08/12/2021
CDC PANEL SAYS J&J COVID-19 VACCINE BENEFITS OUTWEIGH RISKS
• The CDC’s vaccine advisory committee reviewed cases of a rare neurological disorder seen in some people who received the Johnson & Johnson vaccine.
• As of June 30, there have been 100 cases of Guillain-Barré syndrome reported through the CDC’s vaccine safety monitoring system for Johnson & Johnson.
• This comes out to 8.1 cases per million doses administered, which is higher than the 1.6 cases per million doses expected in the general population.
Despite reported cases of a rare, but serious, neurological disorder after vaccination, an advisory group for the Centers for Disease Control and Prevention (CDC) said on Thursday the benefits of Johnson & Johnson’s COVID-19 vaccine “continue to outweigh the risks.”
As of June 30, there have been 100 cases of Guillain-Barré syndrome reported through the CDC’s vaccine safety monitoring system.
This comes out to 8.1 cases per million doses administered, which is higher than the 1.6 cases per million doses expected in the general population, according to slides presented at the Advisory Committee on Immunization Practices (ACIP) meeting on Thursday.
It is also about eight times the rate of Guillain-Barré syndrome seen with the Pfizer-BioNTech and Moderna-NIAID vaccines.
Cases reported to the Vaccine Adverse Event Reporting System (VAERS) still need to be reviewed in depth to confirm that they fit the definition of this neurological condition.
Benefits of vaccine outweigh risk of rare side effects
Guillain-Barré syndrome is a rare disorder in which the immune system mistakenly attacks the body’s nerves.
Symptoms include weakness and tingling in the extremities, difficulty with facial movements or walking, vision problems, and difficulty controlling the bladder or bowel.
This condition can also occur after a respiratory or digestive tract infection, including after infection with SARS-CoV-2, the coronavirus that causes COVID-19.
Of the 100 cases of Guillain-Barré syndrome reported through VAERS, 95 people were hospitalized, according to slides presented on Thursday. Ten patients were intubated and/or required mechanical ventilation and one person died. The other five cases were not serious.
Most of the cases occurred within 42 days following vaccination and in people 18 to 64 years old. In addition, 61 percent occurred in men.
ACIP member Dr. Pablo Sanchez, a pediatrician at The Ohio State University, said during the meeting that although he agrees the benefits of the J&J vaccine outweigh the risks, based on current data he would recommend an mRNA vaccine over the J&J vaccine.
However, “I have no problem continuing to have the [J&J] product available,” he added. “But I think that those risks have got to be stated up front to the person who’s receiving that vaccine.”
The ACIP’s review of these cases comes about a week after the Food and Drug Administration (FDA) updated the fact sheets for the J&J vaccine to include a warning about the risk of Guillain-Barré syndrome within 42 days after vaccination.
On July 12, the FDA updated the fact sheets for both , and healthcare providers.
ACIP chair Dr. José Romero said the one-dose J&J vaccine is an important tool for addressing the recent surge of COVID-19 cases and hospitalizations — almost all in unvaccinated people.
“Having access to a single-dose vaccine is very important to move us out of this situation,” he said, noting there are “individuals who will not come back for a second dose” of an mRNA vaccine.
Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the FDA, said in a video on Twitter that the benefits of getting vaccinated greatly outweigh the risks of rare side effects such as Guillain-Barré syndrome.
“COVID-19 is very real, and it’s unfortunately very much still with us. It is making a comeback [in the United States],” he said. “So if you’re not vaccinated, particularly if you’re in a community where there are low vaccination rates, it’s a good idea to get vaccinated.”
Booster doses for immunocompromised
The CDC’s vaccine advisory committee also discussed the possibility of COVID-19 vaccine booster doses for people who are immunocompromised.
These people are at higher risk of severe COVID-19 and may not generate as robust an immune response to the standard vaccine dose regimen.
During Thursday’s meeting, CDC staff suggested that both regulatory and non-regulatory approaches will be needed to help keep immunocompromised people safe from COVID-19.
Currently, the FDA’s emergency approvals allow people to receive one dose of the J&J vaccine or two doses of an mRNA vaccine.
The FDA would need to modify its current emergency use authorization (EUA) to allow a booster dose to be given. Another route would be full FDA approval, which would allow doctors to recommend a booster dose “off-label.”
FDA liaison Dr. Doran Fink said during the meeting that the agency does not yet have the data on the vaccines to support regulatory actions that would allow for booster doses.
Several studies have already looked at the benefits of booster doses for immunocompromised people.
The ACIP reviewed some studies during the meeting which found that among immunocompromised people who didn’t have a detectable antibody response to two doses of an mRNA vaccine, 33 to 50 percent did after a third dose.
However, without a decision from the FDA on boosters, some immunocompromised people are “taking matters into their own hands” and “proceeding with additional vaccine doses as they see fit,” said ACIP member Dr. Camille Kotton, of Massachusetts General Hospital in Boston.
Until booster doses are available to immunocompromised people in the U.S. — and maybe even after — the CDC recommends that these people continue to take other precautions, such as wearing a face mask while in indoor public spaces, physical distancing, and avoiding crowds.
The agency also says that family members and close friends can help protect immunocompromised people by getting vaccinated against COVID-19 themselves.
