COVID-19 Vaccines are Arriving!

Since the SARS CoV-2 virus arrived in the USA last winter, our lives have been disrupted in many ways.  We are currently in a Winter Surge that has locked down most of the state.  The latest statistics on COVID activity show a doubling or tripling of cases in most of California in the month of December, which greatly increases the risk of outbreaks in our post-acute and long-term care settings.  As of 12/10, the USA had 15.6 million confirmed cases and 294,000 deaths.  Though only 6% of the cases have been in post-acute and long-term care (PALTC), including skilled nursing facilities (SNFs) and assisted living communities (AL), our residents have had a hugely disproportionate 34% of the deaths.  As of Friday, December 11, over 100,000 persons with COVID in the USA were hospitalized and 21,000 were in ICU beds. In California, we had 33.500 new cases reported over the preceding day.  

In this bleak setting, we received good news that same evening that the FDA and 2 independent advisory committees for the FDA and CDC (VRBPAC –The Vaccine and Related Biological Products advisory committee; ACIP – The Advisory Committee on Immunization Practices) had approved the EUA (Emergency Use Authorization) for the Pfizer mRNA vaccine.  This technology has been used safely in cancer therapy for the past 10 years and does not change the host DNA. To be clear, the EUA only sped up the usual process, but didn’t skip any of the usual steps necessary for vaccine approval.  Pfizer set up a randomized, controlled vaccine trial in 43,448 subjects and reported a remarkable 95% reduction in COVID cases compared to the placebo group.  45% of these subjects were 56-85 y/o and 27.4% were from ethnically diverse backgrounds.  Importantly, there were not any differences identified in effectiveness or side effects in these subgroups.  

Because this mRNA vaccine works by temporarily inducing the production of the harmless SARS-CoV-2 spike protein, the side effects are those of the desired immune response to this foreign protein, which is enhanced by the second dose 3 weeks later.  These side effects (headache, myalgias, fatigue, injection site pain, and low grade fever for 1-2 days) occur in < 7% after the second dose and have not been disabling.  Because these are non-specific symptoms that could represent SARS-CoV2, Influenza, RSV or other viral infections, HCWs (Healthcare Workers) may not be able to work while those symptoms are present and your facilities’ usual molecular testing program needs to continue.  For symptomatic residents, antigen testing for the above pathogens and isolation measures would be similar to how we manage our patients characterized as Persons Under Investigation (PUI).  Vaccine protection occurs at least 7 days after the second dose.  In the UK, 2 recipients with serious allergies (carried epi pens) had anaphylaxis immediately after receiving the vaccine, so this vaccine is now contraindicated in people with serious allergies.  However, we won’t know this vaccine’s long term effectiveness and safety for many months.  This means that the usual infection control and prevention procedures must continue at work and home until that is known.  

Today, the Western States (California, Nevada, Oregon, and Washington state) Immunization Advisory Committee approved this vaccine.  California Health and Human Services (CHHS) and CDPH have a Community Vaccine Advisory Committee which has agreed upon a well defined vaccine distribution process, which allows for local county modifications. In most of our state, vaccinations are likely to begin between this Thursday and next Tuesday.  For nursing facilities the vaccine is being distributed by CVS and Walgreens, who will do the necessary reporting and billing of insurances.  At the patient level, there will be no charge.  

Pfizer anticipates delivering 20 million doses this month, 30 million in January and 50 million in February and March.  HCWs (Healthcare Workers) in the PALTC settings have been given top priority for this vaccine and SNF/ALF/RCFE residents are 2nd in line.  Though this vaccine is voluntary, I know most of my physician friends are signing up to receive it as soon as it becomes available.  This is truly something for CALTCM members to document and to post on their social media sites and share with their leadership and staff.    

Moderna has an mRNA vaccine for which we anticipate approval soon after 12/17.  This vaccine will only require -20° C cold storage and has a much longer shelf life.   This should improve on-site access for residents in the PALTC settings and offers more opportunity for staggering staff and residents so that large-scale call offs by staff or illness among residents is less likely to occur.  The second dose is at 4 weeks.  It has a similar efficacy and safety profile.  

AMDA (The Society for Post-Acute and Long-Term Care Medicine) has created a tool kit for which I’ve attached several resources.  This may require signing up with an e-mail address, but does not require a paid membership (  I also found the FAQ from Leading Age helpful.  

With these vaccines and two others expected to be approved in early 2021, we should be on our way to the goal of vaccinating at least 80% of the population.  This should eventually create herd immunity and allow us to relax some of our infection prevention measures and experience less disrupted lives.  We are still uncertain about the durability of these vaccines and whether significant mutations may occur that will require modifications of our vaccines or an annual vaccination program.    

For those who have had COVID or have had COVID antibodies, the ACIP still recommends COVID vaccination since the duration of immunity after COVID is still uncertain and a robust immune response has been shown to reduce the seriousness of COVID, should it occur.  

Even after a facility is fully vaccinated, we can anticipate continued mandatory molecular testing guidance until more is known about the long term efficacy of the vaccines and the community prevalence of COVID is greatly reduced.  

For more information on the roll out of COVID immunization in California, visit our Webinar website ( for the December 14 webinar on this subject.  The power point of the slides and the webinar are freely shared consistent with CALTCM’s mission to be the voice for PALTC in California.  A recent national poll of CNAs noted ~72% were reluctant to take the vaccine.  A constructive approach to this vaccine hesitancy was a major focus of this webinar.  This webinar suggested waiting for the Moderna vaccine, since it has a 30 day shelf life and would allow for early staff volunteer vaccination and subsequent staggered vaccinations that should reduce the risk of large staff “call offs'' and the risk of caring for too many residents with near simultaneous significant vaccine side effects.  Our facilities should plan for closer monitoring of our residents who receive the vaccine since SNF residents were not subjects in either mRNA study.  Experts on this webinar raised concerns about the unknown risks for delirium and dehydration.  Though the FDA views the consent form as optional, your pharmacy benefit company may require completion of their consent form prior to vaccine administration.  The experts on this webinar recommended use of the Delphi identified consent form that is available on our website, which is more patient friendly.  This form and other important vaccination resources are now available at:  This site will also be adding other resources in the coming days, such as the CDC’s soon to be released patient information form similar to the VIS (Vaccination Information Statement) forms we use for other vaccines.  

The vaccines are arriving and this is truly good news!   

However, the limited presence of these vaccines in our community during this winter will likely have minimal impact on the current surge.  We need to follow Dr. Anthony Fauci’s advice to continue modeling excellent infection prevention measures within our facility and community.  Community adherence to this advice really does work!

Carpe Diem

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