Local providers are pausing distribution of the Johnson & Johnson coronavirus vaccine at the recommendation of two national public health agencies amid a study of “extremely rare” blood clotting side effects.
The Centers for Disease Control and U.S. Food and Drug Administration issued a joint statement Tuesday morning calling for the pause, noting only six cases of rare clotting were connected to the one-shot vaccine, which has been administered to about 7 million Americans.
“Right now, these adverse events appear to be extremely rare,” the agencies said in a joint press release. “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. People who have received the Johnson & Johnson vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.”
Essentia Health and St. Luke’s said Tuesday that they would pause use of the Johnson & Johnson vaccine. A spokesperson for St. Luke’s said the provider has only administered a “very small amount” of the vaccine and Essentia said the pause would only impact its immediate supply in the Brainerd Lakes region.
A St. Louis County spokesperson said only 274 of the 30,599 doses administered have been Johnson & Johnson. They received 375 more for dispersal through mobile clinics, but will instead use the Pfizer/BioNTech vaccine.
“Getting vaccinated remains the safest way for people to protect themselves and our communities from this devastating virus,” the county officials said through a statement. “At all of our larger clinics, we have been administering the Pfizer/BioNTech and Moderna vaccines, so these efforts will not be affected at all.”
CDC and FDA officials said the pause is not related to the effectiveness of the Johnson & Johnson vaccine and those who received it will not need to be revaccinated. The recommendation also doesn’t account for the Pfizer or Moderna vaccines, which use a different technology, and have not been associated with more severe side effects.
In a statement, Johnson & Johnson said “at present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.”
Those six severe cases were found in women between the ages of 18 to 48 since April 12, when more than 6.8 doses of the vaccine were distributed, with symptoms occurring 6 to13 days after vaccination. One woman died and a second woman has been hospitalized in critical condition. None of the six clotting cases were reported in Minnesota.
Large pharmacies including CVS and Walgreens said they would pause the vaccine’s use after the agencies’ recommendation and Minnesota was one of several states to call on providers to follow the newly-issued guidelines.
“While this issue appears to be extremely rare, CDC and FDA are acting in a very cautious manner that underscores our commitment to vaccine safety,” said Minnesota Health Commissioner Jan Malcolm, in a statement Tuesday. “We will be closely monitoring the federal review process and use that information to help guide our efforts here in Minnesota in the days ahead.”
The Minnesota Department of Health noted the Johnson & Johnson vaccine accounts for about 6.6 percent of the total supply of vaccines Minnesota has received to date, and the pause “is not expected to dramatically slow the pace of vaccinations in the state.”
Malcolm said at a late morning press conference that she hoped the delay would be “just a matter of days” and MDH was exploring substitute doses of other vaccines, but acknowledged logistical hurdles.
“This is an unfortunate development, but this is the way the process is supposed to work," Malcolm said when asked if the pause could contribute to vaccine hesitancy.
People with appointments for a Johnson & Johnson dose should watch for cancellation, postponement or rescheduling notices from their provider. Essentia said it would “work to reschedule all appointments for individuals who expected to receive this vaccine in the coming days.” MDH said other vaccination appointments can be found through Vaccine Locator map, local pharmacies or health care providers.
Minnesota reported more than 1,300 new COVID-19 infections Tuesday amid a recent increase in case growth rate. St. Louis County has particularly felt the new infection rate, reporting 100 cases in a day late last week, registered 60 new cases Tuesday. Itasca County officials also pointed out a “sustained rise” in new cases, especially among young people, with 98 new infections over the past week.