The United States Food and Drug Administration on Monday updated its fact sheet for the single-dose Johnson & Johnson’s Covid-19 vaccine to include Guillain Barré syndrome, a rare neurological disorder. However, the American drug regulator clarified that the chances of developing the disorder were very low.

“Guillain Barré syndrome...has occurred in some people who have received the Janssen Covid-19 Vaccine,” the FDA said. “In most of these people, symptoms began within 42 days following receipt of the Janssen Covid-19 Vaccine.”

The Guillain Barré syndrome can be caused due to several infections, including the flu, cytomegalovirus and the Zika virus, reported AP. The disorder damages nerve cells, causing muscle weakness and in some cases paralysis, which could be temporary.

Janssen Pharmaceuticals, the company owned by Johnson & Johnson, is developing the Covid-19 vaccine, known as Janssen. The vaccine is currently approved for use in the United States, the European Union and other countries, including Thailand and South Africa.

The US agency said that 95 of the 100 reported cases had to hospitalised and that one person had died. It added that available evidence may suggest a link between the shot and the rare neurological disorder, but there was insufficient data to definitively establish that the vaccine had caused the illness, reported Bloomberg.

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The FDA and the Centers for Disease Control and Prevention reviewed reports of nearly 100 beneficiaries who had developed the syndrome after receiving Johnson & Johnson’s vaccine.

The American drug regulator said that medical attention should be sought immediately after certain symptoms are noted after receiving the Covid-19 vaccine.

The symptoms are: “Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body, difficulty in walking, difficulty with facial movements (including speaking, chewing, or swallowing), double vision or inability to move eyes, difficulty with bladder control or bowel function.”

Johnson & Johnson said that it has been discussing the reports of adverse effects after vaccination with the FDA and other drug regulators in the world.

The American drug company also said that it’s single-shot Covid-19 vaccine protected against variants of the virus.

So far, about 1,28,00,000 Americans have been given the one-dose vaccine, according to AP.

Vaccines have historically provided overall protection against the diseases with minimal risk. However, some of them occasionally cause side-effects like any other drug or medical treatment. Three Covid-19 vaccines are currently being used in the United States. They were all tested with participation of tens of thousands of citizens. However, even these trials cannot entirely eliminate the extremely rare side-effects of a vaccine.

On April 20, Johnson & Johnson said it has sought approval from India’s drug regulator to begin a clinical trial of its coronavirus vaccine in the country. The vaccine can be stored at refrigerator temperature.

Johnson & Johnson’s request to Indian authorities came days after the central government decided to fast-track emergency approvals for all foreign vaccines that have been approved by the World Health Organization or regulators in the United States, Europe, Britain or Japan.

So far, two vaccines – one developed by Oxford University and AstraZeneca and the other developed by Bharat Biotech – are being used in India. Both the vaccines are being manufactured within the country by domestic firms. While the Oxford/Astrazeneca vaccine, locally known as Covishield, is being manufactured by Serum Institute of India, the indigenously developed Covaxin is being manufactured by Bharat Biotech.

A third vaccine Sputnik V – developed in Russia and to be imported and sold in India by Dr Reddy’s Laboratories – has also been approved by the Indian drug regulator.