U.S. CALLS FOR J&J VACCINE ‘PAUSE’
Move forces state to shift appointments
Pivoting to other available COVID vaccines, Connecticut officials said Tuesday the state’s rollout remains on track and people should feel safe after federal agencies have called to suspend the use of the Johnson & Johnson vaccine.
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have called for an immediate pause on the use of the Johnson & Johnson COVID vaccine amid reports of six cases of individuals developing rare but severe blood clots out of 6.8 million people who have received it.
The sudden news Tuesday morning prompted the state Department of Public Health to issue a similar recommendation to providers to stop using the Johnson & Johnson vaccine until the FDA and CDC conduct a review. It appears all of the providers heeded the call and spent much of Tuesday shifting appointments to use available supplies of Pfizer-BioNTech and Moderna mRNA vaccines.
“DPH will work with providers to minimize the disruptions from this announcement in the near-term to the extent possible, but we anticipate that some
cancellations will occur,” the department said in a statement.
Federal officials said the six cases, all involving women who had received a dose six to 13 days earlier, were out of 6.8 million people nationwide who have received the vaccine. DPH said none of these cases were in Connecticut.
“Roughly 100,000 Connecticut residents have received the J&J vaccine with no reported serious adverse events,” DPH said.
Following the announcement, state officials said there are still appointments available in Connecticut and disruptions should be minor.
“We are still full steam ahead in getting everyone vaccinated,” said Josh Geballe, chief operating officer for Gov. Ned Lamont.
On Tuesday, Connecticut reported a positivity rate of 3.77 percent for new COVID-19 tests. Hospitalizations were up a net of 21 patients for a total of 545 statewide. State officials said another 17 people died with the disease.
While it was unclear how many appointments were affected, it appears the pause had the greatest impact on mobile clinics, which have increasingly relied on the single-dose Johnson & Johnson vaccine.
DPH said the FEMA mobile clinic is modifying its schedule to offer a different vaccine and the Griffin Hospital mobile vans, which rely on the Johnson & Johnson vaccine, canceled clinics on Tuesday.
Lamont said DPH’s 35 mobile vans were “taking a pause” Tuesday, but would soon be equipped with Pfizer and Moderna vaccines.
Following a call with the White House COVID Task Force, Lamont said the hope is the pause will just be a matter of days.
The CDC plans to gather its immunization advisory committee on Wednesday to review the situation and weigh the significance of the small number of blood clot cases.
“Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot,” the FDA said in a statement.
In a news conference Tuesday morning, CDC Principal Deputy Director Anne Schuchat said suspending the use of the Johnson & Johnson vaccine also allows the health care system to prepare to recognize and treat patients properly and to report severe events they may be seeing in people who have received this vaccine.
The latest Connecticut figures show that nearly 97,000 people have received the Johnson & Johnson vaccine — accounting for about 10 percent of state residents who are fully vaccinated.
Providers shift appointments
Shelving the Johnson & Johnson vaccine, state officials said many providers have successfully replaced existing appointments with the Pfizer and Moderna vaccines.
At Hartford HealthCare, which runs a number of mass vaccination sites and smaller clinics across Connecticut, the plan was to halt administering Johnson & Johnson vaccines, but the impact was expected to be minimal since the allocation of those vaccines was expected to decline.
“All of our vaccine sites will still be open ... right now we can fully operationalize what we are doing with our current allocation of the mRNA vaccines,” said Dr. James Cardon, HHC’s chief clinical integration officer.
Cardon said the hospital had to adjust a mobile clinic that was going to use Johnson & Johnson vaccines, but it will instead use Moderna or Pfizer.
“Right now, it does not significantly interrupt a significant number of the appointments we have laid out simply because we had scaled back the J&J administration at our sites preemptively,” Cardon said, referencing the decrease in allocation.
Some pharmacies have similarly stopped plans to administer the Johnson & Johnson vaccine. Walgreens, which administers the vaccines in Connecticut, said it was contacting those with appointments and working to reschedule with the other vaccines “as supply allows.”
At Nuvance Health system — which includes Danbury, Norwalk, New Milford and Sharon hospitals — the pause was not affecting scheduled appointments.
“Nuvance Health is not currently administering J&J vaccines at hospital-based or medical practice clinics for community members due to limited supply so there should be no impact for individuals with scheduled COVID-19 vaccine appointments,” said Dr. Jeff Nicastro, chief medical officer for the system.
Dr. Zane Saul, chief of infectious disease at Bridgeport Hospital, called the blood clot incidents “heartbreaking.”
However, he pointed out the clots seem to be rare, and he was optimistic the pause in the Johnson & Johnson use wouldn’t affect availability of COVID vaccines overall.
“The good news is that Pfizer and Moderna both seem to be ramping up production of their vaccines, so we should be in good shape,” Saul said.
Providers are contacting people to adjust appointments and have been doing broad outreach to inform Johnson & Johnson vaccine recipients about the news, urging people to contact their doctor if they experience severe side effects.
Connecticut saw a recent surge in the number of Johnson & Johnson vaccines allocated to the state. State officials said last week was a “high water mark” for doses. But the allocation dropped sharply this week following a supply issue at a Maryland manufacturing facility, which had to discard 15 million doses.
Lamont said Monday that Connecticut received about 21,000 doses of the Johnson & Johnson vaccine. Last week, figures show the state received about 100,000.
The Johnson & Johnson vaccine has been used widely in local clinics, mobile vaccination efforts and at mass vaccination sites across Connecticut.
While Johnson & Johnson doses appeared to be mostly in use by mobile clinics this week, officials said they are working to deploy Pfizer and Moderna vaccines and determine how to provide second doses to the recipients.
“We know that people will need a second dose, and they’ll get their card and the date that they need their second dose,” Acting DPH Comissioner Deidre Gifford said Tuesday. “Today, we may not be able to schedule that second appointment every time. The goal will be to get the second appointment scheduled at the time of the first. But today and possibly tomorrow, we’re going to have to work through some of those glitches.”
Connecticut continues to receive a stable supply of Pfizer-BioNTech and Moderna vaccines.
“Good news is we are going to get extra doses next week of Pfizer and Moderna, so hopefully we are not going to miss a beat,” Lamont said. “And I don’t want to miss a beat because some of you say, ‘Here’s one more reason not to get vaccinated.’”
Lamont: Other vaccines still safe
While a pause in the use of Johnson & Johnson was unexpected news, officials spent Tuesday reassuring everyone that the other vaccines remain safe and people should continue to get inoculated.
“I’m here to reinforce how important it is that you continue to get vaccinated,” Lamont said. “CDC is being cautious when it comes to the J&J.”
Gifford said its important to note that this is a “rare event” and people should not be overly concerned.
“We were informed this morning by the FDA and CDC that they have not seen this combination of this blood clot with low platelets with any of the mRNA vaccines,” Gifford said, referencing the Pfizer and Moderna vaccines. “... As we’ve been saying all along, all these vaccines continue to be very safe.”
Despite the concerns about Johnson & Johnson, Saul still advises getting a COVID shot.
“Hopefully, this is not going to sway people from getting the vaccine, because millions of lives are being saved,” he said.
While the CDC reviews the matter, federal officials have not said when the pause may be lifted. The FDA said, “vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”
Johnson & Johnson’s vaccine received emergency authorization from the FDA in late February after a trial showed it was safe and effective at preventing serious symptoms and death.
“We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines,” Johnson & Johnson said in a statement. “At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.”