JACKSONVILLE, Fla. – Gateway Mall and its federal satellite vaccination sites run by the federal government in Jacksonville discontinued giving Johnson & Johnson coronavirus vaccines Tuesday morning within hours of a call from the Centers for Disease Control and Prevention and the Federal Drug Administration recommending a pause in giving the vaccine. The state-run sites and privately-run pharmacies quickly followed the federal guidance.
Additionally, Publix in a news release stated Tuesday evening that it too is suspending the administration of the J&J shot.
The CDC and FDA recommended the immediate pause on the one-shot vaccine while authorities investigated reports of potentially dangerous blood clots. The clots were observed in the sinuses of the brain along with reduced platelet counts, making the usual treatment for blood clots -- the blood thinner heparin -- potentially “dangerous.”
All six cases of blood clots occurred among women 18 to 48 years old and symptoms occurred within 13 days of receiving the vaccine. One died and a second is in critical condition.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement.
More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects. Johnson & Johnson said it was aware of the reports of “thromboembolic events,” or blood clots, but that no link to its vaccine had been established.
“People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider,” the CDC said in a statement.
Gov. Ron DeSantis said during a press conference Tuesday there is no need to panic about the vaccine.
“We have not seen any significant effects with J&J here in Florida,” DeSantis said. “I think the track record thus far in Florida has been good. At the same time, because CDC is doing that, you know, we’re respecting that decision, we’re going to follow that recommendation and monitor what they’re doing for the time being. But I think that what they’re doing is that of an abundance of caution.”
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DeSantis said when he received the J&J shot a few weeks ago, his arm was sore for 45 minutes but he had no other side effects.
“I don’t think people should be worried who’ve already had it, who haven’t had any effects,” he said. “I think it’s likely going to be very effective for you.”
Jeff Zients, the White House COVID-19 response coordinator, said in a statement that President Joe Biden’s administration did not anticipate the pause would have a “significant impact” on ongoing vaccine plans. He said the administration was receiving enough doses of the Pfizer and Moderna vaccines to ensure enough supply to maintain the current national pace of 3 million shots a day.
DeSantis echoed that, telling reporters that he expected Florida would continue to have a “robust” supply of doses.
William Chapman arrived at Gateway early Tuesday expecting to get his J&J vaccine.
“Now I’m confused,” William Chapman said as he was turned away. “I thought they got all the testing out of the way.”
Medical experts recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain or shortness of breath within three weeks after receiving the shot contact their health care provider.
“We need to hold off in terms of our judgment right now. I think we are all in an OK boat right now, and certainly, if you have received the Johnson & Johnson vaccine, this is not a cause for alarm,” Dr. Jonathan Kantor with the Penn Center for Epidemiology said Tuesday on The Morning Show. “That is exactly what I would tell my family as well.”
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The Federal Emergency Management Agency is waiting on further guidance on how to proceed at their mass vaccination sites around the country.
Moderna, Pfizer vaccinations continue
The other two authorized vaccines, from Moderna and Pfizer, make up 95% of COVID-19 shots administered in the U.S. and are not affected by the pause. Jacksonville’s second-largest vaccination site -- Regency Square -- is giving the Pfizer vaccines. Edward Waters College, the Legends Center and Celebration Church also do not use J&J and remain open.
Most pharmacies offer a choice of vaccines. Southeastern Grocers, which owns Winn-Dixie and Harveys, announced that people who had a J&J vaccine scheduled will be sent a text notifying them their appointment is canceled, but they are encouraged to make a new appointment to receive either the Moderna or Pfizer vaccine.
The J&J vaccine received emergency use authorization from the FDA in late February with great fanfare, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country. Yet the shot only makes up a small fraction of the doses administered in the U.S. as J&J has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.
Last week the drugmaker took over the facility to scale up production in hopes of meeting its commitment to the U.S. government of providing about 100 million doses by the end of May.
The European Medicines Agency stressed that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have imposed limits on who can receive the vaccine; Britain recommended that people under 30 be offered alternatives.
But the J&J and AstraZeneca vaccines are made with the same technology. Leading COVID-19 vaccines train the body to recognize the spike protein that coats the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body. J&J uses a human adenovirus to create its vaccine while AstraZeneca uses a chimpanzee version.
The announcement hit U.S. stock markets immediately, with Dow futures falling almost 200 points just over two hours before the opening bell. Shares of Johnson & Johnson dropped almost 3%
