The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) this morning said the United States should pause the administration of the Johnson & Johnson COVID-19 vaccine immediately, while the agencies examine how and if the vaccine was linked to six cases of a rare type of blood clots in women 18 to 49, including one death.
"Right now I'd like to stress these events seem to be extremely rare," said Janet Woodcock, MD, acting FDA commissioner. Approximately 7 million doses of the Johnson & Johnson, or J&J, vaccine have been administered in the United States.
Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research, said people who recently got the J&J vaccine should not panic, but should look for the following symptoms: persistent headache, abdominal pain, leg pain, and shortness of breath. The case-patients experienced their clots 6 to 13 days following injection, with a median of 9 days.
Marks said physicians should be on the lookout for patients who recently got the vaccine, have symptoms, and also present with low platelets.
"At that time, consider this entity," Marks said. The type of blood clot, called cerebral venous sinus thrombosis, occurs when clots form in veins that drain blood from the brain, but is not treated with standard coagulants, including heparin.
Though not mandated, CVS, Walgreens, and dozens of states announced today they were immediately halting the distribution of the vaccine.
In a statement, Johnson & Johnson said: "We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine."
ACIP to review cases tomorrow
Tomorrow the independent group of vaccine experts, ACIP (Advisory Committee on Immunization Practices), will meet to review the cases of blood clots.
The halt is reminiscent of problems seen in the European Union with the AstraZeneca vaccine. Both the AstraZeneca and J&J vaccines are adenovirus-based, as opposed to the mRNA-based vaccines made by Pfizer/BioNTech and Moderna.
A small number of blood clots were found in recent AstraZeneca vaccine recipients in the European Union. European officials dubbed the phenomenon "vaccine-induced immune thrombotic thrombocytopenia," and classified it as an extremely rare and severe immune reaction to the vaccine, with clots less likely to occur from the vaccine than they do from birth control pills.
Though Marks would not confirm so, he suggested the clots may be part of a "class effect" of adenovirus-based vaccines, and said the FDA was investigating all data from other adenovirus based vaccines, including J&J's Ebola vaccine, to see if there was a similar history.
This afternoon Jeff Zients, the White House COVID-19 response coordinator, and Anthony Fauci, MD, the White House chief medical adviser, answered questions from the press.
They confirmed that it was the FDA and CDC's decision to halt the J&J vaccine, and said they believed it would be a matter of days before more was known.
Zients said the United States still had enough vaccine supply, via Pfizer and Moderna, to vaccinate all 260 million US adults by May 31, and said the war-time mentality of Operation War Speed had helped the administration plan for events such as this.
Fauci said the blood clots, if determined to be caused by the vaccine, occurred at a rate of less than 1 per 1,000,000, and urged Americans to keep getting the Pfizer and Moderna vaccines, which have shown no major safety issues after more than 180 million doses administered.
The CDC COVID Data Tracker shows 245,364,805 COVID-19 vaccine doses have been delivered in the United States, and 192,282,781 have been administered, with 75,322,283 Americans fully vaccinated.
Across the United States, all residents over the age of 16 will be eligible to get a COVID-19 vaccine by next Monday, the New York Times reports.
With respirator shortage over, new guidance
"Based on the increased domestic supply of new respirators approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) currently available to facilitate this transition, the FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems," the FDA said.
Both agencies said hospitals should provider healthcare workers with fresh or new N95s or other approved respirators. However, the Occupational Safety and Health Administration Emergency Temporary Standard remains in limbo, so there is no mandated requirement that hospitals follow the revised guidance.
Other US developments
- A study being conducted at 20 US colleges will aim to determine how well the Moderna vaccine prevents inoculated people from becoming carriers of the virus, according to the Washington Post. The study will randomize students into a group that receives vaccines immediately and a group that gets vaccinated 4 months later, and all participants will be asked to provide daily swabs of their nose. The study will help answer the question how and if vaccinated people can transmit the virus.
- At least five US hospitals have started pediatric long-haul clinics to help children with lingering COVID-19 illness, CBS News reports.
- Yesterday the United States reported 72,286 new COVID-19 cases yesterday, and 476 deaths, according to data from the New York Times. In total, Johns Hopkins University has tracked 31,297,614 COVID-19 cases, including 562,937 deaths.