• Updated at 3PM NZST to include response from Ministry of Health

The U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration announced on Friday a possible link between the new Pfizer-BioNTech bivalent COVID-19 vaccine and strokes in people aged 65 and older.

Pfizer’s bivalent shots are produced specifically to protect against two omicron variants, called BA4 and BA5.

Medsafe ‘status of applications’ webpage shows provisional approval for use in New Zealand was granted to the two bivalent Omicron vaccines on Wednesday, December 21. 2022.

However, a Ministry of Health spokesperson said the bivalent vaccines are not currently being used in New Zealand.

Messenger RNA Covid shots have been linked to pericarditis and myocarditis, inflammation of the heart and surrounding tissue.

The CDC said “following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink, a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.”

It said “Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination.”

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent.

The CDC said “although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal.”

Pfizer and its partner BioNTech “have been made aware of limited reports of ischemic stroke” in the CDC Vaccine Safety DataLink database in people 65 and older following vaccination a spokesperson for the CDC told Bloomberg news.

A Ministry of Health spokesperson told Chris Lynch Media, the COVID-19 Vaccine Technical Advisory Group has provided initial advice to the Director-General of Health regarding the use of the BA.4/5 bivalent version of the Pfizer Comirnaty Covid vaccine.

“In view of the recent provisional approval of the vaccine provided by Medsafe, the Ministry of Health will provide policy advice to the COVID-19 Response Minister in the coming weeks.

Decisions regarding the eligibility, timing and roll-out of any additional vaccines are made by Cabinet.”