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Dear Patients,

I suspect you all know how dire the situation is with COVID-19 right now.  It is spreading widely in the community and hospitals (including the ones in our community) are being pushed to the limits of what we all previously assumed was the maximum amount of difficulty we would ever see from a viral illness.  As of now, we have not been as overrun as hospitals in LA County, but the rise of cases is concerning both among patients not hospitalized and particularly those hospitalized. 
 
The ray of hope we have right now is the appearance of vaccines on the scene.  As you all have heard, two vaccines have received an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA).  Both use the same mechanism to generate immunity in the recipients. They are mRNA (messenger RNA) vaccines, meaning that they work by injecting a tiny amount of genetic material (mRNA), which is picked up by our cells.  Our cells then use that fragment of mRNA as a “blueprint” which instructs our own cells to make a replica of the part of the novel coronavirus called the “spike protein”.  Our bodies recognize the spike protein as a foreign substance and make antibodies to it.   The spike protein is what the virus uses to get into human cells.  It is the “key” that unlocks the way into human (and other mammals’) cells.   By making antibodies to the spike protein, the “key” no longer works to unlock the cells.  Infection is thus prevented.  The mRNA blueprint degrades in a short amount of time so that we don’t continue to make this foreign substance.  The two vaccines available, one made by Pfizer and one made by Moderna, are both about 95% effective, which is remarkable.   To have these two vaccines on the market in under a year is even more remarkable and literally lifesaving.  (Much of this is reviewed again in the Q&A that follows this.)
 
We expect to get Moderna vaccine shortly and will begin to vaccinate our own healthcare workers in the next week.  The initial tier of people eligible is healthcare workers and those living in nursing homes and other congregate living situations that the Public Health Department (PHD) has designated.  We will be working with the Public Health Department to vaccinate those that are eligible, according to rules established by the PHD about whose turn it is.  Once the healthcare workers are done, the PHD will announce the next tier that will be eligible and we can move on to that tier.   While the CDC has made a recommendation about the next group, that decision will ultimately be made by the California Department of Public Health in conjunction with the local PHDs throughout the State.  We will follow their directions.  
 
There are challenges that are new with these vaccines, compared to flu shots.   In the past, pre-pandemic days, we could vaccinate (with flu vaccines) close to 1,000 people in an afternoon at a single site. This will be very different.  Because of the allergic reactions seen with the Pfizer vaccine (we don’t yet know if that will be true with the Moderna vaccine) patients will have to be closely observed for 15 minutes after their shot.   Because there is an ongoing pandemic, we have to also be sure that patients are not too close physically.   
 
Also, each of these vaccines requires two doses several weeks apart, 21 days (Pfizer) or 28 days (Moderna).  The combination of the mandated observation period, the need to observe people yet keep them somewhat separate, and the fact that people have to return for round two means this whole process will be slower than with flu vaccinations.    We don’t yet know how much slower, but the number of people per hour that can be done will be a fraction of a pre-pandemic flu vaccination clinic and the number of people in a period of two months, let’s say, will be smaller with the same number of people providing vaccinations.
 
When will the next tier start?  Because that tier will certainly extend beyond healthcare workers, everyone wants to know, even healthcare workers, as we ourselves have parents, spouses, siblings and children who have to wait too.   Obviously, the availability of vaccine itself will be paramount.  How much vaccine will there be and how fast will it arrive?    The number of providers giving out vaccine will matter in terms of how fast a given tier is completed.  How many entities will be out there vaccinating the first tier?  If the requirement for allergic-reaction observation diminishes with more experience, that will speed things up.  If the issue with allergic reactions remains an issue, that will cause the system to move more slowly.
 
Right now, we don’t know the answers to those questions, but most people are guessing/predicting that through January and into February or even March it will be the first tier of healthcare workers and those in congregate living situations getting vaccinated.   I hope that proves to be wrong and it moves more quickly.
 
There are other vaccine candidates coming along, some of which are only a single injection.  Hopefully, they will be as effective as the early data shows these two new mRNA vaccines are.  But, that is as of now out in the future.
 
There is no list for patients to be put on at this point.  People always ask.  We don’t yet know what the California Public Health officials will determine is the next tier or when that tier will be eligible.    But, it will take a while to get through the first tier and we will keep you posted about when we will be able to move beyond healthcare workers.
 
Compared to where we have been previously – no vaccine in sight and low levels of infection – to where we are now with high levels of infection and two vaccines approved, the need to socially distance and wear a mask is even more critical.  More critical because the large amount of illness out there means we all need to be more vigilant (not less) to protect ourselves, our loved ones and the strangers you come across and because there will be help coming in the form of these seemingly very, very effective vaccines.   So, it is worth keeping up with these measures, even though we are all ready to go back to “normal.”  
 
Stay safe, please.  Try to enjoy the Holidays, though they will be different than before.  We’ll be here to help as we join our hospital partners to help vaccinate the community.  
 
And yes, we will be smiling (and vaccinating) under our masks,
 
Kurt Ransohoff, MD, FACP
 

 
FREQUENTLY ASKED QUESTIONS ABOUT THE VACCINES THEMSELVES

How do the Pfizer and Moderna COVID-19 vaccines work? 
These vaccines are mRNA vaccines, which is a new type of vaccine that contains genetic material (messenger RNA) from the virus that causes COVID-19 and gives our cells instructions for how to make a replica of the viral  “spike protein”, a protein that is on the surface of  the virus and is unique to the virus. Our bodies recognize that the protein is “foreign” and should not be there and mounts an immune response by building up T-lymphocytes and B-lymphocytes (and generates antibodies) that will remember how to fight the virus that causes COVID-19 if we are exposed to and infected with the virus in the future.  After our cells make copies of the harmless spike protein, the mRNA that was injected degrades and is no longer able to act as a blueprint to allow for future replica spike protein without getting another (booster) dose of mRNA with a second injection. 

Can these vaccines cause COVID-19? 
No. these vaccines do not contain the virus and cannot cause COVID-19 illness.

How do we know if these COVID-19 vaccines are safe and effective?  
We understand that this accelerated timeline is unprecedented and has raised concerns for some people that safety may be sacrificed in favor of speed. However, as with all vaccines, safety is paramount.  COVID-19 vaccines have been and are continuing to be tested in large clinical trials to make sure they meet efficacy and safety standards. With the Pfizer vaccine, 44,000 people age 16 and older were vaccinated and there were no safety concerns identified that would preclude the vaccines use. Many people were recruited to participate in these trials to see how the vaccine offers protection to people of different ages, races, and ethnicities, as well as those with different medical conditions.  The Pfizer vaccine was reported to be 95 % effective and the Moderna vaccine was reported to be 94.5% effective, after completing the two-dose series.
 
The Food and Drug Administration (FDA) carefully reviews all safety data from the clinical trials and authorizes emergency vaccine use only when the expected benefits outweigh potential risks. Then the Advisory Committee on Immunization Practices (ACIP) reviews all safety data before recommending any COVID-19 vaccine for use.  However, given the newness of the disease and the rapidity of vaccine development, it does take time, and more people getting vaccinated before we learn about very rare or long-term side effects. That is why safety monitoring will continue. CDC has an independent group of experts that reviews all the safety data as it comes in and provides regular safety updates. If a safety issue is detected, immediate action will take place to determine if the issue is related to the COVID-19 vaccine and determine the best course of action.
 
Since the Pfizer vaccine has been in wider use, there have been rare (currently reported to be about 1 in 100,000 people) allergic reactions that require emergency treatment.   That has resulted in the need for observation for 15 minutes after vaccination. 
 
How did the vaccines get approved so quickly?
There had been a great deal of basic science work on mRNA vaccines and earlier work on SARS and MERS – previous coronavirus outbreaks.   The Federal Government then made large investments so that production of vaccine could start prior to final approval, something that is not normally done.  In the case of COVID-19 vaccines, the federal government invested taxpayer dollars to encourage pharmaceutical companies to start production before the development stage was completed. The vaccines are still going through the same rigorous testing for safety and effectiveness, review and approval process.

What are the storage requirements for this new Pfizer COVID-19 vaccine and the Moderna vaccine? 
The Pfizer vaccine requires storage at ultra-low temperatures (-90 degrees Fahrenheit).  The shipping boxes can be used to store vaccine for up to 30 days with dry ice. Once removed from the ultra-cold storage the vaccine has a 5-day shelf life in the refrigerator.  The Moderna vaccine must be stored in a freezer (at –4 degrees Fahrenheit) typically available in pharmacies and medical offices and has a shelf life of 30 days in a refrigerator. 

What is the vaccine regimen for the Pfizer COVID-19 vaccine and the Moderna vaccine?
The Pfizer vaccine is a two-dose regimen with the second dose administered at least 21 days after the first. The Moderna vaccines requires a second dose 28 days after the first. . The first shot primes the immune system, helping it recognize the virus, and the second shot strengthens (boosts) the immune response.  Anyone who gets vaccinated with one formulation must stay with that vaccine formulation for the second dose (e.g., Pfizer vaccine for the first dose must also be used for the second dose-there is no interchanging of formulations).

What are the side effects of the vaccine? 
Most people do not have serious problems after being vaccinated. However, your arm may be sore, red, or warm to the touch. These symptoms usually go away on their own within a few days. Some people report getting a headache, muscle aches or fever when getting the vaccine, particularly the second dose. These side effects are a sign that the immune system is doing exactly what it is supposed to do by building up protection to disease by mounting an antibody response. There have been rare serious allergic reactions with the Pfizer vaccination.  These have not yet been reported with the Moderna vaccine. 

Do I have to take both doses of the vaccine?
Yes. It is very important that patients return for the second dose of the vaccine in order to receive full protection from the vaccine. Please also remember that side effects may be more severe with your second dose.

What happens if another COVID-19 vaccine is made available?
It is very likely that there will be many vaccines that will be made available to the public in the coming months. We will be closely reviewing their safety and effectiveness data and whether we will be able to offer additional vaccines to team members and our community.

How long does protection last with these vaccines? 
Both this disease and the vaccine are new. We don’t know how long protection lasts for those who get infected or those who are vaccinated. What we do know is that COVID-19 has caused very serious illness and death for many people, mostly because of the sheer numbers of people infected.   If you get COVID-19, you also risk giving it to loved ones who may get very sick. Getting a COVID-19 vaccine is a safer choice.  But further information will become public over time from ongoing clinical trials.

If the vaccine is not 100% effective, can I still get COVID-19?
The current vaccines under FDA review appear to provide significant protection against COVID-19 but they do not offer 100% protection. In fact, there is no vaccine which provides 100% protection. Preliminary data suggests the Pfizer and Moderna vaccines offer 95% protection against infection.

How long does it take for “full protection?”
You need to have both doses to achieve the highest level of protection. Additionally, it typically takes a few weeks for the body to build immunity after vaccination. That means it’s possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination.   There is some evidence that even one injection provides some benefit, but full benefit is achieved after the second dose. 

If I have an underlying health condition, can I get the vaccine?
There is currently no data that suggests having an underlying health condition is a reason to avoid getting the vaccine.  In fact, those with an underlying illness or health conditions like diabetes, heart disease or obesity, are at an increased risk of developing severe side effects or hospitalization due to COVID.  If you have any condition which weakens your immune system, you may not have protection against COVID-19 infection. However, it is safe to receive the vaccine if you are immunocompromised. For instance, if you are infected with HIV, are on immunosuppressive medication, or a transplant recipient there do not appear to be any special safety concerns but you may not get as strong a protective response. You should address your individual concerns with your primary medical provider.

Does the vaccine have any effect on fertility?
There is no evidence that the vaccine could affect fertility.  The vaccine mimics infection with the virus that causes COVID-19. The vaccine targets a single protein of the virus, called the spike protein. The vaccine does not contain live virus.

If I’m pregnant or of child-bearing age, is it safe for me to get the vaccine?
Pregnant and breastfeeding women have been excluded from the leading vaccine clinical trials so far, including those from Pfizer/BioNTech, Moderna, Janssen, AstraZeneca and Novavax.  This is not unusual as vaccine clinical trials typically don’t enroll participants who are pregnant or lactating until the vaccine has been shown to be safely tolerated in people who are not pregnant.  There are current studies on the COVID vaccine in which pregnant women are part of the study pool. We should have that data in the coming year.  Many experts believe that while no COVID-19 vaccines have been tested on pregnant women, the virus itself may pose greater risks both to the pregnant woman and to the fetus.  Pregnant and breast feeding women should make a shared medical decision with their practitioners to weigh the risk and benefit of vaccine versus COVID-19 infection.
 
The Advisory Committee on Immunization Recommendation states that pregnant women who are healthcare workers should receive the vaccine because the benefit (immunity to COVID-19) outweighs the risk of the vaccine. You should talk to your provider about whether the vaccine is right for you.

If I’m breastfeeding, can I still get the vaccine?
The Advisory Committee on Immunization Practices states that breastfeeding women may receive the vaccine. If is not known if the COVID-19 mRNA vaccine is passed through breast milk. Even if the mRNA is in the breast milk, there is no known harm to feeding an infant.  It is also important to remember that live viral vaccines — measles, mumps and rubella vaccine are routinely given to lactating women. But keep in mind that the COVID vaccine does not contain any live virus.  Again, pregnant and breast feeding women should make a shared medical decision with their practitioners to weigh the risk and benefit of vaccine versus COVID-19 infection.

Can I receive the vaccine if I had convalescent plasma or monoclonal antibody treatment?
If you have had COVID and received either convalescent plasma or Monoclonal antibodies, you should not receive vaccine for 90 days as these drugs may interfere with the effectiveness of the vaccine.

If I have side effects after receiving the vaccine, am I contagious to those around me?
If you have side effects after vaccination this does not mean you are in any way contagious to your family or community. You should continue to follow all safety measures like mask-wearing, hand-washing etc., just as you have been doing.

Where are the vaccines manufactured?
The Pfizer vaccine is manufactured in Kalamazoo, Andover, MA and St Louis, MO. There is also an overseas plant in Belgium.  The Moderna vaccine is manufactured in plants in New Hampshire and in Switzerland.
 
Will we finish vaccinating our whole employee population before offering vaccine to patients and community members?
Per the guidelines that we are following, we will first offer the vaccine to our frontline healthcare workers and will continue to offer vaccine to our remaining team members as part of the prioritization process. When the vaccine supply increases and we have ample supply to begin offering the vaccine to community members, we will do so, in accordance with PHD directives.

Why the delay in being able to vaccinate our patients?
This is a uniquely complex, community-wide vaccination campaign that requires an unprecedented level of partnership and collaboration, especially as initial supplies remain low. We are working closely with our local, state and other partners to prioritize both frontline healthcare workers who are most at risk and those who are most vulnerable to the severe effects of COVID-19. According to CDC and state guidelines, hospitals and health systems are advised to prioritize frontline team members.  As we have noted elsewhere, we anticipate that vaccinating healthcare workers and other frontline workers who are designated as eligible by the PDH will take more than a month or two.  So, we think the patients not in those categories will not start for 2 or 3 months or more.  We hope it will go more quickly.

Is there a new coronavirus strain in the UK which may be more infectious? 
Over the past several days there have been reports from Britain and South Africa of a new coronavirus strain that seems to spread more easily.  As we know, all viruses naturally evolve and mutate as they move through the population.  New variants (or strains) of the virus that causes COVID-19 have been seen almost since it was first detected in China. It appears that this new variant in the UK accounts for more than 60% of recent cases identified in London and based upon mathematical modeling data, appears to be 70% more transmissible.  However, even if it is more transmissible it doesn’t appear to be associated with an increase in virulence.  Genomic researchers have found that several of the genetic mutations of this variant may result in significant changes to the spike protein, the part of the virus that plays a key role in infecting cells. However, much more investigation is required to determine the significance of these mutations and the real life implications of transmissibility.  As a result, this new variant is under investigation by the World Health Organization because its significance is not yet known.

Will this new strain undermine current vaccine efforts? 
Infectious disease experts have indicated that there is no reason to believe that the vaccines that have been developed will not be effective against this variant as well.  Vaccines produce wide ranging responses by the immune system beyond just those to the spike protein.  Experts note that a significant number of changes in the genetic code would be required to undermine the vaccine, not just one or two mutations.  Also we know that vaccines can be adjusted to keep up with viral pathogens, as is the case with the annual flu vaccine.






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Sansum Clinic · 470 S Patterson Ave · Santa Barbara, CA 93111-2404 · USA