The CDC and the FDA on April 13, 2021, issued a pause on the administration of the Janssen (Johnson & Johnson) COVID-19 vaccine. Per these agencies, out of approximately 7 million doses given, a small number of reports of a rare blood clot were seen in women between the ages of 18 and 59. Symptoms for these women began day 6-15 post vaccination. More than 180 million doses of the Pfizer and Moderna vaccines have been administered as of April 13, 2021, and there have been no cases matching those associated with the Johnson & Johnson vaccine. However, following a thorough safety review, the CDC and FDA have lifted the pause on the Johnson & Johnson vaccine and recommend that its use be resumed.
Here are some frequently asked questions regarding the Johnson & Johnson COVID-19 vaccine:
What type of clot was seen?
The women who were affected were noted to have what is called a cerebral venous sinus thrombosis, a rare clot in the brain. Low platelets were also noted.
If I received the Johnson & Johnson COVID-19 vaccine a few months ago, am I at risk of this rare blood clot?
The risks of these events are low, and symptoms typically occurred between 6-15 days after the vaccine.
Are there particular symptoms I should be concerned about following the Johnson & Johnson COVID-19 vaccine?
You should contact your doctor immediately if you experience any of the following symptoms: a reddish rash on the skin that appears like pinpoint spots (petechiae), shortness of breath, leg swelling, chest pain, abdominal pain, or neurological symptoms (severe or persistent headache, blurry vision). It is not uncommon to have mild symptoms post vaccine such as a mild headache, fever, chills, or muscle aches. These symptoms typically resolve within 24-48 hours.
How well does the Johnson & Johnson COVID-19 vaccine prevent COVID-19?
The vaccine was 67% effective in preventing moderate to severe/critical COVID-19 infection.
Did the Johnson & Johnson clinical trial include racial and ethnic minorities?
The trial is still ongoing. 45.3% of the trial participants identify as Hispanic/Latino, 19.4% Black or African American, 9.5% American Indian or Alaska Native, 3.3% Asian, 0.2% Native Hawaiian or other pacific Islander and 5.6% Multiracial.
Can the Johnson & Johnson COVID-19 vaccine be administered to people over 60 with health conditions like hypertension and diabetes?
Yes. The known potential benefits of the vaccine outweigh the known potential risks of the vaccine.
How will additional safety monitoring be conducted?
Per Johnson & Johnson, the company has issued a safety plan to the FDA for longer-term safety monitoring of its ongoing clinical trial participants.
If I received one dose of either the Moderna or Pfizer vaccine, can I complete the series with the Johnson & Johnson vaccine?
No, the series must be completed with the original vaccine.
These were just a few of the frequently asked questions regarding the Johnson & Johnson vaccine. Bottom line: the vaccine is again in circulation for use. All three vaccines, Moderna, Pfizer and Johnson & Johnson have been approved for emergency use by the FDA. These vaccines will prevent you from getting sick from COVID-19. Please do not delay getting vaccinated.
Denise Hooks-Anderson, M.D., FAAFP is The St. Louis American Medical Accuracy Editor, Associate Professor, SLUCare Family Medicine and Interim Assistant Dean of Diversity Equity and Inclusion. She can be reached at yourhealthmatters@stlamerican.com.