Medsafe is currently monitoring advice and scientific evidence after the Janssen COVID-19 vaccine was linked to a rare neurological disorder.
The United States' Food and Drug Administration (FDA) on Monday confirmed the vaccine, which is produced by Johnson & Johnson, can lead to an increased risk of Guillain-Barré syndrome.
"Guillain Barré syndrome (a neurological disorder in which the body's immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 vaccine," the FDA said in a fact sheet which is supplied to those receiving the jab.
"In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 vaccine."
Regulators have assured that the chances of developing the condition are low after receiving the vaccine, with around 100 suspected cases identified by US federal officials, the New York Times reported.
Of those cases, 95 percent are considered serious, the Food and Drug Administration said.
Medsafe's acting general manager Derek Fitzgerald said they are in touch with other regulators with whom they are sharing information regarding adverse reactions to medicines and they are aware of the link to Guillain-Barré syndrome.
"This is an example of pharmacovigilance working in the way it is supposed to, which is to catch potential adverse reactions quickly and assess them," Fitzgerald told Newshub.
"It’s important to note that while Medsafe has given provisional approval for the Janssen vaccine, it has yet to be approved for use in New Zealand by Cabinet. Medsafe continues to monitor scientific evidence of vaccine safety and efficacy, and other medical information as it comes available."
Medsafe last Wednesday gave conditional approval for the Janssen vaccine to be rolled out in New Zealand for people over the age of 18 but it's yet to be approved by Cabinet.
"New Zealand secured two million doses of the Janssen vaccine through an advance purchase agreement last year," COVID-19 Response Minister Chris Hipkins announced at the time.
"Medsafe follows a rigorous assessment process informed by the most up to date medical and scientific data. Approval has been very carefully considered with safety the key priority.
"The medical evidence shows Janssen is a very safe and effective vaccine. It is a great addition to our vaccine options."
The vaccine rollout is expected to be extended to the general public from the end of July.
