CDC committee votes to restart J&J vaccinations – Endpoints News
A CDC advisory committee on Friday voted to restart vaccinations with J&J’s Covid-19 vaccine but stopped short of restricting its use to specific populations or specifying a new warning for rare but sometimes fatal side effects of blood clot with low platelets linked to the vaccine.
The vote in favor of restarting the vaccinations for anyone over the age of 18 follows J&J comments on Friday that it has agreed with the FDA to add a warning to the label regarding the risks.
“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,” the warning says, according to J&J’s presentation Friday, after cautioning the committee against restricting use of the vaccine. “Based on currently available evidence, a causal relationship between thrombosis with thrombocytopenia and the Janssen COVID-19 Vaccine is plausible.”
The CDC said Friday that it has now spotted 15 cases of the blood clots with low platelets, also known as thrombosis with thrombocytopenia syndrome (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.
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 Friday also noted the importance of having a single shot in their armamentarium for unique populations like those who are homeless, home-bound or migrant and seasonal communities.