The Food and Drug Administration and Centers for Disease Control and Prevention issued a joint statement on April 13, recommending an immediate pause on administering the Johnson and Johnson/Janssen COVID-19 vaccine “out of an abundance of caution.” The ensuing 11-day pause was a result of six reported cases in which women ranging from 18 to 48 years of age experienced severe blood clots — a new condition known as thrombosis with thrombocytopenia syndrome (TTS) — less than two weeks after receiving the Johnson and Johnson vaccine. By the time the vaccine had been brought to a halt, 6.8 million doses of the vaccine had already been administered in the U.S.
The J&J vaccine is one of three CDC-authorized and recommended COVID-19 vaccinations, along with the Pfizer and Moderna vaccines. The J&J vaccine is currently only approved for those 18 and over and was reported as 66.3% effective in clinical trials at preventing COVID-19 two weeks after vaccination, compared to Pfizer and Moderna, which were 95% and 94.1% effective respectively.
Despite the lower efficacy, the J&J vaccine was 100% effective in trials against hospitalizations and death from COVID-19. Unlike the Pfizer and Moderna vaccinations, the J&J vaccination does not need to be stored at sub-zero temperatures and is administered in one shot rather than two. The single required shot makes administration and distribution easier for communities with limited access to health resources and may be more attractive to individuals with needle anxiety or busy schedules.
Less than a week before the recommended pause of the J&J vaccine, University President Mark Schlissel sent out an email to the campus community announcing that 7,500 doses of the J&J vaccine would be available for students to receive at locations across the three University of Michigan campuses at no cost.
After the recall was announced, student appointments for the J&J vaccine were either switched to Pfizer vaccine or cancelled altogether.
On April 23, Martino Harmon, vice president of student life, announced that being fully vaccinated against COVID-19 would be required for all students living in on-campus housing for the Fall 2021 semester. The University said students are considered fully vaccinated two weeks after receiving a single dose vaccine — like J&J — or two weeks after receiving the second shot in a two-dose vaccine series.
On that same day, the FDA and CDC put out an additional statement lifting the pause on the J&J vaccine, publicly reaffirming that it is both safe and effective.
As of May 14, including the six reported cases before the pause, there have been 28 total confirmed cases of TTS — six of them males. All of them were individuals who had recently received the J&J vaccine, and three patients died as a result.
Campus community remains confident in Johnson and Johnson vaccine safety
Although there were concerns regarding the J&J vaccine’s safety after the recall, a national poll conducted by the de Beaumont Foundation reported that 76% of those surveyed were just as likely to get a COVID-19 vaccine as they were before the pause. Additionally, a Kaiser Family Foundation poll found that only 18% of Hispanic women, 11% of Black men and 7% of white women said the news regarding the TTS cases made them less likely to get vaccinated.
U-M students have also expressed minimal concern about the recall of J&J or campus vaccination requirements. As of May 13, Michigan Medicine had administered over 126,000 COVID-19 vaccines with no signs of slowing down.
LSA sophomore Sophie Rogoff received the J&J vaccine prior to the recall and said she has no concerns about the safety of the vaccine. She mentioned her experience with using birth control, which the FDA states has between a 0.09% and 0.3% chance of causing blood clots. The risk of developing TTS after receiving the J&J vaccine is significantly lower than the blood clots occasionally caused by birth control.
“There’s literally so many more blood clots that happen from taking birth control than there were from the vaccination,” Rogoff said. “From what I read, it seemed like for other vaccines, something like this probably wouldn’t have forced a recall just because it was such a small percentage of people that got blood clots.”
U-M alum Caroline Sisson had also received the J&J vaccine before the recall and said ultimately, she was happy she received the vaccine.
“(The recall) freaked me out a little bit, even though I knew that I shouldn’t (be worried) because I take birth control, and the risk of getting a blood clot is way higher from that,” Sisson said.
Sisson also expressed support for a vaccination requirement for the entire U-M community and emphasized that recalls and subsequent research are important parts of the scientific process — something to be expected for some new vaccinations. The recall, Sisson said, is a sign that the medical system is working and safety concerns are being taken seriously.
“The recall just kind of demonstrates that science is evolving, and that sometimes there are things that go wrong,” Sisson said. “But all in all, I think that the research that they put into these vaccines is something that we have to respect, and I don’t think that (vaccination requirements) should change. People need to get it.”
University medical leaders are concerned vaccine hesitancy may increase for ‘fence-sitters’
Although American vaccine hesitancy levels are difficult to gauge right now, they present significant obstacles for healthcare providers. While the University Health Service (UHS) hopes to administer J&J vaccines again in the near future, the sudden nationwide pause led to increased scepticism about receiving them.
Abram Wagner, a research assistant professor of epidemiology at the School of Public Health, described how people process risk information regarding vaccines.
“If you (present) statistics to people and say there is a certain chance of blood clots after getting a COVID-19 vaccine, people don’t necessarily process risk information in a completely robotic and scientifically minded way,” Wagner said. “There is a large proportion of the population who I would term ‘fence-sitters’ who can be pushed into getting the vaccine (or) can be pushed into not getting the vaccine.”
Wagner noted that the pause of the J&J vaccine might have a stronger effect on these “fence-sitters,” who are often more sensitive to changes in public opinion or new information pertaining to vaccine safety.
“For a lot of these people there is this concern that the (J&J) vaccine was developed really quickly and they want to wait and see what the safety of the vaccine is like,” Wagner said. “For them, maybe this pause is a counterexample of this not being a safe vaccine.”
Beyond individualized hesitancy, some religious groups have expressed moral concerns about the J&J vaccine, encouraging members of their faiths to opt for Pfizer or Moderna instead. The state of Michigan currently permits religious and personal belief exemptions from school-required vaccinations for K-12 schools. The University will also accommodate certain exemptions to the COVID-19 vaccine requirement for on-campus housing. However, University Housing has not yet provided examples of acceptable reasons for exemption, and they note exemptions will be limited.
Not long after the J&J vaccine was first authorized by the FDA at the end of February, Grand Rapids Catholic bishops advised parishioners not to get J&J on account of moral concerns. More specifically, they criticized the vaccine because it was partially produced by using a stem cell line from an aborted human fetus.
The Catholic Student Evangelization and Catholic Campus Community did not respond to requests for comment in time for publication.
In an emailed statement to The Michigan Daily, Michigan Medicine highlighted its agreement with the FDA and CDC, emphasizing the University’s choice to provide one type of a two-dose vaccine series — either Moderna or Pfizer — at each University administration site in hopes to efficiently administer these vaccines to the campus community.
“U-M’s (UHS) is going to stock and offer Moderna. All University of Michigan sites have chosen one vaccine each to administer to simplify administration and dosing,” the Michigan Medicine statement read.
The Michigan Medicine statement added that it has not administered any doses of the J&J vaccine to patients since the pause a month ago but mentioned that they could be made available at “pop-up” vaccination sites in future semesters.
When discussing possible causes of vaccine hesitancy, Wagner explained that certain demographics may be more mistrustful of medical and government services in general due to past experiences with racism and medical mistreatment.
Black Americans and other marginalized populations have long been subjected to medical experimentation and abuse. Starting in 1932 and lasting over 40 years, the United States Public Health Service and the Tuskegee Institute in Alabama denied syphilis treatment to Black men in order to study the progression of the disease, even though treatment was available. The study cost many Black men their lives and their health. This medical atrocity, along with many others, is one of many reasons why experts expect increased vaccine hesitancy within BIPOC populations.
“I think there are certainly (concerns) within the Black community’s current lived experience with racism with medical mistreatment, which, of course, leads to mistrust of government and health authorities,” Wagner said.
At the University, the Central Student Government has already begun attempting to combat BIPOC vaccine hesitancy through a COVID-19 People of Color Impact Task Force.
Wagner specified another group that is less likely to trust any information or recommendations released by the current federal administration.
“Another group that has had stubbornly high vaccine hesitancy would be Republicans, typically white, Republican men, although it bleeds across the conservative spectrum,” Wagner said. “Their concern is that COVID-19 is not a serious disease.”
Wagner said most vaccine-related research has historically focused on parents who are cautious of their children receiving pediatric vaccines. Two studies from 1998 and 2002 are frequently cited by those claiming that the measles, mumps and rubella (MMR) vaccine causes autism in children. Although both studies were substantially flawed and the CDC reports no link between vaccines and autism, a 2020 study from the Oregon Health and Science University found one in six U.S. caregivers still believe immunizations could cause autism.
Wagner said parental vaccine hesitancy applies to the COVID-19 vaccine as well.
“With pediatric vaccines we know people have a lot of concerns and I don’t think that’s really translatable to the adult,” Wagner said. “When we’re thinking of adult vaccines prior to COVID-19, it was like seasonal influenza for all adults. But there is this perception that it wasn’t really that severe of a disease and I think that impedes people thinking that influenza might be a serious disease to want to protect against it.”
Wagner shared his recommendations for how to “nudge” those who are on the fence to get vaccinated. He described specific ways to make the vaccination more accessible and suggested working to influence public opinion such that getting vaccinated becomes second nature.
“Nudges in vaccination are really important to make it the default behavior that people get a COVID-19 vaccine, and these (nudges) can happen if you have the vaccine in more places,” Wagner said. “Like if you go to a doctor’s appointment, I would want … for the doctor to say, ‘We’re going to (offer) you the COVID-19 vaccine.’”
Wagner then discussed reaching herd immunity and the importance of not allowing a pause in the administration of the J&J vaccine to deter the community from reaching that benchmark. According to the Johns Hopkins School of Public Health, between 50% and 90% of a population must be immune to a virus in order to ensure herd immunity. This model may not apply perfectly to COVID-19 because it is a novel virus and new strains continue to be reported, but higher vaccination rates should help decrease the rate of infection and transmission.
“I think it’s just important for people to see that their friends and family around them have been vaccinated and have had good experiences with it,” Wagner said. “Certainly there are adverse reactions, but that goes away really quickly, and as a society I think we’ve done a pretty good job talking about that. So just continuing those conversations with people in their social networks will be really important.”
Daily Staff Reporters Emily Blumberg and Madeleine Bauer can be reached at email@example.com and firstname.lastname@example.org.