CDC, FDA lift pause on J&J single-dose vaccine. What that could mean for California
U.S. health officials have lifted the pause on the single-dose COVID-19 vaccine from Johnson & Johnson, 10 days after federal health officials recommended providers halt its use to investigate instances of blood clotting in a very small number of recipients.
The end of the pause clears the way for hundreds of thousands of doses shelved in California vaccine providers’ inventories to be put back into use.
The Centers for Disease Control and Prevention and the Food and Drug Administration in a joint statement Friday afternoon said the two agencies “have determined that the recommended pause regarding the use of the Janssen (Johnson & Johnson) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.”
“This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases,” Dr. Janet Woodcock, acting FDA commissioner, said in a prepared statement.
That statement came about two hours after a CDC advisory panel of health experts voted Friday to recommend resuming use of Johnson & Johnson’s single-dose COVID-19 vaccine.
Use of the vaccine was suspended while federal health officials investigated a group initially consisting of six reported cases of a rare, severe blood clotting condition in recipients of the J&J jab, which was granted emergency use authorization by the Food and Drug Administration in late February.
Health experts said during Friday’s advisory committee meeting that the review identified 15 total cases of the blood clotting condition, up from the original six reports. All 15 were in women, 13 of them under age 50 and the other two 50 or older. Close to 8 million people had received the J&J vaccine in the U.S. prior to the pause.
The advisory committee near the conclusion of the meeting narrowed the options to two choices, both of which would recommend ending the pause; one of the options would have also appended language stating that women under age 50 should be aware of increased risk of blood clotting and may be advised to use a different COVID-19 vaccine.
The panel voted 10 to 4 to recommend lifting the pause without the addendum pertaining to women under 50.
Neither California health officials nor Gov. Gavin Newsom had immediately responded to the lifting of the pause as of Friday afternoon.
Last week, Newsom and the California Department of Public Health swiftly directed providers to pause use of the J&J vaccine, within hours of the CDC and FDA recommendation the morning of April 13. Clinics across the state had to either cancel appointments or quickly pivot to giving first doses of Pfizer or Moderna’s two-dose vaccines.
California and other West Coast states have their own independent panel of medical and scientific experts, known as the Western States Scientific Review Workgroup, that assesses COVID-19 vaccine information and guides policy decisions in those states.
J&J, which has had manufacturing issues slowing output since before the pause began, did not ship any doses to U.S. providers this week due to the pause and this week’s allocation data from the CDC shows no deliveries of the shots set for next week.
But CDC vaccine data also indicates there are about 9 million doses of J&J still in providers’ inventories nationwide. That includes about 1.2 million in California, compared to 1.06 million that have already been administered in the state.
The J&J vaccine, authorized for emergency use and rolled out in early March, makes up only a small fraction of the 27 million doses given in California but accounts for close to 10% of the state’s more than 11 million fully vaccinated residents, according to CDPH data updated Friday.
This story was originally published April 23, 2021 at 2:13 PM.
