JACKSONVILLE, Fla. — The nearby train echoed through the Gateway vaccination site's parking lot Tuesday.
The staff, mainly the only ones at the site most of the day, after Gateway and sites across the state stopped giving the Johnson & Johnson vaccine around 7:35 a.m. Tuesday. The halt was due to national concerns about blood clots.
"Right now, I'd like to stress these events appear to be extremely rare, however, COVID-19 safety is a top priority for the federal government and we take all reports of adverse events following vaccination very seriously," Dr. Janet Woodcock, acting Commissioner of the Food and Drug Administration said Tuesday morning on a call with the press.
The FDA and the Centers for Disease Control and Prevention pressed pause on the J&J vaccine after six cases of blood clots were found among women 18 to 48-years-old who presented with symptoms six to 13 days after getting the shot. One woman died and another is in critical condition.
Almost seven million Americans have received the J&J shot and the FDA and CDC said the cases of clots were only seen in six people. This means the odds of getting the clots due to the vaccine are less than one in a million
Dr. Peter Marks of the FDA said the clots were likely caused by a certain type of immune response that happens rarely after getting the vaccine and involves the activation of platelets. He said while they're rare, they're severe because they can't be treated like a typical clot.
“Thee fact is that every day that people get the vaccine, the vaccine is protecting them against COVID-19, which kills people," Dr. Michael Koren, who heads up local vaccine trials at the Jacksonville Center for Clinical Research, said. "So, you always have to weigh these things of the risk versus the benefit.”
“Any medical intervention has risks, even something as simple as taking an Aspirin has a risk, but you weigh that against the benefit," Koren continued. "And again, we know the benefit of the Johnson & Johnson vaccine and the vaccines in general, that the benefits are very, very large. So, when you look at a very rare side effect, please put that into perspective."
A spokesperson for the Florida Division of Emergency Management said the state will follow CDC and FDA guidance when it comes to the J&J shot. Sites across the state, mobile vaccine clinics and homebound vaccinations will not use the J&J shot until further notice.
State officials are reviewing vaccine supply of Pfizer and Moderna to determine how to supplement sites affected by the J&J pause. Doses of J&J allocated to sites, clinics and homebound vaccinations will move to county health departments to be kept in storage in the meantime.
Prior to the CDC and FDA's announcement about the pause, eight people were given J&J at the federally supported vaccination site in Jacksonville, 195 in Orlando, 70 in Tampa and 134 in Miami, according to the spokesperson. The spokesperson for the Florida Division of Emergency Management said the agency found out about the pause at the same time everyone else did.
Healthcare workers at Gateway in Jacksonville said they had to turn away 70 to 80 people Tuesday asking for J&J, not aware of the pause.
Koren and a spokesperson for the state encouraged people to get the Pfizer or Moderna shots if they're able to.
You can go to Regency, the Legends Center, Edward Waters College or Celebration Church to get the shot. Those sites are all walkup sites. You can also go to either Panama Pharmacy location, but you have to make an appointment.
Pharmacies at stores like Publix, CVS, Winn Dixie and Harveys also halted administering J&J shots until further notice. Spokespeople at most of the stores said they're working to reschedule appointments for the public who were supposed to get J&J. Most also offer the Moderna and Pfizer vaccines, but that depends on the locations of the stores.
Dr. Anthony Fauci said Tuesday that the FDA and CDC's decision to press pause shows how careful the agencies are being with the vaccine.
"This is an extraordinary safety record that the others [vaccines] have and the fact that a pause was done, I think is just a testimony to how seriously we take safety," Fauci said.
Moderna and Pfizer haven't seen cases of clotting. Koren said there's a chance for more side effects in the J&J shot compared to Moderna or Pfizer because Johnson & Johnson involves getting an inactivated virus.
"You're giving an inactivated adenovirus, and that adenovirus can produce the spike protein from COVID-19, but it is a virus," Koren said. "So, you would predict that there may be a little bit more immunogenicity, or a more complicated immune response to a full virus being given to a patient, even though that virus can't reproduce itself," he said.
"The Pfizer and the Moderna products are literally just pieces of RNA. It's instructions that tell the body to make the spike protein, so there's no virus being injected," Koren continued. "So, that is potentially a difference between the two [Moderna and Pfizer vs. J&J]."
According to Fauci, if you got the J&J shot, don't worry too much because, again, the odds of this side effect happening to you are less than one in a million. He said having said that, pay attention to symptoms of shortness of breath, chest discomfort or headaches in that two week window following the shot.
Florida Governor Ron DeSantis commented on the pause at a press conference Tuesday as well.
“We have not seen any significant affects with J and J here in Florida and so, I got J and J and I think my arm was sore for 45 minutes and that was that," DeSantis said.
"So, I think the track record here in Florida thus far has been good. At the same time, because CDC is doing that [pressing pause on J&J], we’re respecting that decision and we’re going to follow that recommendation and monitor what they’re doing for the time being," he said.
The CDC's independent advisory committee meets Wednesday to look at next steps. Woodcock said she expects the pause to last just a few days. A spokesperson for the state of Florida said state officials will follow the CDC and FDA's guidance.