Coronavirus

The Pandemic Could Have Been Over Much Sooner—If Not for the FDA

At critical junctures, the FDA slowed vaccine development and rollout. Its decisions almost certainly cost lives.

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The pandemic isn't over—but it's over, at least in the United States. That's welcome. But it could have been over so much sooner if not for the Food and Drug Administration (FDA). 

Let's start with where we're at. After spiking over the winter, new coronavirus cases and deaths have both dropped dramatically—not to zero, but enough that, in combination with vaccines, local leaders are lifting many pandemic restrictions. 

Even deep-blue cities and states that put in place the strictest pandemic restrictions are moving rapidly toward reopening. In Washington, D.C., where I live, Mayor Muriel Bowser announced this week that the District would become the latest locality to lift a longstanding mask rule, following updated Centers for Disease Control and Prevention (CDC) guidelines last week. New York City will allow restaurants to return to something close to full capacity this weekend. And many lingering restrictions are scheduled to end in the coming weeks and months. 

Yes, the governor of New Jersey is still requiring masks, against CDC guidance. And yes, there are still large groups of people—a disproportionate number of them Republicans—who are still declining to be vaccinated. The virus will linger at some low level, and so will some restrictions. But as the summer goes on, life in most places in America will return to something resembling normal.

Like I said: It's not over—but it's over. 

In some ways, this was a fairly rapid recovery, at least compared to what many were predicting last year. Last summer, Anthony Fauci, the country's lead infectious disease expert, predicted a 12–18 month timeline for the development of effective vaccines. But the first vaccine application was in by November 2020 and approved the following month. The first non-trial dose of the vaccine was administered on December 14. And while the rollout was not without hiccups, by April 2021, every adult in America was eligible to get one. 

Yet as relatively speedy as all this was, it might have happened even faster, and perhaps even mitigated the winter spike in coronavirus cases that killed so many, had federal drug regulators not stood in the way. 

We will be debating the effectiveness and legality of coronavirus policies for a decade or more (one possibility is that none of those policies made much difference in any direction). But the clearest lesson from this last year or so is that the COVID-19 vaccines work, and the faster you can roll them out to the public, the sooner your pandemic will be over.

So I think it's worth imagining an alternate timeline in which the FDA had not slowed the drug rollout at critical junctures, costing lives and allowing deep social disruptions to persist for longer than necessary.

The decline in death in the United States tracks almost perfectly with vaccination. You can see similar correlations in other countries that have widespread vaccination, such as the U.K. and Israel, which has vaccinated even more of its population than the United States. Everywhere there is broad vaccination, deaths and hospitalizations have dropped dramatically. The way to end a pandemic is with an effective vaccine that is widely available. 

This means the priority for policymakers should be to get jabs in arms as soon as the laws of physics will allow. And at several key points last year, the FDA slowed the process down. 

The most glaring example of the FDA slowing down the process was at the very end. After conducting multiple, increasingly large clinical trials throughout the year, as the FDA requires, Pfizer-BioNTech submitted an application for emergency use authorization on November 20. The relevant FDA panel did not meet to approve the request until December 10, which meant the first vaccine was not administered until December 14. 

The FDA could have met immediately, on an emergency basis, reviewing paperwork and data collection on a rolling basis so that by the time the application came in, they were ready to give it the go-ahead. This is not some hypothetical alternative that doesn't work in the real world; it is what drug regulators in the U.K. did last year. (The U.K. is not known for being especially lax with drug regulation.) If the FDA had been willing and ready to approve the vaccine on the day the application was submitted, the vaccine rollout could have started weeks earlier. 

Given the clear real-world evidence of the vaccine's effectiveness not only at preventing death in the vaccinated but at reducing transmission to others (and thus slowing spread at a population level), those weeks could have saved tens of thousands of lives. 

Ostensibly, the reason for the lag time between submission and approval was that the FDA needed time to review the documentation—confirming the safety of the vaccine, and ensuring public trust in the process. At best, that's a political judgment based on little evidence; at worst, it's a cover for maintaining the FDA's regulatory bottleneck on drug development. 

And it's not clear that either public trust or public health are served by delaying the rollout of a life-saving, society-altering treatment. It's hard to avoid the conclusion that the FDA let some number of people die in service of upholding a bureaucratic process. That's supposed to increase public trust in the system? 

An even bigger mistake came earlier in the process. The current drug testing regime for vaccines consists of three primary phases, the last of which is an expensive, time-consuming, large-scale controlled experiment, in which thousands of people who get the vaccine are tracked and compared against thousands of people who get a placebo. Pfizer-BioNTech's Phase Three trial started last summer, at the end of July

Those large-scale randomized trials help determine safety, sussing out potential complications or rare side effects in large groups of people. But it's possible to determine efficacy much more quickly, via a process known as human challenge trials, in which volunteers are intentionally, directly exposed to the virus. Human challenge trials provide actionable data much faster and with far fewer subjects than more conventional large-scale trials, making them particularly excellent tools for emergencies, when the priority is to move quickly. 

Some medical ethicists are opposed to these trials on the grounds that to directly expose someone to a potentially deadly virus would be to do harm. But it's possible to mitigate those concerns by drawing from healthy cohorts who have much lower risk levels (young, healthy adults, for example), by providing volunteers with priority care, and by paying volunteers to take on some level of increased personal risk, as we often do with dangerous professions. 

As with rolling review, human challenge trials are not impractical in the real world. In February, the U.K. approved compensated COVID-19 human challenge trials, with some conditions, in hopes of "helping to identify the most effective vaccines and accelerate their development." 

These sorts of trials, however, could have been approved here in the United States by the FDA last year, dramatically speeding up the final phase of testing. As Reason's Ron Bailey has written, if the FDA had allowed human challenge trials last summer, we might have had public access to vaccines as early as September 2020. 

On the one hand, that's just a few months earlier. On the other hand, consider the difference that just three or four months of vaccine rollout might have made—potentially heading off, or at least reducing the impact of, the huge surge in cases and deaths that came during the winter. 

There's a huge difference between America in December 2020, when the first doses of the vaccine rolled out, and America in March 2021, when millions of people (particularly the vulnerable elderly) had received at least one dose. The first is a country in the midst of a public health catastrophe killing thousands per day. The second is a country in which cases and deaths are down dramatically, and set to decline even further. 

Even a limited number of doses of the vaccine starting in September could have protected the elderly, could have helped slow the spread of the virus and partially prevented the winter surge. 

And that might have been a possibility, if not for the FDA, which repeatedly stalled the testing, development, and rollout of the vaccines in the name of safety—a concern that probably led to the deaths of thousands. 

There were other decisions that affected the vaccine timeline and takeup as well: The FDA has so far declined to approve AstraZeneca's vaccine, despite it being approved for use elsewhere (including, again, in the U.K.), and stuck with a strictly timed two-dose regimen for the Pfizer and Moderna vaccines, despite evidence that those vaccines provide considerable immunity around two weeks after the first dose. In March, the agency paused delivery of Johnson & Johnson's vaccine in response to a tiny number of reports of potential adverse side effects, which may have contributed to the slowing vaccination rate since. The FDA, in other words, is still slowing down the use of the most effective tool we have in fighting the pandemic in ways that are incredibly consequential. 

So it's not just that the pandemic might have been over sooner, allowing many to return to normal lives, although that's true and important. It's also that, if things had gone differently, if the FDA had made different decisions and access to vaccines had become available just a little sooner, there might have been many more lives that could return to normal. 

NEXT: Catherine Lhamon, Obama's Title IX Enforcer, Just Got Her Old Job Back

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  1. The Pandemic Could Have Been Over Much Sooner—If Not for the FDA If we hadn’t been forced to hide in our homes and wear masks, delaying herd immunity.

    FTFY.

    1. Right. Because overwhelmed hospitals that can’t staff their wards and can’t take patients wouldn’t create absolute chaos or anything…

      What a boneheaded comment

      1. Well, 2017 passed without a blip. I don’t see why 2020 was so special.

        1. The boneheaded comment is assuming that the lockdown did anything to slow the spread, avert overwhelmed hospitals, etc. I would suggset you check your premise and study the asymmetry of proof and the concept of black swans (put simply, the existence of one black swan disproves the theory that all swans are white, even if only one out of a billion swans is black). There are plenty of black swans in the U.S. and throughout the world that show that the lockdowns and even near-universal mask usage did absolutely nothing to stop the spread of the virus. Indeed, in keeping with the swan metaphor, the world doesn’t even show us any white swans, because we see zero correlation between lockdowns, mask usage, mobility, you name it, with covid death toll. There is no correlation (there are not even any white swans. There is only the theory that all swans are white, i.e., the theory or mechanistic plausibility, at best, that lockdowns and masks work…but in fact, given that 95% of covid particles in the air are less than a micron in size, per a study in the national academy of sciences conducted on monkeys infected with the virus, the idea that a mask with gaps under which you can slip a human finger could prevent the transmission of an airborne particle of less than a micron is absurd. Indeed, the the tip of a human hair has the surface area of about 4,000 microns. Now think if you could slip a human hair through the gaps around your mask. Now thing if you could breathe in something 1/4000 of that size. Here’s that study: https://www.pnas.org/content/118/8/e2021830118).

          Nor is there any correlation with population density, mobility, etc. The only factors that often correlate are average age and presence of co-morbidities, namely obesity, diabetes, CVD, vitamin D deficiency and immunocompromising diseases. Nonetheless, despite how age-stratified covid
          is (average age of death is around life expectancy in various countries) age is not the sole explanation, as there are plenty of countries in Asia with higher average age than USA and Europe which nonetheless have had negligible death tolls (less than 10% of USA/Europe/the Americas). Every other chart shows a scattershot plot, i.e., no correlation with any non-pharmaceutical measure, mobility, etc., whether within USA or internationally. It is true that correlation does not prove causation, indeed, but lack of correlation does prove lack of causation (asymmetry of proof, Karl Popper).

          What we do know is that lockdowns and masks have had adverse effects on every aspect of human life, from sowing inter-group division to wrecking the economy (a represenation of human flourishing, not some evil profit-first, soulless machine) and no cost-benefit analysis was ever performed.

          1. There is strong evidence that mitigations did prevent hospitals from being overwhelmed. All you have to do is look at countries where this happened, such as Italy, or Mexico.

            Whether that happened due to government mandates or due to voluntary behavior is a different question. I think it certain that is was both – at least, in the early months in the US.

            It is boneheaded to believe that “lockdowns” don’t work. They do. Look at New Zealand if you want an example, or Taiwan.

            It saddens me how people on one side (my side, for the most part) let their political views direct their opinions on issues of science, while people on the other side do the same, but in the opposite direction.

            1. There is strong evidence that mitigations did prevent hospitals from being overwhelmed. All you have to do is look at countries where this happened, such as Italy, or Mexico.

              You also need to know the baseline in order to manage these cases effectively. The US has an extremely high number of staffed ICU beds per capita, so we actually have a greater tolerance to openness than most countries, even advanced ones, and advantage buttressed by how spread out our society is.

              Lockdowns definitely do something, but the total positive impact is overstated by its adherents. It’s meant to be an emergency measure, and as such its imposition really needs to be handled locally/regionally and with clear guidelines as to when its warranted. Neither was the case here; it was done out of panic and not relieved fast enough, due mostly to some combination of distrust in the populace by leadership, and by their own stubbornness in admitting error.

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              2. Reasonable.

            2. It is boneheaded to believe that “lockdowns” don’t work. They do. Look at New Zealand if you want an example, or Taiwan.

              You mean two islands?

            3. Reasonable.

            4. Taiwan didnt lock down though.

              1. My guess is that Taiwan’s contact tracing is a big part of how they controlled the outbreaks they did have (not many, as they quarantined all travelers). The US only contact tracing folks who were within 6 feet of a case for 15 minutes seems highly ineffective for an airborne illness. Our CDC was running around telling asymptomatic people to double mask. Meanwhile, Taiwan’s CDC was using credit card transaction records to help trace everyone who ate at a restaurant with a case. That the latter would be less disruptive and more effective isn’t a shock.

                What does shock me is that the CDC still hasn’t internalized that it is dealing with an airborne disease. All their guidance about washing surfaces and avoiding sharing items is worthless. All of their advice on masks and social distancing only works on droplet transmission, which is a thing, but doesn’t appear to be the primary driver. Meanwhile, they have said precious little about stuff that will impact airborne transmission. How the heck did the CDC not come out when schools were buying all those transparent desk shields and say: “stop wasting money and stop f***ing up the airflow”?! The CDC has been great at fighting COVID based on what we knew about it in April 2020. The last year of research seems to have totally passed it by.

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          2. Masks stop the spread of viruses, bacteria, and every other airborne contagion transmitted by coughing, talking, sneezing, laughing, shouting, and simply breathing. Example: Flu statistics for 2020 are nonexistent. It was an incidental benefit due to a large portion of the population wearing masks and social distancing because of coronavirus.

            Social distancing lowers the number of microns of said contagions radically the further away you are from the transmitting source. Masks + social distancing lowers the chances of infection from any airborne transmission. Same concept as using a tissue and turning away from others when you cough or sneeze when you have a cold.

            The balance of your narrative is Monday morning quarterbacking. It’s easy to bray on about how effectual or ineffectual safeguards were ‘after the fact’ when a mountain of data has been collected and scrutinized. We started with NO DATA. Now we know, then we didn’t.

            The human condition with a new entirely unknown VARIABLE is no one knows what they don’t know. We still don’t know enough. Breathe before you damn others for being over-cautious during a worldwide pandemic involving a previously unknown source/type/origin/transmission mode contagion that kills people.

            1. Social distancing lowers the number of microns of said contagions radically the further away you are from the transmitting source.
              Difficult to believe anything you say after that garbage.

            2. Masks stop the spread of viruses, bacteria, and every other airborne contagion transmitted by coughing, talking, sneezing, laughing, shouting, and simply breathing. Example: Flu statistics for 2020 are nonexistent

              The masks stopped the flu last fall, but didn’t stop COVID? Make up your mind.

            3. Reasonable.

            4. The flu statistics canard does not stand up to reality. Flu statistics are derived by surveys of medical practices seeking the number of office visits presenting for flu and number of hospitalizations. Flu deaths are also an estimate driven by the visit/hospitalization surveys – not a head count.

              Assertions that the flu was limited by masks in 2020/2021 are easily dismissed by the following:

              Office visits for flu were massively reduced by people staying away from doctors’ offices out of fear of COVID.

              Office visits for flu were massively reduced by offices being closed or limiting appointments.

              Hospitalizations were massively reduced out of patients’ fear of going to a hospital and limitations on hospital room availability driven by COVID response.

              Flu and COVID largely cause mortality in the same demographic of elderly, comorbid patients. Some people who died this year of COVID would have died of flu in any other year.

              The CDC mandate to override other causes of deaths when COVID is present overstates COVID mortality and understates mortality by other causes, including flu.

              Annual variants of flu strains vary widely in terms of “strength”. Similarly, each year’s vaccine has varying degrees of effectiveness.
              That is why seasonal mortality estimates over the past decade have run as low as 10,000 (and as high as 95,000). If this year’s variants were weak for the strain and strong for the vaccine, the past season would have produced significantly lower impact regardless of masks.

              In short, the current low flu estimates are mostly the result of a lack of data and behaviors in response to COVID that are completely unrelated to mask use. Sorry, but you can’t excuse this intrusion into our liberties based on an imaginary side effect.

      2. Hospitals weren’t overwhelmed. Not even close. They couldn’t take patients because elective surgeries were canceled. Doctors were laid off during opening weeks of the pandemic.

        Get up off of your damn knees.

        1. Hospitals came very close. In Washington State one was overwhelmed.

          Doctors got laid off because the hospitals put off all sorts of admissions that would have happened otherwise, at a cost to health and the lives of people. They did so because early on, they could not tell if the mitigations would, in fact, work well enough to flatten the curve.

          But it is a simple epidemiological fact that, without changes in behavior by people, the hospitals would have been dramatically overwhelmed, as they were in Mexico. That happened in Wuhan, where the measures were too late. It happened in Italy. It happened in Brazil and Ecuador.

          I have watched the detailed hospital stats in Arizona, which has very good reporting. The winter surge came close to overwhelming our hospitals. A friend who is a paramedic on ambulances was transferring patients on ventilators(!!) for COVID from one hospital to another. This was at a time when the usage for other procedures was called way back.

          1. One of the enduring lessons of the pandemic should be that hospital capacity is far more elastic then anybody expected. Our flagship facility scaled up by some 40% between mid-March and early April and by the end of the surge essentially the whole hospital acted like an ICU.

            Staffing was challenged during this year’s winter plateau, but that had as much to do with the quarantine rules as anything else. Vaccinated and prior-recovered staff still had to stay isolated for the full duration following exposure, even if there was a negative test, which I always found to be silly.

          2. In Washington state our usage has been flat all year long.

            https://coronavirus.wa.gov/what-you-need-know/roadmap-recovery-metrics

        2. Inpatient capacity was nearly overwhelmed at quite a few hospitals in our state; multiple facilities were on divert daily. But the canceling of electives did little to help that (OR staff isn’t really doing anything to boost capacity during these surges, nor are the doctors). Frankly, the only argument for cancelling electives is to limit hospital-acquired infection.

        3. ^this

      3. Come onman, hositals were NEVERoverwhelmed, particularly since most sent any other kind of patient packing. Various agencies built HUGE field hospitals,none of which were even partially full, FedGov sent a large hospital ship to NYC which hever got used either, Those hospitals that DID have wuflu patients mostly failed to give them EFFECTIVE treatment, thus proling their stay, mostly until they were trensfered from the upstairs wards to the morgue in the basement, because thy intubated so many unnecessarily, denied effective treatment, etc. Thousands of nurses were laid off (I know wome who were, in a large city system), wards were closed off unused.

        Check your “news” sources. Don’t trust ANYTING that was put out by CDC, Phautchee, or any such critters.

    2. If we had simply treated it like every other mild virus and gone about life as normal.
      But destroying lives, and our way of life, was the goal – and Reason was all too happy to help spread hysteria.

      1. And Reason is STILL FUCKING DOING IT by writing articles premised on the idea that the reaction to covid was in any way justified or rational.
        Wtf kind of liberty or independence is promoted by saying that a product was needed instead of people making their own choices to avoid or survive the bug?

        1. You seem to have missed growing evidence that Covid was leaked from a lab in Wuhan. So you need to change your conspiracy theory. Covid IS dangerous and it’s China’s fault. Better stop dismissing all the mortality stats since you’re going to need them.

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    4. One has to bear in mind that it was Donald Trump who got us into this whole Covid-19 pandemic in the first place by simply laughing it off as a hoax, and refusing to do a damned thing about it, and it got to the point where it was too late to contain and control it. The fact that there were a half a million or more deaths here in the United States from Covid-19 as a result is way too much.

    5. Wrong! The Pandemic could’ve been avoided altogether if Trump hadn’t just laughed Covid-19 off as a hoax and refused to do a damned thing about it until it was way too late to contain and control it. More than a half a million deaths from the Covid-19 virus is way more than is tolerable.

  2. didn’t have to be a PANDEMIC!!!!! at all.

  3. As long as you continue to wear a mask in perpetuity so that you can virtue signal to your neighbors, does it matter if and when the pandemic ends?

    1. Many are actually sad it ended.

      1. Yeah, I’ve seen that. If anything sad is too light a word; some appear to be in downright despair. They’ve announced their intention to bitterly cling to their masks until Doomsday.

        1. And they seem to be hoping that a variant will appear that the current vaccines won’t handle.

          Strange people.

    2. It’s not virtue signaling when you are : immune compromised, unvaccinated, have a health condition precluding vaccination, are allergic to the vaccine, decided not to take the vaccine at all for personal reasons, are protecting other family members, or it simply makes you feel more secure.

      I don’t assume negative things about people who do not wear a mask in a populous venue or on mass transportation. In Asian countries, mask wearing is so commonplace it’s regarded as IMPOLITE to not wear a mask in public if you have even the sniffles. It’s also done to abate allergy symptoms. Get a grip. It’s a personal choice, not some imagined slight.

      1. In Asian countries, mask wearing is so commonplace it’s regarded as IMPOLITE to not wear a mask in public if you have even the sniffles.

        No, they wear them all the time in China because China has nasty air pollution that you can cut with a dull knife.

      2. We are still in the USA buddy…for now anyways.

      3. If wearing a mask when there is no purpose in doing so makes you feel more secure, you ARE virtue signaling.

      4. The point is that when people refuse to wear masks in public and on public transportation, they’re putting themselves, as well as other people at risk. Covid-19 is extremely contagious–and deadlier than the regular flu(s) that hit us every fall and winter.

  4. You mean when they could have announced the vaccines BEFORE the election and instead waited until after.

  5. I have worked in the pharmaceutical industry for years and strangely enough, unlike in many other bureaucratic areas, the FDA is the worst by far of all the major regulatory agencies. Normally you would think the EU would be stricter and more ridiculous, but this is not the case here.

    1. If a bureaucrat commits to an action and is proven to be wrong, she gets fired. If she does not act, an omission, nothing bad will happen to her.
      So, the government will delay making any act that might later be criticized. Remember about three years ago when the FDA announced approval of a drug that ‘will save 10,000 lives a year?’ The approval process took a decade, eight years of which were spent looking at the drug trials that had been completed.
      No reporter asked ‘then what about the 100,000 lives already lost?’

      1. Since when can bureaucrats be fired for anything? It’s just easier to do nothing than it is to do something. Pure laziness.

  6. The pandemic wouldn’t have been so bad if Drumpf hadn’t restricted travel from China. Because I read that travel bans are exactly the wrong way to fight a virus.

    The best way to deal with a scary new contagious disease is to do what we Koch / Reason libertarians already wanted to do anyway — allow unlimited, unrestricted immigration.

    #OpenBorders
    #(EspeciallyDuringAPandemic)

    1. PS — Of course I must applaud Governor Andrew Cuomo for literally writing the book on effective pandemic response. And Biden deserves credit for delivering the vaccine and shutting down the virus like he promised during the campaign.

      #VoteDemocratToFightViruses

    2. The only problem I have with your statement is using the name Drumpf. It sort of undermines your serious points by making you sound like a typical low-info voter. Just something to think about.

      1. Parody account.

      2. Name calling – it’s juvenile and unnecessary for making a cogent argument. But it is a political fallback along with half truths, suggestively negative press releases about opponents, finger pointing, nitpicking, projection, blame laying, and out and out LYING.

        1. Good points! Well said. Thanks. The stuff that you mentioned in your comment goes on far too often in what passes for discourse these days, and it’s just plain disgusting.

  7. Shouldn’t “expert” now be in quotes when describing Dr. Fauci? He’s hardly earned that title legitimately, considering his scattershot pronouncements about almost everything pandemic-related.

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  9. I was fully expecting this article to be about Trump and not the FDA. I guess a bit of intellectual honesty was too much to ask from Reason.

    Trump knew the virus was airborne. Trump knew it was deadly and yet spent the majority of the last year of his presidency demonizing the agencies fighting the virus, spreading lies and false hope about the virus “our 15 case will soon be going to zero”, and even after he was in the ICU with a team of 12 taxpayer funded doctors and several experimental drugs unavailabke to the public and nearly died, he still played it down.

    I really feel bad for the Americans who were misled by him. Trump had an opportunity to lead and did the opposite.

    1. Eat a bullet, hivemind

    2. Got to be a parody account.

      1. Never underestimate the stupidity caused by TDS.

      2. Just a troll/50 center.

        They post something obviously inflammatory, always from the same scripts, just to try and stir the shit, distract from the conversation, etc. This fits that bill to a tee.

      3. No, it’s some middle-aged Karen in Silicon Valley that runs a bunch of nursing homes . She’s using the same screenname as her Twitter account but with a “b” added at the end.

      4. Did you get triggered by facts? Sorry. Must be hard to have your bubble burst

        1. Read an actual book.

    3. meanwhile all the other countries who did what you think we should have are now going into another lockdown. mask don’t work it only delays the herd immunity form those who can survive it with minor inconvenience to no inconvenience which is 99.8% of the population

      1. It would have been so much more effective if it hadn’t been politicized. It’s a virus, it’s not politically affiliated with any party.

    4. I’ll give you the virus is airborne. Indeed, more than 95% of covid particles exhaled by monkeys infected with the virus (https://www.pnas.org/content/118/8/e2021830118) are less than one micron in size, the tip of a human hair being about 89 microns in diameter and 4,000 in surface are. In other words, masks and facial coverings are a joke…just look at the fine print in OSHA’s and CDC’s guidance on them. The only thing that could truly protect someone is an individually-fitted, properly worn respirator, N95s being the bottom of the barrel as they are not tailor-made to each user’s face. Not to mention that the seal of all facial coverings and even respirators (N95 and good ones) are broken by facial hair. That is, forthright guidance would’ve included telling men to shave.

      Given all that, what measure would have been effective to stop the spread of the virus? Despite all the lockdowns and working from home, 80% of the workforce still kept working in public, and they weren’t wearing respirators. The virus was going to spread no matter what. The only thing achieved by locking people in their homes was to shift the burden of the spread on to the elderly and less mobile, as the relative mobility of the young and healthy compared to that of the elderly and frail was reduced by the stay-at-home orders. Track and trace? Nope. Lockdown? Nope. Masks? Absurd. Earlier vaccine development? Probably, but we can’t attribute falling numbers to the vaccine, deaths in the US peaked on Jan 26, 2021 (10 deaths per million per day, 5.95% of population having received at least one dose of vaccine) and hit less than 3 deaths per million per day by the end of March 21, when 24.34% of the population had received at least one dose of the vaccine in the US. The numbers rose and fell in a similar fashion during the first covid season in the hard-hit states, in winter 2019-20. There was no reason to expect the numbers wouldn’t rise and fall the same way in winter 2020-21, especially since we now have evidence around the world that there is not even a correlation between lockdown stringency, mask usage and/or mobility and covid death tolls. So no, the vaccines are not responsible for the plummeting numbers. The idea is that the vaccines prevent the NEXT covid season from being as bad as the first two, but the first two came and went naturally.

    5. NO, Trump did not know it was airborne. Heck, the WHO didn’t admit that until last week! The CDC didn’t admit it for a long time.

      Trump demonized the FDA and the CDC because both agencies were screwing up, royally. FDA not only got in the way of vaccines, but earlier, they blocked labs from testing for the virus, requiring research labs to destroy the tests they had created. When Trump’s folks stomped on the FDA, they then said, okay, send us your data. When they got it over the Internet, they said that it had to be sent by CDROM, by US Mail, only.

      Trump is not a scientist and doesn’t pretend to be one. He made some big mistakes, later in the year, by downplaying the virus and ridiculing masks (which do work, but are not perfect). But early on, he did not. He set up his task force in January, when the Democrats were impeaching him while telling people to go out and party. He used his office to correct agencies that were obstructive, and his Operation Warp Speed is why the US is way ahead of most of the rest of the world in vaccinations.

      1. Don’t forget the FDA test kit fiasco. Their kits didn’t work, but they wouldn’t let anyone use anyone elses test kit. That probably didn’t help at all to contain the virus in the early stages. And it really isn’t possible to blame Trump for the FDA screwing that up, he had to defer to the FDA on a purely technical issue like that until the proved themselves incompetent.

      2. See Trumps interview with Bob Woodward in February 2020 where he admits it is airborne.

        Get out of your fucking idiot bubble and get a dose of reality, bud

    6. “I was fully expecting this article to be about Trump and not the FDA. I guess a bit of intellectual honesty was too much to ask from Reason…”

      TDS-addled shit piles do that.

    7. Nothing says “intellectual honesty” like scapegoating Orange Man, though inventing his near death is a strong contender.

    8. While I totally agree with what you’re saying about Donald Trump’s cavalier and irresponsible attitude towards the Covid-19 virus, that upward of a half a million deaths here in the United States from Covid-19 as a result of Donald Trump’s irresponsible attitudes, and the fact that he fired the government’s anti-pandemic coalition, and still playing it down even after he himself almost died, I think that many, if not most of the people who supported him are the ones who refuse to get vaccinated against Covid-19, refuse to wear masks in public, refuse to believe in science, and who really don’t give a damn who they put at risk for hospitalization, ventilators, and/or death. It’s just plain dangerous, and disgusting.

  10. I learned just how reasonable those who thought Covid 19 was serious and how independent they are in their thinking and not following the whims of the media circus when I learned that 2017’s excess deaths were higher than 2020 and no one said one, damn word about it. Crickets. Silence. Certainly, if we don’t let the media drive our amygdala, then the lack of reporting on death in 2017 would not have affected us, right? We’d still demand the government figure out what went on, right?

    Nope. 2020 was a media creation.

      1. “In 2017, excess deaths and years of life lost in the United States represent a larger annual loss of life than that associated with the COVID-19 epidemic in 2020.” Excess mortality in the United States in the 21st century
        Samuel H. Preston and Yana C. Vierboom PNAS April 20, 2021 118 (16) e2024850118;

    1. Looks like you got taken for a ride by some lies someone posted on Facebook. So much for letting “the media drive your amygdala.”

      Excess deaths in 2020 were the highest they’ve been in 100 years. COVID is the worst mass death event from a disease in US history

      1. Excess deaths in 2020 were the highest they’ve been in 100 years. COVID is the worst mass death event from a disease in US history

        Still pimping this bullshit?

      2. Have you even seen what the Spanish Flu did in 1918? 700,000 deaths when the US population was 30% of what it is now?

    2. “COVID is the worst mass death event in US history”

      Where did this new talking point originate? Ive been seeing the same phrase repeated (almost) verbatim for a couple of days now.

  11. Give me a fucking break.

    The first COVID-19 vaccine was granted regulatory approval on 2 December by the UK medicines regulator MHRA. EIGHT days before the US and there’s no reason to think these 8 days had any material effect on the actual scale up of production.

    In contrast, Moderna was approved in the US on December 18. In the UK on January 8. So that argues against the FDA being slower than the UK.

    The challenge trials argument of skipping over the safety question could only come from someone who has chosen to ignore the biggest obstacle to universal uptake of the vaccine.

  12. This article is shite. It is written to criticize in hindsight and serves no useful purpose, other than to inflate Petey’s ego.

    1. I’m good with the Barnstormer assessment.

  13. I think the author badly understates his case. The vaccine took a few days to develop — all of the time since then was to get it approved and ramp up production. To demonstrate that it was not very dangerous it would be sufficient to vaccinate a thousand volunteers and wait a few weeks. To demonstrate that it was effective, challenge trials with a thousand young adults would have been sufficient, and on the odds zero or one person would have died if it wasn’t effective, zero if it was.

    At that point, subject to production limits, they could have started vaccinating as many people as wanted it, keeping track of the effects. That would not produce as much information as the controlled double blind experiment they did, but that information was not worth the cost of hundreds of thousands of lives.

  14. You mean they could have allowed egregiously poorly-tested medicines even *more* poorly-tested? Eek.

  15. Good thing no one cares about the truth on this web-site. Good thing that the author had no problem with Donald Trump’s Opioid Commission’s systematic culling of chronically disabled patients with direct intervention that deliberately withheld life providing pain medication from those who so desperately needed them.

    I told the Administration that #CannabisCuresCovid over a year ago. To prove this theory, I spent as much time as I could around covid suffers and yet I never got sick. I was just tested for the anti-bodies & bingo, there was no doubt that I had Covid based upon the anti-bodies test.

    It’s pathetic that all the Trumpers out there are still wearing their “I’m part of the uneducated populace that Trump & the GOP love so much” badge of courage so proudly. As long as stupidity is allowed to flourish through magazines/web-sites like this one, our nation is fucked.

    I suggest this author watch Jon Oliver’s story regarding the FDA’s approval system for medical devices and generic medication approval.

    1. Rare combination of TDS-addled shit-pile, and conspiracy buff.
      No cure for your TDS, asshole, but the tin-foil hats are on aisle #6.

    2. Stop punishing the rest of society for your daddy issues.

    3. By the way, moron–that chart you showed that had opioid deaths climbing? That started in 2013.

      Who was President between 2013-2016?

  16. Seems the entire premise of thise piece is that vaccines are first, effective, second, safe, and third necessary. They are none of the above.

    Fift percent likelihood one’s symptoms might be reduced is the biggest half-valid promise I’ve seen so far.
    Meanwhile I never was ONE government agency advising what dietary supplements might be taken to good advantage to strengthen one’s onw God-designed immune system to equip one’s own body to deal with the virus that might invade. There are also at leasst TWO compounds that have been proven near 100% effective at both preventing contraction of the virus and overcoming it when one does contract it. But our wunnerfow CDC prohibited use of both….
    not tested”. But both have been proven safe over many decades of use, including self-administration/regulating. Yet WE could not use it, even if we COULD find/purchase it. Other nations used either or botn extensively and and VERY few folks needed any particular medical traetment

    1. You’re dead wrong here, Tionico! The vaccines ARE safe, affective and necessary.

  17. Hindsight is 20/20. Moreover, if we took all of reason’s suggestions we could’ve easily had over a million dead so what can ya do?

    1. “…Moreover, if we took all of reason’s suggestions we could’ve easily had over a million dead so what can ya do?

      Lefty shits are stupid *and* dishonest:
      You.
      Are.
      Full.
      Of.
      Shit.

    2. Same number of dead people as the Spanish flu, same public health recommendations.

      What can ya do?

      1. I guess, in your brain, 100 years of scientific and medical breakthroughs have no effects on disease treatment, prevention, or modeling?

        Give me a break. Everyone sees through your BS

        1. It’s not my fault you’re too illiterate to read material that’s more complex than young adult fiction stories about the adventures of teenage wizards.

        2. Also, fuckin’ LOL at you arguing that all those medical advances were helpless to stop the same number of people dying. Talk about an own goal.

          1. That’s not what I’m arguing at all. I’m stating the obvious: that all of our medical advancements in treatment, prevention, and understanding saved millions of lives. 1918 was a primitive world. Very little sanitation.

            Can’t believe you missed the point so badly.

            1. That’s not what I’m arguing at all.

              You literally said this was the worst mass death event in US history, while bragging about all of our medical advancements in the same breath.

              1. Are you familiar with the word “despite”? We lost 2/3 of a million Americans DESPITE all of our medical advances, testing, emergency treatments, etc.

                You think they had testing for the Spanish Flu in 1918? They had no idea who was sick. I’m embarrassed to have to even explain this down to your level.

  18. I can’t wrap my head around someone actually being ignorant enough to write an article like this, so i can only assume it is just another attempt to sell how great vaccines are.

    You can’t write an article about the FDA affecting the response to Covid without mentioning how their refusal to allow private testing, along with the insistence that every positive be confirmed by what turned out to be bad CDC tests, cost the US three weeks of response time in the critical period of February 2020. Estimates have been high as an 80% reduction in cases by the time of the lockdowns if the private companies that came up with Covid tests had been been given EUSAs by the FDA to manufacture and distribute them from the beginning.

    Also “after cases spiked in the winter” completely ignores that plenty of people were arguing that continuing lockdowns into last summer was crazy, as most viruses have difficulty surviving summer conditions, and lifestyles meant that even people exposed to Covid in the summer are more likely to have a minor/asymptomatic case because of the small viral load passed. Instead, the winter spike was worse because they kept everyone away from each other in the summer.

    Finally, they give credit for the vaccine causing the drop in cases even though the drop correlated to a time the vaccine was being given but few people had gotten it yet, so it couldn’t have stopped the spread on its own. They continue to ignore natural immunity to push the vaccine, even though vaccine rates haven’t gotten anywhere near the number they claim is needed for herd immunity. The only way that could have happened is if natural immunity is effective.

    Yet, they are still arguing that people who previously had Covid need a vaccine even though the only study released so far comparing natural immunity to vaccine derived immunity put natural as equal to the Pfizer/Moderna vaccines, and better than the others, without any unnecessary side effects.

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  20. I have no doubt that things could have gone better if the FDA were reformed and improved. However, the elephant in the room is that a fast-tracked approval process would have raised alarm bells with the anti-vax crowd. We can’t ignore that the FDA is being watched like a hawk for mistakes. Even with a drawn-out review process there are still skeptics. If there are too many skeptics then not enough people will take the vaccine. Challenge trials would bring out naysayers who say the volunteers were coerced.

    A commission should be created to review the whole pandemic response so that we can improve. Many of the ideas presented in this article should be reviewed and perhaps implemented in the future. But we all know that if the FDA adopted these ideas tonight some crowd would come out and cry foul. And if we just gave corporations free reign and tamped down on government oversight, even the Trumpsters would come out barking. This is a tough nut to crack.

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  22. The FDA process could not have been faster. I wanted to sign up for the phase 3 Moderna one but missed the boat where I was.

    Still got the vaccine as did my whole adult family as soon as we could.

    Meanwhile the Ohio lottery thing seems to be working. They already had the money allocated so had to spend it anyway. Giveaways are an old and proven marketing technique. They are up in new vaccines now. You can enter for one of the five $1 million prizes. Also for younger people they are giving chances at a full scholarship to a state U.

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