Friday, May 20, 2022

Biden Still Searching For A New Covid Strategy

First, the good news. The number of hospital patients with Covid-19 continues to fall across the US (with some exceptions), adding to signs that the omicron wave of the pandemic has peaked even though deaths from those previously infected by the virus are still rising.

The seven-day average of hospital patients with a confirmed or suspected coronavirus infection has fallen daily for the last two weeks, even while the rolling seven-day average of daily deaths due to Covid has reached 2,439, the highest level since last February.

In addition, the seven-day average of daily new recorded infections has fallen from a peak of more than 800,000 two weeks ago to 450,000.

However, two years into the pandemic, the CDC estimates that America’s virus-related death toll is now approaching one million.

Included in that number are about 700,000 vulnerable seniors killed by the virus, and thousands of frontline health workers who exposed themselves to infected patients. In addition, Covid has had a disproportionately larger health and economic impact on minority populations.

In 2019, the US recorded 2.85 million overall deaths, following a climb of about 1.6% a year over the previous decade. In 2020, the number ballooned by 18.5% to 3.38 million deaths. Last year, provisional data show 3.42 million deaths. The CDC believes the difference represents the true death toll due to Covid, exceeding by about 100,000 the 875,000 Covid fatalities registered on death certificates as the primary or contributing cause over the past two years.

Around the world, many countries have relaxed Covid restrictions, even in some places where the number of new infections continues to rise, because the current omicron variant is much less lethal to populations that have mostly been vaccinated.

Many countries have allowed more of their schools and businesses to remain open to limit the economic impact of the current wave. Still, the omicron surge is having a depressing impact both here and abroad on both the level of business activity and consumer sentiment.

THE SUPPRESSED TRUTH ABOUT NATURAL IMMUNITY

Meanwhile, there is a growing realization in this country that the rise of the omicron variant has exposed key weaknesses in government policies. According to a Wall Street Journal op-ed by Dr. Marty Makary, a widely followed Johns Hopkins public health policy critic, the Biden administration’s vaccine mandates have needlessly ruined the lives of tens of thousands of American workers who were fired because they weren’t fully vaccinated, even though they had a natural immunity to Covid due to a previous infection.

The firings were unnecessary, because, based upon two years of clinical data, the superiority of natural immunity over vaccinated immunity is now clear. Because the government ordered businesses to fire staff with natural immunity, those who were least likely to infect others were wrongfully punished. They lost their jobs due to the false premises that only unvaccinated people could spread the virus and only vaccination could prevent its spread, and they now deserve to be reinstated with an apology, Makary writes.

Those responsible for the vaccine mandates ignored a fact which had been reported by many practicing physicians from the outset of the pandemic. Those who had recovered from a bout of Covid and were then reinfected were not ending up on ventilators or dying, except for the few who had preexisting immune disorders. But the public health establishment refused to reevaluate its initial skeptical view of natural immunity, that “there is no evidence for lasting protective immunity to SARS-CoV-2 following natural infection,” even as evidence was growing that natural immunity provides even greater protection against Covid than vaccination does.

For most of last year, the CDC rejected calls from public health officials to release its data on reinfection rates. Finally, a few weeks ago, the CDC released data from New York and California, which showed natural immunity was 2.8 times as effective in preventing hospitalization and 3.3 to 4.7 times as effective in preventing infection compared with vaccination.

Yet the CDC still refused to recognize that natural immunity, on its own, was just as effective as vaccination in protecting against infection. It continued to insist that “vaccination remains the safest [but not necessarily the most effective] strategy.” The data was also clear that insisting upon vaccinating people who had already had Covid didn’t significantly reduce their risk of hospitalization.

Similarly, the National Institutes of Health continued to argue that the duration of natural immunity was unknown, while at the same time making no effort to find out what it actually was. As a result of the NIH’s inaction, Dr. Makary and his colleagues at Johns Hopkins conducted their own study of 295 unvaccinated people who had previously from a bout of Covid. They found antibodies to Covid still present in the blood of 99% of those patients up to nearly two years after their infection. They also found that natural immunity created by infection by prior variants of the virus were much more effective at reducing the risk of infection with the omicron variant than two doses of the Moderna vaccine, especially after several months had passed since vaccination.

More than 100 other studies around the world on natural immunity came to the same conclusion: The natural reaction of the human immune system works better at fighting infection than any vaccine. The largest of these studies, from Israel, found that natural immunity was 27 times as effective as vaccinated immunity in preventing symptomatic Covid illness.

NEEDLESSLY RUINED LIVES

Nevertheless, public-health policies continued to call for punitive vaccine mandates, while ignoring the value of natural immunity. The mandates needlessly destroyed the livelihoods of countless thousands of airline pilots, truck drivers, and others essential members or the supply-chain workforce who didn’t get vaccinated. They were forced to quit or be fired from their jobs, even if they could prove that they had natural immunity.

This short-sighted policy is still being enforced in the health care industry by the federal Centers for Medicare and Medicaid Services, at President Biden’s insistence. It has further exacerbated an already critical nationwide shortage of health workers, which is especially severe in hospitals serving rural areas.

For example, after the Multicare hospital system in Washington state fired 55 members of its care staff in October for failing to follow a vaccine mandate ordered by Washington’s Democrat Governor Jay Inslee, the worker shortage got so bad that the hospital quietly asked infected members of its staff who were still Covid-positive to return to work, according to an internal memo obtained by a local news reporter for KTTH radio. The memo stated that “positive staff with mild to moderate illness” could work, so long as they wear appropriate personal protective equipment, don’t take breaks with others, and agree to stay home “if symptoms worsen.” The only precaution was that hospital managers were instructed to assign Covid-positive staff to already Covid-positive patients and vaccinated patients, but not to immunosuppressed patients.

The Supreme Court has now struck down President Biden’s order to OSHA to issue an emergency order to all private businesses with more than 100 employees to fire its workers who refuse to comply with Biden’s vaccine mandate. OSHA has now withdrawn the mandate, but it is now starting to draft a new vaccine mandate on employers through its normal workplace safety rule-making process, which will likely take a year or more before it becomes effective.

However, the Supreme Court upheld a separate vaccine mandate which Biden ordered on all health care providers receiving federal Medicare or Medicaid reimbursements.

MANDATES REFUSE TO DIE

In addition, the sweeping vaccine mandates ordered by former New York City Mayor Bill de Blasio just a few weeks before he left at the end of last year are still technically in effect, despite reassurances from newly installed Mayor Eric Adams that he has no intention to have them actively enforced.

The political lesson to be learned is clear. Covid mask and vaccine mandates, like higher prices and taxes, are much easier to put in place than to eliminate when they are no longer necessary. Too many of our public officials enjoy wielding the additional power over our daily lives that vaccine and mask mandates gives them.

At the same time, two years of media hysteria over Covid have so badly frightened many members of the public that they are afraid to send their naturally Covid-immune children to school for fear that they will come into contact with their unmasked classmates.

BIDEN’S FLAWED STRATEGY

President Biden entered office with a clear plan to put a quick end to the pandemic by launching a vigorous campaign to inoculate virtually the entire US population against Covid. But it didn’t work. The Biden administration overestimated its ability to push vaccinations via incentives and mandates. At the same time, it failed to adequately push other mitigation measures, such as making Covid testing more widely available, mass producing promising therapeutics that could effectively treat patients, and pushing the distribution of more effective masks which would have enabled it to respond more effectively to the emergence of more highly transmissible variants.

As a result, one year after Biden took office, about a third of eligible Americans still aren’t fully vaccinated. The latest surge due to the omicron variant resulted in a huge spike in new infections, again threatening to push some of the nation’s largest hospital systems past their breaking points. Meanwhile, most Americans are now suffering from pandemic fatigue due to shortages of Covid medications, testing kits, as well as all kinds of consumer goods hung up in Covid-snarled supply chains around the world.

According to Ezekiel Emanuel, former Chicago Mayor Rahm Emanuel’s brother, who had served as Biden’s chief health policy advisor, “[The Biden administration] had a very good strategic plan coming in… we were all feeling good by the end of June.” But then the delta variant spike hit just as Biden was preparing to take a premature victory lap for ending the pandemic.

The CDC was also premature in recommending last May that fully vaccinated people no longer needed to wear masks in most settings. But when research then indicated that vaccinated people could still transmit the delta variant, that guidance had to be reversed. This created much disappointment and skepticism among many members of the public, who thought the government had led them to believe that the pandemic was already effectively over, and badly damaged public confidence in Biden’s anti-Covid policies.

MANDATES WERE AN ADMISSION OF FAILURE

Biden’s decision to start imposing sweeping new national vaccine mandates last September was a tacit admission that his effort to beat Covid by vaccinating the entire population was failing. Then it became clear that the vaccines were not as effective at preventing infections over the long term as Biden had claimed they were; they required a booster shot to prolong their protection. Finally, there was the disturbing spike in breakthrough infections due to the omicron variant, which challenged the fundamental rationale for Biden’s vaccine mandates in the first place — the false assumption that vaccines alone could stop the spread of the virus.

Polls showed that public confidence in Biden’s handling of the Covid challenge had turned negative. Meanwhile, calls are growing for a major shakeup in Biden’s anti-Covid team, starting at the top, with Dr. Anthony Fauci, who is still being accused of covering up the coronavirus’ suspected origins at a partially US-supported virus lab in Wuhan, China. Next comes CDC director Rochelle Walensky, who after a year of trying, still can’t deliver easily understandable Covid guidance to the American people, and most recently Biden’s Secretary of Health and Human Services, Xavier Becerra, who has been largely “missing in action” during the administration’s Covid battles.

PLAYING CATCH-UP

The Biden administration is now busy trying to play catch-up on several fronts, responding to Covid-related challenges that it should have anticipated, such as inadequate supplies of rapid home tests and the effective Pfizer anti-Covid drug known as paxlovid.

Even when the Biden administration got the basic policy right, it has often overlooked key details. For example, when the Biden administration required all private insurers to pay for at-home coronavirus tests, it failed to offer the same protection to the 64 million older or disabled Americans covered under Medicare, triggering thousands of complaints to members of Congress and letters from advocates for older Americans to President Biden and other senior administration officials demanding that they change Medicare’s rules to pay for the home antigen tests. Medicare’s public telephone hotline has been flooded with phone calls about coverage of the tests, and the answers callers have been receiving are not encouraging.

Those covered by traditional Medicare are simply not covered for a testing procedure carried out by a person using an over-the-counter device at home instead of a doctor’s office or hospital. In addition, the private companies which provide Medicare Advantage (Part C) plans for almost 28 million recipients are not required under Medicare rules to cover the Covid tests either, and many are currently choosing not to do so.

This was a very serious oversight, especially in light of the fact that at least 550,000 Americans in the Medicare age group of 65 and over have already died due to Covid, and the rest remain at heightened risk. It is unacceptable for the Biden administration to tell most older Americans that they will have to pay for their Covid testing kits out of their own pockets, or find one of the public sites which can provide them with a free test, especially when everyone with private insurance doesn’t have to pay for it themselves. If the White House does not act quickly to fix this problem, the resulting public uproar will quickly become politically intolerable.

THE POLITICS OF MANDATES

Vaccine and mask mandates have now become divisive partisan political issues, regardless of whether they are actually still necessary or even effective to slow the spread of the omicron variant.

While there is still ample justification for encouraging people, especially those in higher risk categories, to take the vaccine, because it still protects against life-threatening illness, the case for imposing strict mask mandates outside of high-risk environments has always been highly questionable.

Mask mandates have been especially controversial for younger school children, because they are inherently less vulnerable to Covid infections. In addition, wearing a mask properly for an extended period of time is difficult for many young children, and it can interfere with their ability to learn both curriculum material and important social skills in a classroom setting. For this reason, they have become important partisan political issues dividing Republican from Democrat officials in red states such as Florida, Texas, and, most recently, Virginia.

When Florida Governor Ron DeSantis signed an executive order last year forbidding local Florida school districts from imposing mask mandates on their students, the Biden administration openly sided with those districts which publicly defied DeSantis’ order, and condemned the Republican governor for endangering the health of the schoolchildren.

The right of parents to have a say in local school board policies became the key issue in the November gubernatorial campaign in Virginia, enabling Republican political newcomer Glenn Youngkin to score an upset victory over former Virginia Democrat governor Terry McAuliffe. Now that he has taken office, Youngkin has issued his own executive order making mask wearing optional in all public schools in the state, which prompted a major story published by the pro-Democrat Washington Post last week which featured the strong objections of some Virginia parents and teachers to the lifting of the statewide mask mandate which had previously been in place.

THE CASE AGAINST MASKS IN SCHOOLS

Margery Samelkinson, an infectious disease scientist at Dr. Fauci’s National Institute of Allergy and Infectious Diseases (NIAD), along with Leslie Bienen, a faculty member at the Portland State University School of Public Health, and Jeanne Noble, an emergency medicine doctor at the University of California San Francisco, co-wrote an article published in the Atlantic magazine titled, “The Case Against Masks at School.”

They cited several recent studies which compared the rate of Covid infections in school districts where mask wearing was optional and those where it was mandatory. The studies found little or no difference between them, which suggests that imposing mask mandates in schools may likely be more trouble than they are worth.

The article notes that, “about half of the country’s 53 million children remain compulsorily masked in school for the indefinite future. Sixteen US states and the District of Columbia follow the CDC guidance closely and require masks for students of all ages, regardless of vaccination status; other states rely on a patchwork of policies, usually leaving decisions up to local school districts. (Nine states have banned school mask mandates, though in five of them, lawsuits have delayed implementation of the ban.) Many deep-blue areas such as Portland, Oregon; Los Angeles; and New York City have gone beyond CDC guidance and are masking students outdoors at recess.”

Another problem is that many of the clinical tests conducted in school districts to date have not met rigorous scientific standards, such as adjusting for various risk factors and the utilization of proper randomization techniques. The clinical picture is also complicated by the fact that most of the available school masking studies were carried out before the spread of the omicron variant, to which younger children seem to be more susceptible than they were to earlier versions of the virus.

As a result, the authors of the Atlantic article admit that there is still not enough clinical evidence on either side at this time to make a clear determination of the cost/benefit ratio of the effectiveness of school masking mandates at preventing infections against the educational harm masking does to young children. However, the authors also note that, in general, when the initial school shutdowns were ended and other layers of infection mitigation procedures were then cautiously lifted, the schools did not become new hot spots of Covid infections. This suggests that doing away with current school mask mandates may also prove not to be harmful.

In its conclusion, the article refuses to endorse school mask mandates for the following reasons: “Imposing on millions of children an intervention that provides little discernible benefit, on the grounds that we have not yet gathered solid evidence of its negative effects, violates the most basic tenet of medicine: First, do no harm. The foundation of medical and public-health interventions should be that they work, not that we have insufficient evidence to say whether they are harmful. Continued mandatory masking of children in schools, especially now that most schoolchildren are eligible for vaccination, fails this test.”

TIME TO SWITCH TO MASKS THAT WORK

Virtually all mandates in this country did not, until very recently, distinguish between cloth masks, which are much less effective at preventing the spread of the virus, and the N95 or similar KN95 versions, whose use had initially been reserved to health care professionals at the start of the pandemic.

When the CDC released its initial mask guidance in April 2020, there were not enough surgical masks and N95s in this country to protect hospital personnel, so the CDC said that a simple cloth mask that could be sewn together at home from old T-shirts would be good enough to provide minimal protection for most people. However, when the initial shortage of N95 masks and other forms of medical personal protection equipment was relieved just a few months later, the original CDC cloth mask mandates was not upgraded. This gave the public a false sense of security by encouraging the belief that the cloth masks many were wearing because they were more comfortable were offering adequate protection — but that was not true.

In fact, the evidence shows that masks are relatively low on the list of most effective anti-Covid infection measures. At the top of the list are vaccines, followed by improved ventilation systems and social distancing. Mask wearing comes in at a distant fourth place.

Surprisingly, two years into the pandemic, there is still a shortage of reliable clinical data on the effectiveness of the most common types of masks. The best study to date was carried out in Bangladesh, which compared cloth masks to surgical masks. It found that wearing surgical masks resulted in an 11.2% reduction in the number of infections, whereas cloth masks yielded only a 5% reduction, confirming the findings of previous studies. This is why many foreign countries, including France, Austria, and Germany, declared cloth masks to be insufficient a long time ago, whereas in the United States, cloth masks are still widely considered to be acceptable.

In addition, the federal government still has done nothing to prevent the widespread sale in supermarkets and pharmacies of fake N95 and KN95 masks, which do not offer the level of protection against spreading the virus that they promise. The bottom line is that American consumers buying FDA-labeled suntan lotion off of a store shelf enjoy much more effective protection than they do when buying Chinese-made fake KN95 masks in the same stores.

Only now is the Biden administration beginning to make a serious effort to supply Americans with effective masks, free of charge — a year after it launched an even more vigorous campaign to make free vaccines available to everyone. President Biden has announced the distribution, starting this month, of 400 million free N95 masks taken from the federal government’s strategic stockpile, at local pharmacies and community-health centers across the country.

BEHIND THE REST OF THE WORLD

Yet with regard to providing an adequate supply of more effective masks, the US is far behind countries like Taiwan, which began to sending its citizens a fresh supply of high-quality masks each week, starting last April. Hong Kong has been distributing its own patented six-layer masks to every citizen, and Singapore which has distributed four rounds of free, reusable, multilayer masks with filters to everyone, including kids, who get a smaller version designed for them.

The CDC only recently began an overdue effort to provide clarity for consumers over the difference between high-quality face coverings, such as N95s or KN95s, and less effective surgical or cloth masks. But it is still far more difficult than it should be for consumers to be sure about the differences among the various types of masks now being sold if they are relying just on the information printed on their labels.

Authentic N95 masks which have been certified by the National Institute for Occupational Safety and Health must carry a NIOSH stamp. They should also have an approval code (“TC-84A,” followed by four additional numbers), an expiration date, and headbands to assure a tight fit, rather than simple ear loops for straps.

Genuine KN95 masks are marked with “GB2626-2019,” to show that they have passed the Chinese government’s standards for filtering 95% of virus particles. However, the CDC estimates that about 60% of KN95 masks currently sold in the United States are counterfeits.

KF94-labeled consumer masks are manufactured in South Korea and meet South Korean government standards, and are also required to have a product name and manufacturer listed on the package. There is also the FFP2 mask which meets the medical standards in the European Union, but it is much less widely available here than the Asian KN95 and KF94 varieties.

Simple blue surgical masks for use in medical settings are superior to cloth masks, but not nearly as effective as the N95, KN95, and KF94 versions. They are supposed to be regulated by the Food and Drug Administration, but most are manufactured in other countries, and may be falsely marketed and sold as FDA-cleared or certified.

THE NEED FOR CONSUMER PROTECTION

There is a clear, urgent need for an effective federal mask certification and labeling program. While it has been established that wearing any mask is safer than wearing no mask at all in high-risk environments, Americans need more reliable information to make intelligent choices about the level of protection they are getting. Ideally, mask packaging should be labeled with the level of particle filtration, leakage amounts, comfort, fit, and breathability. It shouldn’t be that hard — if the government can do it routinely for all our packaged food products, why haven’t we already done the same to enable people to protect themselves from Covid?

In addition to their protective function, masks have also now become a visible symbol of a person’s political affiliation. Someone who goes maskless at an indoor gathering in a blue state will immediately become suspect of harboring pro-Trump sympathies, while a masked person walking around outside by themselves may be assumed to be showing off their woke-liberal good-guy credentials.

NEXT FIGHT: VACCINATION MANDATES FOR SCHOOLCHILDREN

There is also a lively controversy in states across the country over whether to permit the imposition of vaccine mandates for all schoolchildren over the age of five, now that the FDA has given Pfizer vaccines for that age group emergency approval. The Wall Street Journal reports that in 14 states with Republican governors, there is proposed legislation to bar or tighten restrictions against vaccination requirements for attending K-12 schools, and 15 states where laws or executive orders are already in place barring such a requirement for school children.

The American Federation of Teachers has said that it would push to make vaccines mandatory for students as soon as the FDA gives the shot full authorization, but a poll published in December shows that a majority of US parents oppose making the vaccine mandatory for their schoolchildren, and about 30% said that they will “definitely not” have their children vaccinated against Covid.

WILL WE LEARN THE RIGHT LESSONS?

So the politically-driven Covid policy battles are still far from over. Even if the pandemic is finally brought under control be”H, it will definitely be a major factor influencing the outcome of this November’s midterm election, and possibly the presidential election in 2024.

Hopefully, by the time the pandemic is over, our public health officials and policymakers will have learned the appropriate lessons from the many mistakes they made in trying to contain the coronavirus threat. We all need to be ready, because someday, probably when we least expect it, a similar challenge is virtually certain to rise once again.

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