UPDATED: J&J vaccinations resume as FDA, CDC confident in benefit-risk profile
The FDA and CDC on Friday evening lifted the pause on J&J vaccinations after deciding that a very rare but sometimes fatal side effect does not change the fact that the vaccine’s known and potential benefits still outweigh the risks.
FDA also updated the fact sheets for vaccine recipients and providers to note the risk of blood clots and low levels of platelets, known as thrombosis with thrombocytopenia syndrome (TTS).
“Most cases of thrombosis with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in females ages 18 through 49 years; some have been fatal,” a section on page three of the 24-page fact sheet for health providers says. FDA added a similar line to the updated fact sheet for recipients and caregivers, although in this update, the agency did not mention that the side effect could be fatal.
Some public health officials raised concerns over the weekend that US officials were downplaying the risks.
The risk in women <50 of TTS (the severe clotting disorder) after J&J is 1:80,000. This is low, but not the same risk of lightening striking. What's more, mRNA vaccines do not carry this risk. https://t.co/BKj4gT5vEi
— Leana Wen, M.D. (@DrLeanaWen) April 25, 2021
The decision to restart the vaccinations follows a CDC advisory committee’s vote earlier Friday that made the same recommendation and stopped short of restricting its use for specific populations.
J&J and FDA worked out the details of the warning earlier in the day, according to J&J’s presentation Friday, and J&J cautioned the committee against restricting use of the vaccine.
The CDC said Friday that it has now spotted 15 cases of TTS, among about 8 million receiving the vaccine. Those 15 cases include three deaths (up from one death from last week), seven people hospitalized, four of whom are in intensive care, and five people discharged.
Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, also noted about 10 other possible cases of TTS are under investigation.
The features of TTS appear similar to what is being observed in rare instances following the AstraZeneca Covid-19 vaccine in Europe, Shimabukuro added, echoing comments made earlier this week when the European Medicines Agency added a warning to its J&J Covid vaccine label due to TTS.
But unlike the EU, the US currently has plentiful and available quantities of both of the mRNA vaccines from Moderna and Pfizer, which may change the benefit-risk scenario for J&J vaccines in the US.
CDC modeling on Friday showed that even if the FDA restarted vaccinations with the J&J shot in all age categories immediately, the available doses would only speed up US vaccinations for all intending to do so by about two weeks (from 74 days to 88 days after Friday).
But physicians at the meeting also noted the importance of having a single-shot vaccine in their armamentarium for unique populations like those who are homeless, home-bound or migrant and seasonal communities.