CDC panel says benefits of J&J COVID-19 vaccine outweigh risks

Guillain-Barré syndrome is a rare sickness in which the immune system mistakenly attacks the nerves in the body.

Symptoms include weakness and tingling in the extremities, difficulty moving your face or walking, vision problems, and difficulty controlling the bladder or bowels.

This condition can also occur after an infection of the respiratory or digestive tracts, including after SARS-CoV-2 infection, the coronavirus that causes COVID-19.

Of the 100 cases of Guillain-Barré syndrome reported via VAERS, 95 people have been 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 cases have occurred within 42 days of vaccination and in people aged 18 to 64 years. Additionally, 61 percent occurred in men.

member of ACIP Dr. Pablo Sanchez, a pediatrician at Ohio State University, told the meeting that while he agrees that the benefits of the J&J vaccine outweigh the risks, based on current data, he would recommend an mRNA vaccine rather than the J&J vaccine.

However, “I have no problem continuing to have the [J&J] product available, ”he added. “But I think those risks need to be declared up front to the person receiving this vaccine.”

ACIP’s review of these cases comes about a week after the Food and Drug Administration (FDA) updated the J&J vaccine fact sheets to include a warning about the risk of Guillain-Barré syndrome. within 42 days of vaccination.

On July 12, the FDA updated the fact sheets for the two beneficiaries and carers, and health care providers.

ACIP President Dr José Romero said the single-dose J&J vaccine is an important tool to deal with the recent ascend of COVID-19 cases and hospitalizations – almost all in unvaccinated people.

“Having access to a single dose vaccine is very important in getting us out of this situation,” he said, noting that there are “individuals who will not come back for a second dose” from vaccine to vaccine. MRNA.

Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in a video on Twitter that the benefits of getting the vaccine far outweigh the risks of rare side effects such as Guillain-Barré syndrome.

“COVID-19 is very real, and it is unfortunately still with us. he is back [in the United States], “he said.” So if you are not vaccinated, especially if you are in a community where vaccination rates are low, it is a good idea to get vaccinated. “

The CDC’s vaccine advisory committee also discussed the possibility of booster doses of the COVID-19 vaccine for people who are immunocompromised.

These people are at a higher risk of severe COVID-19 and may not generate such a robust immune response to the standard vaccine regimen.

During Thursday’s meeting, CDC staff suggested that regulatory and non-regulatory approaches will be needed to help protect immunocompromised people from COVID-19.

Currently, emergency FDA approvals allow people to receive one dose of the J&J vaccine or two doses of an mRNA vaccine.

The FDA is expected to amend its current Emergency Use Authorization (EUA) to allow for the administration of a booster dose. Another route would be full FDA approval, which would allow doctors to recommend an “off label” booster dose.

Liaison with the FDA Dr Doran Fink said at the meeting that the agency does not yet have the vaccine data to support regulatory actions that would allow booster doses.

Several studies have already looked at the benefits of booster doses for people who are immunocompromised.

ACIP reviewed some studies during the meeting that found that among immunocompromised people who did not have a detectable antibody response to two doses of an mRNA vaccine, 33 to 50 percent did so after one. third dose.

However, without an FDA decision on the recalls, some immunocompromised people are “taking matters into their own hands” and “taking additional doses of the vaccine as they see fit,” said an ACIP member. Dr Camille Kotton, from Massachusetts General Hospital in Boston.

Until booster doses are available for immunocompromised people in the United States – and possibly even after – the CDC recommends that these people continue to take other precautions, such as wearing a face mask. in indoor public spaces, physical distancing and avoiding crowds.

The agency also says family members and close friends can help protect people with compromised immune systems by getting themselves vaccinated against COVID-19.