Risk of rare nerve disorder associated with J&J vaccine 'remains low': DOH

Katrina Domingo and Vivienne Gulla, ABS-CBN News

Posted at Jul 13 2021 05:15 PM

Risk of rare nerve disorder associated with J&J vaccine 'remains low': DOH 1
A lab worker holds a vial of Johnson & Johnson's Janssen COVID-19 vaccine candidate in an undated photograph. Johnson & Johnson, Handout/Reuters

MANILA - The "increased risk" of a rare neurological disorder called Guillain-Barre Syndrome (GBS) associated with the Johnson & Johnson's Janssen COVID-19 vaccine "still remains low," the Department of Health (DOH) said Tuesday.

The US Food and Drug Administration has updated its warning labels for Janssen to include information about an observed "increased risk" of a rare neurological disorder called Guillain-Barre Syndrome (GBS).

Based on analysis of a federal vaccine safety monitoring system, officials have identified 100 preliminary reports of GBS after approximately 12.5 million doses administered, people familiar with the matter said.

Of these reports, 95 of them were serious and required hospitalization. There was 1 reported death.

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.

"This increased risk still remains very low," Health spokesperson Undersecretary Maria Rosario Vergeire said in a statement.

"Current data still shows out that the benefits of getting vaccinated and the protection from COVID-19 hospitalization and death still outweigh the risks for any reported reactions to vaccines, such as GBS," she said.

Eric Domingo, Director General of the Philippines' FDA, said "the association with the Janssen vaccine is still being investigated and the benefits of using the vaccine against COVID continue to outweigh the risk.”

Vergeire noted that "GBS is a very rare condition that is also noted to be an adverse event following immunization based on its occurrence AFTER vaccination."

“GBS is a rare disorder and it is something that should be watched out for after vaccination," added Domingo.

The DOH urged "patients to report to their local vaccine operations center (LVOC) for any cases of GBS or immediately contact a healthcare provider if they feel any symptoms."

"We call on all physicians and hospitals to ensure that for all suspected reactions to vaccines, you report these immediately to your respective epidemiology and surveillance unit so that these could be appropriately investigated and records be retrieved and assessed for causality by the pool of experts nationwide," Vergeire said.

Domingo said the US FDA’s warning on the risk of GBS for Janssen “will be automatically added to product information for all countries”, including the Philippines.

The Philippine government expects to receive over 3 million Janssen doses donated by the US through the COVAX facility. Deliveries are expected to begin this July, according to the World Health Organization- Philippines.

The Philippine drug regulator granted emergency use authorization to the single-dose regimen vaccine on April 19 this year. 

- with report from Agence France-Presse


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