When Is It Okay for Pharmacists to Administer Janssen COVID-19 Vaccine?
The use of the Janssen (Johnson & Johnson) COVID-19 vaccine has been limited but not prohibited. So, when is it appropriate for pharmacists to administer the one-dose viral vector vaccine instead of one of the two preferred mRNA vaccines from Pfizer and Moderna. Find out what public health officials have to say about that.
SILVER SPRING, MD – Use of the Janssen (Johnson & Johnson) COVID-19 vaccine has been limited as a last result for adults 18 or older because of safety concerns. The mRNA vaccines from Pfizer-BioNTech and Moderna remain the preferred products.
That the FDA limited use but still authorizes the Janssen vaccine in some situations raises the issue for pharmacists about when it would be appropriate to administer the vector virus vaccine administered in a single dose.
The FDA answers that it should be used in adults for whom “other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.”
More specifically, according to the national Centers for Disease Control and Prevention and the FDA, the following situations might argue for recipients to get the Janssen vaccine:
- They had a severe reaction after an mRNA vaccine dose or have a severe allergy to an ingredient of Pfizer-BioNTech or Moderna mRNA vaccines.
- They otherwise would remain unvaccinated for COVID-19 because of the inability to come back for a second dose. Examples might be adults who are homeless, migrant workers or who are unable to take extra time away from their jobs, public health officials advise.
- They opt to receive the J&J/Janssen COVID-19 vaccine despite the safety concerns and a clear explanation of them. An example might be those who have personal concerns or objections to mRNA vaccines.
The CDC advises that the J&J/Janssen COVID-19 vaccine was 66.3% effective in clinical trials at preventing laboratory-confirmed COVID-19 infection in people who received the vaccine and had no evidence of being previously infected. As with the other vaccines, recipients had the most protection 2 weeks after getting vaccinated.
In the clinical trials, the vaccine also had high efficacy at preventing hospitalization and death in people who did get sick, it adds.
A suspension for intramuscular injection, the Janssen COVID-19 vaccine is administered as a 0.5 mL single dose. The 0.5 mL booster dose can be administered at least 2 months after primary vaccination with the original vaccine. In addition, the FDA says a single booster dose of the Janssen COVID-19 Vaccine (0.5 mL) can be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.
In December 2021, after reviewing updated vaccine effectiveness and safety data, the CDC’s Advisory Council on Immunization Practices (ACIP) made a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine for all adults.
The latest FDA action came after an updated analysis was performed, leading to the conclusion that “the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine.”
“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “