US health regulators on Friday suspended a recommended pause in the use of Johnson & Johnson’s Covid-19 vaccine, giving state and local authorities support to distribute the doses, which are seen as critical to obtaining vaccines that save lives in communities that are difficult to access.
The announcement by the Centers for Disease Control and Prevention and the Food and Drug Administration comes after the CDC’s Immunization Practices Advisory Committee, known as ACIP, recommended on Friday for continued use of the J&J vaccine, saying the benefits the injection outweighed the risks. The committee is an external panel of experts that advises the CDC.
Advisory panel members did not recommend that US regulators restrict the use of the J&J vaccine based on age or sex, but proposed that the Food and Drug Administration consider adding a warning label for women under 50.
In a statement on Friday, the FDA and CDC said they are confident that the vaccine is safe and effective in preventing Covid-19, adding that the risk of blood clots is “very low”.
“Safety is our highest priority,” said FDA Acting Commissioner Dr. Janet Woodcock in a statement. “This pause was an example of our extensive security monitoring working the way it was designed to work – identifying even that small number of cases.”
“We have suspended the pause based on a review by the FDA and CDC of all available data and in consultation with medical experts and based on the recommendations of the CDC Immunization Practices Advisory Committee,” said Woodcock. “We concluded that the known and potential benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age or older.”
During a press conference on the announcement, Woodcock said health professionals should review the FDA’s revised vaccine brochures, which include details on rare blood clots. People who have doubts about the vaccine should talk to a health professional, she said.
The Covid-19 vaccine from J&J, as well as the vaccines from Pfizer and Moderna, received an emergency use authorization from the FDA to begin distributing doses in the United States. An USA grants conditional release based on two months of security data, pending another submission for full approval, which generally requires at least six months of data.
On April 13, the FDA and CDC asked states to temporarily stop using the J&J vaccine “just in case” after reports that six women, aged 18 to 48, developed cerebral venous sinus thrombosis in combination with low blood platelets. CVST occurs when a blood clot forms in the venous sinuses of the brain. It can prevent blood from draining from the brain and can eventually cause bleeding and other brain damage.
Within hours of notice from US regulators, more than a dozen states, along with some national pharmacies, have suspended inoculations with the J&J vaccine. Some locations have replaced J&J vaccines for appointments scheduled with the Pfizer or Moderna vaccine.
The US government was expected to suspend the recommended pause shortly after the committee’s favorable vote.
Before Friday’s vote, the committee debated whether to recommend against using the J&J vaccine or endorse it with US regulators by imposing a warning label. The committee also considered limiting the use of the vaccine based on age or other risk factors.
During the meeting, CDC official Dr. Tom Shimabukuro said there were no reports of the condition in those who received the mRNA vaccine from Pfizer-BioNTech. There have been three reports of CVST in patients who received the Modern vaccine, he said, although the patients did not have the low level of blood platelets seen in J&J receptors.
Blood platelets help the body form clots to heal wounds. US health officials have warned that using a treatment like heparin for anticoagulants in people with low platelets may worsen their condition.
Rare blood clots with low platelets are occurring at a rate of 7 per 1 million vaccinations in women aged 18 to 49 for the J&J injection and 0.9 per 1 million in women aged 50 and over, according to a slide presented at the CDC panel meeting. The CDC confirmed a total of 15 cases of rare blood clot conditions, which include 12 women who developed blood clots in the brain. Three women died and 7 remained hospitalized, according to the presentation.
There are no confirmed cases in men, although officials have said they are reviewing additional potential cases.
Dr. Michael Streiff, a hematologist at the Johns Hopkins University School of Medicine, said the condition, under normal circumstances, is very rare. “I can tell from my experience, treating these patients, I never saw that,” he told the committee during a presentation on Friday.
Earlier this week, J&J said it would resume launching its vaccine in Europe after local regulators supported the single injection vaccine with the recommendation that a warning be added to the label. The European Medicines Agency researched all available evidence, it said, including reports from the United States.