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
- 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.
- 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
For more information about all of the COVID-19 Vaccines currently available, please visit the Grane Rx Vaccine Information Center.
Vaccine Information Center
Q: What are the benefits of receiving a COVID-19 vaccine?
A: Getting vaccinated will decrease your risk of contracting and getting sick from the COVID-19 virus like the influenza vaccine decreases your risk of contracting the flu virus. The benefits of receiving the vaccine far exceed the risks of contracting COVID-19 and potentially having serious, life-threatening or life-long complications. Being vaccinated will help stop the pandemic in combination with following CDC guidelines.
Q: Vaccines usually take years to develop. The COVID-19 vaccines have been developed in under a year, how do I know they are safe?
A: The Phase 3 trials that took place for the COVID-19 vaccines were of similar size and nature to the Phase 3 trials that have taken place for other vaccines and medications.
Here is what the process looks like:
The data gathered from Phase 3 trials is subject to extensive review by independent experts in multiple areas of science including immunology, statistics, infectious diseases, virology, and vaccinology.
Once a pharmaceutical or biotechnology company submits a vaccine to the FDA for Emergency Authorization Use, it undergoes another round of review by the Vaccine and Related Biologics Product Approval Committee (VRBPAC). This committee then provides advice to the FDA before any decision is made.
Once the FDA decides to approve a vaccine, it goes through another round of review by the Advisory Committee on Immunization Practices (ACIP). The ACIP then makes recommendations to the CDC on who should and shouldn’t get the vaccine.
Finally, once a vaccine is approved and individuals are deciding whether to get it, they will have access to information that summarizes the clinical trial findings. This includes data related to any side effects found during the trials and who should or should not get the vaccine.
Authorized Vaccines (as of 2/18/21)
Q: Can you get sick from receiving the SARS-CoV2 protein or the modified virus through the vaccine?
A: No, the proteins will not make you sick, however you may experience side effects from the vaccine.
Q: Will I experience side effects from receiving the COVID-19 vaccine?
A: Yes, it is possible to experience side effects from these vaccines much like the annual influenza vaccine or any other vaccination. These side effects can range from a sore arm to feeling warm or muscle aches. These are signs that an immune response is building in your body and are completely normal. Experiencing these side effects does not mean you have a mild form of the virus
Q: Will I have to receive multiple shots in order to gain the full immunity to COVID-19?
A: The Pfizer vaccine and Moderna vaccine both require the use of two vaccinations to gain the full effect. The Johnson & Johnson vaccine (currently under FDA review for emergency use authorization) will require a single vaccination.
Q: Should I get the vaccine if I already had COVID-19?
A: Yes, it is recommended. Previous COVID-19 infection is not considered a contraindication to receiving the vaccine. Antibody testing is not necessary or recommended prior to receiving the COVID-19 vaccination per CDC guidance.
Healthcare workers who tested positive for COVID-19 within the previous 90 days have a choice to delay receiving the vaccine until near the end of the 90 days to allow other healthcare workers to get vaccinated first. There is evidence suggesting reinfection of COVID-19 is not common 90-days post initial infection.
Q: Will the COVID-19 vaccine make me test positive for COVID?
A: No, the COVID vaccine will not cause you to test positive for a viral test. You may however test positive if the test is measuring antibodies. This is the desired result of the vaccine. The goal of vaccination is for your body to produce antibodies to be ready to fight COVID-19 once you are exposed.
Q: Once I receive the vaccine do I still have to wear a mask and follow social distancing guidelines?
A: Yes, it is recommended that even if you receive the vaccine that you still follow all guidelines set by the CDC. This is because it will take time to immunize the entire country to the point where there is no concern of transmission.
For Grane Rx’s full vaccine FAQ please visit our COVID-19 Vaccine Information Center.