Biden’s Politicized Vaccine Booster Plan

Both before and after the 2020 election, Joe Biden complained that President Donald Trump had politicized the Covid-19 pandemic. Biden insisted that he, in contrast with Trump, would “follow the science” and listen to the experts at the Center for Disease Control and Prevention and the Food and Drug Administration. And yet, President Biden has pushed vaccine booster shots for all adults despite opposition from the very agencies he touted as sentinels of science. Now an outside advisory panel to the FDA has overwhelmingly rejected the Biden plan, opting to recommend boosters only for a high-risk subset of those who have received the vaccine.

The administration announced plans for vaccine boosters beginning September 20 before any vaccine maker had even applied for booster approval. The first application, and thus far the only completed application ready for consideration, came from Pfizer on August 25, one week after the booster announcement. It seeks booster authorization for ages 16 and up. Pfizer’s supporting evidence was thin. Its application reported increased immune responses to the original viral variant following boosters in 317 subjects aged 18 to 55 and 12 subjects ages 65 to 85. Evidence on activity against the Delta variant that currently predominates was limited to just 11 subjects aged 18 to 55 and 12 subjects aged 65 to 85. No increase in severe adverse events related to boosters was found in the 329 subjects. Pfizer extrapolated safety and effectiveness for 16-17-year-olds from the adult data even though young males have the highest risk of heart inflammation (pericarditis/myocarditis) reported after initial vaccinations.

Politico reports that several CDC officials disagreed with the Biden administration’s booster plans, announced in mid-August. Many felt that the timetable was too rushed to allow the agency to complete studies and review vaccine manufacturer data that would justify the shots before the September 20 start date.

Two top FDA vaccine regulators, Marion Gruber and Philip Krause, announced their retirements shortly after the announcement in a move that many interpreted as a protest against the plan. Both joined with 16 other authors in a recently published Lancet article that concludes the booster policy is not supported by current evidence. They argue that vaccine efficacy remains high and that the unvaccinated remain the major drivers of transmission. Going ahead with boosters now, before adequate data and analysis are available, risks vaccine side effects that could undermine confidence in vaccines and undercut efforts to increase primary vaccinations. Moreover, they suggest that new vaccines, crafted against currently circulating variants, would likely be better boosters than administering additional doses of the original.

Other reports suggest widespread dissatisfaction among FDA staff and outside vaccine advisers who feel that White House political officials steered the announcement and cut key, career FDA employees out of the decision-making. Members of the CDC’s independent vaccine-advisory panel— the Advisory Committee on Immunization Practices (ACIP)—voiced frustration that the administration announced a plan before scientists had an opportunity to review the data and approve boosters.

Now the outside advisory panel to the FDA has voted 16–2 against recommending additional Pfizer shots for ages 16 and up. The panel did approve the booster for people 65 and older or at high risk of severe Covid-19 illness. The FDA is not obliged to follow the panel’s recommendation, but it usually does. The CDC’s ACIP will be meeting to consider boosters this week.

No one should be surprised that the Biden administration recommended boosters at the height of the Delta surge even though scientific evidence was lacking. The administration has a history of politicizing the pandemic. Candidates Biden and Kamala Harris repeatedly criticized the vaccine development under President Trump and impugned the FDA’s independence and integrity, thereby undermining public confidence in what are highly effective vaccines. The administration extended a politically popular CDC eviction moratorium after acknowledging that it lacked the legal authority to do so, only to have it struck down by the Supreme Court. Now the administration has proposed that OSHA impose workplace vaccine mandates, though it is doubtful that this step can be legally justified.

President Biden and his advisors clearly want to be seen as taking action to end the pandemic. They probably think that they are doing the right thing. But going forward, their policies should follow the science and the law.

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Good News from CDC on Delta Variant, Covid Pandemic

Despite media claims that “We Can’t Turn the Corner on Covid,” the numbers of Covid-19 cases, new hospitalizations, and deaths nationwide peaked and started to decline around the beginning of September. The combination of this milestone, new findings from the Centers for Disease Control and Prevention showing widespread levels of vaccination and natural immunity, and improved availability of treatments suggests that, outside of isolated pockets, Covid-19 is likely to become a diminishing health risk in the United States.

The CDC looked for evidence of prior infection or vaccination in the blood of approximately 1.5 million blood donors from around the country between July 2020 and May 2021. Based on the antibodies found in the specimens, they were able to distinguish between those who had been vaccinated and those with antibodies resulting from infection. As of the end of May, the combined vaccine and infection seroprevalence (indicating the proportion of the population with antibodies and some level of immune protection) was 83 percent for those 16 and older (children under 16 can’t donate blood). Over 20 percent had antibodies indicating an earlier infection and recovery. Based on the infection-induced seroprevalence, the researchers estimated that there were actually 2.1 infections per reported Covid-19 case.

Now, following the surge from the Delta variant, the number of confirmed Covid-19 cases (all ages) is over 40 million, or 8 million more than on May 31. Applying the 2.1 multiple from the blood donation study to the entire population results in a real number of cases and people with natural immunity of 84 million, or 25 percent of the population. In addition, 177 million people are fully vaccinated, which is 53 percent of the total population and 34 million more than at the end of May. An additional 10 percent of the population has received a single dose, which provides some protection, albeit less than the full two doses.

While there is overlap because some previously infected people have been vaccinated, roughly 80 percent of the country has vaccine or natural immunity. Both types of immunity provide effective protection against Covid-19. The risk of breakthrough infections among the vaccinated is small, and when they occur, the vaccines continue to be effective in preventing serious illness, even for the Delta variant. The CDC also acknowledges that reinfection of recovered Covid-19 patients is rare.

Though a few vaccines induce a better immune response than natural infection, experts generally say that “natural infection almost always causes better immunity than vaccines.” This appears to be true with Covid-19.

A new study from Israel confirms that natural immunity to Covid-19 is superior to vaccine-induced immunity, even with the Delta variant. Between June 1 and August 14, when Delta was dominant in Israel, the risk of infections was 13 times higher for vaccinated people than for previously infected, unvaccinated people when either the infection or vaccination had occurred between four and seven months before. The risk for symptomatic breakthrough infections was 27-fold higher. While natural immunity did wane somewhat over time, vaccinated persons still had a six-fold higher risk for infection and a seven-fold higher risk for symptomatic illness than people infected up to ten months before vaccinations started.

An earlier study at the Cleveland Clinic of more than 52,000 health-care workers from December 16, 2020 to May 15, 2021 (just before Delta became dominant in the U.S.) found that both natural immunity and vaccine immunity provide good protection against infections. Not one of the 1,359 previously infected subjects who remained unvaccinated was reinfected. Their risk of infection was no higher than for vaccinated people, whether they were previously infected or uninfected.

Moreover, natural immunity thus far appears to be at least as long-lasting as vaccine immunity. Even before vaccines were widely available, studies indicated that four types of immune memory persist for more than six months after infection. The Cleveland Clinic results suggested that natural immunity provides protection against reinfection for ten or more months, leading the authors to conclude that previously infected Covid-19 patients are “unlikely to benefit” from vaccination. Another study found that convalescent individuals maintained immunologic protection for 12 months without vaccination, though protection could be enhanced by vaccination.

Covid-19 treatments have improved as well. Several versions of monoclonal antibodies have been authorized and are now readily available. These medicines are highly effective at keeping early Covid-19 from progressing, thus decreasing the risk of hospitalization or death by 70 percent to 85 percent, particularly for people at high risk of developing severe disease. Steroids and new, more effective ICU protocols have also led to lower Covid-19 mortality.

Of course, some super-variant that escapes vaccine and natural immunity and is resistant to treatments could emerge, much as the emergence of Delta upset many forecasts. There is no way to predict such developments. But even the highly contagious Delta variant, which raised estimates of the percentages needed for herd immunity, did not evade vaccine and natural immunity protection. Delta morbidity and mortality has been heavily concentrated among those who had neither vaccine nor natural immunity.

Ending the Covid-19 pandemic doesn’t mean that the virus will be eradicated or that there will be no new cases. It means that serious illness and death resulting from infection with a virus that has likely become endemic will become rare. Our innovative, free-market economy has provided new vaccines and therapies in record time. Thanks to that, and to the undersold but important phenomenon of natural immunity, we are most of the way there.

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More Vaccination, Not Booster Shots, Should Be the Priority

Several weeks ago, the Centers for Disease Control and Prevention changed its guidance and recommended that fully vaccinated individuals wear a mask in public indoor settings, in areas of the United States with high or substantial Covid-19 transmission—in other words, the whole country. Now the agency is recommending that starting September 20, Americans who received their second vaccine dose eight months or longer ago get a booster shot.

Yet the evidence for these new recommendations is somewhat sketchy, and the recommendations create the risk of undermining confidence in vaccines.

What is the purpose of adding these new measures to the recommendation that everyone be fully vaccinated? Is it to protect against infection in general, or against serious complications of infection?

The current evidence is that vaccines continue to provide strong protection against severe disease, hospitalization, and death. CDC data show that during the surge of the highly contagious Delta variant, the mRNA vaccines (Pfizer and Moderna) showed continued high effectiveness against hospitalizations (86 percent) that did not significantly drop off over 24 weeks. (There was not enough information to evaluate the J&J vaccine.) Effectiveness was higher for healthy people and significantly lower for people with immunocompromising conditions such as cancer, HIV infection, receipt of immunosuppressive drugs, and others. A just-released CDC study of Covid-19 in Los Angeles between May 1 and July 25, 2021, a period in which Delta rapidly became the predominant variant, found that on July 25 hospitalization rates in unvaccinated people were 29 times the rates in fully vaccinated people.

The new recommendations appear to be primarily aimed at stopping infections. They are predicated on the belief that vaccinated people are vulnerable to breakthrough infections—infections 14 days or more after completing vaccination—and may then transmit the virus to others. Breakthrough infections are more common with the currently dominant Delta variant. And because most breakthrough cases are mild or asymptomatic, patients may not even realize they are infected and pose a threat to others.

No vaccine stops 100 percent of cases. Some vaccinated people will become infected. But how many, and what risk do they actually pose to others?

The CDC says the number of breakthrough infections is small. How small is hard to know, since the CDC stopped following all breakthrough cases on May 1, 2021, and now collects data only on hospitalized or fatal breakthroughs. Through May 1, the CDC reported 10,262 breakthrough infections. There were 91,369,257 people fully vaccinated by April 17—14 days prior to the end of the breakthrough data-collection period. A back-of-the-envelope calculation shows that one one-hundredth of a percent of those vaccinated suffered a breakthrough infection. Undoubtedly, this is an underestimate, since asymptomatic or mild breakthroughs were unlikely to get tested and because of the brevity of follow-up for those vaccinated. But even if the breakthrough infection rate is 100 times higher, it would still amount to only 1 percent of those vaccinated.

Through mid-August, 9,716 people with breakthrough cases were hospitalized or died, out of more than 168 million vaccinated people—five one-thousandths of a percent.

Vaccines appear to continue to be effective against infection, though that effectiveness may be slipping for a variety of reasons, including the new predominance of Delta and the passage of time since vaccination for much of the population. But in assessing whether effectiveness is decreasing and what importance it might have for public health, it’s important to understand what effectiveness means.

Vaccine effectiveness measures the proportionate reduction in infections or illnesses among vaccinated persons as compared with unvaccinated persons. Ninety percent effectiveness does not indicate that 10 percent of vaccinated persons will be infected or get sick. Rather, it indicates a 90 percent reduction from the numbers expected if they had not been vaccinated.

The background risk of infection in the unvaccinated that vaccine effectiveness is measured against is actually small and probably declining. Transmission requires relatively prolonged close contact with an infected person who is actively shedding the virus. Even in areas with high or substantial transmission, unvaccinated persons are unlikely to have contact with a person shedding virus. A high percentage of people have vaccine or natural immunity and are therefore extremely unlikely to be infected—more than half the U.S. is vaccinated, and nearly half the country, some of whom have also been vaccinated, have likely recovered from Covid. Even among those who lack immunity, active shedding infections are uncommon.

As time has passed, more people have had and recovered from Covid, changing the background risk of transmission in the unvaccinated. Reinfection after recovery is rare. Failing to account for the decreased risk among the unvaccinated could result in the false appearance of diminishing vaccine effectiveness, since an increasing proportion of all infections would then be occurring among the vaccinated. Similarly, rapidly increasing vaccination rates—the percentage of the population vaccinated in the CDC’s L.A. study nearly doubled, from 27 to 51 percent, in less than three months—makes it less likely an unvaccinated person will encounter an infected person, lowering the risk to the unvaccinated and, again, artificially lowering perceptions of vaccine effectiveness.

Economists have long known, and multiple studies of the Covid-19 pandemic have documented, that when cases and illnesses of communicable diseases rise people react by taking measures, independent of government orders, to avoid infection risk. Since the odds of encountering someone with an active infection rise sharply with increasing group sizes, voluntary avoidance of large groups, especially indoors, lowers the transmission risk. Similarly, rising vaccination rates in states with high Covid prevalence lower the risk to the unvaccinated. Hotspots like Texas and Florida, for example, reacted to the Delta surge by steadily increasing vaccinations over July and August; daily vaccinations doubled in the two states. In Louisiana, vaccinations more than tripled.

A recent update of a CDC prospective study that is testing frontline workers weekly found 80 percent vaccine effectiveness against infection. Estimates of vaccine effectiveness declined from 91 percent before Delta became predominant to 66 percent afterward, though the researchers said that the result should be interpreted with caution because there were so few infections among participants and because effectiveness might be declining as participants’ time since vaccination increases. The study estimated a small decline in vaccine effectiveness among participants for whom less than 120 days had elapsed since vaccination compared with those for whom 150 days or more had elapsed, though the difference was not statistically significant.

The CDC study in L.A. confirmed that vaccines remained effective during the period that Delta became predominant. It found that infection rates in unvaccinated persons were five times the rates in vaccinated persons. But it also found that while viral loads in breakthrough cases with earlier variants had been lower than in unvaccinated cases, Delta breakthroughs had viral loads as high as those seen in Delta infections of unvaccinated people, raising the possibility that Delta breakthroughs present a high risk of viral transmission to others.

The CDC findings are similar to those of a new Oxford study of randomly selected households, tested at fixed intervals, independent of symptoms. It found continued effectiveness against infection from the Pfizer vaccine against Delta (85 percent), though effectiveness did wane somewhat over four to five months. Similarly, Delta breakthroughs had viral loads as high as those in infections of unvaccinated people. But, as seen with earlier variants, the amount of virus produced in Delta breakthroughs goes down faster than in infections of unvaccinated people, likely making Delta breakthroughs infectious for shorter periods and mitigating the transmission risk.

A new Dutch study of health-care workers suggests that breakthrough cases may not present a large transmission risk. In 161 primarily Delta breakthrough infections in workers immunized with various vaccines, there was a lower probability of infectious virus detected in respiratory samples of Delta breakthrough infections versus that of earlier variants found in unvaccinated infections. Viral loads were higher in symptomatic infections, and no relationship was found between time since vaccination and viral load. A small Chinese study of Delta cases found that breakthrough cases (inoculated with an inactivated-virus vaccine) had lower viral loads and were 65 percent less likely than unvaccinated cases to infect others.

The bottom line? While hard to quantify exactly, the current risk of breakthrough infections is probably quite small, and the risk of subsequent transmission still rarer and probably confined to symptomatic breakthrough cases. Longer-term follow-up is needed to see if the risks change.

Yet the CDC’s new recommendations seem destined to undermine public confidence in vaccines at a time when Covid-19 anxiety has doubled over the past two months to levels—41 percent now extremely or very worried about infections—not seen in eight months. This is especially true for the 64 percent of unvaccinated Americans who think vaccines are ineffective against variants.

Booster vaccinations for everyone to eliminate a small risk of infection and a practically nonexistent risk of serious illness in the fully vaccinated and a very low risk of transmission to others seems like overkill. The same benefits could probably be obtained with two more targeted policies: first, giving boosters to immunocompromised people and possibly the elderly where there is evidence that vaccine effectiveness is lower; second, if the finding in the Dutch study that symptomatic breakthroughs have higher viral loads and therefore present a bigger transmission risk is confirmed, then inform vaccine recipients to be on the lookout for Covid symptoms, get tested if they have them, and isolate if the test is positive.

The primary challenge remains getting more people vaccinated. Additional, universally applied precautions for the fully vaccinated is just tinkering at the margins.

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Science Matters—and So Do Individual Rights

As battles over Covid-19 mandates roil the country, it is vital that policies be scientifically based. Well-established legal precedent gives state governments and private entities the authority to impose vaccine mandates in appropriate circumstances, but mandates must be rationally related to a legitimate health aim—protecting against the spread of an infectious disease. A recent legal battle at George Mason University, a public university in northern Virginia, illustrates what happens when they aren’t.

GMU’s reopening policy requires all students, faculty, and staff to verify their vaccination status unless they obtain a religious or medical exemption—or risk disciplinary measures including unpaid leave, loss of merit pay, and termination of employment. Todd Zywicki, a longtime professor at GMU’s Antonin Scalia Law School, objected. He had already contracted and fully recovered from Covid-19 and, as a result, acquired natural immunity, confirmed by multiple positive SARS-CoV-2 antibody tests. His physician advised him that vaccination was unnecessary.

GMU insisted. Zywicki sued, claiming that the university could not show a compelling interest that should override his autonomy and constitutional rights to refuse a vaccine made unnecessary by his naturally acquired immunity.

GMU blinked. It granted Zywicki a medical exemption allowing him to hold office hours and attend in-person events provided that he maintains six feet of distance and that he undergo free, weekly Covid tests.

The GMU policy exemplifies the type of rigid, irrational rule-making that has characterized much of the pandemic response. If an individual can demonstrate immunity via circulating antibodies after a previous Covid infection, there is no compelling reason to require him to undergo an invasive vaccination.

The CDC acknowledges that reinfection of recovered Covid-19 patients is rare. Nevertheless, it still recommends that recovered patients be vaccinated. The agency cites two reasons: first, that experts don’t know how long natural immunity protection lasts; and second, that vaccination provides a strong boost to natural immunity. The first— uncertainty about the duration of protective natural immunity—is not, by itself, a convincing reason for vaccinating previously infected individuals. The second, while true, does not provide a rationale for a vaccine mandate.

No one yet knows how long natural Covid immunity will last—but the same holds true for vaccine immunity. Indeed, the duration of follow-up of people after infection is far longer than the follow-up after vaccination; it shows that natural immunity after infection is durable and long-term, lasting at least a year. Comparison with other coronaviruses indicates that natural antibody-mediated protection in Covid-19 will likely last one to two years, and that other mechanisms of immunity (such as relying on T and B cells) persist far longer.

The recent CDC announcement recommending booster shots for vaccinated people is based on data showing waning vaccine effectiveness in halting infection over time. This may be related to the gradual decline in circulating antibodies over seven months. The increasing prevalence of the Delta variant has also clearly played a role. Vaccines are moderately less effective against the transmission of Delta. The good news, though, is that the vaccines show sustained, strong effectiveness against severe Covid disease, hospitalization, and death for all variants, including Delta.

Booster shots appear to lift antibody levels and should enhance protection against infection for fully vaccinated people. The same antibody increase appears to occur following vaccination of previously infected persons. But it is unclear when or whether such a boost is needed to protect previously infected people who have a demonstrated antibody response. Nor is it known exactly what the impact of the Delta variant will be on natural immunity.

A Kentucky study of previously infected people, some of whom were subsequently vaccinated and some of whom were not, compared 246 people who were re-infected with matched controls who were not re-infected. It found that vaccination significantly reduced the risk of re-infection. But the study relied on voluntary testing to assess re-infection. If vaccinated people were less likely to be tested, either because they believed they couldn’t be re-infected or because the vaccination made the re-infection less severe than in unvaccinated subjects, then the association between reinfection and lack of vaccination would be overestimated.

In contrast, a study of over 52,000 Cleveland Clinic employees found the incidence of infection was the same among previously infected unvaccinated employees and vaccinated employees, including those who had and had not been previously infected. None of the 1,359 previously infected subjects who remained unvaccinated was re-infected. The authors concluded that individuals with previous Covid-19 infections are “unlikely to benefit” from vaccination.

While the CDC is recommending booster shots, no one has yet suggested mandating boosters for fully vaccinated people. Even without boosters, the likelihood of vaccinated persons being infected and passing it on to others is simply too low to provide a compelling interest that should override personal autonomy.

Similarly, no institution should mandate a vaccine—in effect, a booster—for people with demonstrated natural immunity who represent a low risk of re-infection. GMU showed that it could easily accommodate professor Zywicki’s wishes. Yet, the measures the school is subjecting him to may be overkill, since he does not represent any bigger threat to his students and colleagues than those with documented vaccination. And he poses little threat to a school population that, because of the policy, is fully vaccinated.

Mandates should be imposed only when absolutely necessary and then should be applied as narrowly as possible. Institutional policies should conform with both the science and with respect for individual rights.

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Individual Choices, Not Lockdowns | City Journal

After a year of start-and-stop public-health measures, more often guided by intuition than by science, studies are confirming what economists long suspected: the Covid-19 lockdowns were an expensive, unnecessary failure, based on models that overestimated the number of cases and deaths because they failed to account for individual responses to the pandemic. 

Epidemiologists viewed lockdowns as the logical response to a new virus to which humans lacked immunity and that could overwhelm hospitals and cause many deaths. Yet health economists, following seminal work by Tomas Philipson, have long understood that people respond to incentives and alter their behaviors to avoid the risks and costs of infectious diseases. Epidemiologists failed to account for these voluntary changes in assessing what would happen without a lockdown. Even now, as the Delta variant spreads in some regions and officials debate new lockdowns and other mandates, people are already reacting to greater risk by altering their own actions. 

The influential Imperial College of London model was typical. In March 2020, it predicted exponential growth of Covid cases that would overwhelm ICU bed capacity by early April and cause 2.2 million U.S. deaths by July. The authors recommended prolonged lockdowns until vaccines became available.

The model grossly overpredicted deaths because of critical errors, including an unrealistically high infection-fatality rate. Most important, its predictions were based on the “unlikely” scenario that there would be no changes in individual behaviors. The model used a reproduction number, or Rt—the average number of secondary infections that each infected person produces in a susceptible population—that was too high and, contrary to standard epidemiological practice, did not vary over time. In fact, Rt declines as people voluntarily avoid contact with others and as the number of recovered people no longer susceptible to infection grows.

The Imperial College model also assumed that hospital and ICU capacity was fixed and unchangeable. But hospitals voluntarily adapted to increasing Covid hospitalizations by limiting their elective procedures and redirecting assets to increase capacity even without government direction. Instances of U.S. hospitals reaching, or exceeding, capacity were rare.

Other businesses also made adjustments. Employers had incentives to limit workplace infections in order to reduce absenteeism, lower insurance costs, and enhance their reputation as safe places to work and shop. University of Chicago economist Casey Mulligan found that private companies voluntarily implemented infection-prevention measures that lowered workplace Covid-19 transmission to levels below household rates.

Failing to account for voluntary actions overstated the risks of the pandemic, creating a counterfactual that would never occur. Moreover, it overstated the benefits of a lockdown, attributing entirely to mandates the improvements that were actually a combination of voluntary responses and responses to mandates.

Another widely cited Imperial College paper from June 2020 illustrated this mistake by attributing decreased European Covid-19 deaths entirely to lockdowns. Yet, as the authors acknowledged, “We do not account for changes in behaviour; in reality, even in the absence of government interventions we would expect Rt to decrease and therefore would overestimate deaths in the no-intervention model.”

Indeed, changes in individual behaviors generally precede government actions and can have a more significant impact. An early study of mobility data found that people had already started to reduce time outside their homes before the government implemented restrictions. In another study, the growth rate in Covid deaths across 23 countries and all U.S. states fell from a wide range of initially high levels to nearly zero in 20 to 30 days in each region, regardless of differences in the type or degree of lockdown imposed. Canadian economist Douglas Allen reviewed nearly 20 studies that distinguish between voluntary and mandated lockdown effects. All found that lockdowns had only marginal effects and that voluntary changes in behavior explain most of the changes in cases and deaths.

In fact, there is little correlation between deaths and the imposition or severity of lockdowns, whether in U.S. states or in other countries. Sweden, criticized for its light restrictions, saw fewer cumulative deaths per million population (1,443) than did the European Union (1,648), the U.S. (1,812), or the U.K. (1,888). Florida, condemned for fully lifting restrictions too early (September 2020), and Texas, accused of “Neanderthal thinking” for fully lifting restrictions in March 2021, have registered lower deaths per 100,000 than states with stringent, long-term restrictions like New York, New Jersey, Connecticut, Massachusetts, Michigan, and Illinois.

People responded to the degree of risk they faced. Covid-19 fatality rates are closely connected to age—low for young people but rising dramatically for those aged 60 and older. Many people reduced their consumer spending in response to the pandemic, but older consumers reduced theirs—particularly on goods likely to involve close contact with others—by more than younger consumers, mirroring the age dependency in Covid-19 fatality rates. This effect was most pronounced in periods of high infection rates. Similarly, people with medical comorbidities that put them at higher risk cut expenditures more than healthier people, an effect that proved to be independent of age.

Another study, using cell-phone location data of customer visits to millions of businesses, found that declines in traffic preceded lockdowns and that nearly all the overall decrease was explained by choices to stay home, which were highly influenced by the number of local Covid-19 deaths. Government-imposed restrictions had little impact.

Lockdowns are an indiscriminate tool that can undermine more effective, particularized, private responses. Government mandates affect everyone—from high-risk individuals who would have taken precautions anyway to low-risk individuals who might not need the same level of protection. Stay-at-home orders short-circuit the discovery and implementation of innovative measures to limit workplace transmission and force workers from safer employment settings into households, where Covid transmission rates are higher.

In short, changes in behavior are more important than mandates. Most people don’t ignore risks, and they can react more quickly than governments.

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CDC’s New Mask Guidance | City Journal

The Centers for Disease Control and Prevention (CDC) has reversed its guidance from two months ago and now recommends that fully vaccinated individuals should wear a mask in public indoor settings in areas of the country with high or substantial transmission—23 and 20 states, respectively, according to the CDC. There is little in the data to support this reversal. The agency is probably being overcautious or responding to political pressure to “do something.”

The CDC says that “preliminary evidence” suggests that breakthrough infections of vaccinated people from the Delta variant of Covid-19 can spread the virus to others. Masking vaccinated people will thus protect them from infection and from passing the virus to unvaccinated people. But the agency never quantifies either the risks of breakthrough infections and secondary transmission or the benefits of masking.

Delta poses little risk to the vaccinated. The vaccines protect against infection and are highly effective in preventing serious Covid-19 illness and death with all variants, including Delta. In addition, the symptoms and duration of illness in those vaccinated people suffering breakthrough infections have been attenuated compared with cases among unvaccinated people.

So what has changed? The CDC’s assessment of the risk that breakthrough cases might pose to others. Viral loads in breakthrough infections have been shown to be lower than those in infected unvaccinated people, suggesting that breakthrough cases would be less likely to transmit the infection. But now the CDC, citing a non-peer-reviewed, preprint study, along with unpublished data, claims that breakthrough Delta infections are more transmissible than breakthrough infections from other variants. The study examined breakthrough infections in 100 Indian health-care workers vaccinated with an Indian version of the Astra-Zeneca vaccine (not used in the U.S.). Infections with the Delta variant showed higher respiratory viral loads compared with non-Delta infections, leading to increased transmission between health-care workers.

The CDC also cited another preprint study showing that Delta-variant infections make up a higher percentage of breakthrough cases than other variants in Houston. But the study also showed that breakthrough cases were only 6.5 percent of all cases and were far less likely to require hospitalization. Significantly, the study showed that breakthrough cases had lower viral loads, indicating less transmission potential than in unvaccinated patients (though this portion of the study did not distinguish between Delta and non-delta variants).

These small and somewhat contradictory studies seem like a slim reed on which to base a nationwide change in policy. The CDC has not released any other data showing that breakthrough Delta infections present as high a transmission risk as infections of the unvaccinated. Despite the current Delta surge, vaccinated people likely pose a minimal risk to the uninfected.

The CDC acknowledges that even with Delta, only a small percentage of fully vaccinated people will be infected. For a vaccinated person to become infected, they have to encounter an infected person who is actively shedding the virus. A large percentage of the population is immune and unlikely to be infected or shedding; half the U.S. population is vaccinated, and at least another 20 percent to 25 percent more have natural immunity after recovering from Covid-19. Even in areas with high or substantial transmission, the prevalence is low; most of the unvaccinated we meet do not have an active Covid-19 infection. Moreover, even if they are infected, relatively prolonged close contact is needed to create a transmission risk. Finally, the vaccines appear to be about 90 percent effective in limiting transmission.

Considering the tenuous nature of the evidence and the likelihood that the Delta surge will dissipate in the next few weeks, the CDC should have taken a more measured approach, concentrating on the subset of vaccinated people most vulnerable to breakthrough infection. Nearly half of breakthrough infections are in immunocompromised people. These people should be advised to take precautions like avoiding crowded indoor settings and wearing masks. In addition, serious breakthrough cases are concentrated in the elderly: 75 percent of hospitalized or fatal breakthrough cases were aged 65 or older. They should also be cautious.

Until public-health officials release studies proving that fully vaccinated people are transmitting Delta, it is hard not to conclude that they are either practicing the precautionary principle (mandating preventive action to limit any possible harmful effects) or are trying to give the appearance of acting to combat the latest surge in cases. Neither approach is warranted, and both will only further erode public confidence in vaccines.

In an AP-NORC poll published last week, 30 percent of Americans said that they were not confident that vaccines are effective against new variants. Only 28 percent are very confident the vaccines work. Among the unvaccinated—the group that the CDC must convince to get the shots—64 percent lack confidence in the vaccines. This new mask guidance will undoubtedly make matters worse. After a year and half of sacrifice, the American public deserves information and evidence-based policy that encourages rather than discourages vaccinations.

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Delta Variant Doesn’t Justify New Covid Restrictions

One cannot open a newspaper, turn on a TV, or scroll through an online news feed without hearing about Covid-19’s new Delta variant. While the variant is cause for concern among unvaccinated Americans and in many foreign countries, it shouldn’t make us reconsider our approach to the virus at this stage in the reopening process.

Delta is a variant of the SARS-CoV-2 virus that causes Covid-19. It was first identified in India more than six months ago and has spread to 100 plus countries, having become the dominant variant in many, including the United States. It is 60 percent more transmissible than the Alpha, or U.K., variant, which previously predominated in the U.S. and was itself 50 percent more transmissible than the original viral strain from China. This has led to increased infections both here and worldwide.

But the bump in infections is nearly entirely among the unvaccinated. The authorized Covid-19 vaccines appear to be effective against Delta. And Delta is not clearly more dangerous than earlier variants: the average Covid-19 case with Delta is no more likely to lead to severe disease, hospitalization, or death than cases with other variants. Despite rising numbers of U.S. Delta cases, hospitalizations in July have risen only minimally, while Covid-19 deaths have remained flat.

The accumulating evidence shows that the authorized vaccines are highly effective at lessening transmission for all variants—including Delta. In the rare cases where vaccinated people become infected, their disease is mild and they pose a lower risk of transmitting the virus to others than do unvaccinated people.

Thankfully, 59 percent of American adults are fully vaccinated. Sixty-eight percent have received at least one dose, which provides them some protection, though not as much as the complete regimen. The news is even better for the most vulnerable population: those 65 and older. Nearly 80 percent have been fully vaccinated and nearly 90 percent received at least one dose.

While younger people remain unvaccinated—authorization was only recently approved for those age 12 and up—Covid-19 is rarely a severe disease for people under 18. Deaths in those 18 and younger account for only one-tenth of 1 percent of Covid-19 deaths. Deaths below age 12 are practically unheard of. In fact, severe disease in people under 50 is rare unless they have comorbidities.

Despite this good news, pockets of concern do exist. Nine southern states, along with Wyoming and Idaho, significantly lag the nation in vaccination rates. Moreover, even well-vaccinated states have localized communities with large numbers of unvaccinated people.

But none of this indicates that we need to change current policies. While some countries and a few localities here have re-imposed mask mandates, travel restrictions, and other precautions—even for vaccinated people—these actions are generally not warranted in the United States. Centers for Disease Control and Prevention director Rochelle Walensky recently declared that vaccinated people need not wear masks, since vaccines are effective against all the variants circulating here—including Delta. The same is likely true for people with natural immunity after recovery from an earlier Covid-19 infection, who appear to be protected for at least a year. (Of course, non-immune people in vulnerable groups should continue to be cautious, continuing distancing efforts when possible.)

Delta should also not affect plans to reopen schools for in-person learning. The CDC recently updated its recommendations for schools. For the first time, the agency acknowledged “the importance of offering in-person learning, regardless of whether all of the prevention strategies can be implemented at the school.” The CDC did not make an exception for Delta, nor should it. Children and schools have not been a source of community spread at any point in the pandemic, even before the availability of vaccines.

Increasing vaccinations continues to be a priority, especially where vaccination rates are low. All the variants, including the highly transmissible Delta, pose a risk to those who lack immunity. While we have achieved high vaccination rates, particularly among the vulnerable elderly, a small share of younger people remains at risk of severe disease. A Scottish study found a higher risk of hospitalization with Delta infections than with earlier variants in young people, but the danger was concentrated in those with five or more relevant comorbidities.

Localized Covid-19 outbreaks in areas with low vaccination rates remain a possibility here., Other countries struggling with their vaccine rollouts have been hit hard. But in the U.S., any rise in cases will likely occur among young people, most of whom are at low risk of severe illness and death. We should continue on our current path: relaxing public-health restrictions, encouraging vaccinations, protecting vulnerable populations—and returning to normal.

Photo by Spencer Platt/Getty Images

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CA v. TX Likely Marks End of Legal Challenges to Obamacare

The Supreme Court has now ruled on three legal challenges to the Affordable Care Act, and for opponents of the statute the third time was not a charm. In yesterday’s 7–2 ruling in California v. Texas, the Court held that the 18 states and two individuals claiming that the ACA’s individual mandate was unconstitutional lacked the standing to bring the case because they failed to demonstrate that they were injured by that now-unenforceable mandate. The case likely marks the end of the line for legal challenges to the health-care law.

In two earlier decisions, the Court saved the law with creative legal reasoning. In the first, 2012’s National Federation of Independent Business v. Sebelius, the Court characterized the penalty imposed on individuals who failed to purchase health insurance as a constitutionally permissible “tax” despite the fact that Congress had explicitly said the penalty was not a tax. The second, 2015’s King v. Burwell, interpreted an ACA provision that made premium subsidies available on health-insurance exchanges established by a “state” to include federally established exchanges. (The case was coordinated by the Competitive Enterprise Institute, where I am now a senior fellow.)

In both cases, the government argued that the individual mandate was critical to the functioning of the ACA. Invalidating the mandate would undermine the effectiveness of the guaranteed-issue and community-rating provisions of the law, which bar insurers from denying coverage or charging higher premiums based on individuals’ medical conditions, and lead to the collapse of the ACA’s insurance market.

Texas, along with the other state and individual plaintiffs, brought a lawsuit arguing that without a penalty, the individual mandate raises no revenue, is no longer a tax, and is therefore unconstitutional, since Congress would lack the authority to enact it. They further argued that the mandate, which Congress had earlier labeled as “essential” to the ACA, was not severable from the rest of the statute—and therefore that the entire ACA is unconstitutional.

A federal district court in Texas held that the plaintiffs had standing to challenge the constitutionality of the mandate and that the mandate is unconstitutional and not severable, making the entire ACA unconstitutional. The Fifth Circuit Court of Appeals agreed that the plaintiffs had standing, and that the individual-mandate provision was unconstitutional, but questioned the adequacy of the district court’s severability analysis.

The Supreme Court’s decision addresses neither the constitutionality of the now-toothless individual mandate nor its severability from the rest of the statute. It goes no further than finding that the plaintiffs lacked standing—the right to seek judicial relief—under Article III of the Constitution. Generally speaking, to establish standing a plaintiff must show an actual injury that is reasonably traceable to the challenged conduct of the defendant and is likely to be redressed by the requested relief.

None of the nine justices found that the individual plaintiffs had standing. Without a penalty for noncompliance, the mandate is unenforceable, and there is no injury that can be redressed by judicial relief.

The majority also found that the 18 plaintiff states lacked standing. The Court held the states had not provided evidence to support their claim of increased Medicaid enrollment and expenses resulting from the mandate. It noted that once the mandate penalty was zeroed, the mandate ceased being an independent incentive for people to enroll in Medicaid. The Court also rejected the states’ claims that the ACA imposes administrative costs and requires them to offer their employees insurance because these obligations were created by other provisions of the ACA that operate independently of the individual mandate, and which the plaintiffs had not directly challenged.

Two justices disagreed with the holding regarding the states. Justice Samuel Alito penned a vigorous dissent, joined by Justice Neil Gorsuch, arguing that the states did have standing, that the mandate with zero penalty is “clearly unconstitutional,” and that it is inseverable from the other ACA provisions that burden the states. On the standing issue, Alito argued that the states had clearly shown injury from the ACA that would be redressed by a favorable judicial ruling, but that the majority had misinterpreted the Court’s precedents on whether the injury was traceable to the government’s unlawful conduct. Alito claimed that the injury need only be traceable to the government’s administration and enforcement of the ACA, not specifically to the individual-mandate provision.

Regardless of which side is right on the standing argument, the case likely represents the last legal challenge to the ACA. Its opponents have tried three theories without success. Notably, Justice Clarence Thomas’s concurring opinion made clear that while he disagreed with the Court’s reasoning in the first two ACA challenges, he agreed with its decision on standing in the third. The Court’s unwillingness to grant standing and hear this most recent case on the merits suggests that a critical mass of justices will not look favorably on additional challenges—however creative they may be.

Photo by Kevin Dietsch/Getty Images

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The Beginning—and End—of the Pandemic

Physician Joel Zinberg joins Brian Anderson to discuss the success of the vaccine rollout in beating back the pandemic, the lab-leak theory of Covid-19’s origins, and the Biden administration’s push to waive intellectual-property protections for vaccines.

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On Covid-19 Origins, Elites Followed Politics, Not Science

It is a disturbing prospect, like something out of a science fiction novel, but it’s appearing increasingly plausible nonetheless: the cause of the worldwide Covid-19 pandemic, which has killed millions and cost tens of trillions of dollars, may have been a viral escape from a Wuhan, China virology laboratory.

The latest indicator pointing toward a man-made catastrophe—that, until now, has been obscured with the aid of credulous media and scientists—comes from the Wall Street Journal, which reported that U.S. intelligence found that three researchers from the Wuhan Institute of Virology were hospitalized in November 2019 with symptoms consistent with Covid-19. That is well before the Chinese government’s claim that the first confirmed case occurred on December 8, 2019. This new report echoes a January 15, 2021 State Department fact sheet that reported several Wuhan Institute researchers became ill in autumn 2019. The steady accumulation of circumstantial evidence has prompted President Biden to order a review.

Early in the pandemic, conservative newspapers, like the Daily Mail and the Washington Times, and Senator Tom Cotton raised the possibility of a Chinese lab leak. The Washington Post dismissed such speculation as a debunked conspiracy theory. The New York Times labeled it a “fringe theory.”

The scientific establishment also weighed in, disregarding early papers from Chinese and American scientists with evidence that suggested a lab leak origin. One group, citing mostly Chinese sources, declared in The Lancet that the coronavirus originated in wildlife, not a laboratory, and praised Chinese scientists and public-health officials “who continue to save lives and protect global health.” Five other virologists in a letter to Nature Medicine stated that “SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus.” Anthony Fauci, in a May 2020 National Geographic interview, said the evidence indicated that the virus “evolved in nature and then jumped species” and had not escaped from a Chinese lab.

These early reassurances were based on surmise, not facts. They ignored that virologists in China—most prominently, the Wuhan Institute’s Shi Zhengli (“the Bat Lady”)—were actively engaged in gain-of-function research in which naturally occurring coronaviruses collected from bats were manipulated to acquire the ability to infect humans. They ignored that such research often utilizes serial viral passage through lab animals that mimics the process of a natural zoonotic jump between species. When a World Health Organization team visited Wuhan in February 2020, the institute’s staff refused to share data, safety logs, or lab records. Remarkably, that did not stop the WHO from concluding that a lab leak was “extremely unlikely.” Only four of the 313 pages of their report addressed the possibility of a lab accident.

More than a year has passed since then, with scientists assuring for most of that time that SARS-CoV-2, the virus responsible for Covid-19, emerged naturally. But no scientist, Chinese or Western, has produced a presumed bat source population, an intermediate species that functioned as a viral conduit between bats and humans, or evidence that the virus was present anywhere before it emerged in Wuhan. In contrast, during the 2003 SARS outbreak in China, researchers uncovered evidence of intermediate animal hosts and serologic signs of infections in animal traders within months. Analyses of SARS-CoV-2’s rate of mutation indicate that it likely began spreading several weeks earlier than the official first case date—December 8, 2019—a fact that makes the Covid-19-like illness of three lab workers in November so intriguing.

Scientists are finally beginning to take the possibility of Chinese negligence or malfeasance seriously. In a letter to the journal Science, 18 leading virologists wrote that accidental lab release remains a viable possibility and urged the Wuhan scientists to cooperate fully with additional investigations. One of the signatories, Ralph Baric, is the world’s leading expert on gain-of-function research in coronaviruses and had collaborated with Zhengli in the past. While he believes natural evolution is a more likely explanation than gain-of-function research and a lab leak, he is calling for an open, through investigation of the Wuhan Institute and its safety protocols. Other scientists point out that several peculiar characteristics of SARS-CoV-2 are inconsistent with a natural zoonotic origin and that a lab-leak origin should be investigated. Even Fauci has now admitted that he is “not convinced” Covid-19 developed naturally outside of the Wuhan lab.

Some journalists are also beginning to examine the issue. Science writer Nicholas Wade published an extensive examination of the competing natural-emergence and lab-escape hypotheses. He concludes there can be no definitive evidence for either without examining Chinese data, but that a lab leak is far more likely.

The Chinese authorities are unlikely to allow a thorough investigation, so the true origin of Covid-19 may never be known. But even more disturbing than the Chinese government’s attempts to obfuscate the pandemic’s origins is the way scientists and the media nearly uniformly insisted that a lab leak was out of the question.

Scientists may have been protecting Chinese colleagues that many had worked with and even funded. Perhaps, Western scientists feared that the possibility of Chinese culpability would reflect badly on them and their own viral-gain-of-function research.

Journalists, on the other hand, seemed intent on countering an anti-China, anti-WHO narrative advanced by President Trump and other conservatives. New York Times reporter Apoorva Mandavilli, for instance, recently tweeted (and later deleted) her hope that people would “stop talking” about the lab-leak hypothesis, on account of its “racist roots.” The scientists’ opinions in the early days of the pandemic gave such journalists cover to indulge in their usual Trump-bashing and assert that they were only “following the science,” in contrast to Trump’s allegedly baser motivations.

We’ve seen this pattern play out time and again over the past year. From the value of lockdowns and masks to the likelihood of speedy and safe vaccine development, scientists and experts based their opinions more on intuition than on facts—until the facts finally forced a reversal. And journalists seemed remarkably incurious about those expert opinions, especially when they presented them with an opportunity to criticize conservatives. Both groups, who have frequently decried official “misinformation,” ought to look first to their own failings.

Photo by HECTOR RETAMAL/AFP via Getty Images

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