U.S., STATE HALT USE OF J&J COVID-19 VACCINE
Six cases reported of women who developed blood clots; none seen in San Diego
state and local officials have called for a pause on the use of a coronavirus vaccine made by American pharma giant Johnson & Johnson after rare reports of severe blood clots among those who’ve been immunized.
Six women between the ages of 18 and 48 received the vaccine and developed blood clots in the veins that drain blood from the brain; they also had low platelet levels. One person has died, while another is in critical condition, according to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
These symptoms appear to be extremely rare. The six cases were reported out of 6.8 million people who’ve received the Johnson & Johnson vaccine in the U.S. — about one out of every million immunized individuals.
Nonetheless, the Centers for Disease Control and Prevention and the Food and Drug Administration issued a joint state-Federal, ment on Tuesday calling for a halt on the use of the vaccine. The California Department of Public Health and San Diego County followed suit hours later.
While any report of serious vaccine side effects is bound to raise fears, the announcement reassured local researchers that federal regulators aren’t compromising vaccine safety to fasttrack the rollout.
“It’s good that they’re monitoring it. It’s good that they paused. And that should give us all comfort that somebody is watching over the data and the safety of the vaccines as they go forward,” said Dr. Davey Smith, UC San Diego’s chief of infectious disease research.
The FDA and CDC are asking anyone who develops a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of getting the vaccine to contact their health care provider. Officials for these agencies say that anyone who got the shot more than a month ago is at low risk for developing
any symptoms.
None of the six cases were linked to San Diego County, where nearly 58,000 people have gotten the Johnson & Johnson vaccine, according to county officials. Roughly 1.2 million San Diegans have been immunized against the coronavirus, with the vast majority receiving the Pfizer or Moderna vaccines.
Johnson & Johnson announced that it is also suspending the rollout of its vaccine in Europe, and South African authorities have said they will halt their use of the vaccine, too.
“It is concerning. Any serious side effect linked to these vaccines needs to be looked at very carefully,” said Dr. Mark Sawyer, an infectious disease expert at Rady Children’s Hospital in San Diego. “This kind of thing is essentially inevitable when you roll out a vaccine across the whole population. We learn about rare side effects only when we start using the vaccine extensively.”
Johnson & Johnson’s vaccine was tested in about 40,000 volunteers. Even a trial of that size can’t predict whether a vaccine will have rare side effects that show up after immunizing millions. About 270 trial participants are part of a local study overseen by Dr. Susan Little of UC San Diego. Little says no one in the study has had severe blood clots, but she confirmed a prior report from STAT News that Johnson & Johnson paused its trial last fall after one participant showed signs of a blood clot. The study resumed after a couple weeks, with the company referring to the case as an “unexplained illness.”
People who’ve been vaccinated can develop symptoms unrelated to their shot. But a combination of blood clots and low platelet counts is quite unusual, said FDA officials during a call with reporters on Tuesday.
That combination closely resembles reports from Europe. Last week, the European Union’s equivalent of the FDA, the European Medicines Agency, announced that rare blood clots and low platelet levels should be listed as possible side effects of the AstraZeneca vaccine. These cases, which have occurred in around 1 out of every 100,000 vaccinated people, have mostly been seen in women under 60.
The AstraZeneca and Johnson & Johnson vaccines use modified common cold viruses loaded with genetic instructions that help spark immunity against the coronavirus. It’s possible that the immune response to these vaccines activates platelets and causes them to clot in some people. But it’s unclear at this point whether that’s truly the case, and, if so, why.
A CDC advisory committee will meet today and decide whether to update guidelines around who should receive the Johnson & Johnson vaccine, which is currently authorized for anyone 18 and up. The independent panel of experts may also conclude that it needs more time to decide what, if any, link exists between the vaccine and these cases.
A committee of scientists and doctors spanning California, Nevada, Oregon and Washington will conduct its own review. Sawyer serves on that committee, as does Dr. Rodney Hood of San Diego’s Multicultural Health Foundation.
“My biggest concern is that we may come out of this thorough investigation without a definitive answer,” said UCSD’s Little. “At that point, it is going to be necessary to look very carefully at the relative risk of acquiring COVID and the serious consequences that may come along with COVID hospitalization and death compared to the relative risk of this very rare disorder — which, admittedly, has some very potentially serious lifethreatening consequences.”
Janet Woodcock, acting commissioner of the FDA, framed Tuesday’s announcement as one made out of an abundance of caution, saying that the agency wants to identify any additional cases and help doctors treat vaccinated patients who showed similar symptoms. The standard remedy for blood clots, a blood thinner known as heparin, can actually be dangerous for those with this combination of blood clots and low platelet levels, so the CDC and FDA are advising doctors to try other options if they see such cases.
Woodcock expects the pause to last “a matter of days.”
But even a brief pause could stoke vaccine hesitancy at a time when public health officials stress that immunizing as many people as possible, as quickly as possible is key to avoiding new surges in cases and hospitalizations driven by fastspreading viral variants. On Thursday, all Californians 16 and up become eligible for a coronavirus vaccine.
Public health officials were already worried that Johnson & Johnson’s reported vaccine effectiveness, which is in the 60 percent to 70 percent range, would make it seem less protective than the Moderna and Pfizer shots. The latter two vaccines were tested before the rise of viral variants first spotted in the U.K., South Africa and Brazil, so scientists have cautioned against direct comparisons of vaccine efficacy.
Prior to Tuesday’s announcement, supply was the major issue for the Johnson & Johnson vaccine. Last week, California received nearly 575,000 doses of the company’s vaccine. This week, state officials expect to receive 68,000 doses. Next week, the figure drops to 22,000.
Vaccine manufacturer Emergent BioSolutions recently came under fire for mixing up ingredients between the Johnson & Johnson and AstraZeneca vaccines, causing up to 15 million doses to be wasted. It’s unclear if the lower-than-expected supply figures are the result of that blunder or a different issue.
The one-shot vaccine is being offered to the general population of eligible San Diegans, as well as groups where not having to return for a second dose is especially valuable — such as the homeless and farm workers. Sharp HealthCare has also used the vaccine to inoculate homebound seniors but may pause those efforts or switch to the Pfizer or Moderna vaccines, according to a Sharp spokesperson.
Dr. Wilma Wooten, the county’s public health officer, received the Johnson & Johnson vaccine in March.
Despite upticks in COVID-19 cases and hospitalizations in other parts of the U.S., local measures of the pandemic remain stable. The county reported 278 new infections on Tuesday and two additional deaths. There are 174 San Diegans in the hospital with COVID-19, up from the 158 regionwide hospitalizations reported Monday but within the range of the past couple weeks.