The Benefits of Johnson & Johnson COVID-19 Vaccine ‘Continue to Outweigh’ the Risk of Neurological Disorder: CDC Advisory Panel

The vaccine advisory panel to the Centers for Disease Control and Prevention (CDC) said on Thursday that the benefits of Johnson & Johnson’s COVID-19 vaccine still outweigh the risk of a serious, but rare, neurological disorder following vaccination.

The Advisory Committee on Immunization Practices met to discuss the incidence of Guillain-Barré syndrome (GBS) following a J&J shot and agreed that the vaccine should continue to be used in people 18 and older under the Food and Drug Administration’s (FDA) emergency use authorization, saying that the vaccine’s benefits far outweigh the risks.

GBS is a condition where the individual’s immune system attacks the body’s nerve cells, causing numbness, pain, and muscle weakness. In severe cases, it can progress to paralysis. An estimated 3,000 to 6,000 cases of GBS are reported annually in the United States with most people making a full recovery, “but some have permanent nerve damage,” according to Dr. Mathew Daley of the advisory panel’s COVID-19 Vaccines Work Group.

However, cases of GBS after a J&J vaccine were higher than expected in the general population with 8.1 cases per one million doses. This was also higher than reported cases of GBS after receiving the messenger RNA vaccines: 1.21 cases per one million for the Moderna vaccine and 1.05 cases per million for the Pfizer vaccine.

About 100 cases of GBS were reported within 42 days following vaccination with a J&J vaccine on the Vaccine Adverse Event Reporting System (VAERS) as of June 30. Around 12.6 million doses of the vaccine have been administered.

Of the 100 cases, 95 were serious and required hospitalization, with 10 patients needing a ventilator and one death 25 days post-vaccination of a 57-year-old man with a medical history of stroke, heart failure, high blood pressure, and diabetes.

According to a presentation by Dr. Meghna Alimchandani of the FDA, 83 percent of the cases occurred in patients aged 18 to 64 years, with the risk of GBS being highest in males and a median onset time of 13 days.

While 84 percent of the cases occurred in the 21-day risk window used for assessment, “the majority of the cases, 98 percent, occurred in that 42-day risk window,” Alimchandani said. Two cases were not included in the timeframe as one occurred outside the 42-day window and the other didn’t specify the onset of the condition.

Alimchandani said the FDA was still in the process of trying to collect the medical records of the 100 reported cases, and additional follow-up information was still forthcoming. So far, only seven cases have been verified.

The federal health regulator has updated the emergency use authorization fact sheet for the J&J vaccine on July 12, warning vaccine providers and recipients that the vaccine is linked to the neurological disorder.

The European Medicines Agency (EMA) announced Thursday that Guillain-Barré syndrome will be listed as a “very rare side effect” of the Johnson & Johnson COVID-19 vaccine, and “a warning will be included in the product information to raise awareness among healthcare professionals and people taking the vaccine.”

The EMA’s safety committee said a causal relationship between the J&J vaccine and GBS was possible after reviewing the available evidence.

“Vaccinated people are advised to seek immediate medical attention if they develop signs and symptoms suggestive of GBS, such as weakness in the extremities, double vision, or difficulty moving eyes,” the EMA said in a statement.

Despite the added warning of GBS, the European regulator said the benefits of the Johnson & Johnson COVID-19 vaccine continue to outweigh the risks of the vaccine.

Guillain-Barré syndrome has been reported following other vaccines, including the annual influenza vaccine, the 1976 swine flu vaccine, and the zoster vaccine. While a causal relationship has not been established between the zoster vaccine and GBS, a warning has been added to the “package insert due to around three to six excess GBS cases per one million doses administered to persons [65 and older] in the six weeks after vaccination.”

There are three COVID-19 vaccines approved for use in the U.S., with a fourth still in clinical trials. The Pfizer, Moderna, and Johnson & Johnson vaccines are all highly effective in protecting you against the virus that causes COVID-19.

But each is slightly different. Compare them below. If you’re still not sure which vaccine is best for you, talk to your doctor.

Vaccine developer:	Pfizer	Moderna	AstraZeneca	Johnson & Johnson
How it works	Messenger RNA	Messenger RNA	Inactivated cold virus	Modified cold virus
When approved/expected approval	Dec. 11, 2021	Dec. 18, 2021	Not yet available. Phase III clinical trials in progress as of Feb. 27	Feb. 27
What percentage of people did it protect from getting infected in clinical studies?	95%	94.1%	70%	66.1% globally; 72% in the U.S.; 86% effective against severe disease
Who is it recommended for?	People 12 years and older	People 18 years and older	Not yet available	People 18 years and older
How many shots do you need?	Two doses, 3 weeks apart	Two doses, 4 weeks apart	Two doses, a month apart	One dose
What are the side effects?	Fatigue, headache, chills, muscle pain, especially after the second dose	Fever, muscle aches, headaches lasting a few days. Effects worse after second dose.	Pain where you get the shot, fever, muscle aches, headache	Pain where you get the shot, headache, fatigue, muscle pain
Any warnings?	The FDA issued a warning in June about heart inflammation. Since April 2021, there have been more than a thousand reports of myocarditis and pericarditis. These cases are still relatively low.	The FDA issued a warning in June about heart inflammation. Since April 2021, there have been more than a thousand reports of myocarditis and pericarditis. These cases are still relatively low.		In July, the FDA issued a warning about an increased risk for developing Guillain-Barre syndrome.
What about pregnant women and nursing moms?	Pregnant women or nursing moms who want the COVID-19 vaccine should get one, experts say. The vaccine has not yet been studied in pregnant women. Read guidelines here.	There's limited data. Studies in rats that were immunized before and during pregnancy found no safety concerns. The CDC says pregnant women may choose to receive the vaccine.	Not yet available	Discuss your options with your health care provider.
Is there anyone who shouldn’t get the vaccine?	People with a history of serious allergic reactions, anyone with a history of allergic reactions to vaccine ingredients, including polyethylene glycol, and anyone with a history of allergic reactions to polysorbate	People with a history of serious allergic reactions, anyone with a history of allergic reactions to vaccine ingredients, including polyethylene glycol, and anyone with a history of allergic reactions to polysorbate	Not yet available	Anyone who’s had an allergic reaction to an ingredient in the vaccine, like polysorbate
Any significant side effects?	Extremely rare cases of anaphylaxis in people who received the vaccine. Extremely rare cases of Bell's palsy, a type of temporary facial paralysis, reported in people who received the vaccine.	Extremely rare cases of anaphylaxis in people who received the vaccine. Extremely rare cases of Bell's palsy, a type of temporary facial paralysis, reported in people who received the vaccine.	Four total serious side effects, including two cases of transverse myelitis	There is a possible, rare relationship between this vaccine and blood clots with low platelets.
What about people with lowered immune function?	OK for people whose immune function is lowered by HIV or immunosuppressing drugs if they have no other reasons to avoid it. There is limited safety data in this group. Discuss the benefits and risks with your doctor.	OK for people whose immune function is lowered by HIV or immunosuppressing drugs if they have no other reasons to avoid it. There is limited safety data in this group. Discuss the benefits and risks with your doctor.	Not yet available	Not yet available
What about people with autoimmune diseases?	No data is available on the safety or effectiveness of mRNA vaccines in people with autoimmune disease. People with autoimmune conditions may still get the shots if they have no other reasons to avoid vaccination.	No data is available on the safety or effectiveness of mRNA vaccines in people with autoimmune disease. People with autoimmune conditions may still get the shots if they have no other reasons to avoid vaccination.	Not yet available	Not yet available
Is the vaccine safe for people with a history of Guillain-Barre syndrome (GBS)?	To date, no cases of GBS have been seen in people vaccinated for COVID-19. The CDC says a history of GBS is not a reason to avoid vaccination.	To date, no cases of GBS have been seen in people vaccinated for COVID-19. The CDC says a history of GBS is not a reason to avoid vaccination.	Not yet available	There’s a possible, but rare risk in developing Guillain-Barre syndrome after this vaccine.

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