Coronavirus news & views

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.

2. 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.

3. 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 30^th, 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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What Is Going On In India?

The situation. India is in the throes of a second major Covid-19 surge that has hit faster and harder than the first wave did. That is often how viral pandemics behave. This catastrophic second wave came after a strict lockdown of the country in early 2020 following the first wave. In January 2021 India’s Prime Minister Modi declared that the lockdown had succeeded and that they had defeated the virus, and he re-opened the country. Until March, India was recording barely 13,000 new COVID-19 cases a day, fewer than Germany or France, and a drop in the bucket for a nation of 1.4 billion people. A few weeks after Modi’s victory declaration, however, daily cases began slowly climbing, then in late March they exploded, becoming a vertical line rather than an upward sloping curve. By mid-April India reported 315,000 new cases in one day, setting a world record. Yesterday (May 5) India set yet another record with 3700 daily deaths, according to the Johns Hopkins University tracker. The case and death rates are still climbing. Today, almost 50% of the world’s new cases come from India, according to the WHO.

India has reported 2,000-4,000 COVID-19 deaths a day for several weeks now. Since the country’s health infrastructure is poor, this likely represents a significant undercount of the mortality. As of April 30, the official total death count was around 200,000. However, the official tallies do not reflect the thousands in poor and rural areas who cannot get medical care and die at home and are not counted. For example, in just one day at one crematorium in Bhopal, workers cremated 110 COVID-19 victims, but the official total death toll for the city was just 10. Experts suspect that the total death toll in India is 1-2 million.

The second wave of the pandemic also has overwhelmed hospitals across India. Securing a hospital bed, even for the critically ill, is nearly impossible. Hospitals put up signs declaring they have no beds, and families in large cities have to search for days to find beds, often hundreds of miles away. Sick people die on the roads outside hospitals and in traffic jams created by ambulances ferrying critically ill patients in search of a bed. There are images of patients gasping for oxygen while waiting to see a doctor.

Because getting admitted to a hospital is so difficult now, patients who are admitted are much sicker than in India’s first wave. The average temperature readings of second wave patients are 2 to 3 degrees higher than they were during the first wave when temperatures averaged 100-101 degrees Fahrenheit. Blood oxygen levels of recently admitted patients run lower than they did last year meaning the patients are more critical and in greater need of oxygen. The patients are also younger this time around, between the ages of 35 and 45, and often without other pre-existing conditions.

Critical healthcare necessities are in short supply in India, from intensive care beds, medicine, oxygen, and ventilators. Delhi hospitals have tweeted messages appealing for oxygen. At one Delhi hospital, 20 critically ill patients died after the hospital’s oxygen delivery was delayed seven hours. Families are often told that they have to provide their own oxygen for hospitalized family members or take them home. In a video post, the director of a hospital said they had 60 patients in need of oxygen with only two hours of supply left.

Help for India has been offered by several countries, including the US, UK, Germany and even from India’s archrival Pakistan, which offered ventilators, oxygen supply kits, digital X-ray machines, PPE, and related items.

Bottom line. This is a snapshot of what things look like in India now, almost a year and a half after the virus first introduced itself to the world. In January, India believed that its strict lockdown measures had defeated the virus. They did not. How the more deadly second wave of the virus and disease appeared, almost overnight, will be the topic of the next blog post. It should concern all of us, because it could also happen here.

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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.

Vaccine Disinformation

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There is a lot of misinformation and downright disinformation out there regarding face masks, hydroxychloroquine, ivermectin, the seriousness of COVID-19, etc. Many of these I already addressed in prior posts (see here and here). In this post, I focus solely on vaccine misinformation and disinformation in hopes my unvarnished explanation of the science might help vaccine skeptics make decisions based on facts rather than on disinformation spread by people with an anti-vaccine agenda, or who want to sell you something.

Several anti-vaccine disinformation themes have been circulating over the past weeks and a friend recently sent me a video by an MD that was full of disinformation and dishonesty. The video was thinly disguised marketing propaganda by Houston-based Dr. Steve Hotze. He is an MD, who does not seem to practice much medicine anymore, but has built an alternative medicine empire that pushes many vitamin and mineral supplement nostrums that he claims is all you need to fight the virus and other diseases. In other words, he advises people to avoid the vaccines and, instead, buy his concoctions. In December 2020, the FDA and FTC sent him a cease-and-desist letter to stop claiming that his supplements can treat diseases, especially COVID-19. The FDA found the products and marketing to be misleading. The FTC found him in violation of interstate transportation laws. I address his several points below, many of which have been echoed by other anti-vaxers.

• The vaccines do not confer immunity to the virus and COVID-19. There is very much evidence that the vaccines do provide immunity against CoV-2 and strongly protect against COVID-19. That evidence is found in the many reports of antibody production, of T cell anti-viral responses, of cytokine responses to the vaccines, and in recently published reports out of Israel that the vaccines retard virus transmission. Then there are the several studies showing that the vaccines strongly prevent COVID-19 disease. Hotze and others provide zero evidence to back their allegations and ignore data that contradict their points.

• These are not vaccines, but experimental gene therapies. The mRNA shots from Pfizer and Moderna, and the modified adenovirus vaccines from Johnson & Johnson and AstraZeneca are indeed vaccines. Researchers whittled down the virus genome to the essential viral spike genetic sequence needed to confer immunity. This means that the minimally effective part of the virus genome, rather than the whole viral genome, is used to provide protection from future infection. Old fashioned vaccines grew batches of viruses and then crippled them so that upon injection, they would infect cells, use their genetic information to express all their viral molecules on the cells, but not spread. The current vaccines simply use the genetic sequence for the spike protein, eliminating all other viral genetic sequences. That single genetic sequence is translated into the spike protein that is expressed on your cell surfaces much like what would have happened with an inactivated, whole virus vaccine. Therefore, the current vaccines are no more “gene therapy” than the whole virus vaccine. Both require expression of viral genes in order to alert the immune system.

Also, the term “gene therapy” conjures images of "Frankenscience." This is wrong. First, vaccines are not “therapy,” which is something that treats a disease after you catch it. Rather vaccines are prophylaxis, which prevents you from catching the disease in the first place. Gene therapy is a still developing field that works to replace, correct, or “knock-out” aberrant genes that cause non-viral health problems.

Furthermore, as I posted earlier, these vaccines are not experimental or hastily developed. They are based on vaccine platforms that have been over a decade in development, and, in some cases, have been used to develop human vaccines to rabies and Ebola. The only novel thing about them is using the CoV-2 spike protein to drive a protective immune response to subsequent infection with the virus. These spike-protein vaccines have been tested in tens of thousands of volunteers in phase 3 trials, and now have been injected into tens of millions vaccine recipients around the world. The vaccines have been wildly successful at preventing COVID-19, and have been proven to be very safe (see below). These are not experimental vaccines, but well developed, and well tested vaccines.

• The vaccines alter your DNA. They absolutely do not. It is biologically impossible for them to do that. I discussed this fallacy in a prior post.

• There is no off switch for the viral gene expression caused by the vaccines. This too is not at all true. No vaccine in history has had its viral genes expressed long term. In fact, your cells continually produce their own mRNA to direct production of cellular proteins that drive cell function. Cells are also full of enzymes called RNases that digest mRNA once it has done its job. Thus, your own mRNA is very short lived in your cells. The same is true for the viral mRNA inserted into cells from an inactivated viral vaccine, from an adenovirus-based vaccine, or from an mRNA vaccine. The mRNA will only last a day or two in your cells before it is digested and permanently disappears. This is the off switch.

• We do not know about the long-term or delayed responses to the vaccines. Yes we do. First, I challenge people who purport to be worried about long-term effects to name one vaccine that has ever had a long-term adverse effect. As I described above, vaccines are short-lived; their only long-lasting legacy are memory T and B cells that protect you from future exposure to the pathogen.

On the other hand, delayed adverse effects were a potential concern when the vaccine was being developed as I described earlier, but that has proven to be of no concern. There is a rare adverse response to prior exposure to a pathogen, whether naturally or via vaccine. This is called Antibody Dependent Enhancement (ADE) of the infection. This was seen with the vaccine against the Dengue virus where the antibody response actually enhanced viral infection in new cells. Because of this, all new vaccines to novel viruses are carefully tested for potential ADE effects.

During the early stages of anti-CoV-2 vaccine development, caution prevailed, and the vaccines were assessed for potential ADE, as reported earlier in these pages. The clinical trials showed absolutely no evidence for ADE. Since then, millions of people around the world have been vaccinated and not a single case of ADE has been found.

Therefore, concern over ADE was theoretical and never became a practical matter. Anti-vaxers who keep bringing this up as a concern, such as Dr. Hotze, and America’s Frontline Doctors choose to ignore demonstrable facts in favor of continued fear mongering and appealing to emotions. A few countries around the world have begun arresting people for spreading such disinformation that disuades people from being vaccinated, which can lead to deaths caused by the disease.

• Many people have died from the vaccines. That is flat wrong, and in fact, the opposite is true. In the US, ~550,000 people have died from recognizable COVID-19 while only nine (out of several million vaccinated people) might have died due to vaccine complications (discussed below). The CDC has a Vaccine Adverse Event Reporting System (VAERS) that lists all reported adverse events and deaths that occur shortly after vaccination, whether or not they are caused by the vaccine. Seeing as how tens of millions od people in the US have been vaccinated, unrelated health problems and deaths are expected to occur by chance. If you blew kisses at 50 million people, several of them would die in the next day or two just by chance. The air kisses did not kill them. The trick is to distinguish chance deaths vs possible vaccine-related deaths.

In order to determine whether a new vax causes adverse health effects, CDC doctors look for recurring patterns. If they see a pattern of similar types of death in certain people they pay closer attention to that group and even back off vaccinating them. With one extremely rare exception with one of the current vaccines as discussed below, these kinds of patterns have not been seen with the current vaccines.

• The COVID vaccines will not eradicate the virus any more than flu vax eradicates flu. This statement by Hotze and others is either dishonest or they are ignorant of basic virology. It ignores the fact that flu rapidly changes every season, making it very hard to eradicate. The statement also ignores the facts that small pox has been fully eradicated by vaccines, and that in the US measles and polio have been eradicated—the only cases we see here come from overseas. Whether or not the COVID vaccines can eradicate CoV-2 depends on how well they work against the viral variants, how quickly the variants arise, and how many people are vaccinated in the next few months.

• Herd immunity caused by natural infection is better than the vaccine. This statement too betrays ignorance of the disease and of vaccinology. Natural immunity to CoV-2 comes with the cost of many deaths and with many more people suffering long-term health problems caused by COVID-19. Again, the vaccines have not been linked to deaths or to lasting health problems. Vaccines are used to confer herd immunity without running the risk of the deadly consequences of the disease. By all measures, the vaccines confer significant protection against the disease and are more reliable than natural immunity where you cannot ensure a uniform level of infection and immunity for everyone.

• Companies are reaping great profits off their lies. Pfizer and Moderna and other vaccine producers are providing the vaccines at cost during the pandemic. They are not profiting from them. Also, Moderna has announced it will not enforce its patents on its vaccine platform, but will share its technology with other companies and researchers during the current pandemic. In contrast, Dr. Hotze and others clearly are using the pandemic for their profit.
  

• Companies are withholding raw data on their vaccines. Raw data for the approved vaccines was shared with two CDC committees consisting of scientists, vaccinologists, pathologists, epidemiologists and statisticians. That raw data was the basis for the emergency authorization of the vaccines (see below). Generally, raw data are only released to CDC and FDA and not to the public. What is released to the public are data summaries in the form of peer-reviewed journal publications and these are coming out and will continue to come out over the next few years.

The above are points Hotze has made and that are often repeated by other anti-vaxers. Below, I address other criticisms and questions about the vaccines that I have heard others, but not Hotze raise.

• The vaccines are not FDA approved. Well, I wonder then who gave the vaccines Emergency Use Authorization (EUA)! True, EUA is not full FDA approval, but EUA approval still comes from 30 FDA experts after a rigorous evaluation of all existing data for efficacy and safety. That is well above the 2-3 experts that typically review science papers for peer reviewed publications. The EUA approval for each vaccine was based on data from about 40,000 subjects enrolled in the late stage clinical trials. Since then, millions more people have been vaccinated and their data continues to be collected and reviewed. Recent reports of this "real world" data continue to support the great safety and efficacy of the vaccines.
• Some vaccines are better than others. The Pfizer and Moderna mRNA vaccines, which were the first tested and approved, showed ~95% efficacy, while the Adenovirus-based Johnson & Johnson vaccine, which was later tested and approved, only showed around 70% efficacy. So, shouldn’t we favor the Pfizer and Moderna vaccines? No. All the currently approved vaccines, including the J&J one, are very effective. And it is impossible to compare the relative efficacy of different vaccines from data obtained in separate trials. In order to gain an accurate comparison of different vaccines, they need to be tested in head-to-head, controlled trials in order to assure that similar patient populations are being tested against the same viral variant. For example, the Pfizer and Moderna vaccines were tested before we noticed viral variants that seem to be more infectious than the original virus. And neither company tested their vaccines in South Africa where one of the more infectious variants is rampant. In contrast, J&J began testing their vaccine after the variants began spreading around the world, and they also tested their vaccine in South Africa. This means that the Pfizer/Moderna vaccines were tested against different strains of the virus than the J&J vaccine, which confounds comparing their relative efficacy.
• Bill Gates is promoting vaccines so he can inject us with microchips to track us. [big sigh]…Yeah, and one of the America’s Frontline Doctors, a group that claims hydroxychloroquine can cure COVID-19, said there is alien DNA in some of our medicines. I don’t waste my time with tinfoil-hat comments.
• The vaccines cause infertility. This is based on bunk-science that began circulating last December. That rumor was solidly debunked by several sources, but the meme has been repackaged into new messages about de-population strategies. I give this the same attention I give to the silly notion that Bill Gates is trying to use the vaccines to microchip us. The vaccines do not cause infertility.

But, what about nursing mothers? Will the vaccines affect their babies? The answer is yes, but in a good way. Since babies are born with a very immature immune system, their first line of defense against pathogens comes from their mother’s antibodies that cross the placenta and that are found in mother’s milk. This “passive immunity” is an important first line of immune defense for newborns. Lactating women who have been vaccinated do show anti-CoV-2 antibodies in their milk, which provides the newborns with a temporary defense against the virus. That is a good thing.

• The AstraZeneca vaccine causes blood clots. Over the past few weeks, 25 patients in Europe, almost all women under the age of 55, who received the AstraZeneca vaccine developed rare blood clots and nine died. The European Medicines Academy (EMA) met to review the data and found that overall clotting in vaccine recipients was less than in the general unvaccinated population. However, there are different clinical types of blood clotting problems, and for two very, very rare types, it was expected that ~2 clotting cases would arise by chance out of the ~20 million vaccinated people. But, 17 cases were reported. This is the kind of adverse event pattern that public health officials look for, as I described above. Again, exercising an abundance of caution, more than 20 European countries paused using the vaccine. However, within a week, the WHO and the EMA had reviewed the data and found that the extremely rare risk of vaccine-associated blood clots was significantly less than the risk of serious health problems from COVID-19 disease and advised that the vaccine be continued.

Final words. The disinformation about the anti-CoV-2 vaccines is disheartening, but seems to have been spawned by the roundly discredited claims by Dr. Andrew Wakefield a few years ago that the MMR vaccine was responsible for autism in kids. For that fraudulent reporting, Dr. Wakefield's paper was retracted and his medical license was taken away. Sadly, the damage was already done and continues today against all vaccines. Vaccines are one of the greatest health protection tools in the healthcare tool box and the naysayers are indeed killing people with their illogical and emotional appeals that are bereft of facts. How to counter such disinformation was a topic in a very recent article in Scientific American. What they recommend is beyond the scope of this post, but I hope that my presentation of the facts and reasoned criticism of anti-vax rhetoric is a step in that direction.

Wearing Glasses Might Protect Against COVID-19

A new report summarizing several studies claims that wearing glasses can protect you from COVID-19. The investigators reviewed multiple studies that have shown that glasses wearers contract COVID-19 at greatly reduced levels compared to those who do not wear glasses. It has been long known that respiratory viruses can infect people through the eyes, so this finding is not a surprise. If a virus lands in your eye, it can go through the tear duct and down into your nose and infect your upper respiratory system.

One study published this month in India, looked at 304 COVID-19 patients. About 40% of India’s adult population wears glasses, but only 19% of the people infected with the coronavirus wore glasses leading the researchers to conclude that the risk of COVID-19 was about 2 to 3 times less for folks who wear spectacles compared to non-wearers. These results mirror an earlier study from China.

All of this raises the question of whether wearing glasses to protect against COVID should be called nerd immunity?

Increasingly Contagious And Lethal CoV-2 Variants Are Popping Up Around The World

In September, the UK noticed a coronavirus variant that has a surprising number of genome mutations, including eight point mutations in the spike protein, which is the viral antigen targeted by most of the vaccines. In just a couple of months, the variant became the prevalent cause of COVID-2 in the UK, meaning that it spreads faster than other iterations of the virus. It also has been found in a few pockets in the US and is expected to become the dominant strain here by March. It appears that the variant is 30-50% more infectious in all age groups (down from the early 70% estimate in December). Fortunately, all indications are that the two mRNA vaccines being rolled out by Pfizer and Moderna are effective against the variant (expect two more vaccines based on different technology platforms soon, from AstraZeneca and J&J).

The bad news is that British public health officials just warned that the virus variant is just not more contagious, it also is 30-40% more lethal. Out of 1000 60-year old patients infected with the UK variant, 13-14 would be expected to die, compared to 10 deaths in patients infected with the previous virus. This warning was based on four separate UK studies.

Related, but not identical, viral variants also have appeared in South Africa and in Brazil. These variants also seem to be more contagious and, not surprisingly, share some of the same spike protein mutations as the British variant. There is no word, yet, on the lethality of these variants. However, three lab studies in South Africa have raised concerns that their variant might be resistant to the current vaccines. Pfizer studies found that their vaccine protects well against the British variant, but the South African variant seems to be more resistant to the two vaccines currently in use. It too has quickly become the dominant virus strain in that country and has been found in 22 other countries. It has not yet been found in the US, but give it time.

These new virus variants that are more contagious and more lethal are appearing in countries where a significant percentage of people have already built some immunity to the original CoV-2 strain. This raises concern that our immune responses can provide natural selection pressure that favors virus variants that avoid the specificity of our immune response. In other words, our immune systems and the vaccines might be driving the emergence of more contagious and deadly forms of the virus. If so, this would necessitate adapting the vaccines to meet the variants and establishing a regular vaccine schedule with continually changing vaccines like we do now for the flu virus.

The CEO of BioNTech, the German biotech company that spent a decade developing the mRNA vaccine platform used in Pfizer’s vaccine, said it would take only six weeks to design a new vaccine specific for new variants in the spike protein. The platform is in place and all they would need to do is swap out the spike protein mRNA for the new variant sequence. Then it would take some time to produce the new vax and get it into arms. But, again, that is similar to what we do each year for the new flu strains that pop up annually.

Hopefully, the new vax technology will let us develop new vaccines as fast as the virus mutates.

The race is on. Bet on the new vax technology, which I earlier christened, BioX.

400,000 Total COVID-19 Deaths In A Year

Shortly after Thanksgiving, I wrote in these pages how the post-turkey surge moved COVID-19 to the top cause of death in the US. I reported that the disease was killing more than 14,000 people a week, above the ~12,000 killed weekly by the former top killers, heart disease and cancer.

Grim.

It is getting grimmer: Now the CDC estimates that 92,000 people will die from the disease in the next three weeks. That is almost 31,000 deaths a week, more than double the death rate in early December. And, a study just published in the Proceedings of the National Academy of Sciences reported that the average life expectancy in the US in 2020, dropped by more than a year. The study was conducted by researchers from Princeton and the University of Southern California using data from the Institute for Health Metrics and Evaluation.

If the pandemic didn’t take place, the study authors note that a person born in 2020 would, on average, live to about 79 years. The virus shaved almost 1.22 years off of that average life span. Black and Latino populations were projected to suffer significantly greater declines in life expectancy compared to White populations.  Reduced life expectancy among minorities was projected to be about triple that for White populations: life expectancy is projected to be 0.73 years lower for the White population, 2.26 years lower for the Black population, and 3.28 years lower for Latinos.

While 400,000 deaths is very tragic, it is a mere drop in the bucket compared to the many more COVID-19 patients who suffer long term, or even permanent morbidity. More on that later.

Shifting Topics: From June to November, Public Health England, tested thousands of healthcare workers in the UK. They reported that out of 6,614 healthcare workers who tested positive for COVID-19 antibodies, there were 44 reinfections. That is a good rate of protection against reinfection, but the reinfection rate still is surprisingly high.

This means that even though you had the virus or even were vaccinated, you might still be able to pass it on. What should you do?

• Still get the shot.
• Still mask up.
• Still socially distance.
• Still wash your hands.

In other words, be a good neighbor.

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The Lesson Behind The Long Recovery From COVID-19 For A Young Physician Assistant

This is an update to a story published on March 10, 2020 by MedPageToday. You can read the original piece here.

In March, James Cai, a physician assistant and New Jersey's first COVID-19 patient, made headlines for warning the country that even young, healthy 32-year-olds like himself were vulnerable to the virus. He came down with the disease in early March and was admitted to the hospital on March 3. Because the disease was so new, he was worried that he wasn't getting the right treatment at the hospital, so he took his case to Twitter.

In the beginning, he was treated like he had a serious case of the flu. He received high-flow oxygen, chloroquine, and lopinavir/ritonavir (Kaletra), and was one of the first patients to receive remdesivir under compassionate use approval. He was able to connect with Chinese physicians who had experience with the disease, and a Chinese-American doctor translated the Chinese protocols into English for Cai's New Jersey doctors.

He was discharged on March 21, but still needed supplemental oxygen -- especially at night. A month after his discharge he went back to work as a physician assistant, but only virtually and half-time. But even by mid-summer, Cai was still seeing impairments in his oxygen saturation and activity levels. His O2 saturation was 97% during the day, which is good, but it dropped to 90% when he lay down to sleep, necessitating the oxygen supplement. He tired very easily and was unable to run and exercise like he did before. Through that time, he was taking dual anticoagulant therapy of Xarelto and aspirin.

In late summer, things started to look up. On August 21, he confirmed that he could sleep through the night without oxygen, but the results of his latest chest CT showed permanent fibrotic lung damage in his left lower lung. As of December, he was still testing positive for coronavirus antibodies.

We still do not know why some people, especially young, healthy people can be so hard hit by the virus while others are not. Why did Cai become so ill and suffer permanent lung damage, while a couple of my nearly 70 year old friends caught it and had milder, temporary symptoms? It will be a while before we understand this.

This story also illustrates the folly of just looking at mortality numbers when assessing COVID risk. The death rate for COVID-19  is low, about 1% or less of people who get infected die from the disease, so some folks cite that low death risk and take a cavalier approach and avoid social restrictions designed to slow the virus spread. By focusing on that simple statistic, they ignore the fact that COVID is now the leading cause of death in the US by far and has killed 10 times the number of people who are killed by seasonal flu. The devastating 1918 Spanish flu also had a very low death rate, but in just 24 weeks, it killed more people around the world than were killed in the 10 years of WWI and WWII combined!

And those people who cherry pick their statistics to justify their careless behavior ignore the greater number of people like Cai who survive the disease, but suffer long term and even permanent health problems. Is it really worth the risk of permanent lung damage to exercise your freedom to not wear a mask?

Some People Worry About The Vaccines Because They Were Developed So Quickly

A poll published by Gallup in early August found that 35% of surveyed Americans would decline a Covid-19 shot offered to them at no cost. I have seen other studies that say 50% of Americans will not get the vaccine. And on social media sites I have seen discussion and comments about why folks are so reticent to get the vaccine. Let me address the concerns.

1) Problem: People will not take a vaccine pushed out by Trump. Nancy Pelosi and Chuck Schumer are the more prominent members of this cadre. Answer: Well, Trump has had nothing to do with the vaccine development. The two leading vaccines now available are based on RNA vaccine technology that is a decade old. In other words, the technology was being developed way before Trump had presidential aspirations. Also, the Pfizer vaccine was developed in the UK using technology from a German biotech company and was developed without any US dollars. Trump did set up Operation Warp Speed to produce and disseminate a vaccine quickly, but the Pfizer vaccine’s share of that initiative is only a four star Army general, Gus Parna, who is overseeing the enormous logistics of getting a few hundred million people vaccinated. Trump’s fingerprint on all that is negligible.

2) Problem: The vaccine was rolled out too fast for comfort. Answer: As I wrote above, the RNA vaccines are based on technology platforms that are at least a decade old. All the companies needed to do was take a short CoV-2 genome sequence and add it to that well developed platform then test it. With a raging pandemic, the vax testing went quickly—when several thousands of people get infected every day, the results of a test vaccine come quickly. Similar vaccines were being developed for the earlier coronaviruses, SARS and MERS, but both of those pandemics fizzled out before enough data about the vaccines could be collected. Those platforms were repurposed to accommodate the SARS-CoV-2  virus. During the several months of testing, tens of thousands of people were given the vaccines and adequate efficacy and safety data were rapidly gathered. Since the vaccines were approved, a few million people around the world have been vaccinated and that larger sample simply confirms the data from the clinical trials. The vaccines are safe and effective.

Keep in mind, every year we roll out new flu vaccines in just a few months and they are safe. This vaccine has been adequately tested.

3) Problem: The RNA vaccines can alter your cellular DNA. Answer: Total bull scat. There is no way that the short stretch of the virus’ RNA genome that is used in the two leading vaccines can interfere with cell DNA. That is biologically impossible. Having said that, let me elaborate. There is a family of RNA viruses, called lentivirus, that can mess with your DNA. The lentivirus family includes HIV, human T cell leukemia virus, and several animal viruses that cause cancer. However, the unique thing about lentiviruses is that their genome carries a gene that encodes the enzyme, reverse transcriptase, which copies RNA into DNA allowing it to insert randomly into cellular genomes. Two of my science mentors and friends, David Baltimore and Howard Temin, shared the Nobel Prize for discovering reverse transcriptase. Most RNA viruses, like flu and coronaviruses do not express reverse transcriptase, so they do not affect cellular genomes. It is biologically impossible for the Pfizer and Moderna vaccines to alter your cells’ DNA.

4) Problem: The vaccines will infect you with the virus. Answer: Balderdash! The RNA vaccines are not produced using any living microorganism. A short stretch of DNA is tethered to insoluble beads and used to produce copies of a short RNA sequence that will produce the viral spike protein. The insoluble DNA templates are easily separated from the RNA that remains in solution, and the RNA is then encapsulated in lipid nanoparticles. That is what is injected. After injection, the lipid nanoparticles fuse with lipid cell membranes to empty the encapsulated RNA into the cells. Then normal cell machinery takes over producing the spike protein, which generates an immune response and immune memory that protects you from subsequent infection. The vaccine RNA is gone in about two days.

5) Problem: We need several years of data to be assured of the safety of the vaccine. And we do not know how the vaccine will interact with other drugs many people take. Answer: Wrong. Vaccines are not drugs and do not interact with drugs you might take. And since vaccines are just one or two shots, and not taken chronically like drugs, long term problems are not a concern. I challenge any naysayer to name one long term health problem caused by vaccines.

6) Problem: Vaccines cause allergic reactions. Answer: Some do, but that risk is nothing compared to the risk of serious consequences of getting the disease that the vaccine prevents. The FDA and other regulatory agencies weigh these risk factors and the vaccines that are approved come out way on top. Such reactions can occur with any vaccine, but are extremely rare—about one per 1 million doses.

There have been very few allergic problems with the CoV-2 vaccines and that problem has been linked to polyethylene glycol (PEG), a component of the lipid nanoparticles that carry the RNA sequence. PEGs are also used in everyday products such as toothpaste and shampoo as thickeners, solvents, softeners, and moisture carriers, and they have been used as a laxative for decades. So, most of us have been exposed to PEGs, but very few of has have a problem with them.

Endnote: As published in these pages in late October, there are several examples of vaccine production errors that led to tragic consequences. In 1955, the Salk polio vaccine was rushed into production just hours after it was approved. This was an inactivated virus, which means that live virus was grown, then killed, then injected. Some lots from one of the manufacturers, Cutter Laboratories, were not fully inactivated and some patients received injections of live virus leading to tragic results. Similar production errors have led to people being infected with live measles virus, and respiratory syncytial virus. In 1976, an H1N1 flu that was similar to the 1918 Spanish flu reached pandemic stage and we rushed out a vaccine that was associated with a spike in the very rare Guillaume Barre disease (GBD), which is a type of paralysis. It is thought that the rushed vaccine somehow caused the small, but significant spike in the disease in fewer than 500 patients across the country. It is not known how the vaccine was related to GBD.

Note: your humble blogger was a college student and working in a hospital physical therapy department at the time, and worked with two GBD patients.

Those problems using inactivated virus vaccines are very rare and have not arisen in over 40 years. Since the CoV-2 RNA vaccines do not use any live microorganisms, this will not be a problem with the vaccines.

I will willingly get mine as soon as it is offered. How about you?