccines that the U.S. could be getting with a more concerted government effort, but which we are not getting.
First, there’s Novavax. A friend of mine, who had an allergic reaction to her first vaccine shot, is not allowed to get any more shots — unless she uses Novavax. One vaccine shot by itself doesn’t provide much protection, so she has been forced to go essentially unvaccinated for over a year. Novavax is also easier to store, which helps with distribution. But after rushing through approval of the first batch of vaccines, the FDA has slow-walked the approval of Novavax:
Lawrence Gostin, director of the O'Neill Institute for National and Global Health Law at Georgetown University, says the FDA is "slow-walking" Novavax's authorization.
"They've got all the data that they need, but I'd say it's also kind of a general irritation with the company," Gostin told Yahoo Finance.
That "irritation" stems from earlier issues with manufacturing and other delays, which are now resolved. But in relying on a plant abroad — the Serum Institute of India, the world's largest vaccine maker — Novavax has opened the door for more scrutiny of manufacturing quality, Gostin said.
"I think another reason they're slow-walking it is there's a widespread perception that we have enough supply here, and that the mRNA vaccines are good, maybe better. But I think that's very short-sighted," he said.
It’s been available in Canada since February, but not in the U.S. Biden could have leaned on the FDA for an accelerated approval, as Trump did in 2020, but has not done so, for reasons unknown.
Even more importantly, there are nasal vaccines. In May, leading virologist Akiko Iwasaki, who has worked on these vaccines, penned an op-ed for the New York Times explaining why nasal vaccines are important. Our current vaccines have proven very effective at preventing severe disease and death, but are not very effective at preventing actual infection. So lots of people are still being put at risk for long Covid, and immunocompromised people are still in mortal danger. Nasal vaccines, which you spray into your nose instead of get injected into your shoulder, will probably be much better at preventing transmission than current vaccines. They also might offer more robust protection against future variants. Here’s a Twitter thread by Iwasaki explaining how they work:
Finally, there are pan-sarbecovirus vaccines. Eric Topol, who directs the Scripps institute, has been the chief evangelist for vaccines that are good against any variant of Covid. This virus has demonstrated a remarkable ability to evolve into new forms that increase transmissibility and evade immunity to earlier variants — Delta, Omicron, and now new Omicron variants. It’s not clear how long it’ll keep on evolving. Currently, companies are making Omicron-specific boosters, but if another variant evolves, we might have to do that again and again. A vaccine that works against all possible variants of the coronavirus, Topol explains, would represent a permanent escape for most people:
With the prospect of more noxious variants ahead, it is unfathomable that we now surrender. [There is] no more funding from the government. The only new vaccine in the hopper is an Omicron booster…
The concept of a…pan-sarbecovirus vaccine is alluring and has been pursued by academic labs throughout the world over the past two years. Tens of broad neutralizing antibodies (bnAbs) have been discovered, which have high likelihood of protecting against any future variant. But there is nearly a void of developing and testing a vaccine based on these bnAbs. Such vaccines are clearly in our reach, but the lack of investment in a high priority and velocity initiative is holding us back. A combination of nasal or oral vaccines, more and better drugs, and a variant-proof coronavirus vaccine would likely catalyze a definitive pandemic exit.
The failure of the U.S. to follow up on the success of Operation Warp Speed is an enormous failure — an error of omission, a dog that didn’t bark. The Biden administration’s Covid Plan simply doesn’t mention any of these new technologies. It’s not even clear whether or not Operation Warp Speed still exists in some organizational form or has been quietly dismantled. There has certainly been none of the sense of urgency toward new vaccines that the Trump administration displayed in early 2020.
And thus Covid rolls on, killing hundreds and disabling unknown numbers of Americans every day, with no permanent exit in sight.
What’s the holdup?
How is it that the Biden administration has failed so badly where the Trump administration succeeded? Biden was supposed to represent a return to competence after the mess of the Trump years. And Democrats are widely believed to take the threat of Covid more seriously than Republicans do. What’s going on here? I can’t really know, but I can offer conjectures.
First, the administration might be worried that trumpeting the development of newer, better vaccines might reduce confidence in the existing vaccines — after all, if we’re making better vaccines, might that mean that our originals don’t actually work? But it seems pretty late in the game to be worrying about this — if people are still unwilling to get vaccinated, due to fear or politics, it’s unlikely that deliberately avoiding the creation of better vaccines will somehow convince them to change their minds.
Second, some in the administration might be worried that producing new vaccines would divert materials and money from vaccinating people in poor countries. This was the reason that some public health people argued against booster shots in the fall of 2021 — a choice that proved deadly for some Americans when the Omicron wave hit. But this was never a good argument — to the degree that low vaccination rates in poor countries is a limitation of supply rather than demand, it’s best addressed by simply spending more on ramping up production, not by trying to prevent Americans from getting shots. And as far as nasal vaccines and pan-sarbecovirus vaccines are concerned, this reasoning would be even worse; these new vaccines would save a lot of lives in poor countries, if only we spent the money and effort on developing them.
Third, the Biden administration is facing funding constraints. Most of the money from the original CARES Act, which funded Operation Warp Speed, has run out, and Congress has refused to authorize more. This is itself a startling and reprehensible failure of American governmental effectiveness. But Biden could be using the promise of nasal vaccines and pan-sarbecovirus vaccines to pressure Congress to authorize more funding for Covid in general. Instead he is doing no such thing.
This brings me to my fourth candidate explanation: Simple inertia and distraction. The percent of Americans naming the coronavirus as the country’s top problem has faded into insignificance, replaced by concerns like inflation and crime (and, after this week, possibly abortion rights). Even though many Americans are still dying or being afflicted with long Covid, the Biden administration may have simply concluded that the disease is no longer an issue worth spending political capital or attention on (not that they’re doing much about inflation either, but that’s a topic for another post).
So the real problem here might be that our leadership, like some segments of the American populace, have simply decided that they’re “done with Covid”, even if the virus isn’t done with America. This is unacceptable. Vaccines are one of our most amazing accomplishments, and we’ve just decided to leave it in the past and rest on our laurels. Not the kind of thing a first-rate nation ought to do.
And you didn't even mention that they only approved vaccines for younger kids one week ago. They sat on the data: Moderna submitted almost 2 months ago, they cancelled the meeting Vaccines and Related Biological Products Advisory Committee scheduled for shortly afterwards and didn't request any further data. Just sat, doing nothing while it swept through preschools and lots of kids got sick. Sure, not many in that age group will die, but why have them get sick/have long-term effects for absolutely zero reason.
The administration needed to fire Dr. Marks long ago.
I'm in the Novavax trial and it's been astounding to me how much it's been slow walked. It's been well over a year since the vaccine was deemed effective enough that everyone in the trial was given the vaccine because it would have been considered unethical to withhold from those that got the placebo. If you would have told me then that it still wouldn't have FDA approval now and that my infant would have an approved vaccine first, I'd have thought you were insane. The supposed manufacturing concerns get more nonsensical as more and more countries are using it without any indication of problems. If it had been the first vaccine to report its data there is no doubt it in my mind, it would have been approved long ago.