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.
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.
Patricia Hopkins, MD
Hopkins Medical Group