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July 2021

New Evidence That The Wuhan Lab Might Not Be The Source Of The Virus

There is a lot of speculation, but few facts, on the origin of the SARS-CoV-2 virus. About six weeks ago, even I speculated that the virus might not even have originated in Wuhan. This was based on the fact that at the same time unusual clusters of novel respiratory diseases were popping up in Wuhan, other clusters were also popping up across China and even in Los Angeles. Unfortunately, we have no confirmation that any of these clusters outside Wuhan were caused by the coronavirus. In that blog post, I also wrote about a child in Italy who became sick with a respiratory illness during this time. The child died, but some of his tissues were stored and later proven to be infected with the virus. More recently, Italy also reported on a woman who also died at that time from a respiratory disease. Her stored samples also were positive for the virus. Therefore, we do have proof that COVID-19 was in Italy at the same time it was found in Wuhan. These observations cast some doubt that Wuhan is actually the epicenter of the pandemic.

Of course, these observations are circumstantial and it remains possible that Wuhan indeed is where the virus first infected humans. And the Wuhan Institute of Virology (WIV) labs remain the trendy choice for the origin of the virus, even though there are no data to support that. However,  new provocative research just published threw a monkey wrench into the lab origin notion. University of Arizona evolutionary biologist, Michael Worobey, has data very consistent with the virus originating from a different market in Wuhan, the Uhanan Seafood Wholesale Market. The market is 10 miles from the Wuhan lab, and Chinese researchers recently published that the market was illegally selling civets and raccoon dogs, both known to transmit coronaviruses, including SARS, to humans. Worobey has studied the origins of pandemics for over a decade. His research helped explain how the 1918 Spanish flu emerged and how HIV came to the US around 1970-71, much earlier than originally thought.

Confirmed cases of COVID-19 began spreading in Wuhan in December 2019 and Worobey mapped the geography of those early cases. What he found was that the Huanan market, not the WIV, seemed to be the center of the new cases. His striking data shows clustering of early COVID-19 cases around the market, not the lab, and can be seen here. If the virus came from the WIV, it would be expected to see early cases near the lab. That was not seen.

How ever the virus got to Wuhan, cluster analysis indicates that it first spread from the market rather than the lab. While provocative, these data do not at all prove an animal origin for the virus. They also do not disprove the lab-origin theory. These data are a piece of the puzzle that is being assembled, which is how science is often done; one puzzle piece at a time.

Keep in mind it took over a decade to find the origin of HIV, and it took a few years to identify the sources of Ebola and the original SARS virus. It also is very possible we will never know where SARS-CoV-2 came from.

We will see.

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Average US Life Expectancy Drops In 2020

There remain people who try to explain away COVID-19 mortality as due to underlying conditions like diabetes or asthma. This is like claiming that someone with diabetes who was run over by a bus was felled by the diabetes, not the bus. I continue to point these skeptics to two actuarial studies done in the US and UK that showed that COVID-19 was causing much earlier than expected deaths in patients with these and other comorbid conditions. All of this was later confirmed in another report published in the Journal of the American Medical Association. In other words, research has well established COVID-19 as the cause of death in most patients with comorbid conditions.

If something causes the death rate to increase, it is reasonable to expect life expectancy to decrease. This is what has happened in the US during the pandemic. Two recent studies reveal just how much of a toll COVID-19 has taken on life expectancy in the US in 2020.

An updated study published in mid-June (originally published in January) in the Journal of the American Medical Association by researchers from the USC School of Gerontology and from Princeton University reported that in 2020, the average US life expectancy dropped by 1.3 years (from 78.74 to 77.43 years). It also reported that compared to white people, the reduction in life expectancy was three times as large for Latinos and twice as large for blacks. The research was based on data obtained from the CDC, the Census Bureau, and the US Vital Statistics System. The study warned to expect a continued decline in life expectancy in 2021.

A separate study published around the same time in the British Medical Journal, confirmed the racial disparity in life expectancy due to COVID-19, and indicated that the pandemic took a much greater toll on life expectancy in the US than in other high-income nations.

The effects of the coronavirus pandemic on life expectancy include deaths directly attributed to COVID-19, as well as those due to pandemic-related reduced access to health care. It is important to understand that these factors are partly offset by a simultaneous reduction in deaths from other causes such as other infectious diseases and accidents as Americans sanitized more and traveled less. In other words, we saw a reduction in deaths due to common causes, which should improve life expectancy. Therefore, the fact that life expectancy dropped, rather than improved, makes the overall decline in longevity more alarming.

Increased mortality represents only part of the burden of COVID-19; for every death, a much larger number of infected individuals experience serious acute illness that requires hospitalization, many more face long term health and life complications that drain personal finances, stress health resources, and affect ability to work at jobs.

Greater than 95% of hospitalizations and >99% of COVID-19 deaths now occur in unvaccinated people. Almost all of this is preventable with vaccination.

Vaccines And Myocarditis In Young People

Rare cases of inflammation of the heart muscle, or myocarditis, have been found in 1,200 younger people (16-24) after receiving an mRNA vaccine, and this has been used by anti-vaxers to further the hysteria around the vaccine. But, if you talk to a pediatric cardiologist you will learn that we should be much more worried about the disease than the vaccine. There simply is no comparison.

The post-vaccine myocarditis is very mild, has caused no deaths, is easily treated with anti-inflammatory drugs, and quickly goes away without lasting problems. On the other hand, COVID-19 can linger for months, and, as of June 9, has caused ~3000 deaths in young people. Because of this, the American Heart Association and American Academy of Pediatrics continue to strongly recommend vaccination for young people.

Myocarditis in young people is not a new thing, and is usually associated with a viral or bacterial infection. One vaccine against small pox has also been weakly linked to myocarditis. People from puberty through their early 30s are at higher risk for myocarditis, according to the Myocarditis Foundation. Males are affected twice as often as females. Most of these cases are very mild and many times people with myocarditis do not even know they have the problem. The incidence of myocarditis in young people peaks this time of year when the coxsackie virus, which can infect the heart, is more common. This means that an undetermined fraction of post-vaccine myocarditis is likely due to concomitant infection with coxsakie virus and not due to the vaccine.

Bottom line: Post-vaccine myocarditis is much ado about next to nothing. This should not cause one to hesitate getting the vaccine, unless the person has another underlying cardiac problem. The mildness of this rare side effect contrasts with the thousands of young people who have contracted serious COVID-19 and have even succumbed to the infection. While severe morbidity and mortality from COVID-19 is rarer in children and adolescents than in older adults, the number of cases in young people has been steadily rising on a weekly basis according to the CDC. This trend will likely accelerate as the more infectious, and possibly more lethal Delta variant becomes dominant in the US. Since most older adults have been vaccinated, that leaves younger people as available targets for the new virus surge. There is no rational reason for 99.9% of people to not be vaccinated.

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Has The FDA Approved The COVID Vaccines Or Not?

As SARS-CoV-2 and its more virulent variants continue to spread around the world, it becomes even more critical to get the vaccines to unvaccinated people. The slow pace of vaccination in Africa, parts of Asia, and South America is largely due to lack of vaccine access or poor healthcare infrastructure. However, slowing vaccination rates in the US and Europe are now mostly due to vaccine hesitancy. Earlier in these pages, I addressed several of the most common anti-vax myths that people invoke as reasons to avoid the vaccine. These are largely fears based on mis- or even dis-information about the vaccines and COVID-19.

However, there also are people who are not necessarily anti-vaxers, but who hesitate to be vaccinated because of the perception that the current vaccines are not FDA approved.

The vaccines are FDA approved. An FDA panel gave them Emergency Use Authorization (EUA), which is not much different from full approval.

What is EUA? EUA comes from an expedited review process that is used to approve new medicines during public health emergencies, like a pandemic, in order to lessen roadblocks to get needed therapies to the public as soon as possible. EUA also puts significant limits on the medicine’s manufacturers. Many people do not understanding what the EUA entails and assume that the vaccines are not fully vetted.

That is not the case.

When people hear “Emergency Use Authorization,” they focus on the word emergency, and jump to the conclusion that the vaccines have not been fully tested, and are not known to be safe or effective. However, the reality is that a vaccine given EUA has gone through the same clinical tests as a vaccine given Full Approval, and all the clinical trial data have gone through the same rigorous review by the same large FDA science panel that also confers Full Approval.

How does EUA differ from Full Approval? For full vaccine approval, a large panel of FDA scientists reviews all the clinical trial data, including data collected six months following the end of the trial. The FDA also uses a fine tooth comb to examine the vaccine’s manufacturing plans to ensure the quality and consistency of the vaccines that are produced. This also includes extended negotiations with manufacturers to determine how the vaccines will be labeled (i.e., what claims and warnings will be placed on the informational insert and on the bottle). It is the review of the manufacturing processes and the negotiations over labeling that draws out the approval process.

In order to streamline the whole approval process during a time of emergency, the FDA allows temporary emergency use after carefully vetting the medicine. As with Full Approval, for EUA the FDA panel reviews all the clinical trial data. However, the post-trial data review is shortened to two, rather than six months. (Note that after either EUA or Full Approval, data continue to be collected and reviewed in order to identify extremely rare side effects that would not be picked up in a study of 30-40,000 participants). Both full and EUA reviews assess the relative risk of receiving the vaccine vs the risk of catching the disease the vaccine is designed to prevent. If that risk calculus is favorable, the vaccine is approved. I repeat, if the risk/benefit ratio of the vaccine outweigh the risk of the disease, the vaccine is approved. This is FDA approval and it is why it is disingenuous to claim that the CoV-2 vaccines have not been approved by the FDA.

More than 180 million doses of the Pfizer and 133 million of the Moderna vaccines have been distributed in the US, with millions more worldwide. Data from all of these recipients continue to be collected making these vaccines the most scrutinized for efficacy and safety in the history of biologics medicine. To summarize: clinical trials on about 70,000 volunteers showed both vaccines to be 95% effective and extremely safe; since then, a number of peer reviewed reports in leading journals have confirmed this using real-life data from vaccine recipients collected in Israel, Qatar, the UK, US and other countries. In other words, the mRNA vaccines have been proven safe and effective in clinical trials, and by independent research examining the real life experiences of hundreds of millions of people who have been vaccinated.

But, that is not enough for some people. Many claim that they want the full imprimatur of the FDA before they will get the vaccine. A survey by the Kaiser Family Foundation found that 32% of unvaccinated adults in the US said that they would be more likely to get the “Fauci Ouchie” if it had full FDA approval. They do not realize that the EUA is very similar to Full Approval. So, their hesitation is based on not understanding the approval processes and focusing on the word emergency in the EUA approval.

Pfizer filed for full approval on May 7, and Moderna followed with its own application on June 1. It will be 3-5 months before the full approval is granted, on which I would bet my house. But, the vaccine delay in hesitant people will lead to preventable mortality and morbidity. That is why I have written this blog post. Hopefully, it will convince some vax hesitators that they can be confident in the EUA approval status of the vaccines and will be vaccinated in order to avoid significant health consequences of the aggressive Delta variant that is overtaking many countries, including the US.

If EUA is almost as good as Full Approval, why would a vax company ever go for full approval after they have EUA? There are several reasons for doing so, which mostly have to do with marketing and sales. Without Full Approval vaccine companies cannot give the vaccine a brand name and market it directly to consumers on TV, radio, and other media. With EUA, the companies can also have price restrictions on their vaccines that could be lifted after Full Approval. Also, without Full Approval, law-suit averse employers and schools are often reluctant to mandate the vaccines like they have with other fully approved vaccines. Sure, a few colleges and hospitals already have mandated CoV-2 vaccinations, but others, like the University of California and California State University systems said that they will only mandate a fully approved vaccine. The US military also is waiting for full FDA approval before mandating the vaccine.

Bottom line. All of this shows that having Full Approval for the vaccines makes little difference for assuring the safety and efficacy of the vaccines. However, having Full Approval mostly means that you will see commercials and posters advertising the shots, may be required to get the shots, and will pay more for them.

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