Making Sense of Medical Science (MSMS)

A medical scientist explains medical news for lay people

recent posts

about

Steve Clark, PhD is a retired university professor with a PhD in immunology and a past Special Fellow of the Leukemia Society of America. Clark has published dozens of papers based on his research and holds two drug patents. He taught medical and graduate students about cancer biology and genetics, and about research ethics. He also directed an NIH-funded PhD Graduate Program and chaired several executive-level faculty committees. Clark served on the University Chancellor’s Speaker’s Bureau. While retired, Clark has been blogging on the COVID pandemic, which is the subject of his next book.

  • Messenger-RNA Vaccines Are The Buzz, But The Real Technology Advance Is The Lipid Mixture That Delivers The mRNA

    The back story: Messenger-RNA vaccines have been wildly successful against the coronavirus and are very safe. Expect more of them in the future, even for flu. As exciting as it is to see a simple mRNA sequence generate immunity to a pathogen, it is the less “sexy” lipid, or concoction of fat molecules that makes it possible and has been a bit of a bottleneck in manufacturing the vaccines.

    Messenger RNA is a fragile molecule since there are RNA-degrading enzymes called RNases all over the place. Therefore, researchers decided to encapsulate the genetic material inside a protective shell composed of a cocktail of different types of the fatty molecules that, in a solution, will form mini-cells called lipid nanoparticles. These nanoparticles essentially mimic the lipid membrane of your cells so that when, after injection and they bump into a cell, the lipids of the nanoparticle and of the cell membrane fuse, spilling the mRNA into the cells. There, normal cellular machinery can transcribe the mRNA sequence into a viral spike protein that is expressed on the cell surface, stimulating an immune response. There also are RNase enzymes inside cells that digest the mRNA after it has done its business so the vaccine genetic material naturally disappears in a couple of days and cells cease expressing the spike protein.

    Some history: Since the 70s, research has been underway into using lipid nanoparticles to deliver large, fragile bio-molecules and drugs to cells. But, but the nanoparticles are notoriously difficult to make and use. Bob Langer, now a Professor of Biological Engineering at MIT has been working with lipid nanoparticles since the 70s when he was a pioneer trying to prove you can capture and transport big, complex molecules like DNA and RNA inside tiny lipid nanoparticles without destroying them. Many people told him it was not possible and he had his first 9 grant applications rejected—and this was a time when research grants were pretty easy to get. He also could not get a faculty position because people did not believe in his research.

    But, he did succeed. Today, Professor Langer has a bioengineering lab at MIT bearing his name. The lab is focused on the intersection of biotechnology and materials science. In 2010, Langer branched out and co-founded a small biotech company named Moderna where he’s still on the board. That company, like the German biotech company, BioNTech, has, over the last decade been developing mRNA vaccines for infectious diseases, cancer and rare illnesses. The Moderna mRNA vaccine, developed along with researchers at NIH, is Moderna’s first commercial product.

    The lipid nanoparticle field had a watershed moment in 2018, when the FDA approved the first drug delivered via lipid nanoparticles from yet another biotech, Alnylam Pharmaceuticals based in Cambridge, Massachusetts.  Their nanoparticles were used to encapsulate and deliver a drug, Onpattro, to treat a rare genetic disease that causes nerve and heart damage. That meant that before the coronavirus pandemic, regulators already had some familiarity and comfort with using lipid nanoparticles to deliver therapeutic molecules. The technology is not brand new as some vaccine naysayers like to claim.

    Another scientist, Thomas Madden, worked for years with Alnylam on developing that pioneering lipid delivery system. However, before the FDA approved Alnylam’s delivery system, Madden had moved on to his own Vancouver-based company, Acuitas Therapeutics, which hoped to develop mRNA therapeutics for different diseases. Madden recalls an epiphany in 2011, when he realized that in order to successfully use mRNA for therapeutic purposes; they needed a better delivery system to protect the mRNA from the ubiquitous RNases that quickly digest any mRNA found circulating outside of cells.

    To prevent that from happening, he adapted the lipid-packaging technology developed at Alnylam, thinking that if the mRNA could be packaged inside the artificial lipid membranes it  would protect the fragile genetic mRNA from the ubiquitous RNase enzymes. This became the basis for the technology behind the Pfizer/BioNTech and Moderna mRNA vaccines. The mRNA in Covid shots sits inside a lipid shell composed of four lipids. After protecting the mRNA on its journey into a person’s arm, the nanoparticle gets taken up into a cell and the mRNA is released inside the cells. Once inside the cell, the mRNA instructs the cell to produce copies of the coronavirus spike protein, which is then recognized by the body’s immune system.

    Moderna has designed its own lipids used to create the nanoparticles, while Pfizer has licensed the Acuitas lipid delivery technology. Yet another mRNA vaccine is being developed by another biotec, CureVac, which also is using the Acuitas lipid technology. Each of these companies was engaged in early clinical trials of other mRNA therapeutics before the pandemic and CoV-2 burst onto the world stage. They all pivoted their efforts to develop several novel vaccines against the novel coronavirus in record time.

    When Covid-19 emerged, Madden, from Acuitis Therapeutis, flew to Germany to talk to regulators and BioNTech officials about how they could most quickly commence clinical trials of mRNA COVID-19 shots. They decided to repurpose the lipid nanoparticle from a very new rabies vaccine recently developed by CureVac, since it had proven effective in people. This gave regulators further confidence on the safety and potential for lipid delivery of the coronavirus spike protein mRNA.

    In a nut shell, that is how we got to this point so quickly. An important take-home message is that the mRNA vaccine technology and lipid nanoparticle delivery system are not new concepts. The vaccines are the product of decades of research and trials conducted by several academic and biotechnology labs. The lipid nanoparticle delivery system has proven effective and safe for delivering other vaccines and drugs.

    In an earlier blog post, I dubbed this amazing new biology, BioX, after the name of the new and amazing space enterprise known as SpaceX.

    New challenges: As Moderna and Pfizer have, almost overnight, greatly ramped up production of their lipid nanoparticle delivery systems, supply chain issues became evident. Soon after getting its mRNA vaccine approved, Pfizer announced it was scaling back the number of doses it would deliver due to difficulty obtaining the raw chemical materials needed to make the necessary lipid compounds. Until a year ago, the German biotech company, BioNTech, that partnered with Pfizer, purchased only a few grams at a time of the needed chemicals to produce its lipids for a cancer vaccine research program. Now the company is tapping huge German chemical conglomerates like Merck and Evonik Industries for barrels of the stuff in order to manufacture 2 billion vaccine doses this year. Moderna also has dramatically scaled up its need for chemicals to produce the lipids that go into its promised one billion vaccine doses. Other mRNA vaccines are also being developed by CureVac NV and Sanofi, both of which will require massive amounts of the raw materials. Lipids have leaped to the top of the world’s health-care supply-chain priority list.

    Major drug and chemical makers have taken notice of the new demand for the lipid chemicals. In early February, Germany’s Merck agreed to speed up the supply of lipids to BioNTech while Evonik followed suit a week later. Evonik is repurposing tanks and vessels at two plants in Germany and buying new instruments for the purification process. Typically, in the pharma industry such large-scale manufacturing scale-up takes a year or two, but Evonik plans to do this in a couple of months in order to meet the sudden and immediate demand.

    That is the German version of Warp Speed.

    Note: In order to have blog updates delivered to your email, see the simple Subscription Instructions here. Remember, you can easily unsubscribe when you want.

  • 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?

  • One Shot Is Effective And The Vax Does Not Need To Be Stored At Ultra-Cold Temperatures

    The mRNA Covid-19 vaccine developed by Pfizer and BioNTech generates robust immunity 2-4 weeks after one dose and can be stored in ordinary freezers instead of at ultracold temperatures as previously believed, according to new studies conducted by the Israeli Sheba Medical Center and published in the Lancet medical journal.

    The Phase 3 trials completed in December only assessed the efficacy of the first shot two weeks after it was given. This showed that at two weeks, a single dose was about 52% effective. However, the recent study assessed the vaccines efficacy 2-4 weeks after the single shot. This showed that that the vaccine is 85% effective in preventing symptomatic disease. That is impressive. The second shot adds an additional 10% protection.

    Learning that a single shot approaches the efficacy of the two-dose regimen supports spreading the first dose as widely as possible around the world and delaying the second shot. This strategy would ensure that more people around the world would be protected before the second shot was rolled out. The UK has adopted this approach and there is some support for it in the US. However, the FDA and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, are not budging from the two shot regimen. The argument is that adding the second shot might lead to a more durable immune response

    Your humble blogger believes that this strategy is a mistake. It seems more prudent to get the vaccine out to as many people as possible as soon as possible, especially if the second dose only adds 10% additional protection to individuals.

    In separate news, research also showed that the Pfizer vaccine can be safely stored and transported at temperatures found in your freezer, rather than the ultra-cold temperatures as first believed. This greatly simplifies the logistics of delivering the virus around the world. No longer needed are the sophisticated ultra-cold freezers that are not often found in the third world, or even in your local pharmacy or clinic. Simple freezers, like the one you have your home will suffice, enabling ordinary pharmacies and clinics to handle the vax, thereby facilitating its distribution.

    Just don't confuse the vaccines with the ice cream.

     

  • The Coronavirus Might Not Have Originated In Wuhan Or Even In China

    About 90 people were hospitalized with an unusual respiratory disease in central China two months before COVID-19 was first identified in Wuhan on Dec. 8 2019, according to the World Health Organization. Preliminary indications are that this could have been COVID-19, but that remains uncertain at this time since China is not cooperating with international health scientists.

    More recently, Italian researchers found CoV-2 infection in a 4-year-old boy who was treated for respiratory symptoms and vomiting on Nov. 30, 2019—also before the disease was first noticed in Wuhan. And, as reported earlier in these pages, the UCLA medical center recently reported that they had an unexpected 50% spike in patients with respiratory illness beginning in December, 2019, about the time COVID-19 was first recognized in Wuhan. It is not certain that these UCLA cases were due to COVID-19, but it is suspect.

    Together, these findings, especially the Italian observation, suggest that the virus was already across China and even around the globe before the Wuhan outbreak was recognized. All this raises anew the question whether COVID-19 actually originated in Wuhan. Did it even begin in China?  

    There has been much speculation, from both serious and unserious commentators, that the virus originated, either on purpose or by accident, in the Wuhan Laboratory of Virology, a world-class research laboratory that studies coronaviruses. But, if it was spreading in other parts of China and in Italy before it was noticed in Wuhan that would raise a strong possibility that the virus did not come from the lab. Unfortunately, the Chinese government refuses to release data on their early repiratory patients  that is needed to definitively determine whether the respiratory symptoms were due to COVID-19. For example, it would be enormously helpful if international researchers could review the records of the 90-some people in central China who had COVID-like symptoms. Even more helpful would be for international scientists to test stored biological samples from these patients, if available, for the virus, like the Italian investigators did.

    Meanwhile, the CCP has floated the idea that the virus did not originate in China. One would think that if that was true, and they wanted the world to believe that, they would be more transparent with their evidence.

    We will see….maybe.

    Note: In order to have blog updates delivered to your email, see the simple Subscription Instructions here. Remember, you can easily unsubscribe when you want.

  • 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.

     Note: In order to have blog updates delivered to your email, see the simple Subscription Instructions here. Remember, you can easily unsubscribe when you want.

     

  • More Than Half CoV-2 Transmission Comes From People Without COVID-19 Symptoms

    The Journal of the American Medical Association just reported that 59% of new CoV-2 infections are likely caused by infected people who do not show COVID-19 symptoms. This conclusion is based on the results of a decision analytical model that assessed the spread from pre-symptomatic, never-symptomatic and symptomatic people infected with CoV-2. 35% of viral transmission came from pre-symptomatic people, and 24% from people who never develop symptoms.  

    This means that until the vaccines are widely disseminated, identifying and isolating people with COVID-19 will be much less effective at controlling the spread of the virus than previously thought. Effective control of the disease still requires social isolation measures such as wearing face masks indoors, distancing from others, hand hygiene, and limiting indoor contact with other people.

  • 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?

  • New Coronavirus Mutation Enhances Spread

    The Wall Street Journal reports that countries across Europe and beyond are banning travel from the UK in order to stem a more-infectious strain of Covid-19 that has been found in the London area. The new strain was first reported last Monday, and on Saturday, England announced that it is imposing fresh lockdowns in London and surrounding areas, which also include a ban on households mixing at Christmas. Similar restrictions have been taken across Europe with Italy announcing a complete lock down across the country. Germany and the Netherlands imposed lockdowns through Christmas, and Austria said Friday that nonessential businesses will be closed starting Dec. 26. However, it also appears that the new strain has popped up in Denmark and South Africa. Holland reported one case with the new virus variant.

    Scientists believe the new strain of the coronavirus could be as much as 70% more transmissible than previous strains, but there is no evidence at this time that it is any more deadly or more resistant to the vaccines.

    It seems that the virus mutated to change the spike protein on the surface of the virus, increasing the protein’s ability to cling to and chauffeur the virus into human cells. These changes allow the mutation, known as N501Y, to spread faster than other versions of the virus. Early analysis suggests the variant first occurred in September either in London—where it was identified on Sept. 21—or in the nearby county of Kent, where it was found on Sept. 20. That might explain why quarantine restrictions that have been effective elsewhere in England have not been effective in Kent. By mid-November, 28% of cases in London were attributable to the new variant. In the week starting Dec. 9, it was responsible for 62% of cases in the capital. In other words, this variant is winning the infection race against all other CoV-2 strains out there. As of December 19, there has been no evidence of the new strain in the US.

    Viruses mutate all the time, but coronaviruses do so less than, say, the flu virus. Mutations happen when rare, random errors are made while cells copy millions of viral genomes. Most mutations are innocuous, but sometimes these accidental changes alter the behavior of the virus. Scientists have identified 23 genetic changes in the genome of the new variant, an unusually large number, some of which are associated with small changes in the proteins the virus makes, which, therefore, can change viral behavior. Those include changes in areas known to be associated with how the virus binds and enters cells, which probably explains why it spreads more quickly. While efforts, including quarantine measures and the new vaccines, are designed to drop the infection rate of the virus, or the R0 number, these mutations threaten to work against those efforts and increase the virus R0 value.

    Two main questions are now being investigated: Is the new variant more likely to cause increased morbidity and/or mortality, and is it more likely to avoid the body’s immune responses, including those encouraged by vaccines? The provisional answers to those questions are no and no, but the research continues, so these conclusions are preliminary. We will see.

    The new variant isn’t the first time a more-transmissible CoV-2 strain has emerged. As reported in these pages last summer, scientists in July described a viral variant that displaced an older strain of coronavirus to become the dominant strain in the global pandemic. Experiments showed that the variant replicated more quickly in tissue culture, but appeared to be just as susceptible to antibodies that targeted the earlier strain, and was not associated with more severe illness.

    The bottom line is that as viruses replicate in cells, spread, and replicate some more, they acquire small mutations in their genome. It is like playing the lottery, an occasional mutation will be the “winner” and the ability to spread and even cause new diseases can arise. Like the lottery, the more you play the greater the chance of a winner. This is why calls for “natural herd immunity” by letting people get infected are really bad ideas–they are gambling that while spreading through a population, the virus does not become even more virulent. This also is why health professionals recommend quarantine measures to limit the reproduction-spread-more reproduction of the virus until we have vaccines that effectively block the reproduction and spread and mutation of the virus.

    Otherwise, we are just playing the virus lottery.

    Note: In order to have blog updates delivered to your email, see the simple Subscription Instructions here. Remember, you can easily unsubscribe when you want.