The Centers for Disease Control and Prevention and the Food and Drug Administration called for a temporary stop to the so-called “one-and-done” vaccine after six women in the United States developed a rare disorder involving blood clots. Their illnesses surfaced within about two weeks of receiving the vaccination.
Some 6.8 million people in the United States have received the Johnson & Johnson shot so far, according to the CDC and FDA.
@MonroeHealth will suspend use of J&J COVID-19 vaccine until further notice in accordance with FDA and CDC recommendations.— Dr. Mike Mendoza (@DrMikeMendoza) April 13, 2021
RELATED: The CDC and FDA's joint statement in full
“Right now, these adverse events appear to be extremely rare,” the statement went on. “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.”
The officials urged people who have received the J&J vaccine and develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination to contact their health care provider.
Mendoza said he did not know exactly how many J&J vaccines had been administered in the region. But Dr. Ed Walsh, head of infectious diseases at Rochester General Hospital, said the number is believed to be relatively small.
Walsh thinks that is related to two factors: the slow rollout of the vaccine in general and the fact that in New York state, the vaccine was initially restricted to small populations, including patients who were about to be discharged from a hospital.
"Most of the people who received (the vaccine) upon discharge from the hospital in Rochester were not in the category that seems to have been susceptible to this unusual event,” Walsh said in reference to the six women between the ages of 18 and 49 who experienced blood clots after getting the vaccination.
Walsh said Rochester-area residents who received the J&J vaccine were likely older.
He added that the symptoms reported by the patients who experienced blood clots are not uncommon in anyone who has been recently vaccinated, say, within the past three to four weeks.
"Individuals who were vaccinated several months ago, it would appear, have no risk,” Walsh said. “Someone in that category would probably not require as careful an investigation."
Although Walsh believes people who were already hesitant about the vaccines will probably be further discouraged by the news about the apparently rare but potentially serious side effects from the J&J vaccine, he believes the CDC’s and FDA’s decision to pause and investigate it are warranted.
"Clearly the risk of dying from COVID far exceeds the risk of dying, say, from one of these very rare, one-in-a-million events,” he added. “But it still raises concerns for all individuals and it's understandable."
Mendoza called the pause a "setback in the effort to vaccinate," but said it's "a sign that the system is working."
"We were able to pull together a response to the news that came out just very shortly ago, and mobilize the entire community around an appropriate response," he said. He stressed that the public should not panic.
“I do want to remind people that association doesn't equal causation,” Mendoza said. “Right now, we have an association that we need to understand, we need to see if the vaccine was in fact, the cause of these side effects. But we don't know that yet.”
State Health Commissioner Dr. Howard Zucker said in a statement that the state would follow the FDA and CDC's recommendation and immediately pause use of the vaccine.
"All appointments for Johnson & Johnson vaccines today at New York State mass vaccination sites will be honored with the Pfizer vaccine," Zucker said.
The State University of New York system, which had planned to use the J&J vaccine for its students this semester, also said it would hold off.
Chancellor Jim Malatras said in a statement that SUNY is working with the state to acquire other vaccines for students.
"We urge all students with appointments for the Johnson & Johnson vaccine to contact their campus or vaccination site because alternatives have already been found in some instances," he said. "While we must not slow down the process of protecting our students from the COVID-19 virus, we must also do all we can to ensure their safety and health every step of the way. We will keep our campus communities informed as more information becomes available.”
SUNY Brockport was preparing for its first day of on-campus student vaccinations when news of the J&J vaccine broke.
John Follaco, Brockport’s director of communications, said the student body is disappointed, but understands the health and safety of their community will continue to be at the forefront of the college’s plans.
“When scientists tell us that we need to pause, delay, or stop vaccinating people using the Johnson & Johnson vaccine, that's what we're going to do,” Follaco said.
Brockport is holding on to its 300 doses of J&J vaccine until instructed otherwise by the SUNY Board of Trustees, he added.
St. John Fisher and Nazareth colleges, which were planning to use the J&J shots, postponed its clinics for students.
Beth Adams and Racquel Stephen are reporters for WXXI, a media partner of CITY. David Andreatta is CITY’s editor. He can be reached at firstname.lastname@example.org.