Health Commissioner Steven Stack and Gov. Beshear spoke about the Johnson & Johnson vaccine.
By Melissa Patrick
Kentucky Health News
On advice of federal experts, Gov. Andy Beshear announced Tuesday that Kentucky will pause the use of the single-dose Johnson & Johnson coronavirus vaccine after reports of blood clots in six of the 6.8 million people who have received it.
Other states did likewise. Beshear said the nation’s top health officials told him and other governors in a teleconference meeting that the pause is expected to be days to possibly a week, and is not likely to be longer.
“They believe that they will find the Johnson & Johnson vaccine to be safe to administer in the future,” said Beshear in an online news conference.
The six cases have all been women between 18 and 49 who have developed a rare and severe type of blood clot called cerebral venous sinus thrombosis, combined with low blood-platelet counts, with symptoms occurring six to 13 days after vaccination. The New York Times reports that one of the six has died and another has been hospitalized in critical condition.
“To my knowledge, we have not seen any side effects like this, this clotting, in Kentucky,” Beshear said. He added, “Obviously, this isn’t good news, but it is also not crippling news for our vaccination efforts. Kentucky has received very little Johnson & Johnson as has the country in terms of overall vaccination programs.”
In a joint statement, the Food and Drug Administration and the Centers for Disease Control and Prevention said these adverse events appear to be “extremely rare” and they have asked fora pause out of an “abundance of caution.”
“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,” they said.
He said federal officials are “doing what they think they they have to, but we’re all a little concerned about the the risk of dying from Covid versus just six people out of 6.8 million in the United States and the impact that this may have.”
Nate Silver, a national analyst of political and other data, tweeted, “6 cases out of 7 million people. What a disaster. This is going to get people killed. And it’s going to create more vaccine hesitancy. These people don’t understand cost-benefit analysis. They keep making mistakes by orders of magnitude.”
Dr. Kevin Kavanaugh, an infection-control activist who leads the Somerset-based watchdog group Health Watch USA, said we need “to be very careful that the enemy of the good is not better.”
Kavanaugh first noted that these severe episodes have occurred in less than one in a million people and then said to his knowledge the J&J vaccine was the only one so far that had been field tested in people with the South African variant and found to be effective. “So all things combined, personally I would still be willing to take the Johnson and Johnson vaccine,” he said.
Risk vs. reward
Stack also pointed to the need to balance the risks and the benefits of getting a coronavirus vaccine. “There is no risk-free choice in life,” he said.
Offering context and contrast, Beshear said there is less than a one in a million chance of getting such clots from the J&J vaccine, while Americans have a 1 in 558 chance of dying from Covid-19 if they get it.
“So, get a vaccine; [it’s] incredibly important during this period of time and we cannot let this slow us down,” he said.
Beshear encouraged anyone who was scheduled for a J&J vaccine in the next few days to call their provider to reschedule, noting that there are plenty of appointments available to get the two-dose Pfizer- BioNTech or Moderna vaccines.
“We need people, absolutely need you to get [one of those vaccines] so that we can hit our 2.5 million adult goal of vaccinations in Kentucky but also so we can get towards herd immunity,” he said.
He said about 5 percent of the coronavirus shots in Kentucky have been the J&J vaccine, about the same as the nation as a whole.
Anyone who has more than four or five days from Tuesday should hold on to their appointment for now and wait until the CDC and FDA have concluded their analysis, Beshear said.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices Wednesday to further review the cases, and the FDA will review that analysis as it also investigates them, their news release said.
Stack said we should be reassured that the surveillance system for vaccines is working as it should, noting that finding six people out of 6.8 million plus people so quickly “is like finding needles in a haystack.”
He added, “While this process unfolds, people who have received the J&J vaccine who develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination with J&J should contact their healthcare provider. And if you are more than four weeks out, it is incredibly unlikely you’ll have this problem.”
Health-care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html