Update : The Johnson & Johnson Vaccine
Last Friday, April 23rd, the Centers for Disease Control and Prevention (CDC) issued a Johnson & Johnson vaccine update when they voted to end the pause on its use. That vote paved the way for the Food and Drug Administration (FDA) to officially end its recommended pause as well. Therefore, this week the nation will see states and territories resume use of the single-dose Covid-19 vaccine.
Moving forward, the FDA will include a warning on the J&J packaging which notes the potential risk of rare blood clots. This warning reflects the events that triggered the vaccine’s pause last week, when reports emerged of a rare clotting disorder in six women who received the J&J vaccine. Since then, nine more cases have emerged, all in women.
In their announcement on Friday the FDA released updated fact sheets on the vaccine, and noted that most of those who developed the rare clots were women between the ages of 18 and 49. They also stated that the “chance of having this occur is very rare”. To date there have been seven cases reported per million doses given among women in that age group.
“Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases. We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices. We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider,”
– Janet Woodcock, M.D., Acting FDA Commissioner.
While news like this can be alarming, this pause and investigation into the emerging reports is actually reassuring. It indicates that the system used to monitor vaccine safety is working as intended. Nearly eight million doses of the J&J vaccine have been administered so far. Among men and women 50 or older, there has been less than one case reported per million doses administered.
In addition to being a single-dose vaccine, the Johnson & Johnson shot is easier to store than the two dose versions from Moderna and Pfizer. Therefore, the vaccine is especially useful when providing equitable access to homebound, homeless, and incarcerated populations, as well as remote communities. Here in the U.S.V.I. the Johnson & Johnson vaccine is being prioritized for homebound residents. Appointments can be made through the Virgin Islands Department of Health
As always, you should speak to your primary care provider before getting the vaccine if you have any underlying conditions. Specifically, the FDA recommends you speak to your physician if you:
- Have allergies
- Have a fever
- Have a bleeding disorder or are taking blood thinners
- Are immunocompromised or are taking a medicine that affects your immune system
- Are pregnant or planning to become pregnant
- Are breastfeeding
- Have received another Covid-19 vaccine
As the nation and much of the world mount wide reaching vaccination campaigns, vaccine hesitancy continues to be a significant hurdle in many communities. It is important to remember that if you have questions or concerns, those are best addressed by your primary care provider. Additionally, you can find more resources at CDC.gov, FDA.gov, and here on our LCS blog, where we’ve discussed the Covid-19 vaccine experience with our Go Team as well as featured a “Q&A” with the Clinical Director of Island Health & Wellness Center.