Georgia will temporarily stop administering the Johnson & Johnson COVID-19 vaccine, following federal recommendations after six recipients nationwide reported a rare and severe stroke-like illness, which caused a death in one case.
Officials stress that the six patients comprise fewer than one in 1 million Americans who received the Johnson & Johnson vaccine.
Healthy Georgians who have gotten the vaccine should not be overly concerned because the side effects are so rare, said Georgia State University public health professor Dr. Harry J. Heiman, but the pause will allow medical experts to assess the situation.
“The studies that that we use to evaluate the vaccines are data on tens of thousands of people, so we can get a really good idea about how safe they are, but when you’re talking about very rare potential side effects that might occur in one in a million, you can’t begin to see those until you literally have millions of people who’ve been vaccinated,” Heiman said.
The federal government did not specify how long the pause would last. Additional information for Georgians, including about rescheduling appointments, will be released shortly, according to the state Department of Public Health.
Johnson & Johnson produced about 256,000 of the more than 5.7 million vaccines shipped to Georgia, less than 5%. The bulk of Georgia’s vaccines were made by either Pfizer or Moderna, neither of which have produced severe side effects.
Because of that, the pause is not likely to have a major effect on Georgia’s vaccination efforts, though the one-dose Johnson & Johnson shot has its advantages, Heiman said.
“The nice thing about the Johnson & Johnson vaccine was that it’s a single dose and it doesn’t have some of the same requirements around storage,” he said. “That made it more accessible to both individual providers and to people practicing in more remote settings, rural areas and things like that. So it would certainly be concerning if we’re not able to resume using it, but at the same time, we have other options from the perspective of vaccines.”
The pause comes after six vaccine recipients in the U.S., all women between 18 and 48, reported a rare blood clotting disorder called cerebral venous sinus thrombosis, or CVST, within two weeks of getting the shot.
About 6.8 million Americans have received the Johnson & Johnson vaccine without these serious side effects, said acting Food and Drug Administration Commissioner Dr. Janet Woodcock.
“I’d like to stress these events appear to be extremely rare, however COVID-19 vaccine safety is a top concern for the federal government, and we take all reports of adverse events following vaccination very seriously,” Woodcock said.
The type of treatment doctors normally administer for blood clots could be dangerous for a patient with CVST, federal officials warned, so doctors will need to determine a patient’s vaccination history before providing blood clot treatments.
A pause in Johnson & Johnson vaccinations will give health care providers time to prepare to watch out for symptoms of CVST among patients with blood clots, said Dr. Anne Schuchat, principal deputy director of the Centers for Disease Control and Prevention in Atlanta, which is scheduled to host a committee on immunization practices Wednesday to review the cases,
“This will allow careful deliberation about what we know so far about these events and consider next steps given the current context of the COVID-19 pandemic in the United States and our broader immunization efforts,” Schuchat said.
People who have gotten the shot in the last two weeks and experience severe headaches, abdominal pain, leg pain or shortness of breath should call a doctor, Schuchat said.
Mild flu-like symptoms in the days following COVID-19 vaccinations are common and not a major concern, and people who have received the Johnson & Johnson shot over a month ago are at very low risk, she added.
Jeff Zients, the White House’s COVID-19 response coordinator, said Tuesday that there is enough supply available of Pfizer and Moderna doses to continue the current pace of 3 million shots per day, adding that the Biden administration is working with states and federally run vaccine sites to reschedule anyone with a Johnson & Johnson appointment to receive one of the other available shots.
As of Monday, Georgia has administered nearly 4.8 million doses, and more than 1.7 Georgians are fully vaccinated.
But Georgia has ranked near the bottom of states in per capita immunizations, according to CDC data. Gov. Brian Kemp has criticized that data, but he has also acknowledged many Georgians are hesitant to get the vaccine, especially in more rural parts of the state.
Heiman said he is concerned a pause in Johnson & Johnson vaccinations could increase hesitancy, when he thinks it shows the system is working as intended.
“From where I’m sitting, information like this and the response that’s being taken should actually reassure the public that we’re doing everything that we need to be doing to ensure that vaccines are safe,” he said. “When there are concerns that are raised in a very clear and transparent way, that’s communicated with the public, and when appropriate, we pause or stop giving the vaccine until we have all the information we need to know that it’s safe and appropriate.
“This isn’t something that someone discovered and leaked to the media,” he added. “This is actually an example of the vaccine surveillance system working exactly the way it was designed to work.”