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By Jana Hill
Mill Creek Beacon Editor 

J&J emergency meeting is Wednesday

Rare potential side-effect prompted safety review

 

Last updated 4/20/2021 at 8:24am

Courtesy of Snohomish Health District

A medical reserve volunteer administers a J&J vaccine at the Angel of the Winds Arena in Everett. The site closed the day the J&J pause was announced.

Editor's Note: This story was last updated at 8:15 a.m. April 20. Check back for updates.

The J&J vaccine is paused due to a rare form of stroke that occurred in fewer than a dozen people, after the single-dose shot was given and a European Union agency has recommended a warning for that vaccine.

One person died, per the information available April 20.

The other two emergency use vaccines – Pfizer and Moderna – are still in circulation, and no concerns have risen to the level of interrupted-use. Appointments are available now, for everyone older than 16.

As of April 20, the panel of CDC advisers tasked with assessing J&J had not yet completed a review of the data on the vaccine, to consider its safety profile. Health officials anticipate the vaccine will be returned to circulation, once the review is complete.

Dr. Chris Spitters, Health Officer for the Snohomish Health District during a Joint Information Commission briefing on April 13 offered perspective for the cases that prompted the J&J review, and the half-dozen cases that prompted the vaccine-pause. Another JIC meeting is scheduled for today, April 20.

"That's one in a million, and it's not been definitively established that these events are connected to the vaccination," Spitters said.

Reuters reports a goal by the CDC: to develop advice for health care officials, for treatment of the rare stroke that may be a side effect of the vaccine.

The European Medicine's Agency's statement on April 20 recommended a warning for J&J after reviewing data from eight reports from the United States, all with "serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome." The EMA report is here: https://bit.ly/2RGG35M.

Jason Biermann, Director of Emergency Management for the county, said Everett's new mass vaccination site, Angel of the Winds Arena in Everett, is closed April 13, the day the announcement was made.

The county will reschedule the appointments there, once the review of J&J is complete, or appointments can be made at other sites that carry Pfizer and Moderna, the two other emergency use vaccines for COVID-19. The county's mobile vaccination program continued with available COVID-19 vaccines.

Once more information is gathered on the status of J&J, the usual plans are likely to resume.

Medical professionals are required to report adverse events, so that they are weighed against successful experiences, according to the CDC's guidance on adverse events. COVID-19 vaccines are included in that protocol. The medical profession always applies a risk-benefit analysis to treatment: Pfizer and Moderna are safe, per that assessment of the available data.

"Of the more than 180 million doses administered so far of the Pfizer-BioNTech or Moderna vaccines, no reports matching those associated with the J&J/Janssen vaccine have been received," said the CDC statement on April 16.

The CDC will review the data through its Advisory Committee on Immunization Practices in an emergency meeting scheduled for this week. The Department of Health said when the safety-review began that 150,000 people in Washington state have received the J&J vaccine. Angel of the Winds in Everett, Snohomish County's newest mass vaccination site, offered the J&J shot when it first opened.

The CDC said they "do not know enough yet to say if the vaccine is related to or caused this health issue. To be extra careful, CDC and FDA recommend that the vaccine not be given until we learn more."

Fauci said the concern of drawing out the review of J&J is that it may increase overall vaccine hesitancy. But, he said, the caution taken shows that when they say it is safe, you know it's safe (https://reut.rs/3gj3GMb).

The blood clot occurred in women between the ages of 18 and 48, six to 13 days after the vaccination was given, the FDA states. U.S. review has not directly linked the J&J vaccination to those medical events. It is possible the two events – the vaccination and the stroke – occurred at the same time.

Courtesy of Snohomish Health District

J&J vaccines shown here were being prepared at the Angel of the Winds mass vaccination site in Everett. The single-dose vaccine was pulled for a safety review and appointments had to be rescheduled.

The CVST blood clot that triggered a J&J review is a rare form of stroke. When viewing the general population separate from the vaccination-receiving public, CVST affects five people in one million annually, according to Johns Hopkins Medicine.

Spitters said the district does not have full vision on why the pause was implemented. He suspects the reason with the small number of adverse reactions, is "out of an abundance of caution." The reduction in vaccine supply could temporarily slow the pace of vaccination in Snohomish County.

If someone who has had J&J and shows concerning symptoms within three weeks of the shot, a call to a health care provider is advised. Severe symptoms require a call to 911. Regardless of vaccine-status, an emergency call is advised with symptoms of a stroke. They include blurred vision, seizures, loss of control of a part of the body, and severe headache.

The CDC's statement on the safety review is here: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html. A conclusion to their review is anticipated. Check back for updates.

 

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