The Johnson & Johnson vaccine pause: What you need to know

Early today, US health systems announced plans to halt the distribution of the Johnson & Johnson (J&J) COVID-19 vaccine at federal sites following emerging medical concerns.

The Food and Drug Administration has initiated a campaign with the Centers for Disease Control and Prevention to urge state officials to do the same until all relevant safety issues are resolved. Here is everything you need to know about the efficacy of the Johnson & Johnson vaccine.

Why they are pausing the Johnson & Johnson vaccine

Six US recipients of the single J&J COVID-19 vaccine dose developed a rare blood clot disorder called cerebral venous sinus thrombosis within two weeks of vaccination. As of the time of this writing, one has died and another is hospitalized in critical condition. All were women between the ages of 18 and 48.

Cerebral venous sinus thrombosis, defined as the presence of a blood clot in the dural venous sinuses, is reportedly extremely rareaffecting five in 1 million people each year.

Clinicians believe that the six J&J patients may be experiencing an adverse immune response triggered by the vaccine.

Back in early April, the European Medicines Agency announced that it was investigating four cases of blood clots in people (one fatal) who received the J&J vaccine in the US. One of these patients developed blood clots during the clinical trial that took place just before the vaccine was officially authorized.

The CDC’s outside advisory committee has scheduled an emergency meeting for Wednesday.

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the C.D.C., said in a joint statement. “Right now, these adverse events appear to be extremely rare.”

Still, officials presiding in Ohio, New York, Connecticut, Nebraska, and New Hampshire have advised health providers in their respective states to temporarily stop administering J&J shots.

“This news will not slow down New Hampshire. While the federal government has directed a brief pause in the J&J vaccine, the state is already working with our partners to ensure that they have an alternative supply of Pfizer or Moderna to help continue their efforts today,” New Hampshire Governor Chris Sununu said in a statement.

Are the other vaccines affected?

“This announcement is specific to the J&J COVID-19 vaccine and not related to the Moderna and Pfizer vaccines. We encourage people to continue with their scheduled appointments.”

Pfizer-BioNTech and Moderna, which together deliver more than 23 million doses a week of their two-shot vaccines, utilize different technology in order to protect recipients from clinically recognizable COVID-19. You can read more on that here.

Both manufacturers require patients to receive two shots at different intervals, whereas J&J’s vaccine (produced by Janssen) only requires one dose. All are suspected to be effective against the new more transmissive coronavirus strains reported late last year.

The CDC reports that roughly 7 million people have received the J & J shot in the US, and another 9 million more doses have been shipped out.

“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,” Johnson and Johnson said in a media release.

As a result of this update, the Australian government announced it would not purchase Johnson & Johnson vaccines. 

There have been no major adverse outcomes linked to Pfizer or Moderna’s vaccine doses.

“NYC now has the biggest messaging challenge yet in vaccination,” Mark D. Levine, a New York City councilman wrote on Twitter. “We have to do everything possible to avoid a collapse in confidence in vaccination overall.”

What to know if you got the Johnson & Johnson vaccine

If you received the Johnson & Johnson vaccine at least three weeks ago, then you are most likely in the clear. If it was more recent than that, the CDC recommends people monitor themselves for symptoms including severe headache, abdominal pain, leg pain, or shortness of breath.

Most of the symptoms are expected to appear within six to 13 days of getting the shot. If you do exhibit any of these, you are advised to contact your doctor immediately.