Ky. pauses use of one-dose coronavirus vaccine over rare side effects; Beshear worries that federal call will have negative effects

Photo illustration from People.com

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.

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.  

Vaccine hesitancy

Asked if the announcement will increase vaccine hesitancy among those who are already resistant to getting a coronavirus vaccine, Beshear said, "This doesn't help." 

He said it will be important to increase communications and education about the risk of Covid-19 as well as the safety and efficacy of the vaccines. 

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." 

He later added, "I am concerned that if there are not more cases out there that the hesitancy coming out of the pause could potentially outweigh the need for it. But this is how they work. This is how the CDC and the FDA work."

Beshear is not alone in that concern.

Louisville public-relations executive and Republican political operative Scott Jennings said on Twitter, "FDA got people killed today. We will never know how many." In another tweet, he wrote, "The ripple effect of this will last forever. people will die because of this, as it will lead to even more vaccine hesitancy. Nuts."

Tim Alberta, chief political correspondent for Politico magazine, tweeted, "We've already heard from two friends this morning, unsolicited, that this J&J stoppage has convinced them the vaccines were rushed and can't be trusted. Heckuva job." 

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."

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.

The Washington Post's article digs into the payoff between the risk and reward of getting a vaccine to protect against the coronavirus, with a time interactive time-lapse graphic that illustrates the rarity of one in a million. Reporter Philip Bump writes, "By way of comparison, every year about 12 in 100,000 Americans die in a car crash." Or, 120 times as likely as one in a million.

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. 

Beshear announced Monday that he would stop restricting capacity and hours of almost all business and other activities once about 900,000 more Kentuckians have been vaccinated for the coronavirus, for a total of 2.5 million. So far, about 1.6 million Kentuckians have received at least one dose of a coronavirus in Kentucky.

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 to 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 also encouraged Kentuckians to continue to get vaccinated, noting that the majority of vaccines given in the state have been Pfizer BioNTech or Moderna, neither of which have shown any signs of this concern. 

"It's important to remain mindful that Covid-19 is a dangerous disease that in just a single year, has taken the lives of nearly 3 million people worldwide, approximately 560,000 Americans and more than 6,200 Kentuckians," he said.

"Safe and effective vaccines are a critical tool to protecting our people and putting this pandemic behind us. . . . And again, the governor has already shared very compelling statistics that show the relative risk of harm from Covid enormously outweighs the risk of any potential harm from a vaccine."

Beshear said, "They're being careful, they want to make sure they can treat anyone who has a side effect because of this vaccine. But we even believe that the Johnson & Johnson vaccine is likely to be up and running and maybe directed at a different population, but still back in the fold soon."

Symptoms and treatment

Beshear said the pause is necessary to determine how many cases are truly out there and to also ensure that medical providers know the appropriate treatment for this specific type of blood clot, which is different than the treatment that is typically administered. 

The FDA and CDC say, "Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given." 

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