‘The first time this has happened in the history of cancer’

In a “small but compelling” study published Sunday in the New England Journal of Medicine, 18 patients with rectal cancer achieved complete remission, marking “the first time this has happened in the history of cancer,” Gina Kolata reports for the New York Times.

Key takeaways: Defining and assessing value for next-generation therapies

Study details and key findings

For the trial, which was sponsored by GlaxoSmithKline, 18 patients with rectal cancer took a checkpoint inhibitor called dostarlimab. During the six-month study period, the medication was administered every three weeks. Dostarlimab works by exposing cancer cells, allowing the immune system to detect and destroy them.

Before the trial, “[t]hese rectal cancer patients had faced grueling treatments — chemotherapy, radiation and, most likely, life-altering surgery that could result in bowel, urinary and sexual dysfunction,” Kolata writes. “Some would need colostomy bags.”

When the trial began, many of the patients still believed they would have to undergo these procedures when it was over. Ultimately, no one really believed their tumors would disappear.

However, they were met with “astonishing” results, Kolata writes. “The cancer vanished in every single patient, undetectable by physical exam, endoscopy, PET scans or M.R.I. scans.”

“There were a lot of happy tears,” said Andrea Cercek, an oncologist at Memorial Sloan Kettering Cancer Center (MSKCC) and a co-author of the paper, which was presented Sunday at the annual meeting of the American Society of Clinical Oncology.

On average, one in five patients have some type of adverse reaction to checkpoint inhibitors like dostarlimab. But, notably, none of the patients in the trial experienced clinically significant complications.

Commentary

According to Alan Venook, a colorectal cancer specialist at the University of California, San Francisco, who was not involved with the study, the absence of significant side effects means “either they did not treat enough patients or, somehow, these cancers are just plain different.”

In an editorial accompanying the paper, Hanna Sanoff of the University of North Carolina‘s Lineberger Comprehensive Cancer Center, who was not involved in the study, said the study was “small but compelling.” However, she noted that it is still unclear whether the patients are cured.

“Very little is known about the duration of time needed to find out whether a clinical complete response to dostarlimab equates to cure,” Sanoff said.

And while the results were “remarkable” and “unprecedented,” Kimmie Ng, a colorectal cancer expert at Harvard Medical School, said they would need to be replicated.

Still, Luis Diaz Jr., an author of the paper from MSKCC, said he did not know of any other study in which a treatment completely eradicated a cancer in every patient.

“I believe this is the first time this has happened in the history of cancer,” Diaz said.

Separately, Venook agreed, noting that a complete remission in every single patient in a trial is “unheard-of.” (Kolata, New York Times, 6/5)

Biden’s $5.8 trillion budget: 9 healthcare takeaways

President Joe Biden proposed a $5.8 trillion budget March 28 for fiscal year 2023, which includes funding for healthcare. 

Nine healthcare takeaways:

1. Pandemic preparedness. The budget calls for a five-year investment of $81.7 billion to plan ahead for future pandemics. The funding would help support research and development of vaccines, improve clinical trial infrastructure and expand domestic manufacturing. 

2. Mental health parity. Under the proposed budget, federal regulators would get the power to levy fines against health plans that violate mental health parity rules. The budget calls for $275 million over 10 years to increase the Labor Department’s capacity to ensure health plans are complying with the requirements and take action against those plans that do not. The budget also proposes funding to bolster the mental healthcare workforce and boost funding for suicide prevention programs. 

3. Vaccines for uninsured adults. The proposed budget calls for establishing a new Vaccines for Adults program that would provide uninsured adults access to recommended vaccines at no cost.

4. Title X funding. The budget proposes providing $400 million in funding for the Title X Family Planning Program, which provides family planning and other healthcare services to low-income individuals.

5. Cancer Moonshot initiative. The budget proposes several investments across the FDA, CDC, National Cancer Institute and Advanced Research Projects Agency for Health to advance President Biden’s Cancer Moonshot initiative. The initiative aims to reduce the cancer death rate by 50 percent over the next 25 years. 

6. Spending to reduce HIV. The proposed budget includes $850 million to reduce new HIV cases by increasing access to HIV prevention services and support services.

7. Veterans Affairs medical care. President Biden’s proposed budget allocates $119 billion, or a 32 percent increase, to medical care for veterans. The money will fully fund inpatient, outpatient, mental health and long-term care services, while also investing in training programs for clinicians to work in the VA.

8. Discretionary funding for HHS. President Biden is asking Congress to approve $127.3 billion in discretionary funding for HHS in fiscal 2023, representing a $26.9 billion increase from the department’s allotment for fiscal 2021.

9. Mandatory spending for the Indian Health Service. The budget request for the Indian Health Service calls for shifting the healthcare agency from discretionary to mandatory funding. The budget calls for $9.1 billion in funding, a 20 percent increase from the amount allocated in fiscal 2021.

COVID-19 May Be Linked to Spontaneous Psychosis. Researchers Are Trying to Figure Out Why

In May 2020, a 33-year-old mother of three in North Carolina started experiencing symptoms of COVID-19. Four days later, a different set of symptoms set in. She stopped sleeping well and started having paranoid delusions that people were tracking her through her cell phone—culminating in a frantic scene at a fast-food restaurant, in which she tried to pass her children through the drive-through window, where they’d be safe from the phones and other dangers.

A restaurant employee called 911, and emergency medical services workers arrived, gathered up the family, and hurried to the nearby emergency department of the Duke University Medical Center in Durham, where the mother was quickly attended to by physicians. “She was physically in the room, but she wasn’t making consistent eye contact,” says Dr. Colin Smith, who is now chief resident of the hospital’s internal medicine psychiatry program but was a second-year resident when he took care of the patient. “She was not really engaging all that much. Her thought processes were disorganized.”

Despite that, the patient acknowledged two things to Smith and the other doctors: She knew her behavior was out of character, and the changes all happened quickly after she was diagnosed with COVID-19.

There’s growing evidence that COVID-19 and new psychotic episodes are connected. The North Carolina case, reported in the British Medical Journal in August 2020, joins a slew of case reports published in medical journals during the pandemic that detail psychotic episodes following a COVID-19 diagnosis. In the July 2020 issue of BJPsyh Open, researchers reported that a 55-year old woman in the U.K., with no history of mental illness, arrived at a hospital days after recovering from a severe case of COVID-19 with delusions and hallucinations, convinced that the nurses were devils in disguise and that monkeys were jumping out of the doctors’ medical bags. In April 2021, other researchers wrote in BMJ Case Reports of a middle-aged British man, also with no prior mental health disorders, who had appeared at a London hospital experiencing auditory and visual hallucinations and banging his head against walls until he bruised his skin. (Weeks before, he had recovered from a bout with COVID-19 that had landed him in the intensive care unit.) In yet another case, published in the Journal of Psychiatric Practice in March 2021, a 57-year-old-man turned up at Columbia University’s New York Presbyterian Hospital insisting that his wife was poisoning him, that cameras had been planted throughout his apartment, and that the patients in the hospital’s emergency department were being secretly murdered.

“The situation was strikingly similar to one we’d expect from someone who had a schizophrenia spectrum illness,” says Dr. Aaron Slan, now a fourth-year psychiatry resident at Columbia University, who cared for the patient and co-authored the report. But this patient too had no history of mental health disorders and was too old for a first-onset case of schizophrenia, which typically occurs between ages 20 and 30 for men, Slan notes. What the patient did have, as a test in the hospital revealed, was COVID-19.

COVID-19-related psychotic breaks are rare—though researchers say that it’s too early to say exactly how rare—and plenty of experts believe that the connection between the two conditions, if any, is not causal. In a review published in 2021 in Neurological Letters, a group of researchers in the U.K. casts doubt on the emerging body of work on the COVID-19-psychosis link as “beset by both small sample size, and inadequate attention to potential confounding factors,” such as heightened stress, substance abuse, and socioeconomic hardship.

Still, researchers are investigating the link. One U.K. study published in the Lancet in October 2020 found that of 153 people who were diagnosed with COVID-19 early in the pandemic, 10 suffered new-onset psychotic episodes following their COVID-19 diagnosis, and seven exhibited the onset of psychiatric disorders, including catatonia and mania.

A study published last August in General Hospital Psychiatry took a broad view of the phenomenon, analyzing 40 scientific articles, which included 48 adults from 17 different countries who suffered psychotic episodes associated with COVID-19 infection, and tried to find commonalities among them. As with the Neurological Letters paper, the authors of this study found plenty of other variables that might muddy the link between COVID-19 and psychosis—like stress, substance use, and medications—but the relationship still held.

We see post-infectious neuroinflammatory disorders associated with a variety of different viral illnesses,” says Dr. Samuel Pleasure, a neurology professor at the University of California, San Francisco (UCSF). “Normally we see it in very small numbers, but here we have [COVID-19] infecting tens of millions of people at the same time.” Even rare cases of psychiatric conditions will start to show themselves when the sample group of infected people is so large.

There are more questions than answers at this point. It’s still unclear whether the severity of COVID-19 symptoms plays any role in the likelihood of a psychotic break. “There seem to be clearly cases of neuropsychiatric consequences of COVID that are linked to cases that are not severe,” Pleasure says. “I believe that the quality of the studies at this point are so preliminary, and the ability to really capture these patients to study is really at early stages, so it’s hard to be definitive.” Similarly, Pleasure says, it’s impossible to say whether people suffering from Long COVID—symptoms that last for months after the infection is over—are more susceptible to psychotic symptoms.

There are multiple possible mechanisms at work, any one of which—or a combination—could be contributing to the neuropsychiatric symptoms associated with COVID-19. The most straightforward would be direct infection of brain tissue itself, according to Pleasure. If that’s so, the number of COVID-19 patients who suffer loss of the sense of taste and smell would suggest that the brain’s olfactory bulb may be struck by the virus first.

“There are documented cases where people have done MRIs early in the [COVID-19 disease] process and have seen some local inflammation in the olfactory bulb,” Pleasure says. “That has contributed further to the idea that maybe that’s the portal of entry.” Once that portal has been breached, the brain at large could be exposed.

Just how the COVID-19 infection reaches the brain is unclear, but Pleasure and his colleague Dr. Michael Wilson, associate professor of neurology at UCSF, conducted lumbar punctures of three teens with COVID-19 who had developed neuropsychiatric symptoms to examine their cerebrospinal fluid. In two cases, they found antibodies in the fluid that target neural antigens. That presented an apparent puzzle: the patients had SARS-CoV-2; if anything, they should be exhibiting antibodies to the virus, not to their own neural tissue. But Pleasure cites one study he conducted with a group from Yale University showing that antibodies specific to the coronavirus spike protein could also cross-react with nerve cells, attacking them as well.

“There was molecular mimicry between the spike protein and a neural antigen,” he says. “One of the main hypotheses is that if there’s an antibody that targets the virus, then, out of bad luck, you also see damage to the host.” In other words, he says, you start with an immune response adaptive to fighting the virus, and that turns into an autoimmune response.

That’s just one theory. There are still other routes by which COVID-19 can affect the brain. Upper respiratory infections can, on occasion, cause the immune system to go awry and develop antibodies against parts of the brain known as NMDA (N-methyl-D-aspartate) receptors, which are the main excitatory receptors that react to neurotransmitters. A broad attack on receptors spread throughout the brain can lead to quick and severe symptoms, says Dr. Mudasir Firdosi, a Consultant Psychiatrist at the Kent and Medway NHS and Social Care Partnership Trust and a co-author of the 2021 BMJ paper.

“[NMDA involvement] presents a very, very florid way to be psychotic,” Firdosi says. Slan agrees: “When someone has an abrupt onset of psychosis following a viral illness, NMDA antibodies are frequently invoked,” he says.

Yet another suspect in the development of neuropsychiatric symptoms is the so-called cytokine storm that often follows infection with SARS-CoV-2. Cytokines are proteins critical for cell signaling that are produced by the immune system and give rise to inflammation that in turn can fight infection. But if cytokine production spins out of control, extreme body-wide inflammation can follow, and brain tissue would not be spared the impact.

“The neurons themselves are not being invaded,” says Slan, “but what happens is that the systemic inflammatory response causes both stress and changes in signaling throughout the body. That includes the brain, and can precipitate these types of [psychotic] symptoms.”

One other bit of evidence that COVID-19 is linked to psychotic breaks comes not from the current scientific literature, but from history. Following the influenza pandemic of 1918 and 1919, there was a spike in what was called encephalitis lethargica, which was essentially a form of early-onset Parkinson’s disease that often didn’t appear for a number of years after the infection—but left patients in what was effectively a state of catatonia.

“That flu virus caused a post-infection inflammation that killed brain cells that in turn led to the Parkinson’s,” says Pleasure. The book and movie Awakenings, about patients who temporarily recovered consciousness and lucidity after treatment with l-dopa—a precursor of the neurotransmitter dopamine—was based on cases of people suffering from that form of Parkinson’s.

The good news is that unlike more chronic forms of psychosis, most cases seemingly related to COVID-19 do not appear to last. The symptoms can respond to antipsychotic medications like Risperdal (risperidone) and Zyprexa (olanzapine), say Smith and Slan. Intravenous immunoglobulin infusions—which reduce the overall load of abnormal cells and inflammatory agents—and steroids, which also reduce inflammation, can be effective as well.

By no means is the case for virus-triggered psychosis closed. Even Slan, who has first-hand experience treating a patient suffering from a seemingly virus-linked psychotic break believes that there is more work to be done—and acknowledges the doubts of the researchers who believe other psychological factors might be at play.

“Given the stress of COVID,” he says, “given the concerns about mortality, seclusion, all of these things represent huge psychosocial stressors, and they have the potential to precipitate oftentimes short-lived psychotic symptoms.”

Of course, even a transitory psychosis is still a psychosis—something no one wants to experience even fleetingly. That puts a premium on avoiding infection in the first place. “The best way to treat COVID-19 and the risk of psychosis is to prevent it,” says Smith. “Even if neurological complications are rare, getting vaccinated remains the smartest choice.”

The Decentralization of Clinical Trials

Medable and CVS Health partner to expand clinical trial access - Drug  Discovery and Development

CVS Health announced it has struck a deal with Medable, a decentralized clinical trial software company, incorporating its offerings into MinuteClinics to help reach more patients for late-stage clinical trials. With over 40 percent of Americans living near a CVS pharmacy, CVS says it can help gather data and manage patients at MinuteClinic locations, and through its home infusion service, Coram. CVS has already cut its teeth in the clinical research space by conducting COVID-19 vaccine and treatment trials and testing home dialysis machines, and said it plans to engage 10M patients and open up to 150 community research sites this year.

The Gist: With this deal, CVS Health joins companies like Verily, Alphabet’s life sciences subsidiary, in taking advantage of patient appetite for clinical trials without regularly traveling to a research center, which became difficult during the pandemic.

Clinical research is a $50B market that has largely revolved around academic medical centers in large urban areas, which could see their dominance of the research business challenged. CVS’s entry into this space could lower the barriers to entry for community health systems to expand into clinical research. 

Ultimately, the decentralization of the clinical trials business is a win for patients, especially groups that have historically been under-represented in medical research, including rural and lower-income individuals. They may find participation through a local pharmacy—or even completely virtually from the comfort of their own home—much more accessible, affordable, and convenient.

FDA fully approves Moderna’s COVID vaccine

A health care worker preparing a dose of  Moderna's coronavirus vaccine.

The Food and Drug Administration fully approved Moderna’s mRNA COVID-19 vaccine on Monday, saying it meets its safety and manufacturing requirements.

Why it matters: Moderna’s vaccine, which will now be marketed as Spikevax, is the second coronavirus vaccine to receive full approval after the FDA approved Pfizer-BioNTech’s vaccine in August.

What they’re saying: “The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” acting FDA Commissioner Janet Woodcock said in a statement.

  • “The totality of real-world data and the full [Biologics License Application] for Spikevax in the United States reaffirms the importance of vaccination against this virus,” Moderna CEO Stéphane Bancel said.

The big picture: The rise of the Omicron variant forced vaccine makers to reevaluate the effectiveness of their vaccines, which were developed based on eaarlier forms of the virus.

  • Studies show that Moderna and Pfizer-BioNTech’s vaccines still overwhelmingly prevent severe disease and hospitalizations, especially when the first two doses are reinforced with a booster shot.

Long COVID-19: Study author explains four factors that can predict how you get it

https://thehill.com/policy/healthcare/591528-long-covid-study-author-explains-four-factors-that-can-predict-how-you-get?userid=12325

Long COVID-19: Study author explains four factors that can predict how you  get it | KFOR.com Oklahoma City

Long COVID-19 has had an air of mystery around it for months. Doctors have struggled to explain or understand why some people who contract COVID-19 end up having lingering symptoms like fatigue, difficulty thinking clearly, or shortness of breath weeks or even months later.  

A new study published in the journal Cell helps shed some light on the condition, for the first time identifying four factors that can help predict whether someone will develop long COVID-19.  

“Being able to identify the factors that can cause the disease, cause the chronic condition, is the first step towards defining that it actually is a condition that can be treatable,” Jim Heath, president of the Institute for Systems Biology in Seattle, and an author of the study, said in an interview. “And then some of these factors also are in fact the kind of things one can imagine developing treatments for.” 

The most important factor the study identified in predicting long COVID-19 is the presence of certain kinds of antibodies called autoantibodies, which mistakenly attack healthy parts of the body. Autoantibodies are associated with autoimmune diseases, like lupus, where your immune system attacks your own body.  

But someone does not have to have an autoimmune disease to have autoantibodies present and be at higher risk for long COVID-19, Heath said.  

“Most people that have autoantibodies don’t really know it,” he said. “They’re what you call subclinical … maybe you have a risk of some autoimmune disease but it hasn’t developed.” 

Still, he said one practical application of the study is that lupus treatments could be “worth exploring” as treatments for long COVID-19.  

The second factor that can lead to long COVID-19 is the reactivation of a different virus called Epstein-Barr Virus (EBV), which is extremely common, infecting up to 90 percent of people at some point, and often causes only mild symptoms. 

The virus usually becomes inactive in the body following the initial infection, but it can be reactivated when someone gets COVID-19, helping lead to long COVID-19 symptoms.  

Heath said EBV could become reactivated when the immune system is distracted by fighting COVID-19.  

“It could be that the large distraction that’s COVID-19 infection is taking that attention away,” he said.  

The third factor identified is how much of the virus that causes COVID-19, officially called SARS-Cov-2, is present in the blood, known as the “viral load.” 

This factor along with the role of EBV suggests that new antiviral drugs that fight the immediate effects of COVID-19 infection, like the Pfizer pill Paxlovid, might also be useful in treating long COVID-19.  

“Two of these predictive factors are virus levels that are in the blood,” Heath said. “So that suggests that these antivirals that are being used to treat acute disease probably have a role for long COVID as well.” 

The final of the four factors that can predict long COVID-19 is more easily identifiable: if a patient has Type 2 diabetes.  

While these four factors are a step forward in understanding what causes long COVID-19 and helping develop treatments, the mechanism for why they are associated with long COVID-19 is still not fully clear.  

“They have a flavor of mechanistic factors,” Heath said. “The actual mechanism is not clear.” 

The study followed 309 COVID-19 patients, taking blood and swab samples at different points in time.  

In addition, one way to likely cut the risk of long COVID-19 is vaccination. A separate study from the United Kingdom found that vaccinated people were 41 percent less likely to develop long COVID-19.

Researchers link Epstein-Barr virus to multiple sclerosis (MS)

https://mailchi.mp/d57e5f7ea9f1/the-weekly-gist-january-21-2022?e=d1e747d2d8

Does Epstein-Barr Virus Cause MS? Study Shows EBV Increases Risk of Disease  | Health.com

A study of 10M blood samples from active-duty military members, published in the journal Science, found that contracting the Epstein-Barr virus (EBV), best known for causing mononucleosis, was associated with a 32-fold increase in getting an MS diagnosis. While experts were cautious not to conclude that EBV causes MS, it appears to at least be a trigger. What’s left unanswered is how EBV, which is infects an estimated 90 percent of Americans by age 35, leads some to develop MS, while the vast majority do not.  

The Gist: It’s rare to have such a large, well-designed epidemiological study show a definitive and clear link between two diseases. Several viruses, including EBV and the human papillomavirus (HPV), have been linked with cancer; while more research is needed, it is theoretically possible vaccines targeted at EBV could reduce the risk of multiple sclerosis and certain cancers, similar to how HPV vaccines have successfully in lowered cervical cancer risk. 

And with such a large portion of the global population expected to be infected with COVID-19, it will be critical to monitor whether that virus, too, is linked to the development of other diseases years later.

The Next Big COVID Variant Could Be a Triple Whammy Nightmare

https://www.yahoo.com/news/next-big-covid-variant-could-100250868.html

Getty

Even as daily new COVID cases set all-time records and hospitals fill up, epidemiologists have arrived at a perhaps surprising consensus. Yes, the latest Omicron variant of the novel coronavirus is bad. But it could have been a lot worse.

Even as cases have surged, deaths haven’t—at least not to the same degree. Omicron is highly transmissible but generally not as severe as some older variants—“lineages” is the scientific term.

We got lucky. But that luck might not hold. Many of the same epidemiologists who have breathed a sigh of relief over Omicron’s relatively low death rate are anticipating that the next lineage might be much worse.

The New Version of the Omicron Variant Is a Sneaky Little Bastard

Fretting over a possible future lineage that combines Omicron’s extreme transmissibility with the severity of, say, the previous Delta lineage, experts are beginning to embrace a new public health strategy that’s getting an early test run in Israel: a four-shot regimen of messenger-RNA vaccine.

“I think this will be the strategy going forward,” Edwin Michael, an epidemiologist at the Center for Global Health Infectious Disease Research at the University of South Florida, told The Daily Beast.

Omicron raised alarms in health agencies all over the world in late November after officials in South Africa reported the first cases. Compared to older lineages, Omicron features around 50 key mutations, some 30 of which are on the spike protein that helps the virus to grab onto our cells.

Some of the mutations are associated with a virus’s ability to dodge antibodies and thus partially evade vaccines. Others are associated with higher transmissibility. The lineage’s genetic makeup pointed to a huge spike in infections in the unvaccinated as well as an increase in milder “breakthrough” infections in the vaccinated.

That’s exactly what happened. Health officials registered more than 10 million new COVID cases the first week of January. That’s nearly double the previous worst week for new infections, back in May. Around 3 million of those infections were in the United States, where Omicron coincided with the Thanksgiving, Christmas, and New Year holidays and associated traveling and family gatherings.

But mercifully, deaths haven’t increased as much as cases have. Worldwide, there were 43,000 COVID deaths the first week of January—fewer than 10,000 of them in the U.S. While deaths tend to lag infections by a couple weeks, Omicron has been dominant long enough that it’s increasingly evident there’s been what statisticians call a “decoupling” of cases and fatalities.

“We can say we dodged a bullet in that Omicron does not appear to cause as serious of a disease,” Stephanie James, the head of a COVID testing lab at Regis University in Colorado, told The Daily Beast. She stressed that data is still being gathered, so we can’t be certain yet that the apparent decoupling is real.

Assuming the decoupling is happening, experts attribute it to two factors. First, Omicron tends to infect the throat without necessarily descending to the lungs, where the potential for lasting or fatal damage is much, much higher. Second, by now, countries have administered nearly 9.3 billion doses of vaccine—enough for a majority of the world’s population to have received at least one dose.

Omicron Shows the Unvaccinated Will Never Be Safe

In the United States, 73 percent of people have gotten at least one dose. Sixty-two percent have gotten two doses of the best mRNA vaccines. A third have received a booster dose.

Yes, Omicron has some ability to evade antibodies, meaning the vaccines are somewhat less effective against this lineage than they are against Delta and other older lineages. But even when a vaccine doesn’t prevent an infection, it usually greatly reduces its severity.

For many vaccinated people who’ve caught Omicron, the resulting COVID infection is mild. “A common cold or some sniffles in a fully vaxxed and boosted healthy individual,” is how Eric Bortz, a University of Alaska-Anchorage virologist and public health expert, described it to The Daily Beast.

All that is to say, Omicron could have been a lot worse. Viruses evolve to survive. That can mean greater transmissibility, antibody-evasion or more serious infection. Omicron mutated for the former two. There’s a chance some future Sigma or Upsilon lineage could do all three.

When it comes to viral mutations, “extreme events can occur at a non-negligible rate, or probability, and can lead to large consequences,” Michael said. Imagine a lineage that’s as transmissible as Omicron but also attacks the lungs like Delta tends to do. Now imagine that this hypothetical lineage is even more adept than Omicron at evading the vaccines.

2022’s Hottest New Illness: Flurona

That would be the nightmare lineage. And it’s entirely conceivable it’s in our future. There are enough vaccine holdouts, such as the roughly 50 million Americans who say they’ll never get jabbed, that the SARS-CoV-2 pathogen should have ample opportunities for mutation.

“As long as we have unvaccinated people in this country—and across the globe—there is the potential for new and possibly more concerning viral variants to arise,” Aimee Bernard, a University of Colorado immunologist, told The Daily Beast.

Worse, this ongoing viral evolution is happening against a backdrop of waning immunity. Antibodies, whether vaccine-induced or naturally occurring from past infection, fade over time. It’s not for no reason that health agencies in many countries urge booster doses just three months after initial vaccination. The U.S. Centers for Disease Control and Prevention is an outlier, and recommends people get boosted after five months.

A lineage much worse than Omicron could evolve at the same time that antibodies wane in billions of people all over the world. That’s why many experts believe the COVID vaccines will end up being annual or even semi-annual jabs. You’ll need a fourth jab, a fifth jab, a sixth jab, et cetera, forever.

Israel, a world leader in global health, is already turning that expectation into policy. Citing multiple studies that showed a big boost in antibodies with an additional dose of mRNA and no safety concerns, the country’s health ministry this week began offering a fourth dose to anyone over the age of 60, who tend to be more vulnerable to COVID than younger people.

That should be the standard everywhere, Ali Mokdad, a professor of health metrics sciences at the University of Washington Institute for Health, told The Daily Beast. “Scientifically, they’re right,” he said of the Israeli health officials.

If there’s a downside, it’s that there are still a few poorer countries—in Africa, mostly—where many people still struggle to get access to any vaccine, let alone boosters and fourth doses. If and when other richer countries follow Israel’s lead and begin offering additional jabs, there’s some risk of even greater inequity in global vaccine distribution.

“The downside is for the rest of the world,” Mokdad said. “I’m waiting to get my first dose and you guys are getting a fourth?”

The solution isn’t to deprive people of the doses they need to maintain their protection against future—and potentially more dangerous—lineages. The solution, for vaccine-producing countries, is to further boost production and double down on efforts to push vaccines out to the least privileged communities.

A sense of urgency is key. For all its rapid spread, Omicron has actually gone fairly easy on us. Sigma or Upsilon might not.

Pregnancy and The Covid Vaccine

Pregnancy and The Covid Vaccine | The Incidental Economist

Pregnancy can be a scary time for many reasons, one of which is having so many things feel off-limits for the safety of the fetus. But what about vaccines? Especially the Covid-19 vaccine? To understand the answer to this question you need data about the vaccine in pregnancy, but you also need data about lacking protection from Covid-19 in pregnancy. Fortunately, we discuss both in this episode!