Important note: This article is intended for those who understand vaccines as critical to maintaining their health and that of their families. It is NOT intended for those who are anti-vaccine and as such is NOT intended to foster a discussion on the merits of vaccines in this forum. It is also NOT intended to foster a discussion of the lethality of COVID-19 or the need for civic action to limit the spread of the disease.
The US Food and Drug Administration issued Emergency Use Authorization to Moderna’s COVID-19 candidate Friday evening clearing the way for the vaccine to be distributed and administered nationwide to individuals 18-years and older. About six million doses are awaiting US distribution.
The vaccine, which was administered to 15,000 clinical trial participants, was 94.1% effective preventing symptomatic COVID-19 disease with no allergic reactions observed.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen Hahn in a statement.
The Moderna authorization comes as a third healthcare worker in Alaska was reported to have suffered an anaphylactic reaction to the Pfizer COVID-19 vaccine in as many days, bringing the combined total in the US and UK to five after hundreds of thousands of vaccines have been administered.
The worker experienced tongue swelling, hoarse voice and difficulty breathing, according to the healthcare group where she worked. She was transported from the vaccine clinic to Fairbanks Memorial Hospital where she received two doses of epinephrine and was released six hours later.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters Friday night that “out of caution” the agency recommends that people who have severe allergic reactions to any components of the two vaccines should not be vaccinated with either.
Marks indicated investigations are underway to determine what may have caused the allergic reactions to the Pfizer vaccine in a small number of patients that have received it. Focus is on a compound called polyethylene glycol (PEG) a lipid (fat) that is a component in other injectable medicines and has been known to cause allergic reactions in rare circumstances. “That could be a culprit here,” said Marks.
Neither the Pfizer nor Moderna vaccines contain components made from food nor are they cultured in eggs as are other vaccines. Both contain PEG compounds.