Hospice Pharmacy Insights January 2021

It appears that 2020 is ending on a promising note. Two COVID-19 vaccines were given approval by the FDA; the Pfizer-BioNTech received emergency use authorization (EUA) on December 11^th and the Moderna on December 18^th. Both vaccines are messenger RNA (nRNA) and both have a reported effectiveness of 94-95% across age, racial and ethnic groups. Both vaccines rely on two doses give 21 days apart (Pfizer-BioNTech) and 28 days apart (Moderna). There are currently age restrictions with Pfizer-BioNTech approved for persons 16 years and older and Moderna for persons 18 years and older. It is recommended that those who receive either vaccine be observed for 15 to 30 minutes following injection as a precaution against potential severe allergic reactions. 

mRNA: What is it and how does it work?

The make-up of both vaccines is similar but not the same. Both contain mRNA, lipids and buffering salts and sugars. Messenger RNA is a single-stranded RNA molecule that is compatible with a gene’s DNA strand. It isn’t the same as DNA, and it does not combine with a person’s DNA to alter genetic code.

“The mRNA vaccine essentially provides instructions to the immune system by coding for the spike protein and producing an immune response that is similar to what would happen if a person were actually exposed, except the mRNA vaccines have no live virus and cannot interact with or integrate into the vaccinated person’s DNA. The spike protein mRNA and lipid particulate matter are the predominant ingredients in the vaccines along with buffering salts and sugars.

The lipid particles allow the vaccine’s mRNA to travel to the lymph system and enter antigen producing cells. The mRNA instructions are assimilated by the cell, and the spike protein is produced on the surface of the cell. Once that happens, the mRNA and lipids break down quickly. As the spike protein is produced on the surface of the antigen producing cell, a B cell neutralizing antibody response occurs. At the same time, CD4 and CD8 T cells are produced and create the response that establishes the body’s immune ‘memory.’ Thus, the mRNA vaccine works by enabling the body to mount a specific immune response to the virus through the creation of the B and T cells even though the virus itself is not present as a result of the vaccination.”

The most commonly reported side effects for both vaccines were pain at the injection site, headache, fatigue, chills, myalgia (generalized muscle pain) and arthralgia (joint pain). However, side effects for the Moderna vaccine also included nausea/vomiting, axillary swelling, and tenderness, swelling at the injection site, and erythema. Symptoms were usually mild and resolved within one to two days. Antipyretic or analgesic medications may be taken for the treatment of post-vaccination local or systemic symptoms, but prophylactic administration of such medications to prevent post-vaccination symptoms is not recommended.

It is notable with the Pfizer-BioNTech vaccine that side effects were more frequent and more severe following the second dose and among younger people, including those between the ages of 18 and 55. Patients should be encouraged to complete the series unless a significant contraindication develops.

Information about the degree to which the vaccine may reduce transmission in the general population and how long that protection will last is limited. As a result, vaccinated people should continue following all current CDC guidance to protect themselves and others including wearing a mask, social distancing, hand hygiene, and avoiding crowds.

Detailed information and guidance for the Pfizer-BioNTech vaccine is in the links below. At the time this newsletter was being published the guidance for the Moderna vaccine had not been published by the CDC.

Current CMS Emergencies

Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic

Wellsky CDC Update