There continues to be conflicting information on the risks of Covid 19 in the news. For instance, just 2 weeks ago the CDC issued new travel guidelines stating anyone fully immunized may travel without any restrictions so long as they continue to wear masks while in public. Some states have even eliminated any restrictions on large crowd gatherings and mask wearing.
However, also in the news is the continuing rise of infections in certain areas of the country, and new reports detailing people getting Covid19 despite being vaccinated. In addition, the Johnson and Johnson vaccine has been temporarily stopped due to a small number of cases of serious blood clotting issues.
So how does one make sense of it all?
First off, we must understand that all our knowledge is being acquired as this pandemic progresses. Realize that what we state as factual today may turn out to be incorrect or incomplete just 2-4 weeks from now. However, we only can use the information we have at hand, so we are forced to advise and educate with those limitations.
With regards to vaccine protections, despite the new variants the vaccines do appear to be working remarkably well. No vaccine is perfect, and the very small number of breakthrough infections (less than 1%) is not concerning at this point in time. There is a big effort to more fully understand why these failures may be occurring, yet that information will not be available for a while.
Interestingly, while both technologies used in the Covid vaccines (mRNA and Adenovirus) have never been fully utilized clinically, the seemingly new mRNA methodology used in the Pfizer and Moderna products actually has science dating back over ten years and is not novel nor untested. With the Adenovirus vaccines (the Johnson and Johnson and Astra Zeneca products), there appears to be something on the Adenovirus used that may trigger the body in rare circumstances to attack platelets and cause blood clots.
Because all these vaccines are new, any reported serious side effect will lead to a pause in administration while experts take the time to analyze the data and figure out whether to continue using the product. In the case of Astra Zeneca, vaccines were continued (although not without some countries stopping its use altogether) I anticipate we will see the Johnson and Johnson vaccine return with some restrictions.
Finally, while case numbers in Arizona appear to be stable there is discussion in some parts of the medical community that the situation on the border represents a very real threat to cause super spreader events here in Arizona. Testing does not seem ideally coordinated and may not even be done in some areas, and consequently we are in a situation where “we don’t know what we don’t know” (as an infectious disease colleague of mine has stated). Until we have a much higher rate of immunization then the 33% that we currently have, Arizona (and other southern border states) could be at a higher risk then appreciated. Only routine testing of everyone detained at the border will help us figure this out. So please continue to wear a mask in public even if you are immunized.
The news and messaging regarding the pandemic over the last two weeks have been extremely confusing. On the one hand, in some states (including Arizona) the number of cases and hospitalizations continue to decline. In other states (specifically Michigan) there has been an alarming increase in Covid19 cases. Governors of several states are relaxing restrictions on indoor gatherings and mask wearing while public health experts maintain that we may just be experiencing the quiet before the next bad surge.
Knowing who is right is essentially impossible at this moment in time. However, it is important to understand why there is this divide in opinion.
Basically, three main elements worry public health experts. First and foremost is the emergence of Covid19 mutants. These variant strains of the virus are more contagious and according to recently published studies, more deadly. The UK variant known as B1.1.7, which is becoming the dominant strain in the US, has been shown to be up to twice as deadly than the original (or wild type) strain of the virus. Thankfully, current vaccines do protect against this specific variant.
The second major worry is that only 16% of the US population has been vaccinated against Covid19. Many people may still get the virus and become very ill or even die from it. We are literally in an “arms race” trying to immunize people as quickly as possible. As the percentage of people immunized increases, concerns will ease, yet we need at least 70% of the population to be immunized for ideal protection (also described as herd immunity).
The third element is the continuous surge in cases and deaths whenever people stop wearing masks and start congregating in closed spaces. The worry is people will think the risk is past, yet with the more contagious and deadly strains now emerging, nothing could be further from the truth.
On the other hand, we know that Covid19 can be very unpredictable. Why are some states improving when others are worsening? Why in the first surge a year ago were only some areas (such as New York City) severely impacted while others (such as Arizona) were much less affected? Is there a way to find a middle ground between resuming public activities without putting huge numbers of people at risk?
The short answer is sort of. Because we lack an effective therapy for serious infections and because we do not yet have herd immunity, we must remain vigilant about our preventative practices. These practices primarily consist of avoiding large gatherings of people (more then 10-15) and continuing to wear masks while around strangers. If you have been vaccinated and you are in a small gathering with others who have also been vaccinated, then it is now considered safe to be unmasked when together. Six feet remains the recommended ideal social distancing although three feet is now being considered acceptable in schools. Be aware though children under age 12 are not currently considered to be major spreaders of Covid19, and this is possibly why three feet appears safe in schools.
To fully be safe we need to have the ability to identify and isolate those who are infected. Sports have provided a good model, with many infected asymptomatic athletes being identified because they are being tested on a continuing basis. This intense monitoring is not really feasible for the whole population yet applying it to areas where there are rising numbers of cases would make sense.
Finally, many people would like to travel again and are wondering if vaccinated why they are still being advised not to. With the variant strains we are unable to currently gauge how much risk a vaccinated individual may have. Remember that vaccines are designed to prevent a more serious case or death from Covid19. You can still be infected, and if you get infected with a strain that is not well protected by our current vaccines then you could spread it to others or even get ill yourself. I realize the frustration many feel with these recommendations yet in medicine caution is always the better part of valor and we must work with the data and evidence available to us.
With the approval of the Johnson and Johnson vaccine, the US now has 3 vaccines available raising the hope that everyone in the US could be immunized by mid-summer. This new vaccine differs from the Moderna and Pfizer vaccines in many ways and has certain advantages over them.
First off, it is a single shot rather then two. It is easier to transport and store, requiring only regular refrigeration rather than a freezer, and it can also be stored for longer.
It uses a different approach then the other two as well, utilizing an older method of using an inactivated virus to deliver the Covid spike protein, rather than a piece of RNA. Side effects though are similar with a sore arm the most likely reaction. However, just like with Moderna and Pfizer, headaches and flu like symptoms can occur for up to 48 hours after the vaccine.
Some perceive the Johnson and Johnson vaccine as less protective since in studies it was only shown to be effective at preventing symptomatic Covid19 infections 72% of the time (in the US) compared to 95% for the other two vaccines. This perception is inaccurate though. With regards to preventing someone from ending up in the ICU or dying from Covid19 all three vaccines show the same success. The difference in the efficacy numbers relates to the fact that the Johnson and Johnson vaccine was tested in areas of the world where there are more resistant variants. It is unlikely that the current formulations of the Pfizer and Moderna vaccines would show the same high effectiveness rate if they were to be retested in those areas of the world now.
As I have mentioned over the last several weeks the variant strains of Covid19 continue to remain a major concern, as they may reduce the protectiveness of the vaccines. At the moment, the most worrisome variants are the ones from Great Britain, South Africa and now Brazil. Currently, the British strain is the variant most isolated here in the US.
These variant strains represent genetic drift, which is the slow accumulation of mutations that ultimately result in a confirmational change to the virus. This change causes the virus to appear different to our immune systems (sort of like putting on a wig as a disguise) and can lead to reduced immunity. It does not necessarily lead to increased virulence or deadliness.
On the other hand, genetic shift occurs when two strains of the same virus combine to form a brand-new virus. These super mutants are often more deadly and may not even be protected against by existing vaccines. A super mutant consisting of the British variant and a California variant has been isolated by labs in California and Los Alamos New Mexico. For the moment, this super variant strain does not appear to be circulating in the population, yet if it ever does, we may be back to where we were when the pandemic began or even worse.
I have always been bothered by the fact that in the 6 hours between the signing of the Armistice ending World War I and the actual ceasefire, up to 10,000 soldiers were wounded or killed. Many of those casualties were avoidable. I cannot help but feel we are in a similar situation with Covid19. We are potentially seeing the beginning of the end of the pandemic, yet a very real danger still exists for infection and death. I do believe that in another six to eight weeks we will have a much clearer picture, yet for now please continue to remain vigilant and continue to practice social distancing and wear masks while in public.
Nationwide, and here in Arizona, the number of new Covid19 cases and deaths has been declining. While still at high numbers, Arizona is now back to where we were in mid-November, with the seven-day average of cases 1,530 and the seven-day average of number of deaths at 90. Overall, Arizona is now fifth in the nation in number of deaths per capita and fifteenth in number of cases, which is an improvement from January when Arizona was number one in both categories.
It is not entirely clear why the numbers are declining. For the moment, it is too early for vaccines to be making a big difference in the general population. However, for nursing home residents, there has been a dramatic decline in the number of deaths from Covid19 and vaccines are believed to be playing a role in this improvement.
There is great worry that people will become less careful as the number of cases decline, setting us up for another bad outbreak in the next two months. As I mentioned in my message last week, even if you are vaccinated you need to wear a mask and stay socially distanced if in public. As more people get immunized and more time progresses, this recommendation will be modified, yet people must remain vigilant for now.
Also last week I talked about the variant strains of Covid19 being isolated and the concern they could make vaccines less effective or even not protective at all. It is important to realize that so far the only data we have about the resistance of variant strains is based on in vitro or test tube studies. Concentrations of the variant strains are mixed with serum from people who have been immunized and the amount of virus incapacitated or eliminated by the serum is then measured. Realize that while helpful, these in vitro studies do not always reflect what goes on in the real (or in vivo) world of the body, and it is possible that the vaccines may be more beneficial then believed. Nevertheless, both Modena and Pfizer are working on a third dose of their respective vaccines to protect against the most worrisome variants. In addition, the Johnson and Johnson vaccine has been shown to be protective against some of the variants as well.
While vaccines will ultimately be the way Covid19 is controlled, effective therapies are being sought for mild, moderate, and severe cases. Unfortunately to date, we have been unsuccessful in finding a curative treatment. A lot of publicity has been given to several proposed remedies, starting with Plaquenil/hydroxychloroquine about 11 months ago (which was demonstrated to be useless in multiple well-designed studies).
Recent randomized controlled trials have been published looking at Pepcid/Famotidine and Vitamin C and Zinc as either preventative or curative therapies. The studies have not shown any improvement using these agents compared to taking nothing at all.
Vitamin D3 continues to be talked about as possibly preventative, yet currently there is no data supporting this. Indeed, we know that low Vitamin D levels are associated with a multitude of illnesses, and that Vitamin D may enhance innate and adaptive immunity. However, some (including myself) believe those low levels are felt more to be a marker of disease, or nutritional status, rather then the cause of the illness itself.
A Brazilian study published online this week In JAMA (the Journal of the American Medical Association) looked at a single high dose (200,000 units or 5000 mcg) of oral Vitamin D3 versus placebo for hospitalized Covid19 patients. The high dose vitamin D improved the blood levels of vitamin D yet did not result in shorter hospitalizations or better outcomes.
Time will tell if Vitamin D proves effective. If you are considering using Vitamin D, do not use more then 2000 units (or 50 mcg) a day (unless you are on a higher dose for Vitamin D deficiency). Excessive vitamin D can lead to liver damage and death.
Finally, two last items: first, mammograms should not be done until four weeks after the second Covid19 vaccine since the vaccines can cause lymph node enlargement on the side of the injection. This enlargement can be mistaken for a cancer and can lead to an unnecessary biopsy. Lastly, the office will be closed next Friday March 5, 2021 for training. Phones will not be answered, yet if you need something urgently or emergently contact me directly on my cell phone.
Take care and have a wonderful week.
Now that more people are being immunized, I am getting more questions about what activities may be ok to do again. Patients are wondering if going to the gym or eating out can now be done without risk of infection. To answer that question, I need to elaborate on what is going on this week.
In Houston Texas, a small group of people were found with extremely high viral loads and relatively mild disease. This group subsequently infected many individuals supporting a current theory known as the 20/80 rule. It is believed that 20% (or less) of the population causes most infections, and consequently the continuation of the pandemic.
In this Houston group the current predominant strain (D614G) was isolated, yet it is believed that by the end of March or early April this strain will be surpassed by the UK/British variant strain B.1.1.7. Thankfully, the British variant remains sensitive to the Pfizer and Moderna vaccines.
However, there are additional variants which are not. The South African strain (B.1.351) is the most concerning, as that is spreading rapidly through the world and is less responsive to the Pfizer and Moderna vaccines (although they do offer some protection).
With more genomic sequencing of the virus, additional mutant strains are now being identified, and so far, seven additional variants unique to the US have been found. At this time, it is unclear how significant these US variants are, although one (from Southern California) has been isolated here in Arizona in addition to the British variant. So far, no cases caused by the South African variant have been identified in Arizona.
One hypothesized worry about vaccines is that someone immunized can still be an asymptomatic carrier of the virus and pass it on to someone else (remember the 20/80 rule). Variant strains not as well covered by the current vaccines could make this transmission more likely. Indeed, it is theoretically possible that an immunized individual could infect another immunized individual with a resistant strain.
So, even though someone may be immunized, they are not necessarily completely protected. Hence, the continuing advice of staying socially distanced and wearing masks when around others. Eventually, when over 70% of the population is either immunized or has natural immunity, these concerns will most likely ease, yet it will be at least another 3-4 months before that occurs.
Therefore, it is ok to go to a gym if you continue to wear a mask when there with others. Eating in a restaurant is a bit trickier, since obviously you need to remain unmasked, yet if done in a larger room with few people this is probably ok. Eating outdoors or a similar open-air environment would be preferable. Getting together with family who have all been immunized or have recovered from an infection is also probably ok yet remember that most of the spread of the last few months occurred in small family get togethers.
The most frustrating aspect of Covid is the unknown. We continue to understand the virus better as time goes on, so it is likely that some of what we believe today may be disproven in the future. Nonetheless, we are limited by what we know and need to advise accordingly in order to bring this pandemic to a quicker end.
I will be back next week with another update. Take care.
The number of confirmed COVID-19 cases continues to fall here in Arizona. A few weeks ago, Arizona led the nation in the per capita rate of infection. Currently, we are now fourth in the nation with our seven-day average of new cases at 4,080 per day and the number of deaths averaging 133 a day.
While this is encouraging news, these numbers remain extremely high, and some experts maintain that the actual number of cases is much higher since many people still do not get tested if they feel ill or may not feel ill at all. Regardless, the virus is still a very real and present danger. Staying at home as much as possible, wearing a KN95 or N95 mask when going out, and staying 6 feet apart from others while out are still the best way to prevent an infection even if you have received a vaccination.
Mutations or variants of the COVID-19 vaccine continue to be identified and remain worrisome. As noted in my last presentation, the British/UK variant is much more infectious and has been identified here in Arizona as well as other states. Thankfully, this variant does appear sensitive to the vaccines currently in use worldwide. However, the current vaccines may not protect as well against variants from South Africa and Brazil, so the race is on to immunize as many people as possible before these variants become more prevalent.
Unfortunately, vaccine supply continues to be limited both here in Arizona and nationwide. Some of this shortage is due to logistics and distribution of the vaccines from the manufacturers yet most of the problem remains not having enough vaccine for everyone at this time.
A good milestone was achieved this week worldwide, with the number of people receiving at least one dose of vaccine (approx. 104.9 million) now higher than the number of people with confirmed cases of COVID-19 (104.1 million). According to the CDC, in the US, 35 million people have been vaccinated versus 26.4 million confirmed cases, and in Arizona almost 574,000 people have received one dose of the vaccine which means to date, just under 8,000 people per 100,000 have gotten a vaccine dose.
Sadly, getting registered for a vaccine here in Arizona remains a major challenge. Even as pharmacies start to become sites for getting a COVID-19 vaccine, they, like the mass administration sites at Banner, TMC, Kino Sports Complex, and the Tucson Convention Center do not have any appointments available for the next several weeks. Similarly, the 24-hour sites in Phoenix are also booked up. Nevertheless, I encourage those of you with computer access to keep trying. Pima County has now opened registration to those aged 70 and up, and in Phoenix and other parts of the state, vaccines are being given to those 65 and older.
For those of you who do not have computer access and have difficulty getting thru on the phone lines, please contact the office to have my staff try to assist you. We have no special influence so be aware we may not be able to accomplish much at this time, yet at least we can try to help those who are not on the internet.
Finally, there are two to three additional vaccines moving closer to availability with the Johnson and Johnson one up for approval this month. If that occurs, then there is a fair chance that by the end of June about two-thirds of the country could be immunized against COVID-19.
Jeff Mayer, MD
Here are two companies that are reputable mask sellers. The two options are the KN95 masks from China (which are FDA authorized) and the KF94 masks from South Korea. The FDA certification is important to assure these masks are protective. While FDA authorized masks may be available on Amazon or eBay, there are a lot of fake masks around so it can be unclear if you are truly getting a certified mask. Be aware there is a KF80 mask as well yet this is not as protective as the KF94 mask. I’ve also included a link to the FDA website regarding masks. Be aware the term respirators refers to these masks.
FDA Authorized KN95 masks
KF94 (Korean) masks
FDA FAQ regarding masks
FDA Fact sheet on masks. A little technical
Vaccines for Covid19 remain the major focus of our approach to ending this pandemic, yet vaccines will not have a noticeable effect for a few months. As we approach our eleventh month of dealing with Covid19 the guidance given to wear masks and, more importantly, to keep at least 6 feet apart from others when around people you do not live with, continues to be the most valuable way to reduce the spread of this infection.
With regards to masks, when out and about it would be best to wear a Niosh N95, KN95 or K94 mask. These masks can protect the person wearing it as well as anyone around them. They are generally superior to cloth masks yet are tighter fitting and thus can be more uncomfortable. The KN95 is perhaps better tolerated yet needs to be FDA approved as there are many KN95 masks sold which are not protective. On my website I will place links to 2 companies that sell certified masks at a reasonable price.
From my perspective as a physician, Covid19 is both fascinating and frustrating. Intellectually, all the research and knowledge obtained on this virus in just a period of a year is unparalleled in modern medical history. Clinically though, Covid 19 is a nightmare, with great uncertainty on how to treat it, and more concerningly, a tremendous unpredictability.
With many infectious diseases, it can be obvious if someone is going to recover (albeit slowly) or not, yet with Covid19 someone may be doing well and then suddenly decline and die. Age is not an ideal predictor of risk, with newer mutant strains of Covid19 appearing to infect younger people at a higher rate then prior strains. Similarly, people without any obvious underlying conditions may die while others with chronic illnesses get better. To a certain extent, this has always happened, yet not like it does with Covid19.
Mutations of a virus are common, and there are two mutant strains of Covid19 which are concerning. First off, is the UK or British strain which appears to be much more infectious. Over the weekend, there was speculation it may also be more deadly, yet that is not entirely clear yet. Second is the South African strain. This particular mutation is especially worrisome since it alters the spike protein configuration. The spike protein is what helps the virus infect cells and is also the target for the two vaccines currently being used in the US (the Pfizer and the Moderna vaccines).
The worry is that these mutations may make vaccination less effective or not effective at all. So far with regards to the British variant that does not appear to be the case, yet concern is high enough with the South African variant that Moderna has started working on a modified version of the vaccine currently being used.
Another fear is that if immunizations are not completed rapidly enough, vaccines may select out for an even more resistant strain of the virus then those we know of today. This point has been speculated upon in countries like Israel where up to 25% of the population has already been immunized with the Pfizer vaccine. There is NO proof this will happen, and it is not a reason to not get vaccinated.
Because the vaccines are new, there is great scrutiny on any bad events which occur after getting them. Unfortunately, with any vaccine there is always a small number of individuals who have a severe or even life altering reaction, yet the number of people this happens to is extremely low, usually in the range of one out of a hundred thousand people or less.
The most likely reaction from a Covid vaccine is going to be a sore arm. Some people also experience headache, fatigue, and fever. Interestingly, in the approval studies for the Pfizer vaccine, those under age 55 were more likely to have a reaction.
Finally, I was hoping to discuss how best to get a vaccine yet unfortunately there is no easy way to achieve that. Arizona would like to get 400,000 vaccine doses a week yet currently is only receiving 169,000. This discrepancy is limiting the availability of appointment slots for vaccines. However, in the next few weeks this situation will probably improve dramatically, with vaccines becoming available in pharmacies as well. I will keep you updated. Take care and have a wonderful week.
A HOLIDAY MESSAGE
2020 has been a most unusual year and tonight in the sky there will be another once in a centuries event when the planets Jupiter and Saturn will appear at their closest separation in the sky since 1623. The best time to see this conjunction will be between 5 and 7 PM tonight so I strongly recommend trying to view it immediately after hearing this message. You should look to the Southwest. Jupiter will be very bright and slightly above and to the left of Saturn. No telescope is needed yet binoculars will help. You may also see it online if you are on the internet.
Similarly, we are now witnessing one of the most rapid developments of a therapy for an infectious disease in human history. The deployment of a vaccine for Covid19 just one year after the virus was first identified is borderline miraculous, yet the groundwork needed for this event to occur started a decade ago when the mRNA idea began to be studied for other diseases.
This fortuitous conjunction of events is now giving hope that the end of the Pandemic may be in sight. If enough people can be immunized then the spread of the virus will be diminished and, if lucky, stopped almost completely. Life as we like to experience it could resume, and we would once again be able to enjoy events such as eating in a restaurant, going to a concert, or attending a game without worry.
Unfortunately, the unpredictability which has characterized 2020 will not just disappear in 2021. Mutations in viruses are common events, and there is now a new variant of Covid19 in the United Kingdom and South Africa which appears to be much more infectious than other strains. Scientists do not yet know whether this new strain will spread to other countries, yet they do believe the emergence of this strain is due to people not staying masked and/or socially distanced from each other. Resistance of this or other mutations to the Covid19 vaccines does not appear evident yet further study is ongoing.
I again implore everyone to continue wearing a face mask while out in public. Even with vaccines, the need for face masks will not go away for many months. Also, if you are having family or other gatherings for the holidays this year (which I again do not recommend), you should stay masked around family and should either eat outside or in separate rooms. As I mentioned before many new cases are developing from these types of small get togethers. A better way to celebrate would be a Zoom or similar type of virtual get together.
I am giving the office staff two paid four-day weekends so the office will be closed on Christmas Eve and Christmas Day and New Years Eve and New Years Day. If you should need anything, please contact me on my cell phone or through the answering service.
Finally, I read an uplifting article over the weekend from a Naturopathic doctor who advised focusing on what you CAN do during these trying times rather than what you CAN’T do. I think this is a wonderful message and I encourage everyone to find the “Silver Lining in this disaster” as the African proverb goes. Take care and have a peaceful holiday season, and I will be back with another message next year.
THIS MESSAGE IS FROM DEC 11, 2020
In last week’s message I discussed vaccines and now with the approval of the Pfizer vaccine almost completed people are wondering when they can get it. Unfortunately, due to short supply, a vaccine will not be available for most individuals until many months from now.
When the search for a vaccine began in earnest earlier this year, six products emerged as the most promising. Of those six, two (the Pfizer and the Moderna product) are about to become available as early as next week. However, vaccine development and production are notoriously difficult, and in the beginning, it was impossible to know for certain which one of the six would become available first. Hence the government could not completely commit to buying all the doses needed for the whole country from just one company least that vaccine turned out not to be useful.
Ultimately, about 200 million doses will become available by March 2021 from both Pfizer and Moderna. That means 100 million people will be immunized, which is approximately 30 percent of the population in the United States.
For the moment though, nowhere near those number of vaccines will be available, and here in Arizona it is projected we will only be able to immunize about 190,000 individuals initially. Due to the demanding storage requirements of the Pfizer vaccine, distribution in Arizona is only going to occur in Phoenix and Tucson to start. Hospital employees and other health care workers along with nursing home residents are first in line to be immunized due to their high exposure to the virus.
We will not be administering the vaccines in our clinic since we are not capable of adequately storing them. We will notify everyone where they can get one once they become available on a more widescale basis. It has not yet been officially announced who will be in the second group of people to be immunized.
Once again, I need to strongly encourage everyone to please stay at home. Arizona is now leading the nation in Covid 19 spread. Back in March and April we spoke of “flattening the curve” and we need to return to thinking like that in order to prevent both a complete collapse of our hospitals and an astronomical death rate. Please be safe.