Last night, after two scientific meetings and a lengthy discussion of the risks and benefits, the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommended lifting the temporary “pause” on use of the Janssen (Johnson & Johnson) COVID-19 vaccine. After watching their public meetings and reviewing the data they discussed, I agree with lifting the pause and believe that the FDA’s and CDC’s actions illustrate how seriously they take vaccine safety.
As I’ve said before, physicians make decisions by balancing potential risks against potential benefits. Nothing is without risk; even choosing not to act has risks. In this instance, use of the vaccine was initially paused in order to examine risks of a rare blood clotting disorder among young women after receiving the Janssen (Johnson & Johnson) COVID-19 vaccine. However, the vaccine is highly effective in preventing COVID-19 infection, and the pause carried its own risk of less COVID-19 vaccine available in the U.S., fewer opportunities to vaccinate people against COVID-19 and ultimately, more cases of COVID-19 infection resulting from less vaccination. Read on for an explanation of why the benefits of vaccination (and risks of further pausing vaccination) outweigh the risks from the Janssen COVID-19 vaccine.
First, some background: the FDA and CDC jointly recommended temporarily pausing the use of the Janssen COVID-19 vaccine on April 13, 2021 after identifying 6 cases of blood clots with low platelets (thrombotic thrombocytopenia) among young to middle-aged women who had received the vaccine in the previous 3 weeks. The CDC notified healthcare providers and asked them to report any additional cases to the federal Vaccine Adverse Events Reporting System. Over the subsequent week, the CDC identified 15 total cases of thrombotic thrombocytopenia after Janssen vaccine, all among women and 13 out of 15 among women less than 50 years old. Based on their analysis, they estimated a risk of 7 cases of thrombotic thrombocytopenia per 1 million doses (or 1 case per 142,000 doses) of Janssen vaccine among women age less than 50 years, less than 1 case per million doses to women age 50 years and older, and no identified risk to men.
In contrast, they estimated that if use of the Janssen vaccine resumed in all ages and genders in the U.S., then 17 cases of thrombotic thrombocytopenia may occur for every 1 million doses administered (primarily in women age 18-49 years), while over 1300 deaths, over 3000 ICU admissions and over 11,000 hospitalizations due to COVID-19 would be prevented by vaccination. The benefits of Janssen COVID-19 vaccine clearly exceeded the known risks for all age and gender groups studied, even among women age 18-49 years who have the highest risk of thrombotic thrombocytopenia.
After reviewing the evidence, it was clear that lifting the “pause” was the right way to go. Even then, it wasn’t a slam-dunk. The CDC’s Advisory Committee on Immunization Practices (ACIP) met twice to discuss the “pause”, and requested additional data after the first meeting. Some ACIP members voted against recommending the vaccine for all adults, although two of those who voted against it noted that they supported its use but preferred alternative language that explicitly stated that women age 18-49 have a choice of COVID-19 vaccines. And the FDA has already revised the labeling for the Janssen vaccine, and the Fact Sheets for healthcare providers and vaccine recipients and their caregivers, to include information about risks of thrombotic thrombocytopenia.
The bottom line is: the Janssen COVID-19 vaccine is highly effective against COVID-19 infection, hospitalization, ICU admission and death, men have no known risk of thrombotic thrombocytopenia from the Janssen COVID-19 vaccine and women over 50 have less than a 1 in 1 million risk. Women age 18-49 years have about a 7 in 1 million (or 1 in 140,000) risk of blood clots with low platelets after the Janssen COVID-19 vaccine; overall this is less than their risks of severe COVID-19 infection however if they aren’t comfortable with that risk then U.S. women do have 2 other options: the Pfizer and Moderna COVID-19 vaccines. If you’re a woman age 18 to 49 years, then talk to your healthcare provider about your COVID-19 vaccine options.
Stay well, get your shots and keep wearing those masks,
đŸ’‰ Dr. B