The Oregon Health Authority and Washington state Department of Health said on Wednesday they had asked health care providers to immediately stop using the Johnson & Johnson COVID-19 vaccine on patients.
The authority’s move followed an announcement by the federal Centers for Disease Control & Prevention and Food and Drug Administration that they were reviewing six cases of women who developed a “rare and severe” type of blood clot. In its announcement, the authority said its decision is “out of an abundance of caution.”
In a joint statement, the federal agencies said the six cases involve women between 18 and 48 years old. The blood clot is called cerebral venous sinus thrombosis and comes in combination with low levels of blood platelets, the agencies said.
This type of blood clot requires providers to find alternative treatments. Heparin, the anticoagulant drug that traditionally treats blood clots, can be dangerous for this type of blood clot, the agencies said.
The CDC’s Advisory Committee on Immunization Practices will meet Wednesday to review the cases more and determine their potential significance. The FDA will review that analysis and investigate the cases.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Dr. Anne Schuchat, principal deputy director of the CDC, in a joint statement. “This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”
The AstraZeneca vaccine, which was developed in Britain and approved in Europe has also been halted after some people developed blood clots after receiving a shot. The vaccine requires two doses. The cases were mostly in women younger than 60 and they were extremely rare: about 170 cases emerged among 34 million people who’d received a shot. Nevertheless, Germany halted use of the vaccine pending an investigation.
Nearly 7 Million Shots Of J&J Vaccine Administered
Meanwhile in the United States, more than 6.8 million doses of the Johnson & Johnson vaccine had been administered through Monday. Oregon has administered 81,255 doses of that vaccine, state data show.
The move marks a setback in efforts in Oregon to vaccinate as many people as possible as quickly as possible in the face of rising COVID-19 cases, sparked in part by highly infectious variants of the coronavirus. The Johnson & Johnson vaccine is a key part of this effort because it is the only vaccine that requires just one dose. The other two vaccines, Pfizer and Moderna, require two doses spaced several weeks apart.
The Johnson & Johnson doses administered so far in Oregon represent a sliver of the state’s vaccination rollout, primarily because the other two manufacturers obtained emergency federal authorization earlier.
Oregon has administered nearly 1.2 million doses of the Pfizer vaccine and 1 million doses of Moderna. As of Monday, 916,207 people have completed a COVID-19 vaccine series, either through the one-dose Johnson & Johnson vaccine or two doses of Pfizer or Moderna. Overall, 1.4 million people have received at least one dose.
The Oregon Health Authority does not administer shots but it determines where the federal government will send Oregon’s doses based on needs throughout the state. Local health agencies, health care providers, hospitals and clinics administer the vaccines.
Overall, Oregon has received nearly 1.4 million doses of Pfizer vaccine, 1.2 doses of Moderna vaccine and 203,200 doses of Johnson & Johnson vaccine.
Clot Symptoms Include Headache, Leg Pain
This is not the first slowdown for the Johnson & Johnson vaccine. Last month, about 15 million doses had to be thrown out because of a manufacturing error at a plant in Baltimore.
CDC and FDA officials stressed that the clots appear to be “extremely rare” and advised people to look out for the symptoms of a blood clot.
“COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously,” federal officials said. “People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.”
People should be wary of symptoms during the first 21 days after they received a dose, Oregon Health Authority officials said.
In all the cases, symptoms developed in six to 13 days. The longer three-week period creates a buffer, said Dr. Paul Cieslak, senior health advisor and medical director of the Oregon Health Authority’s acute and communicable disease and immunizations division.
In a press call, Cieslak said he expects the pause and review to last days rather than weeks or months.
Cieslak said people with an appointment to get a Johnson & Johnson dose should contact their vaccine provider to see if they can receive the Pfizer or Moderna vaccines.
The state is not changing its time frame for when people will become eligible to get vaccinated. Oregon officials plan to open up eligibility to everyone 16 and older on Monday, April 19. However, people typically cannot necessarily get a jab right when they become eligible. Some people may have to wait a little longer due to the Johnson & Johnson pause, Cieslak said.
The state has unrolled the vaccination to other priority groups, including senior citizens, front-line workers and people with underlying health conditions.
Vaccine Critics May Focus On The Problem
The development could intensify vaccine hesitancy, which happens when people are reluctant to get a shot because they fear unknown side effects. Vaccine hesitancy is a key obstacle to the state’s goal of vaccinating enough people to reach herd immunity, about 75% of the overall population.
“This may give them some additional fuel, but I want to point out this is about one in a million,” Cieslak said.
He stressed that officials still don’t know whether the vaccine caused the blood clots. The federal review will determine that during the pause, he said.
The monitoring systems for vaccines found the blood clot cases, but that doesn’t determine what caused them.
“It just says: Here’s something interesting to look at,” Cieslak said.
The monitoring systems, he said, reflect the higher safety standards for vaccines compared to other medications. Medications such as blood pressure medicine don’t have similar monitoring, he said.
The high standards are in place because vaccines treat people who are healthy. People who are dangerously ill are more willing to take a risk. For example, someone who has a disease and needs an antibiotic may become worse without any treatment.
You can reach Ben Botkin at [email protected] or via Twitter @BenBotkin1.