COVID-19

February 9, 2021

To Our Patients,

We acknowledge that the pandemic has brought many challenges over the last year and for some of us the toll has been devastating.  Our hearts go out to those who have experienced loss.  We care about each of you and appreciate what sacrifices and contributions you all have made to help protect your families and others or provide them with assistance.

Many have asked us about what to do as the vaccines for COVID-19 become available.  Messaging from our public health authorities and different collective groups of medical professionals encourages mass vaccinations as the primary means through which we can overcome the challenges brought by the pandemic.  We share the desire to end this pandemic as soon as possible but also recognize that the decision to undertake any medical intervention is an individual choice that deserves to be respected and honored without judgment.  This sentiment is consistent with the FDA’s position statement on ensuring informed consent is properly discussed for these vaccines (which have not been approved but have been authorized through ‘Emergency Use Authorization’).  Their position states:

…must ensure that recipients of the vaccine under a EUA are informed, to the extent practicable given the applicable circumstances…of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives… [source FDA.gov –  emphasis added]

In line with the above, we feel it is important to share what we know and the limits of what is known about the options with respect to vaccinations both currently and soon to be available for SARS-CoV2/COVID-19.  Please be aware that there are many more vaccines in development, including some using different technology than the 3 different types described here, but we have chosen to limit discussion of options to those which are likely going to be accessible to patients in the USA within the next several months.

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What are your options regarding vaccination against the SARS-CoV2/COVID-19 infection?

Vaccine Option Type of Vaccine FDA Emergency Use Authorization Number of shots Additional Comments
BioNTech/Pfizer mRNA Yes, for individuals 16 years of age or older Two (21 days apart) NOT recommended for some individuals with specific types of allergy.  Discuss with your doctor.
Moderna mRNA Yes, for individuals 18 years of age or older Two (28 days apart) NOT recommended for some individuals with specific types of allergy.  Discuss with your doctor.
Janssen-Johnson and Johnson DNA Recombinant Viral Vector Likely Soon One
AstraZeneca DNA Recombinant Viral Vector Not Yet Two (4 – 12 weeks apart) May not be as effective for new viral strain identified in South Africa
Novavax Protein (Antigen) Based Recombinant Not Yet Two (one month apart) Efficacy is maintained for individuals with new viral strains identified in the UK and South Africa
Waiting or Not Getting a Vaccine N/A Acceptable option per FDA Statement N/A

 

  • mRNA Vaccines. This is a new type of vaccine that has never been used in humans before and the first to become available to the public. The Pfizer/BioNTech and Moderna shots are both this type of vaccine and require 2 injections given between 3 and 4 weeks apart to individuals 16 and 18 years of age and older respectively.  These vaccines are not approved by the FDA but have been made available through “Emergency Use Authorization”.  Many people in the United States, including front line workers and those who are in higher-risk groups in the United States, have already received these injections. This new technology uses a strand of foreign genetic material from the SARS-CoV2 virus and inserts it into the cells of the body for those who get the shot.  The mRNA genetic material then uses our own cells to make a protein that the SARS-CoV2 virus would normally have made, exposing our immune system to the protein and generating some defense against it.Most of the data we have about how effective these vaccines come from the companies that make them.  From the available data, we do not know clearly if it cuts down on the risk of getting or spreading the virus, but it does appear likely that the vaccine will decrease the severity of the virus for those who do get it.  While we hope it will also cut back on the transmission of the virus, it is still too early to tell, and so it is important to be clear that getting the vaccine does NOT (in the near term) take away the need to wear masks and socially distance.Regarding safety, there are possible side effect concerns as with any medical intervention, and while some reports include serious events, the CDC assessment of the available information suggests the risks of serious or significant events occurring in the period shortly after receiving the vaccine for most people are not significantly higher than or atypical for vaccines that many of us have received previously in our lives. The CDC does NOT recommend these vaccines for anyone with a history of an intermediate or severe allergy to any of the ingredients including polyethylene glycol (PEG) or if allergic to polysorbate.  Any individual with a history of an allergic reaction to previous vaccines considering these vaccines should first discuss this with their doctor.  There are many unanswered questions:  it is not known whether these vaccines will remain effective against new strains of the virus as the virus mutates, how long the immunity will last or if repeat ‘booster’ injections will be needed, whether safety concerns are different for specific groups of people including children and pregnant or breastfeeding women, or whether long-term safety data regarding any health problems that could arise months or years down the road will be on par with the short-term safety data to date.

 

  • DNA Recombinant Vector Vaccines. This is also a new type of vaccine that uses similar technology to the mRNA vaccine above, however, there is more experience with this technology, as variations have been used for gene therapy experimentation over the last couple of decades.  While the mRNA vaccines protect the genetic material within the vaccine injection with a layer of fat (nanolipid encapsulation), DNA Recombinant Vector vaccines protect the genetic material by putting them inside the hollowed-out shell of another type of virus—in this case, a virus called an adenovirus—which when injected helps get the genetic material inside the cells of our bodies and all the way into the nucleus of a cell.Janssen-Johnson&Johnson and AstraZeneca both are making this type of vaccine and while at the time of this writing, neither are available to the general public in the USA, Johnson & Johnson is likely to receive “Emergency Use Authorization” shortly and may become available to the public very soon.  Janssen-Johnson&Johnson’s vaccine is a single injection whereas AstraZeneca’s is two injections thought to be best spaced at least 12 weeks apart (spacing interval is not yet clearly established). We have less information than with the mRNA vaccines at this time about the effectiveness though it appears that these vaccines are likely comparable in terms of effectiveness.  As with the mRNA vaccines, there is still uncertainty whether these vaccines will decrease the risk of getting and spreading the virus in addition to decreasing severity (so masks and social distancing may still be necessary), whether they will be effective against new strains of the virus as it mutates (some preliminary data suggests the AstraZeneca vaccine may be less effective for those with a viral variant identified in South Africa), how long the immunity will last or if repeat injections will be needed, as well as uncertainty regarding long-term safety data.  At this point, there is also less short-term safety data as not as many people have received these vaccines.

 

  • Protein (Antigen) Based Recombinant Vaccines. The process for making this type of vaccine is similar to several previous vaccines and doesn’t rely on the newer technology involved in the above vaccines.  A protein is made from genetic material in the lab and then isolated in preparation for the injection.  The material in the injection does not consist of mRNA/DNA genetic material, but of proteins that are made by the SARS-CoV2 virus, which are combined with other ‘adjuvants’ or ingredients designed to stimulate our own immune system to make a defense response. Novavax is making this type of vaccine and while we don’t know all the details of their proprietary formula, the adjuvant used appears to be derived primarily from the saponins of a South American plant (Quillaja) along with some other substances.  It is administered as 2 injections spaced one month apart.  So far it appears to have similar efficacy to the above vaccines, but also has evidence that it maintains this effect for the mutated viruses that have been seen in the UK and South Africa.It is not yet available to the public in the USA though will likely be the first of this type of vaccine to become available in the next few months.  While the safety data is also not yet clear for this vaccine, speculation would suggest it would have some similar risks as previously approved vaccines, though there is the possibility of some unique, new problems distinct from those previous vaccines as well.

 

  • Waiting or Not Getting a Vaccine. The different types of vaccines are not yet available to everyone.  When judging the risk versus benefit, some people may feel more comfortable with one type of vaccine over another, and, depending on an individual’s risk profile, it may be reasonable to wait until your preferred option becomes available.  Additionally, when assessing risk versus benefit some people may wish to have more information regarding how long the efficacy or benefit of the vaccine will last (e.g. it is not known if a new vaccine or ‘booster’ will be needed each year or not), whether it will be good for future strains, whether the morbidity/mortality risk and virulence of the current strain in circulation diminishes over time, and both short- and long-term side effects of the vaccines before getting the shot.  In the face of so much uncertainty it may be reasonable to defer the decision (again, depending on the individual’s risk profile). Finally, there are still unanswered questions regarding the long-term safety of these vaccines for specific populations of people and so for individuals with these specific concerns—[including but not limited to anyone (male or female) considering having children in the future and those with family history or personal history of cancer, autoimmune, neurodegenerative or neuroinflammatory conditions] or those concerned regarding ethical/spiritual/religious implications of the vaccine—deferring this decision may be reasonable until more information becomes available.

 

 

While we may have a reasonable sense of the scope of short-term side effect/safety profile in the next few months (and to some degree now with the mRNA vaccines), questions will likely remain over the coming months or year(s) about how long any vaccine benefit might last.  Some of you may have already had positive PCR tests and documented cases of SARS-CoV2/COVID-19 over the past months.  We are uncertain whether any significant additional benefit to immunity or change in safety risk profile exists for these individuals who may choose to vaccinate after 3 months have passed from the initial infection, but early evidence suggests a single shot, rather than two, maybe all that is necessary to raise antibody levels (however this is not widespread practice at this time).  Many of you, our patients, have compromised immune systems or are on immunosuppressive medication and we do not know clearly if this will affect the efficacy of any vaccine you may choose to get or if this may change the short- or long-term side effect risk for you specifically.  Additionally, in spite of government and professional organization recommendations and widespread claims of safety, ethically we cannot say with any certainty that these vaccines will be unequivocally ‘safe’ for all individuals, as questions regarding long-term safety will likely remain unanswered for several years. 

There are many unknown variables regarding how severe and persistent the ongoing pandemic may be and how effective will be the different prevention and treatment strategies in development.  We acknowledge that for many people a reasonable decision may be to accept the potential risks, of any severity, both known and unknown, for one of the above vaccines if there is the possibility that it can facilitate a quicker end to the pandemic.  We also acknowledge that for many people it is also a reasonable decision to decline any of the above vaccines as the unknown risks could have the potential to outweigh the benefit that may come through the vaccination effort.

Many have also asked about interventions to consider along-side the vaccine to decrease the risk of side effects (or improve efficacy).  Any suggestions pertaining to such would be speculative/theoretical as we are not aware of any reliable information about the proven benefit of interventions designed to address side effects or how these interventions may affect the efficacy of the vaccine.

At Hopkins Medical Group we do not currently offer any vaccinations against SARS-CoV2/COVID-19, although this may change in the coming weeks/months.  At this time, we are available both in the office and through Telemedicine to discuss whether vaccination and which one might be right for you based on what concerns you may have unique to your own specific circumstance.

Sincerely,

Patricia Hopkins, MD
Hopkins Medical Group

COVID-19 Questions & Answers

Q: How important is social distancing?

A: It is the difference between saving lives or not.  Please do your part.  Social distancing practices allow the healthcare system to prepare for more cases and also not have all those most sick to come to the hospital at once, which would overwhelm the hospital and exceed their capacity to take care of those who are the most severely ill.  My hope is that while we are physically distancing ourselves, that we actually have a stronger feeling of connection to each other as we all share in this extraordinary time in history and help those who will be worst affected.

Q: Should I be wearing a mask?

A: Using regular masks when you go outside in everyday life likely only provides limited personal benefit but may help decrease the spread to others if you happen to be a carrier of the virus.  There is some evidence from countries and cultures where mask use is more common practice, that there was decreased transmission which may have come as a result of this, though we cannot be certain.  What is more important for your own benefit however is not touching your face and washing your hands very, very frequently with soap and water. N95 respirator masks do NOT need to be used outside of the hospital setting with few exceptions, and even in the hospital setting likely only for higher risk procedures that result in increased aerosolization of droplets. Please consider donating these to hospitals in your area that may be in short supply if you have them.

Q: I am concerned I may have the Coronavirus. Should I go to the hospital?

A: If you think you were exposed to or have the Coronavirus with only mild symptoms, probably not.  However, if you have shortness of breath it may be important that you go to the hospital, yes.  Not all cases of people with the virus, in fact most, will NOT need to go to the hospital, and it may be better to stay away.  It may be wise for those who are higher risk, in terms of increased age or if with other medical conditions such as lung, heart, kidney, diabetes or immunosuppressive diseases to seek out testing if they develop symptoms, but not everyone who has the virus should be tested at this point.  If in doubt, please call to discuss with your doctor or a healthcare professional.

Q: Are there any treatments for Coronavirus?

A: The main treatments depend on how severe an illness you may experience.  If you need help to breathe, you need to be treated in a hospital.  While we are currently trying to understand what prescription drugs may be helpful and you may be offered some if your disease is severe enough, we can use other tools in the hospital to assist you to breathe if severe and necessary.  If you do not need to go to the hospital treatments are speculative at this point, though people have suggested that Hydroxychloroquine and Azithromycin, Chloroquine phosphate, or Alinia may be helpful.  These should not be taken without guidance from a healthcare professional.  There are also numerous other supplement and herbal/botanical compounds being suggested online, some of which may be helpful, though we do not have any definite knowledge that they will help.

Q: Should I stop taking my blood pressure medication?

A: There has been discussion about the effect of two particular types of blood pressure medication (ACEi and ARBs) and whether they increase the risk of the virus getting into the body.  Currently most medical professional organizations are not recommending patients stop them.  A patient should make their decision about this after speaking with their doctor.  Personally, I can only speculate but do have enough concern such that, if appropriate and with the right patient may suggest switching from their ACEi to an ARB.

Q: Do NSAIDs increase risk of Coronavirus related disease?

A: There have been conflicting suggestions from overseas governments and doctors here at home with respect to NSAID use (such as naproxen, ibuprofen, aleve, motrin, etc), often used for fever and pain, and increased concern for illness.  Most of the information right now is theoretical, however all medication have side effects and potential downsides which we often do not highlight enough in our discussions with patients.  At this point it is worth noting that the more cautious approach would be to avoid using NSAIDs if possible.  However, for many of my rheumatology patients life might become intolerable from a pain point-of-view without them so while I look to other options as much as possible, there may be some situations where my patients continue to use them acknowledging some increase in possible risk.

Q: Are steroids harmful?

A: Sometimes when patients become critically ill, we use steroids in the ICU hoping they will help lung disease and respiratory failure.  While not yet conclusive, they do not appear to be helpful for COVID19 critical illness and may even be harmful.  For patients not yet sick, steroids broadly weaken the immune system and are something I would try to avoid more than I might prior to the pandemic.  It is important however that people not just stop their steroids suddenly if they have already been on them.  And there are likely situations where they still need to be used with patients now for other conditions.

Q: Should I continue to take my immune system blocking or rheumatology prescription drugs?

A: This is a question that needs to be addressed on a case-by-case basis between a patient and a doctor.  Organ transplant and cancer patients may need to stay on them, though we suspect they could be at higher risk of serious disease.  For many rheumatology patients there are many different types of immune blocking drugs that they may be on.  Some of these drugs are very broad in how they interfere with the immune system, like Methotrexate, and may increase my concern for patients in they are using them, and others are very narrow in how they block the immune system, like many of the biologic drugs.  Some of these rheumatology medication such as Actemra/Anakinra-Kineret and others like Xeljanz/Plaquenil-Hydroxychloroquine have been used and may even prove to be helpful in treating COVID19 related illness.

Q: I have read on the internet that 5G or WiFi causes the virus. Is this true?

A: As far as causing the virus, no.  However, it is very plausible that it contributes to a weakened immune system and the inflammatory cascade that results in more serious illness related to the virus.  There is scientific data on how radiofrequency/EMF pollution causes negative health effects, even though it is a non-ionizing form of radiation.  It is certainly the more cautious approach but reducing your WiFi exposure (ie. using an Ethernet cable, turning off your wireless router whenever possible and at least at night, putting your cellphone in airplane mode) while creating some inconvenience, tilts the risk-benefit scale way in favor of taking these precautions for me.

Q: I have heard that Vitamin D might be bad. Should I not be taking it?

A: I have seen and read conflicting thoughts among different people in the integrative medical field about this.  I think it is fair to say that you do not want to be Vitamin D deficient, so I would aim to just make sure you do not have low levels of Vitamin D and for many of us I think there is a good chance we should be taking some as many are deficient without knowing it.

Q: Should I not be taking Elderberry?

A: Elderberry syrup is often taken by people to prevent colds and flu during this time of year.  There has been some discussion that it can lead to ‘cytokine storm’ which is a main concern for people who get serious forms of COVID19 related illness.  While Elderberry can be immunostimulatory, in my reading and in my correspondence with some my herbal medicine mentors including David Winston, a respected elder in the AHG community, this is not likely a legitimate concern.  In fact, we know for other coronaviruses it has some ability to block transmission and uptake which may or may not be relevant for this particular virus.  For those with autoimmune disease, we don’t know whether it can provoke a flare or not of your disease, so for those particular patients it should be used cautiously if taken, but for most people, I do not think it needs to be avoided.

Q: Are there any other supplements that need to be avoided?

A: In theory, I would avoid Selenium, which I often have suggested to my patients with thyroid disease in the past.  It upregulates the AT2 receptor, similar to ACEi blood pressure medication, which the virus uses to gain entry to the human body.  However, Selenium may have other benefits that could overall mean it could be more beneficial than harmful.  Because we do not know however, I am generally suggesting that people stop their Selenium at this time.

Q: What about Vitamin C?

A: Again, data is limited, but Vitamin C given intravenously has been under study in the USA and elsewhere for use in sepsis for some time.  Some hospitals in China used several different protocols of Vitamin C for COVID19 patients.  Some also used it for less severe disease in the community setting to help treat and avoid needing to go to the hospital.  In New York some hospitals have been willing to use it with patients, without clearly knowing if it will be helpful.  In my opinion there are several plausible mechanisms through vitamin C may help and especially to prevent progression to cytokine storm.  I think it is a reasonable thing to take 2 grams by mouth divided into several daily doses (spread out throughout the day is likely better).  There are many different forms of Vitamin C, some of which may be better than others.  Also, should you become sick, the dose may need to be increased or titrated to bowel tolerance.  Discuss with your doctor if you would like to pursue a course like this.

Q: Are there any herbs that are helpful?

A: No one has extensive herbal medicine experience with treating this illness.  Regimens are essentially theoretical at this point.  There are some herbs that were thought to have been helpful during the SARS outbreak and may be of benefit.  Early on in the course of this pandemic, Traditional Chinese Medicine practitioners were reporting success with some of their various herbal regimens.  It is difficult to universally apply what we know from their experience as TCM herbal treatment (and most herbal treatment generally) is very dependent upon the symptoms and presentation of each unique patient and even within the same patient can change over the hours and days through which the illness progresses.  Keeping in mind many of these limitations, some of the herbs suggested by various people in the herbal medicine and integrative medicine community have included but are not limited to Andrographis, Sweet Annie, Licorice, Forsythia, Chrysanthemum, Prince Seng, Isatis tinctoria, Scutellaria Baicalensis, Astragalus, Reishi, Codonopsis, Cordyceps, Agarikon, Asian Ginseng, Ashwagandha, Echinacea, BoneSet tea and others.  Not all of these herbs would be appropriate for every person, so it is important to work with someone knowledgeable about if it might be right for you to consider these.