Operation Warp Speed was a huge success. So why is the US turning away from it?

“Warp Speed deserves substantial credit for saving lives in the early pandemic. Companies making crucial parts for the vaccine have credited Warp Speed’s special authorizations with getting their power turned back on in minutes after an outage and convincing vendors to cut their production times from 75 days to 7. Negotiated partnerships for every part of the supply chain — from glass vials to syringes to packaging for shipping — enabled a rapid rollout. Even the Defense Department got involved in logistics, flying equipment and vaccines from place to place.”

“Immunologist Moncef Slaoui, who headed Warp Speed under the Trump administration, spent years before the pandemic advocating for a simple, cheap measure that would have made it possible to develop vaccines even faster: maintaining idle capacity so the country can respond to emergencies.

As he told Science in a 2021 interview:

“The whole concept—after we went through the flu pandemic, the Ebola outbreak, the Zika outbreak—was to say, “Listen, the problem is always the same, which is there are no manufacturing facilities sitting there idle, waiting to be used. Even if we had one, we would have trouble because we would have to stop manufacturing other vaccines, which are essential for saving people’s life. So we thought, “Why don’t we take a dedicated facility and have them work on discovering vaccines against known potential outbreak agents, one after the other?” They would become incredibly skilled and trained at going fast, discovering vaccines. The company was prepared to make available the facility and ask just for the cost of running it. Unfortunately, it didn’t fly.””

“That investment? Didn’t happen. Before the pandemic, some of this country’s smartest experts spent years telling us that a pandemic was coming and would be catastrophic, but that we could prepare and substantially mitigate the harms. We didn’t.

During the pandemic, we developed significant expertise in vaccine development and distribution, which we easily could have leveraged into maintaining capacity for rapid vaccine development to prevent the next pandemic. We didn’t.”

We Don’t Need a White House Monkeypox ‘Coordinator.’ We Just Need the Vaccines.

“We’re up to about 3,600 known cases of monkeypox in the United States, according to the Centers for Disease Control and Prevention (CDC). That’s more than double the number of cases from just two weeks ago.

As the federal government struggles to distribute vaccines where they’re needed, The Washington Post reports that the White House is thinking of declaring a public health emergency and naming a “White House coordinator” to oversee the response.

The public response should be: Please don’t. Please just get the vaccines to local public health agencies and let them deal with it. Because right now, that’s about half the problem that’s causing monkeypox to spread.

Red tape from the Food and Drug Administration (FDA) and the CDC left more than a million monkeypox vaccine doses stuck in storage in Denmark, and then another roll of red tape made it incredibly difficult for doctors to prescribe an alternative monkeypox treatment because it’s still in clinical trials.

As a result, local health agencies have had to carefully portion out vaccines to the highest-risk citizens—and they’re still running out. In Los Angeles, the county Public Health Department will only administer to people who are infected, people who have had high-risk contact (typically sex) with somebody who is infected, and then gay or bisexual men or trans people who fit in one of the [certain] categories”

“Fortunately, monkeypox’s spread has still remained pretty limited even as it has grown. The percentage of growth seems huge because we’re dealing with a fairly low baseline. And though monkeypox is not technically a sexually transmitted disease—it is spread through contact with the rashes and lesions created by the virus as well as through saliva—this particular version of monkeypox has been pretty resistant so far to being spread through methods other than sexual contact.”

Smallpox used to kill millions of people every year. Here’s how humans beat it.

“More than a million Americans have died of Covid-19, and the World Health Organization estimated this Thursday that the global death toll is around 15 million — a horrifying, and largely unnecessary, tragedy.

But for all that the world has lost in the last few years, the history of infectious disease has a grim message: It could have been even worse. That appalling death toll resulted even though the coronavirus kills only about 0.7 percent of the people it infects. Imagine instead that it killed 30 percent — and that it would take centuries, instead of months, to develop a vaccine against it. And imagine that instead of being deadliest in the elderly, it was deadliest for young children.

That’s smallpox.”

“Before modern vaccine development, humans had to get creative in slowing the spread of infectious disease. It was known that people who’d survived smallpox didn’t get sick again. In China, as early as the 15th century, healthy people deliberately breathed smallpox scabs through their noses and contracted a milder version of the disease. Between 0.5 percent and 2 percent died from such self-inoculation, but this represented a significant improvement on the 30 percent mortality rate of the disease itself.

In England, in 1796, doctor Edward Jenner demonstrated that contracting cowpox — a related but much milder virus — conferred immunity against smallpox, and shortly after that, immunization efforts began in earnest across Europe. By 1813, the US Congress passed legislation to ensure the availability of a smallpox vaccine that reduced smallpox outbreaks in the country throughout the 1800s.”

“By 1900, smallpox was no longer quite as much of a scourge in the world’s richest countries. In the 1800s, about 1 in 13 deaths in London were caused by smallpox; by 1900, smallpox caused only about 1 percent of deaths. Several countries in Northern Europe had also declared the disease eradicated. Over the next few decades, more of Europe, and then the US and Canada, joined them.

But as long as smallpox ravaged other parts of the globe, continual vaccination was necessary to make sure it wasn’t reintroduced, and millions of people continued to die of it. Data is spotty — this is before there was any international authority on infectious disease statistics worldwide — but it is estimated that 10 to 15 million people caught smallpox annually, with 5 million dying of it, during the first half of the 20th century.

It was not until the 1950s that a truly global eradication effort began to appear within reach, thanks to new postwar international institutions. The World Health Organization (WHO), founded in 1948, led the charge and provided a framework for countries that were not always on friendly terms to collaborate on global health efforts.”

“A 1947 outbreak in New York City, traced back to a traveler from Mexico, resulted in a frantic effort to vaccinate 6 million people in four weeks. Europe, Henderson says, repeatedly saw the virus reintroduced by travelers from Asia, with 23 distinct importations (different occasions of someone bringing smallpox into the country) in five years.

As we face down Covid-19, with effective vaccinations finally in hand, we’re encountering the same challenge that the world faced with smallpox in the 1950s: It doesn’t matter if a vaccine exists unless there also exists the international will and creativity to get it to all the people who need it, many of whom will be reluctant and skeptical.”

“features of smallpox made it easier to eradicate than many other diseases. For one thing, it didn’t have animal reservoirs; that is, unlike diseases like Ebola, smallpox doesn’t live in animal populations that can reintroduce the disease in humans. That meant that once it was destroyed in humans, it would be gone forever. And, once a person has survived it, they are immune for life. Only one vaccine is needed for immunity in almost all cases.

Additionally, it largely doesn’t have asymptomatic transmission and has a fairly long incubation period of about a week. That made it possible for public health officials to stay on top of the disease with a strategy of “ring vaccination” — whenever a case was reported, vaccinating every single person who may have come into contact with the affected person, and ideally everyone in the community could keep the disease at bay.”

“Humanity’s triumph over smallpox should stand out as one of our proudest moments. It called on scientists and researchers from around the world, including collaborations between rival countries in the middle of the Cold War.

Unfortunately, we’ve never replicated that success against another virus that affects humans. With some, such as polio, we’re drawing close. Wild polio has been eradicated in Africa and remains only in conflict-torn regions of Afghanistan and Pakistan. “Ring vaccination,” as practiced in the smallpox battle, has been successfully used in public health efforts against other diseases, most recently with the new Ebola vaccine, used against outbreaks in the Democratic Republic of Congo.

But in other cases, like HIV and Covid-19, we’ve let new diseases grow to pandemic proportions. And while those diseases have had devastating effects, it’s worth keeping in mind that they could have been even worse. Some viruses with the potential to escape laboratories or make the jump from animals to humans are as deadly and transmissible as smallpox, and Covid-19 has made it clear that we’re not prepared to handle them.”

“The devastation of Covid-19 has hopefully made us aware of the work public health experts and epidemiologists do, the crucial role of worldwide coordination and disease surveillance programs (which are still underfunded), and the horrors that diseases can wreak when we can’t control them.

We have to do better. The history of the fight against smallpox proves that we’re capable of it.”

Covid vaccine concerns are starting to spill over into routine immunizations

“Kids aren’t getting caught up on routine shots they missed during the pandemic, and many vaccination proponents are pointing to Covid-19 vaccine hesitancy as a big reason why.

Public health experts, pediatricians, school nurses, immunization advocates and state officials in 10 states told POLITICO they are worried that an increasing number of families are projecting their attitudes toward the Covid-19 vaccine onto shots for measles, chickenpox, meningitis and other diseases.”

Time for an Operation Warp Speed to Develop Pan-Coronavirus Vaccines

“Way back in May 2020, three researchers at National Institute of Allergy and Infectious Diseases (NIAID) published an op-ed in Nature arguing that with respect to developing universal coronavirus vaccines “the time to start is now.” As it turns out, the time to start for the NIAID was 15 months later when the agency got around to awarding three academic institutions a little over $36 million to research pan-coronavirus vaccines in September 2021.

The Trump administration’s Operation Warp Speed could serve as a much better model for incentivizing pharmaceutical companies to greatly speed up the development and deployment of the candidate pan-coronavirus vaccines on which some are currently working. In a recent op-ed in the Los Angeles Times, two immunologists point out that the global cost of the COVID-19 pandemic is an estimated $16 trillion, compared to the cost of developing a typical vaccine at $1 billion. They note that even a $10 billion vaccine is minuscule compared with the pandemic’s toll.

Among the promising pan-coronavirus candidate vaccines are the Walter Reed Army Institute of Research’s spike ferritin nanoparticle COVID-19 vaccine; Osivax’s nucleocapsid vaccine targeting a protein widely prevalent among coronaviruses that is unlikely to mutate; and Inovio’s DNA vaccine encoding variant sequences of the spike proteins the virus uses to invade cells.”

‘Recognition of failure’: A shift urged in global vaccination strategy

“47 countries still have inoculation rates below 20 percent.

Now, many health organizations involved in the global vaccination effort aim to immunize 90 percent of vulnerable populations in every country — a move that seems to undercut the WHO’s 70 percent target.”

“Prioritizing vulnerable populations — health care workers, elderly individuals and those with comorbidities — could undermine the global push to prevent variants if it reduces the total number of vaccinated people, some experts said. But facing the reality that the 70-percent-vaccination goal by mid-2022 is virtually doomed, some health groups working on the global vaccination effort are focusing on letting countries set targets according to their abilities and advising them to first target vulnerable populations.”

““Striving to vaccinate 70 percent of the population of every country remains essential for bringing the pandemic under control — with priority given to health workers, older people and other at-risk groups,” WHO Director-General Tedros Adhanom Ghebreyesus told reporters at a press conference Wednesday.”

What can actually convince vaccine skeptics to get their shots

“The researchers surveyed more than 6,000 people in the United States, United Kingdom, European Union, Australia, and New Zealand. They contacted them first in December 2020, to assess their intentions before the vaccines were widely available, and asked them to pick a number between 0 and 10 to represent their likelihood of getting vaccinated. Then they followed up in summer of 2021 to see how people actually behaved.

To me, their most interesting findings concerned the most ardent vaccine refusers. Six months later, one-third of the people who had rated themselves 0 in December had gotten vaccinated.

So what happened? What convinced them?

Some of it was circumstances. Among those who had put themselves between 0 and 3 on getting vaccinated, those who were older (and therefore at higher risk of serious illness) and concerned with their health risks were more likely to get vaccinated in spite of their skepticism. So did the people who anticipated indirect exposure to Covid-19 through their friends or relatives. People who consumed more traditional media and who had more trust in scientists were also more likely to come around.

Vaccine mandates were not in effect at the time of these surveys, but the study generally found a mixed response to compulsory vaccinations among the respondents.”

In the Case That Blocked OSHA’s Vaccine Mandate, the Justices Disagreed About When COVID-19 Counts As a Workplace Hazard

“Underlying that split is the question of whether and when COVID-19 counts as a workplace hazard, justifying regulation by the Occupational Safety and Health Administration (OSHA), as opposed to a general risk that Americans face throughout the day, which goes beyond that agency’s statutory mission. All of the justices agreed that OSHA does not have a general license to protect public health, and all of them agreed that the agency does have the power to address COVID-19 in the workplace. But while the dissenters were willing to let OSHA define that problem in general terms, justifying a broad solution covering 84 million employees, the majority thought the agency was obliged to be more specific and discriminating.”

“OSHA has previously issued regulations that addressed communicable diseases. In 1990, it issued a nonemergency standard dealing with bloodborne pathogens, and last June it published a COVID-19 ETS for the health care industry. But both of those rules aimed to protect employees who faced special hazards because of the nature of their work (handling blood samples and treating COVID-19 patients, respectively), and neither of them encouraged or required employers to make vaccination mandatory. That is something OSHA, which has existed for more than half a century, has never done before—a point that the justices emphasized during oral arguments last week and again in yesterday’s decision.
“OSHA has never before imposed such a mandate,” the Court notes. “Nor has Congress. Indeed, although Congress has enacted significant legislation addressing the COVID–19 pandemic, it has declined to enact any measure similar to what OSHA has promulgated here….The most noteworthy action concerning the vaccine mandate by either House of Congress has been a majority vote of the Senate disapproving the regulation on December 8, 2021.”

In a joint dissent, Justices Stephen Breyer, Sonia Sotomayor, and Elena Kagan argue that OSHA’s unprecedented rule is justified by the unprecedented threat that COVID-19 poses”

“Even as Breyer et al. emphasize the society-wide threat posed by COVID-19, they suggest the risk is especially acute in the workplace, where employees typically gather inside for eight hours a day. That basic fact, the dissenters argue, justifies OSHA’s broad approach, because the coronavirus “spreads mostly without regard to differences in occupation or industry.””

“More generally, the majority says, OSHA has failed to draw appropriate distinctions between different work situations that pose widely varying risks of virus transmission. “Although COVID-19 is a risk that occurs in many workplaces, it is not an occupational hazard in most,” the Court says. “COVID–19 can and does spread at home, in schools, during sporting events, and everywhere else that people gather. That kind of universal risk is no different from the day-to-day dangers that all face from crime, air pollution, or any number of communicable diseases. Permitting OSHA to regulate the hazards of daily life—simply because most Americans have jobs and face those same risks while on the clock—would significantly expand OSHA’s regulatory authority without clear congressional authorization.””

“The majority nevertheless concedes that OSHA has the authority to address COVID-19 in certain contexts:

“Where the virus poses a special danger because of the particular features of
an employee’s job or workplace, targeted regulations are plainly permissible. We do not doubt, for example, that OSHA could regulate researchers who work with the COVID–19 virus. So too could OSHA regulate risks associated with working in particularly crowded or cramped environments. But the danger present in such workplaces differs in both degree and kind from the everyday risk of contracting COVID–19 that all face. OSHA’s indiscriminate approach fails to account for this crucial distinction—between occupational risk and risk more generally—and accordingly the mandate takes on the character of a general public health measure, rather than an “occupational safety or health standard.”””