A News Alert from The Rx Consultant – March 2021

Janssen COVID-19 Vaccine Gets Emergency Use Authorization 

The Janssen Biotech COVID-19 vaccine has received emergency use authorization (EUA) from the FDA. Many individuals are referring to this latest vaccine as the Johnson and Johnson vaccine but the EUA was issued to Janssen Biotech Inc., of which Johnson & Johnson is the parent company. 

Unlike the Pfizer and Moderns mRNA vaccines, the Janssen vaccine is administered as a single dose and it is considered a vector vaccine. A vector is a modified version of a different (harmless) virus that is used to deliver genetic instructions to the host. The Janssen COVID-19 vaccine is manufactured using a type of adenovirus (Ad26). Ad26 delivers a piece of the DNA that codes for the distinctive “spike” protein of the SARS-CoV-2 virus into the body’s cells. Once delivered, the cells’ genetic machinery produces the COVID-19 (harmless) spike protein. Similar to the mRNA vaccines, the spike protein triggers the defensive immune response against SARS-CoV-2.

Among 40,000 study participants, the Janssen vaccine demonstrated protection against several concerning SARS-CoV-2 variants including the Wuhan-H1 variant D614G (predominant in the US), the B.1.351 variant (predominant in South Africa), and a P.2 variant (predominant in Brazil). Effectiveness according to country has been reported as: 

  • US: 74.4% effective and 72% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days and 28 days after vaccination, respectively.
  • South Africa: 52.0% effective and 64.0% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days and 28 days after vaccination, respectively.
  • Brazil: 66.2% effective and 68.1% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days and 28 days after vaccination, respectively.

Similar to mRNA vaccines, the most commonly reported side effects of the Janssen vaccine were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these effects were mild to moderate in severity and lasted 1-2 days.

Storage requirements are a major advantage of the Janssen vaccine. It can be stored unopened at 36°F to 46°F rather than frozen. At temperatures 47°F to 77°F, it can be stored for up to 12 hours (or 6 hours if opened).

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