The announcement comes after the FDA and CDC also authorized the restart of the J&J COVID vaccine
Gov. Jay Inslee today announced the authorization of resuming the Johnson & Johnson COVID-19 vaccine by the Western States Scientific Safety Review Workgroup.
The announcement comes after the FDA and CDC also authorized the restart of the J&J COVID vaccine. The Western States Workgroup, comprised of vaccine experts from Washington, California, Oregon and Nevada, has met to review the data and analysis to ensure the safety and efficacy of all FDA-authorized vaccines.
The Workgroup concluded that the J&J vaccine is safe and effective, and paired with patient and provider educational materials about potential risks, provides an important option to continue to reduce severe COVID-19 illness.
“The benefits of the J&J vaccine outweigh the risks associated with it,” Inslee said. “We want to keep as many people free from COVID and out of the hospital as possible, and the J&J vaccine will help us get through this pandemic. I encourage people to get whatever vaccine is available to them. If you have questions or concerns, consult a provider to help answer questions you have.”
The Washington State Department of Health (DOH) will immediately resume use of the J&J vaccine across the state.
The 11-day pause was taken as a precaution after six cases of a rare but severe type of blood clot were reported following administration of the J&J vaccine. In these cases, a blood clot in the brain formed, which is called thrombosis. This is coupled with low blood platelets, known as thrombocytopenia. When those both occur after a vaccine, it is referred to as thrombosis with thrombocytopenia syndrome (TTS).
On Friday, the CDC said a total of 15 cases of TTS have been reported, which includes the original six cases. All the cases occurred in women between the ages of 18 and 59, occurring six to 15 days after vaccination. DOH is not aware of any cases in Washington. The warning signs of TTS include severe headache, abdominal pain, leg pain, and/or shortness of breath. People experiencing TTS symptoms following vaccination should contact their healthcare provider or seek medical attention immediately. At this time, available data suggest the chance of TTS is very low – with only 15 cases identified out of about 8 million vaccines administered nationwide – and the vaccine’s known and potential benefits outweigh its known and potential risks.
The Advisory Committee on Immunization Practices (ACIP) voted Friday to reaffirm its recommendation of the J&J vaccine for those 18 and older. ACIP recommended the FDA include a warning statement, and for J&J to provide an information sheet at vaccination that informs people about the increased risk of TTS. Members of the Western States Scientific Safety Review Workgroup agreed information needed to be created and shared as soon as possible. DOH quickly acted on the changes, sharing our J&J webpage with providers and creating materials providers can share with those receiving the J&J vaccine. People concerned about the increased risk may instead choose Pfizer-BioNTech or Moderna.
“Above all else, safety is our top priority. The pause was proof the surveillance systems in place to monitor the safety of COVID-19 vaccines are working,” said Secretary of Health Umair A. Shah, MD, MPH. “These findings once again show we have three vaccines available that are effective and safe.”
Providers with J&J on hand can once again begin scheduling appointments and administering the vaccine. During the pause, about 170,000 doses of J&J were being held by providers across the state. Our three-week forecast from the federal government shows Washington will begin receiving more J&J the week of May 2 when 4,300 doses are expected to arrive.
The CDC’s announcement can be found here.