Johnson & Johnson have developed a single shot vaccine that was submitted to the Food and Drug Administration for emergency use authorization in early February. The FDA’s advisory panel, perhaps traveling by stagecoach, will meet to hold a public session on that request February 26. In practice, the delay is not likely to be enormously consequential — J&J has already had some problems with their manufacturing and says the vaccine won’t be available in large quantities until later.
Meanwhile, there is a plant up and running in Baltimore manufacturing a vaccine that was developed by an Oxford University research team in partnership with AstraZeneca. It’s cheaper and easier to manufacture than the mRNA vaccines developed by Pfizer and Moderna. The World Health Organization’s expert panel says the vaccine should be used in adults of all ages. Given that the United States has access to a considerable supply of more effective mRNA vaccines, I would be more cautious than them and continue vaccinating seniors with the Pfizer/Moderna products but start letting non-seniors who are impatient for vaccination get AstraZeneca’s shot.
Unfortunately, the company messed up its clinical trial and gave the wrong dosage to some of the subjects. The good news is that it worked with both dosages. The puzzling news is that it seemed to work better in the people who got the “wrong” dose, which raises a bunch of questions about how effective the vaccine actually is and what the optimal dosage is. As an abstract scientific question, we should get more answers in April because they have a parallel clinical trial running in the United States that is expected to wrap up around then.
That said, it does not require a great deal of statistical expertise to notice that in the combined sample, none of the 5,800 people who got either dose of the vaccine died.
Even with its apparently reduced efficacy against the South African COVID-19, it is still highly effective in preventing hospitalization and death, and for now at least, that strain still isn’t the main danger facing millions of prime-age Americans who don’t have the luxury of working from home but are still months away from access to mRNA vaccinations. When I suggested last week that this data was perfectly sufficient to suggest we should be using the vaccine on non-seniors who are currently looking at a months-long wait considering the urgent need for vaccinations, I got a lot of pushback. Max Kennerly explained that in light of AstraZeneca’s failures, “their failures to do the basics of drug research cannot be dismissed based on the whims of masturbating libertarians.”
But I don’t think that Denmark, which is using the AZ product on non-seniors while reserving the mRNA vaccines for seniors, is run by masturbating libertarians.
What happened instead is that European governments did a very poor job of securing supplies of the mRNA vaccines, so desperation is pushing them to embrace the AstraZeneca one. That the United States did better on this is great. But there are still not enough vaccines for everyone who wants one — and that’s true even though a large share of the population says they don’t want one. But despite the problems with the existing trials, it’s clear that the vaccine is safe and effective. We should use it.
Trust the process
I want to be clear about this, because it’s obviously a sensitive issue to a lot of health and science professionals: When I say that the FDA should approve the AstraZeneca vaccine, what I mean is that mechanically the AstraZeneca vaccine cannot be used in the United States without FDA approval.
I don’t actually think “the FDA” as a collection of civil servants is doing anything wrong. They are doing what civil servants are supposed to do, which is carry out the legal procedure according to scientific standards.
AstraZeneca had some implementation problems with their clinical trial which has resulted in some data quality issues. The U.S. government, for good reason, already pre-purchased hundreds of millions of AstraZeneca doses back in May, so they are under no objective financial pressure to deliver the doses sooner rather than later. And AstraZeneca has another clinical trial underway that has corrected the errors of the earlier trials, and they are therefore confident it will lead to licensing in the United States. As a result of all of that, AstraZeneca has not applied for emergency use authorization in the United States and, by all accounts, will not apply until the completion of their currently-ongoing trial.
So if you have a friend at the FDA or are just defensive about public sector institutions, then rest assured — they are not doing anything wrong.
The system that exists was put in place out of concern that pharmaceutical companies will act like snake oil salesmen and peddle fake cures for profit. Consequently, the system is rigorous in its demands for well-executed, high-quality experimental data, and it presumes that companies will push hard for authorization. It also implicitly assumes that disease and illness are endemic aspects of the human condition and that delaying the arrival of new medication by a month or four is a small price to pay for establishing broad confidence that when doctors prescribe you something, it will work. And, you can see today that Acting Commissioner of the FDA Janet Woodcock is out doing her job of protecting the American people from fake cures.
These are reasonable premises for a drug approval process, but they don’t happen to apply to the current situation. We have an acute public health emergency in which time is a major factor. We have a company that has unusually weak financial incentives to secure approval. And it makes sense to make an exception to business as usual to meet the circumstances of the crisis.
That’s not the job of an acting FDA commissioner or random civil servants. But the larger political system is failing here. It’s time to flip the switch that says “a holistic evaluation of the situation indicates that the normal process isn’t what we need right now.”
Nobody seems to doubt AstraZeneca’s vaccine works
I do all that throat-clearing because spending last week arguing on the internet made it clear to me that a lot of the people pushing back against fast approval of the AZ vaccine are fundamentally process-trusters who are out here to defend the FDA qua FDA, which I think is leading them to miss the forest for the trees.
For example, nobody on epidemiology Twitter seems to believe that the United Kingdom or European Union regulators are making a huge mistake by authorizing the vaccine. And that’s not because epidemiology Twitter is blind to events occurring outside the United States. People who were very critical of Sweden’s “herd immunity” approach to Covid, or the UK’s absurd initiative to pay people to go eat in restaurants have not been criticizing governments on the other side of the pond for using the AstraZeneca vaccine.
Dr. Anthony Fauci, the patron saint of Trust The Experts sentiment online, has talked about the AstraZeneca vaccine a bunch and is not expressing doubts about its safety and efficacy.
I think paying attention to Fauci’s statements is particularly important, because he’s not averse to saying he disagrees with the U.K. authorities when he disagrees with them. They have, for example, decided to prioritize a “one shot for everyone as quickly as possible” strategy over the shot-plus-booster regime.
Fauci says he disagrees with that, but he doesn’t say he disagrees with the U.K. about using the AstraZeneca vaccine.
And note that while you can quibble with the trial if you like, the big picture is genuinely very clear.
Here’s David Leonhardt’s summary:
By those measures, all five of the vaccines — from Pfizer, Moderna, AstraZeneca, Novavax and Johnson & Johnson — look extremely good. Of the roughly 75,000 people who have received one of the five in a research trial, not a single person has died from Covid, and only a few people appear to have been hospitalized. None have remained hospitalized 28 days after receiving a shot.
To put that in perspective, it helps to think about what Covid has done so far to a representative group of 75,000 American adults: It has killed roughly 150 of them and sent several hundred more to the hospital. The vaccines reduce those numbers to zero and nearly zero, based on the research trials.
The statistical power of the AstraZeneca trial is not high enough for us to say exactly how much of the risk of death it reduces, but we are talking about a large reduction in the risks of death and hospitalization. This is a huge deal, and it could be easily saving the lives of teachers, grocery store workers, cooks, flight attendants, and others doing in-person work starting right away, and then rolled out to working age Zoomers to kickstart the economy.
We have the vaccinators we need
One piece of confusion that I think has somewhat injured political discussion of this issue is that folks have seen the challenges states are having with vaccine throughput and concluding that adding a third — somewhat inferior — vaccine to the pile would have few benefits.
But that’s not right.
For better or worse, the current vaccination effort is not some kind of all-hands-on-deck thing where every qualified person is giving out shots. And while the AstraZeneca vaccine appears somewhat less potent than the mRNA vaccines, it only requires normal refrigerator levels of refrigeration to stay viable. This means it could be delivered to pharmacies and doctors’ offices around the country, and given to people under 65 through those distribution channels in just the way we do flu shots. Retail chains could even contract with pharmacies to have personnel come into the store and vaccinate their staff.
We normally do two to three million flu shots per day during peak vaccinations without any kind of emergency mobilization. That would be a game-changingly large increase in vaccine throughput.
The fact that the vaccine is less finicky and easier to store means it could also be a powerful tool for addressing some of the equity issues that are troubling many jurisdictions. Refrigerators are not hard to come by, and with a refrigerator-safe vaccine you could deploy pop-up clinics in small towns, in low-income neighborhoods, or even in targeted ways at food banks or wherever it is you think vulnerable people are. You’d also have the flexibility to take some time to have real conversations and try to address vaccine hesitancy issues.
Time is of the essence
A lot of people have remarked that Biden and congressional Democrats seem to have learned their lesson from 2009.
They are going big on fiscal stimulus, they’re not getting sucked into a Lucy-and-the-football dynamic with moderate Republicans, and generally speaking, they are attacking the economic crisis of 2021 with the full urgency that the crisis of 2009 required. That’s all great, except the 2021 crisis is actually pretty different. Supporting the unemployed and bolstering state and local budgets are great ideas. Sending nearly everyone $1,400 is fun, and I hope it lays the basis for future thinking about the welfare state. Biden’s child allowance proposal will deal a great blow to child poverty. But today’s economic crisis is fundamentally a supply shock induced by the virus, and the best way to heal the economy is to address the pandemic as quickly as possible.
And of course, public health is not only at the root of our economic crisis — it’s a public health crisis on its own terms.
Thousands of people per day are dying. Many people, due to work or family obligations, do not have the luxury of isolating themselves from human contact. Mask enforcement is extremely spotty, even in blue jurisdictions that theoretically mandate it. Faster vaccinations could save their lives. Faster vaccinations also have large positive externalities in the form of reduced spread of the disease (it’s true that we don’t know exactly how much sterilizing immunity the vaccines provide, but it’s more than zero) and reduced burden on hospitals and the health care system.
Biden would do well to be a little less literal in his “learning the lessons of 2009” and instead remember the point about urgency.
Unless someone at the FDA can explain to him in a compelling way that they have actual doubt about the safety and efficacy of the vaccine — as opposed to quibbles about the process or a scientific interest in seeing data from a better-designed trial — he should install a commissioner who’s prepared to authorize it for emergency use on the basis of the existing data. A regulatory system designed to protect us from profit-seeking quacks peddling fake medicine is a perfectly reasonable idea, but it doesn’t apply to this situation, and it’s not the job of political leaders to make that wide-ranging assessment.
Plenty of failure to go around
Biden is the president and he should do the right thing.
At the same time, when I look at this failure, it’s staggering how wide-ranging it is.
“Costly regulations are hurting the country” is the classic conservative and libertarian policy critique. But when I scrolled the front pages of Cato, Heritage, and AEI last week, none of them were highlighting content calling for approval of the AstraZeneca vaccine. Congressional Republicans are criticizing the Biden administration for all kinds of stuff, but they’re not calling on the FDA to approve the AstraZeneca vaccine. We have 50 separate state governors in the United States, all of whom are struggling to keep their economies afloat and get vaccinations running, and none of whom are calling on the FDA to approve the AstraZeneca vaccine.
This is all kind of perverse. And it’s especially perverse because in a slightly different context, huge swaths of American politics are too freedom-loving to wear masks or follow social distancing guidelines. We need to redirect that liberated energy into a more constructive direction.
What is the best argument against approving the AZ vaccine? Every argument I see against this position here is usually a vague notion that regulatory processes are Good or a reference to how the vaccine hasn't actually been submitted for approval. To me, it reads as a kind of knee-jerk "government agency good, pharma company bad" culture war, which is stupid when literally thousands and thousands of lives are at stake.
Is there an actual good argument on the merits opposing an immediate approval of the AZ vaccine?
I too am confused by the actions of the FDA. How about this explanation:
Vaccine skepticism for COVID is more widespread than the normal anti-vaxxer movement, especially for PoC. Estimates of this are up to 35% of the population that doesn’t currently want a vaccine. E.g., my friend works at a vaccine center in the Bronx that had hundreds of doses that were going to waste; they went out on the street to recruit locals but nobody wanted it.
When PoC are told they’re getting a different vaccine from the good one that white people get, that won’t inspire confidence.
Keeping everyone on the same product will alleviate these fears.