public health

Almost All US COVID-19 Deaths Occur In Un-Vaccinated People

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As the anti-CoV-2 vaccines roll out in the US, COVID-19 infections and hospitalizations have plummeted. Deaths, too, have plummeted from a peak of 3,400 a day in mid-January to fewer than 300 today. About 63% of vaccine-eligible Americans (those 12 and older) have received at least one vaccine dose, and 53% are fully vaccinated. All this demonstrates the efficacy of the vaccines.

Also showing how effective the vaccines are, almost all new infections, hospitalizations, and deaths now occur in unvaccinated people. An Associated Press analysis of CDC data since May reveals that fewer than 1,200 vaccinated people, out of a total of 853,000, were hospitalized for COVID-19. Furthermore, in May there were 18,000 COVID-19 deaths in the US, of which only 150 were fully vaccinated. The vaccines are so successful that the CDC director was quoted as saying, “…nearly every death…due to COVID-19 is, at this point, is entirely preventable.” Let me repeat that, COVID-19 deaths are almost 100% preventable now because of the vaccines. Let that sink in, anti-vaxers.

These observations are especially relevant in the face of the Delta, or double mutant virus variant that has taken over India, the UK, Israel, and is rapidly spreading in the US. As I reported earlier, this double mutant variant first appeared in India and carried the same mutations as two earlier variants first identified in the UK and in South Africa. Individually, these mutations made the variants either more virulent, or able to spread faster than the parent virus. Together, they create a more dangerous, faster spreading virus. The good news was that the current vaccines are pretty effective against the Delta variant.

However, there are two concerning things about the Delta variant that raise alarms. First, in Israel, about half of adults infected with the variant were fully vaccinated with the Pfizer vaccine. 90% of new infections in that country are now caused by the Delta variant and children under 16 account for about half of those new infections. So-called “break-through infections” can occur in fully vaccinated people, but have been, so far, rare. This makes the high level of break-through infections in Israel worrisome. Breakthrough infections in previously vaccinated people are especially worrisome--how is the virus avoiding vaccine immunity? These kind of infections are what most concerns this writer, since a virus that can replicate in a fully infected person suggests we could have a new variant that resists vaccine immunity. We do not yet know why break-through infections appear with greater frequency in that country. However, when vaccinated people are infected, they almost always avoid severe symptoms. Hopefully, this will continue to be the case in Israel. We will see.

The second concerning thing is something I have earlier warned anti-vaxers about—the emergence of further variants that could be even more virulent or able to avoid vaccine immunity. India has just reported a new Delta variant, referred to as “Delta Plus.” It also has been detected in 11 countries including the UK, Japan, and the US. Little is known about this variant, but it has been declared a “variant of concern” and is being closely watched. Again, we will see.

Delta Plus arose in people who have not been vaccinated. As I have strongly argued in these pages, each anti-vaxer represents a potential incubator for a new variant for which current vaccines are ineffective and/or is much more lethal. And as I also pleaded in a previous blog post, “get over yourselves; it is not all about you!” Get the shots.


Independent Analyses Suggest COVID-19 Can Cause Diabetes

We know that having co-morbid conditions such as asthma, heart disease, diabetes, and others are risk factors for significant COVID-19 disease and death. Now, independent reports out of the US and the UK strongly suggest that having COVID-19 can also lead to the swift onset of diabetes, even in people with mild infections. This includes children. These observations add to the list of long-term health problems for the millions of COVID-19 survivors living with chronic conditions following infection called "long-haulers."

Some 10-30% of COVID-19 survivors develop persistent and sometimes debilitating symptoms after apparent recovery from the disease. It has been known for a few months that in a subset of these long-haulers, lingering metabolic complications require high doses of insulin suggesting that they are developing diabetes. This possible link between COVID-19 and new-onset diabetes was noticed as early as last summer and was reported in Scientific American last February. Two more recent analyses of patient data strengthen the COVID-diabetes link.

  • In the US, researchers at the Veterans Affairs St Louis Health Care System’s clinical epidemiology center recently published their findings in the journal, Nature. They used data from VA national health-care databases and found that COVID-19 survivors were about 39% more likely to have a new diabetes diagnosis six months after infection compared to non-infected users of the VA health system. This means that there about 6.5 extra diabetes cases per 1000 COVID-19 patients who are not hospitalized. For hospitalized patients, the risk jumped 5-fold to 37 per 1000, and it is even higher for patients who required intensive care.
  • In the UK, a study of 50,000 hospitalized COVID patients was published about three weeks earlier than the US study. The UK study reported that the patients were 50% more likely to develop diabetes 20 weeks after discharge than matched control patients.

How does the virus do this? CoV-2 primarily is a respiratory disease, but we have known since the early days of the pandemic that it also can ravage other organs including the kidneys, brain, and others. The leading theory of how COVID-19 can cause diabetes is that the pancreas, where insulin is produced, also can be damaged by the virus, or by the immune inflammatory response that follows infection. Other possible mechanisms are also being considered.

 Bottom line: As of this month, 153 million people around the world have been infected with the virus. That means that the pandemic has caused a LOT of new cases of diabetes, a chronic disease, for the world to absorb. To monitor global COVID-related diabetes, a world-wide registry has been set up by King’s College London and Monash University in Melbourne. Almost 500 doctors around the world so far have agreed to share data via the registry.

Maybe this information will convince people who down play the disease by only focusing on the low mortality rate of COVID-19 that they also need to consider the accompanying long-term health consequences of the disease.


Why It Is Necessary To Vaccinate Kids

Vaccine makers are applying to the FDA for approval to give the COVID-19 vaccines to children. Some people have questioned the need for this since kids seldom get sick, let alone die from COVID-19. But, there is a very good reason to vaccinate them, which is to protect them, as well as the rest of us from the emerging new viral variants that are more infectious and more potent and that I discussed earlier.

Vaccines do two things; 1) they protect the vaccinated from the disease, and 2) they prevent the further spread of the pathogen and disease. A good example of the latter point is Japan and flu vaccines. A number of years ago, Japan mandated that all school kids be vaccinated against the flu. A major result was a sharp drop in flu deaths in the elderly. Kids are walking incubators for respiratory viruses and carry them home for their families to enjoy. Thus, Japan's flu vaccination program meant that fewer kids were catching the flu and carrying it home to infect their parents and grandparents. Hence, flu mortality dropped.

That is why we need to vaccinate kids against CoV-2 even though they seldom get seriously ill from it. Related to that point is the fact that the more CoV-2 spreads, the greater the chance that the virus will mutate into variants that are increasingly infectious, more deadly, and that can evade the immune response to the current vaccines. If that happened, we would be starting all over again. Hundreds of thousands, if not millions around the world would die, countless more would suffer long term consequences from COVID-19, and the disease could very well become more serious in young people. We already are seeing increases in infections and hospitalizations in younger, healthier people from the viral variants that already have arisen in the UK, South Africa, Brazil, and India.

We need to vaccinate kids in order to slow as much as possible transmission of this virus in order to minimize the development of potentially more deadly variants.


What Caused India’s Devastating Second Wave?

Understanding what contributed to a second, more intense COVID-19 surge in India can inform the rest of the world on how to avoid a similar surge for this and future pathogens. This outbreak threatens to extend the pandemic itself and drive world-wide infections to new highs, creating an enormous a breeding ground for new and potentially more dangerous viral variants. If variants emerge that are not touched by the current vaccines, the world will be at square one with the pandemic. What a depressing thought.

It appears that the second wave arose due to a combination of three things: 1) India’s relaxing quarantine measures back in January, 2) the emergence of more rapidly spreading viral variants, including one that first appeared in India, and 3) a very poor rollout of vaccines to protect India’s population from spread of the virus. These are further discussed below.

  1. Relaxed safety measures. India’s second surge came after loosening restrictions, which let public complacency set in, which, in turn, was exacerbated by government officials like Prime Minister Modi and Health Minister Harsh Vardhan declaring that the pandemic was defeated. Life returned to normal. Masks went away, as did social-distancing. Weddings and parties resumed, which usually are large events in India. A new season of state-level elections ushered in big political rallies and street parades. A massive religious festival known as the Kumbh Mela took place, bringing an estimated 5 million Hindu pilgrims to the banks of the river Ganges in April. By mid-March, cases started gradually climbing again—then suddenly accelerated, becoming a vertical line rather than an upward sloping curve. The government was slow to respond. It was not until late April that Modi finally acknowledged the urgency of the situation. Local containment measures are beginning to be enacted, including shutting down the capitol of Dehli, and a few Indian states. However, Modi remains reluctant to enact country-wide restrictions like he did during the first wave. Without a more aggressive vaccine campaign, that could be a bad decision.

The more the virus spreads throughout India, and even into its neighboring countries of Nepal, Pakistan, and Bangladesh, the greater the risk that it will generate more infectious and dangerous viral variants that will not be affected by the current vaccines. If that happens, well vaccinated countries will have to start over. That is not a pleasant prospect, and is further discussed below.

  1. More infectious viral variants. India’s more deadly second wave of the CoV-2 virus can also be attributed to more infectious and more persistent viral variants. In this second wave, India, like many other countries, has been inundated with viral variants first identified in the UK and South Africa that were recently discussed in these pages. The UK variant has a mutation in its spike protein that makes it more infectious than its parent virus. The South African variant has a different mutation in its spike protein that makes the virus more resistant to some vaccines.

India’s second surge also has introduced the world to a unique viral variant dubbed the "double mutant," which was first identified in October. It is now the dominant strain in the state of Maharashtra, home to India’s financial center, Mumbai.

“Double mutant” is actually a misnomer for this variant since it has 13 mutations throughout its genome. However, it acquired that sobriquet because it has joined the UK and South African spike protein mutations in the same virus. It is a double whammy.

While scientists are still learning about the double mutant variant, India is seeing people who were previously infected become re-infected with this new variant. Also, younger and healthier people are being hospitalized in greater numbers. These observations are concerning. Similar observations of re-infection have also been seen in Brazil with yet another viral variant that was first identified there (more about Brazil in a future post). The ability of viral variants to re-infect people can be an important driver of future pandemic waves even in countries where the population is well vaccinated, but where isolation measures have been lifted or ignored.

For the country overall, the double mutant virus made up 70.4% of the samples collected during the week ending March 25, and that is compared with 16.1% just three weeks earlier, according to Covid CG, a tracking tool from the Broad Institute of MIT and Harvard. The tool mines data from the GISAID Initiative, a global database for coronavirus genomes. These data also show that the double mutant virus has already hopped to at least 21 countries including the US. In Australia viral genome sequencing showed that the double mutant made up 40% of the samples collected over the week ending April 15, compared with 16.7% a month earlier. It accounted for 66.7% of samples from New Zealand for the week that ended April 8, up from 20% a month ago. It also has been detected in California, according to Dr. Benjamin Pinsky, director of the Clinical Virology Laboratory at Stanford University. Clearly, where the double mutant virus appears, it quickly achieves dominance.

  1. Poor vaccine distribution. As of 4/30, India had only administered 15 million vaccinations, a tiny proportion of its population of 1.4 billion people. The country is the primary producer of the AstraZeneca vaccine that has run into supply chain problems causing delays in vaccine delivery. In February, Biden signed the Defense Production Act to boost U.S. COVID-19 vaccine production but that decision cut off US exports of raw materials that India needs in order to maintain its vaccine production capabilities. Thus, vaccine makers around the world, including the Serum Institute of India (SII), the largest vaccine manufacturer in the world, face a shortage of materials to make COVID-19 vaccines. The ban has garnered much criticism as resource hoarding that threatens global vaccine production. On April 16, SII appealed directly to Biden to lift the embargo of raw material exports so that vaccine production could continue. Several days later, the White House announced it would partially lift the ban for materials the Indian company needed to manufacture the AstraZeneca vaccine, specifically.

The US also inexplicably has a large stockpile of millions of doses of the AstraZeneca vaccine, that were made here, even though it is not approved for use in the US. If we are not using it, why not release the stores to the world? The Biden administration also has faced criticism for hoarding these doses that could help India and other countries around the world that also are experiencing a new surge in infections. On Friday, April 30th, the U.S. Chamber of Commerce called on Biden release the AstraZeneca vaccines to India and other hard-hit countries.

There is some irony in all of this since India is a huge manufacturer of vaccines and pharmaceuticals for the world, and likes to bill itself as the “pharmacy of the world.” India produces 60 percent of the world’s vaccines, but cannot supply its own country, partly because of reduced production due to the supply chain problems, but also because it failed to order sufficient vaccine doses. India almost completely halted vaccine exports last month in order to divert supplies to its domestic population, which is affecting supply in the rest of the world. Rather than rely on its own manufacturers for vaccines, India approved Russia’s Sputnik vaccine, and has fast-tracked the approval process for other vaccines manufactured in foreign countries. That means that while the industrialized world was being vaccinated with vaccines produced in India, the country was still looking at approving foreign-made vaccines for use in its country.

Bottom line. The combination of relaxed safety protocols, the appearance of deadlier viral variants, and poor distribution of vaccines to its people has left the country as the world’s epicenter for the pandemic. As the virus races through its huge population, all of this provides an enormous breeding ground for new variants to arise, which is worrisome even for countries that have had successful vaccine rollouts and have begun to see reduced viral spread. Let us hope this is not a perfect storm for restarting the pandemic with vaccine-resistant variants.

And India is not the only problem. In Africa, vaccination is also off to a slow start. Just 6m doses have been administered in sub-Saharan Africa, fewer than in New Jersey. Just 1% of African adults have received a first jab, versus a global average of 13%. Prepare for Africa to become the next hot-spot and breeding ground for troublesome variants, if Brazil and South America do not beat them to the punch.

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COVID-19 mRNA Vaccines Safe For Pregnant Women

I have received a few questions about the safety of the coronavirus vaccines for pregnant and lactating women. I discussed toward the end of one blog post about how maternal immunity can benefit the baby by passing the mother’s antibodies across the placenta and given in mother’s milk, thereby protecting neonates whose immune systems are still developing.

Now, an analysis of the CDC’s Vaccine Adverse Event Reporting System, and the “v-safe after vaccination health checker," and its associated v-safe pregnancy registry, shows that the Pfizer and Moderna mRNA vaccines appear to be safe for mothers and babies. The analysis examined almost 36,000 pregnant women who received one of the mRNA vaccines, and was reported in the New England Journal of Medicine.

Compared to non-pregnant women, pregnant women who were vaccinated reported more injection-site pain, but fewer incidents of headaches, myalgia (muscle pain), chills, and fever. About 14% of vaccinated pregnant women suffered pregnancy loss while about 9% of neonates born to vaccinated women suffered adverse events, and 3% of them were undersized. No neonatal deaths were reported. The important thing is that the incidence of these outcomes was similar to the incidence observed in pregnant women before the pandemic arose. Most of the pregnant women who were evaluated were vaccinated in the third trimester.

The study concluded that the data revealed no obvious warning signals for pregnant women who receive the mRNA vaccines. But, it also advised that followup with women vaccinated earlier in pregnancy is warranted.

Stay tuned.


Paying The Piper

In the face of a pandemic caused by a new and deadly virus, states and local governments enact social-distancing measures, bans on crowds, closure orders, and mask mandates in an effort to flatten the curve and prevent health care systems from being overwhelmed with critically infected people. Initially, people are fairly compliant with the order, but, as the days of restriction turn into weeks, then months, compliance wanes. Theater owners complain about financial losses. Clergy bemoan church closures. People argue whether children are safer in classrooms or at home, and many rebel at having to wear face masks in public, complaining that the government has no right to infringe on their civil liberties. Sound familiar?

But this is not about the 2020-21 coronavirus pandemic; these are descriptions of the US response to the deadly Spanish flu pandemic between 1918 and 1920. In many ways our current pandemic mirrors the one that occurred a century ago, and that is presciently described in the book, The Great Influenza, by John M. Barry. Like CoV-2, the H1N1 “Spanish” flu killed less than 1% of the people it infected, but during a third wave of infection with a more virulent strain, that flu killed more people around the world in just 24 weeks than were killed in the 10 years of WWI and WWII combined! In remote areas with little access to health care, the flu wiped out entire villages.

Like COVID-19, the Spanish flu pandemic hit hard and fast, going from a handful of reported cases in a few cities to a nationwide outbreak within a few weeks, then with increased mobility due to WWI, it quickly spread around the world, from America to Europe and back. Many communities, responding to the ebbs and flows of the epidemic waves, issued several rounds of closure in an attempt to keep the disease in check. These social-distancing orders worked to reduce cases and deaths. However, just as today, they often proved difficult to maintain. By the late autumn of 1918, just weeks after wide-spread social-distancing orders went into effect, the pandemic seemed to be coming to an end as the number of new infections declined. People clamored to return to their normal lives. Businesses pressed officials to be allowed to reopen. Believing the pandemic was waning, some state and local authorities began rescinding public health edicts. Sound familiar?

Americans hurried to return to their pre-pandemic routines. In some cities, they packed into movie theaters and dance halls, crowded into stores and shops, and gathered with friends and family for holidays and celebrations. Meanwhile, officials warned the nation that cases and deaths likely would continue for months to come, but the warnings fell on increasingly deaf ears, as people enjoyed a return to normalcy. The nation carried on, inured to the toll the pandemic was taking. But as health officials warned, the pandemic wore on, stretching into a third deadly wave that lasted through the spring of 1919, with a fourth wave hitting in the winter of 1920. Some blamed those world-wide resurgences on careless Americans.

The different responses and experiences of two large American cities are noteworthy here. In Denver, local business interests lobbied heavily to get rid of the quarantine measures that had shut down schools, churches, libraries, pool halls, businesses, and theaters. The city capitulated. The city opened up and was hammered by the deadly third wave of the flu. On Armistice Day, November 11, 1918, residents poured out of their homes to celebrate the end of World War I. A few days later, many were dead, victims of the pandemic flu. Two weeks later, a headline in the Denver Post captured the devastation: “All Flu Records Smashed in Denver in Last 24 Hours.”  An editorial in the Denver Monthly Magazine said, “For some reason, even the most enlightened citizens will not take the influenza epidemic seriously. They know that it is the most widespread epidemic that has ever visited America. They know the disease is a deadly menace and snuffs out life almost before the victim realizes he is ill. Yet when health officers try to impress upon people the necessity of following essential rules and regulations, the average citizen simply refuses to heed these admonitions.”

In contrast to Denver, St. Louis enacted and maintained strong social distancing measures, including in-home quarantines for infected people. They experienced a fraction of the deaths that Denver saw. The quarantine measures worked there.

The similarities in our responses to the 1919-20 flu and 2020-? coronavirus pandemics are noteworthy. But, there is one big, hopefully defining difference between the two pandemics that might make the outcomes quite different. Vaccines. There were no flu vaccines to rescue the world from the ravages of the Spanish flu. In fact, the influenza virus would not even be discovered for another 15 years, and a vaccine was not available until 1945. For the first 12 or so months of the current coronavirus pandemic, we were in the same boat—we faced a novel virus with no vaccine or effective medicine. When there is no available medical response to a pathogen, we must rely on protective public health measures to provide a buffer against the pathogen while we learn how to respond to it.

Today, we have significant advantages with a much better understanding of virology and epidemiology then we did in 1918. We know that both social distancing and masking work to help save lives. Most critically, we now have multiple safe and effective anti-CoV-2 vaccines that are being deployed, with the pace of vaccinations increasingly weekly.

Still, the deadly third wave of influenza shows what can happen when people prematurely relax their guard against viruses that can mutate and become more deadly. That is why we must remain vigilant while the coronavirus vaccines roll out. We are still learning about this virus and are only beginning to learn about the variants spawned by the virus. We still need a public health buffer from the virus to keep us safe until we better understand its full capabilities and can vaccinate more people.

Be smart. Stay safe. Get the vaccine.