FDA Set to Add Guillain-Barre Warning to J&J COVID Vaccine

MONDAY, July 12, 2021 (HealthDay News) -- The U.S. Food and Drug Administration will soon issue a new warning for the Johnson & Johnson coronavirus vaccine that will say the shot has been tied to a rare autoimmune condition known as Guillain-Barre syndrome.

Four individuals familiar with the situation told the Washington Post that officials will likely stress that the Johnson & Johnson vaccine is still safe. The association is far from definitive, said one of the individuals with knowledge of the situation.

The impending warning will deliver yet another blow to a vaccine that had been widely anticipated for its ease of use -- it requires only a single dose -- but which has also been haunted by problems.

About 100 preliminary reports of Guillain-Barré have been detected after 12.8 million doses of Johnson & Johnson vaccine were administered, the U.S. Centers for Disease Control and Prevention said in a statement, the Post reported. These cases have largely been reported about two weeks after vaccination and occurred mostly in men, many aged 50 and older. Most people fully recover, but a few have permanent nerve damage, according to the CDC.

Available data do not show a pattern suggesting a similar increased risk with the Pfizer and Moderna mRNA vaccines. The Guillain-Barré cases will be discussed as part of an upcoming meeting of CDC advisers, the agency said, the Post reported.

While the cause of the syndrome is not fully understood, it tends to follow infection with a virus such as the flu or bacteria. Each year, an estimated 3,000 to 6,000 Americans develop the illness, according to the CDC.

In April, U.S. officials paused use of the J&J vaccine after it was linked to another rare side effect -- severe blood clots. That pause was lifted within days following a safety review by the FDA and CDC, and a warning label on the association was added to the product.

Johnson & Johnson and the FDA would not comment on the latest safety issue, the Post reported.

"It's not surprising to find these types of adverse events associated with vaccination," Dr. Luciana Borio, a former acting chief scientist at the FDA under President Barack Obama, told The New York Times. The data collected so far suggest that the vaccine's benefits "continue to vastly outweigh the risks," Borio added.

Other COVID-19 vaccines have been linked to rare adverse events. The FDA in late June decided to add a warning to the Pfizer and Moderna coronavirus vaccines about mild, extremely unusual cases of heart inflammation in some young adults and teens after vaccination. Federal health officials said there was "a likely association," and that the problem appears most likely to occur in young men after they receive two doses of the vaccine.

At the time, the CDC and the U.S. Department of Health and Human Services, together with 15 of the country's leading medical and public health organizations, issued a joint statement saying they "strongly encourage everyone 12 and older" to get the shots because the benefits far outweigh any potential harms.

Also in June, the American Neurological Association reported that two studies published in the Annals of Neurology had found 11 cases of Guillain-Barré syndrome two to three weeks after vaccination with the AstraZeneca COVID vaccine. The cases, which were documented in England and India, involved an unusual variant of the disease that caused severe facial weakness, the organization said. An accompanying editorial described a similar case involving a Boston man who received the Johnson & Johnson vaccine, the Post reported.

Pfizer to Meet With U.S. Officials About Third COVID Booster Shot

Pfizer Inc. said it will meet with U.S. officials on Monday to discuss possible authorization for a third booster shot of its COVID-19 vaccine.

Last week, Pfizer cited data from Israel that found its vaccine is showing declining effectiveness at preventing milder coronavirus cases as the highly contagious Delta variant circulates in that country. But some American scientists and health officials have cautioned that only the company has seen that data so far, although Pfizer plans to share it with the U.S. Food and Drug Administration, the Washington Post reported.

At the same time, Dr. Anthony Fauci, the country's top infectious diseases expert, acknowledged Sunday that "it is entirely conceivable, maybe likely" that booster shots will be needed in the future.

Pfizer also announced last week that early data suggests people's antibody levels jumped five- to 10-fold after a third dose, demonstrating a convincing need for a booster shot.

Fauci didn't rule out the possibility of a third dose, but said that it was too soon for the government to recommend another shot, the Associated Press reported.

He added that the U.S. Centers for Disease Control and Prevention and the FDA were right in pushing back against Pfizer's claim with a joint statement that said they did not view booster shots as necessary "at this time."

Clinical studies and laboratory data have yet to fully illustrate the need for a booster shot for either the two-shot Pfizer and Moderna vaccines or the one-shot Johnson & Johnson vaccine, Fauci explained.

"Right now, given the data and the information we have, we do not need to give people a third shot," he said, the AP reported. "That doesn't mean we stop there... There are studies being done now, ongoing as we speak, about looking at the feasibility of if and when we should be boosting people."

"As data evolves" in the coming months, it is possible the government may urge a booster based on such factors as age and underlying medical conditions. "Certainly it is entirely conceivable, maybe likely at some time, we will need a boost,″ Fauci noted, the AP reported.

Only about 48% of the entire U.S. population is fully vaccinated, and in parts of the country where vaccination rates are lower, the highly contagious Delta variant is spreading and cases are climbing. Last week, CDC Director Dr. Rochelle Walensky said that's creating a harsh truth: Highly immunized swaths of America are returning to normal, while cases and hospitalizations are rising in places where vaccination rates are low.

Fauci said Sunday it was inexplicable that some Americans are so resistant to getting a vaccine when scientific data show how effective it is in staving off coronavirus infections and hospitalizations.

Arkansas Gov. Asa Hutchinson, agreed Sunday that there is a vaccine resistance in Southern and rural states like his because "you have that more conservative approach, skepticism about government."

Describing his efforts to boost vaccinations in his state, which is seeing a rise in new infections, Hutchinson said that "we do want those that do not have access otherwise to make sure they know about it."

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19.

SOURCES: Washington Post; Associated Press; The New York Times; CNN