MarkeTouch COVID-19 Clinical and Operations Pharmacy Newsletter (February 18)

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Anaphylaxis Following COVID-19 Vaccination is a Rare Event

Pfizer/BioNTech’s and Moderna’s mRNA COVID-19 vaccines have been associated with 4.7 cases of anaphylaxis per million doses and 2.5 cases per million, respectively, according to data published by CDC in JAMA late last week. Sixty-six total cases have occurred in the US through Jan 18, 2021, making the cumulative frequency 3.8 cases per million doses. No known deaths have been reported. 

JAMA stated “When considered in the context of morbidity and mortality from COVID-19 the benefits of vaccination far outweigh the risk of anaphylaxis…”  CDC has published guidance on the use of mRNA COVID-19 vaccines and any necessary management of anaphylaxis, including “all facilities administering COVID-19 vaccines should have the necessary supplies and trained medical personnel available to manage anaphylaxis.”

Vaccine Updates

Johnson & Johnson – The South African Medical Association has confirmed they are now vaccinating with the J&J COVID-19 vaccine. Also, Henry Ford Health System is enrolling volunteers for J & J’s Phase 3 ENSEMBLE 2 clinical trial to evaluate the safety and efficacy of a two-dose regimen of the COVID-19 vaccine recently submitted by the company to the FDA for Emergency Use Authorization.  

Pfizer – is confident in its ability to deliver 2 billion doses of the Pfizer-BioNTech COVID-19 vaccine by the end of the year.  The company continues to work on efficiencies in the making and distribution of the vaccine.  

Moderna – FDA has concluded Moderna can increase COVID-19 doses per vial from 10 to 14.  Moderna is still required to provide more data to indicate that this increase will not affect vaccine quality. Pediatric trials have begun.   Sanofi –  reports that their COVID-19 vaccine candidate will not be ready this year but could be used at a later stage if the fight against variants continues. Clinical trials are expected to start this quarter.

Patient Care Corner


Elevated rates of axillary adenopathy (changes in the size and consistency of lymph nodes in the armpit) have been reported with administration of both COVID-19 vaccines currently being administered (Moderna and Pfizer-BioNTech).  Lymphadenopathy occurred in the arm and neck 2-4 days following vaccination. 

The Society of Breast Imaging (SBI) recommends “if possible, and when it does not unduly delay care, consider scheduling screening exams
prior to the first dose of a COVID-19 vaccination or 4-6 weeks following the second dose of a COVID-19 vaccination.”

SBI will provide recommendations for additional COVID-19 vaccinations as they are approved for distribution.

Dementia Patients a Higher Risk for COVID Complications

Many of the common comorbidities seen in patients with dementia and Alzheimer’s are also demonstrated risk factors for COVID‐19 and associated with worse clinical outcomes.  A recent retrospective analysis published in the 2/9/21 issue of the Journal of the Alzheimer’s Association details how patients with dementia were at increased risk for COVID‐19 compared to patients without dementia. In patients with dementia, including vascular dementia and Alzheimer’s, the blood‐brain barrier is damaged, which allows certain bacteria and viruses to more easily access the brain making patients more susceptible to infection. In addition, the memory impairment associated with dementia may interfere with the ability to comply with preventive measures for COVID‐19 such as social distancing, mask wearing, and frequent hand sanitizing.

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