FDA Reports Neurological Disorder After Covid Vaccination

Coronavirus Update. Photo: FDA
Coronavirus Update. Photo: FDA

Guillain-Barré Syndrome (GBS) is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness, or in the most severe cases, paralysis.

There is something dubious about Covid-19 vaccines that the governments want to hide. In the past few months, almost all the vaccine brands have reportedly caused serious side effects to recipients.

But the pharmaceutical companies and the drug regulators often divert the issue of harmful side effects of vaccines by saying that the “potential benefits outweigh the known and potential risks.” But this is not a convincing argument. There is an increased hesitancy toward vaccines among people because they do not want to take even the smallest risk.

Now, in a new case, the U.S. Food and Drug Administration (FDA) announced on July 13 revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) Covid-19 vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination.

According to the FDA, GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness, or in the most severe cases, paralysis.

Based on an analysis of Vaccine Adverse Event Reporting (VAERS) data, there have been 100 preliminary reports of GBS following vaccination with the Janssen vaccine after approximately 12.5 million doses administered.

Of these reports, according to the FDA, 95 of them were serious and required hospitalization. There was one reported death. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. FDA said most people fully recover from the disorder, but the drug agency cleverly conceals the information about those who have not recovered. It is also silent about its monitoring mechanism to monitor and record deaths after vaccination. There are chances that more people are dying who are not being reported in official records.

[ Also Read: How Safe and Effective Are Covid-19 Vaccines? ]

Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship, FDA said, adding that no similar signal has been identified with the Moderna and Pfizer-BioNTech Covid-19 vaccines. The FDA claims about the other vaccines cannot be verified.

FDA says it continues to work with its partner in vaccine safety surveillance, the CDC, to monitor reports of GBS following vaccination with the Janssen Covid-19 vaccine. Importantly, the FDA says it has evaluated the available information for the Janssen Covid-19 vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks. It is a totally vague assertion that FDA and others make, because sufficient data does not exist about the benefits of Covid-19 vaccines.

The Janssen Covid-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has been revised to include a warning about GBS and the Fact Sheet for Recipients and Caregivers has been revised to include information about GBS.

The warning in the Fact Sheet for Healthcare Providers Administering Vaccine notes that reports of adverse events suggest an increased risk of GBS. Additionally, the Fact Sheet for Recipients and Caregivers notes that vaccine recipients should seek medical attention right away if they develop any of the following symptoms after receiving the Janssen Covid-19 vaccine: weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body; difficulty walking; difficulty with facial movements, including speaking, chewing or swallowing; double vision or inability to move eyes; or difficulty with bladder control or bowel function.

The agency has also authorized the use, under the emergency use authorization (EUA) for the Janssen Covid-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. To date, according to the FDA, a total of five batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. The FDA claims it has conducted a thorough review of facility records and the results of quality testing performed by the manufacturer.

Based on this review and considering the current Covid-19 public health emergency, the FDA says it has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency says it continues to work through issues there with Janssen and Emergent BioSolutions management.

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Rakesh Raman