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The US FDA is expected to issue a new warning for Johnson & Johnson’s COVID-19 vaccine, linking it to a rare autoimmune disorder, The Washington Post reported on Monday.
The United States Food and Drug Administration (FDA) is preparing to issue a new warning for Johnson & Johnson’s COVID-19 vaccine, linking it to a rare autoimmune disorder, The Washington Post reported on Monday, citing four individuals familiar with the matter.
The US Centers for Disease Control and Prevention (CDC) said in a statement on Monday that about 100 preliminary reports of Guillain-Barre syndrome – a disorder in which the immune system attacks the nerves – have been detected after 12.8 million doses of J&J’s COVID-19 jab in the US.
Some 3,000 to 6,000 people in the US develop Guillain-Barre syndrome each year. The illness, which is not fully understood, often follows a viral or bacterial infection.
An uptick in cases of Guillain-Barre syndrome was linked to swine flu vaccinations in the 1970s, The Washington Post reported.
A new warning would be the latest blow for J&J’s COVID vaccine – which only requires one jab and can be stored more easily than two-dose mRNA vaccines developed by Moderna and Pfizer/BioNTech.
In April, the CDC and the FDA called for a pause in the use of J&J’s COVID-19 vaccine after it was linked to rare cases of severe blood clots, but lifted the temporary halt after determining that the vaccine’s benefits outweighed its risks.
J&J’s COVID-19 jab also suffered production problems earlier this year that led to 75 million doses of the vaccine being thrown away.
Regulators in Europe have also recommended a similar warning that AstraZeneca’s COVID-19 vaccine could lead to an increased risk of Guillain-Barre syndrome.
