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.
Most cases of the rare disease were reported in people aged 50 years and older, usually two weeks after receiving the vaccination.
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.