Medsafe seeks more info on Janssen Covid-19 vaccine – Expert Reaction

New Zealand’s medicines regulator has asked for more information from Janssen, with countries putting the company’s Covid-19 vaccine on hold due to rare blood clot concerns.

The Janssen vaccine was next in line to be approved for use in New Zealand, but over the past few days the US, EU, and South Africa have all suspended its use.

The SMC asked experts to comment.

Associate Professor James Ussher, Department of Microbiology and Immunology, University of Otago, comments:

“I think Medsafe has made the right decision in asking for further information. I note the Americans today have had an emergency meeting on the Janssen vaccine and decided to continue their pause pending further information.

“We don’t know yet whether these clots are a rare vaccine related event or whether they’re just a coincidental event, but I think it’s important to thoroughly investigate it, and therefore a pause in usage overseas is entirely appropriate.

“It shows that the post-marketing monitoring is an effective and responsive process for detecting and acting upon these rare side-effects and can give people confidence in the monitoring system and that regulators will act upon it. It’s important to note that there have been no reports of similar problems with RNA vaccines from Pfizer (currently used in NZ) or Moderna.”

“We’re in a fortunate position in New Zealand that we’re not requiring vaccination because we have no circulating virus. So we can safely wait while further information is gathered.”

Conflict of interest statement: Associate Professor Ussher is Science Director of the Government-funded Vaccine Alliance Aotearoa New Zealand – Ohu Kaupare Huaketo, a partnership between the University of Otago, the Malaghan Institute and Victoria University of Wellington. He is also on the Government Vaccine Taskforce’s Science and Technical Advisory Committee

 Claire Munro, medical advisor, Immunisation Advisory Centre, comments:

“Out of an abundance of caution, the roll out of the Janssen COVID-19 vaccine has been paused while further information on rare unusual clotting abnormalities can be collected. As of the 12th April 2021, six cases of abnormal clotting were reported to the Vaccine Adverse Event Reporting System (VAERS) in the US. While this is only a small number compared to the ~6.8 million doses administered, it is important all information is appropriately reviewed and this pause gives scientists the opportunity to do so.

“In the New Zealand setting, the only vaccine which has been approved for use is the Pfizer-BioNTech COVID-19 vaccine. There have been no reports of this particular clotting concern following 97.9 million doses administered of the Pfizer-BioNTech COVID-19 vaccine. Medsafe will carefully evaluate all the available and emerging data before approval to use can be given.”

No conflict of interest.