J&J Vaccine Overview
Submission and Approvals
- Emergency Use Authorization submission date: 2-4-2021
- Date of FDA meeting for approval: 2-26-2021
- Emergency Use Authorization Approval Date: 2-27-2021
J&J Information Center
- Single dose (0.5 mL) viral vector vaccine
- 72% in the United States and 66% effective overall at preventing moderate to severe COVID-19, 28 days after vaccination
- 43,783 participants, 34% of population over the age of 60
- 468 developed symptomatic cases of COVID-19
Common Adverse Events
- Include injection site pain, headache, fatigue, muscle pain, and nausea
- One report of anaphylaxis in a clinical trial in South Africa
- Unpunctured, multi-dose vials should be stored at 2°C to 8°C (36° to 46°F) and protect from light.
- Do not store frozen
- Unpunctured vials should be stored at 9°C to 25°C (47° to 77°F) for up to 12 hours
- Vaccine initially stored frozen by manufacturer, then shipped at 2°C to 8°C (36° to 46°F).
- If vaccine is frozen upon receipt, thaw at 2°C to 8°C (36° to 46°F).
- If needed immediately, thaw at room temperature 25°C (77°F).
- A carton of 10 vials will take about 2 hours to thaw
- An individual vial will take about 1 hour to thaw
- After first puncture, hold the vial between 2°C to 8°C (36° to 46°F) for up to 6 hours or at room temperature for up to 2 hours
J&J Vaccine FAQ
Q. How does the viral vector vaccine work?
A. Viral vectors use a modified version from a different virus to deliver information to cells. The viral vector COVID-19 vaccine uses a different, harmless virus to enter cells in the body in order to produce the spike protein of the COVID-19 virus. This spike protein is harmless
Similar to the mRNA vaccines effects, our cells present the spike protein on its surface so that our immune system recognizes this foreign protein and can start producing antibodies against it
Q. Can I get the vaccine if I’m pregnant or breastfeeding?
A. There is currently insufficient data to determine whether there are vaccine-associated risks in those who are pregnant or breastfeeding.
However, the CDC states that if you are pregnant you may choose to be vaccinated as there is no evidence that the antibodies formed from COVID-19 vaccination can cause any problem with pregnancy. The CDC is continually updating its guidance on COVID-19 vaccination
Q: Are there any contraindications to the vaccine?
A. Individuals with a known history of severe allergic reaction to any components of the Janssen COVID-19 vaccine are contraindicated
Q: Can the Janssen COVID-19 vaccine be used to complete a vaccination series initiated with another COVID-19 vaccine?
A. There is no data available regarding the use of the Janssen COVID-19 vaccine to complete another vaccination series
Q: Can the Janssen COVID-19 vaccine be administered at or around the same time as other vaccines?
A. There is currently no data available regarding the use of this vaccine with other vaccines