Australia’s TGA approves Johnson & Johnson – FDA issues warning about Guillain-Barré syndrome

Australia’s TGA approves Johnson & Johnson – FDA issues warning about Guillain-Barré syndrome
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On June 25, Australia’s Therapeutic Goods Administration (TGA) gave provisional approval for the Johnson & Johnson Covid vaccine, also known as the Janssen vaccine.

The single-dose viral vector vaccine uses a similar technology to both AstraZeneca and Sputnik V.

While the Johnson & Johnson vaccine is not currently an active part of the Australian roll-out, approval from the TGA paves the way for it to be included in future negotiations.

Unlike Pfizer and Moderna, Johnson & Johnson is not an mRNA vaccine. This makes it significantly easier to transport. As it only requires one shot, it has proved to be an attractive prospect for countries experiencing a sluggish vaccine roll-out.

A spokesperson for Health Minister Greg Hunt confirmed that Australia has no current plans to secure doses of the vaccine.

The government does not intend to purchase any further adenovirus vaccines at this time.”

Johnson & Johnson may remain unavailable to Australians indefinitely after the US Food and Drug Administration (FDA) added yet another warning to the vaccine.

100 out of 12.8 million patients developed a rare neurological condition known as Guillain-Barré syndrome.

The condition causes the body’s immune response to attack its own nervous system along with the virus, causing a range of unpleasant side effects including weakness, coordination issues, and tingling in the hands and feet.

A similar problem occurred with the 1976 swine flu vaccine which saw it discontinued by the US. The ordinary flu vaccine also carries a small risk of developing the condition, but remains in wide circulation globally.

While most recover from the nerve condition, the warning has been added to the Johnson & Johnson vaccine. Other known side effects include Capillary Leak Syndrome and the rare blood clotting disease Thrombosis with Thrombocytopenia Syndrome also linked to AstraZeneca.

The FDA continues to advise that the potential benefits outweigh the known and potential risks.

Johnson & Johnson has full authorisation in Australia and emergency authorisation in Europe, India, America, Canada, parts of South America, Asia and Africa.

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  • By Avi Yemini

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