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Covid-19: Medsafe seeks additional data on Janssen vaccine amid blood clotting reports

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The country’s medical insurance authority, Medsafe, has requested additional information from Janssen before making a decision regarding the approval of the vaccine for New Zealanders.

This comes after the authority received information from the US Food and Drug Administration (FDA) about blood clotting cases reported in the US

The US, South Africa and the European Union are temporarily suspending strikes following reports of clots, The BBC reported this week.

Medsafe has asked for additional information from Janssen, before making a decision whether to approve the vaccine of the pharmaceutical companies Covid-19.

Mary Altaffer / AP

Medsafe has asked for additional information from Janssen, before making a decision whether to approve the vaccine of the pharmaceutical companies Covid-19.

The single-dose vaccine, developed by Johnson & Johnson, is one of four vaccines for which New Zealand has a pre-purchase agreement, with a deal to buy up to five million doses.

READ MORE:
* Covid-19: What you need to know about the AstraZeneca vaccine and its rare blood clotting side effect
* Covid-19: More European countries hit AstraZeneca vaccines following reports of blood clots, Medsafe still rates NZ
* Covid-19: Everything you need to know about New Zealand coronavirus vaccines

Of the more than 6.8 million people vaccinated against Johnson & Johnsons stroke in the United States, six developed severe blood clots in the sinuses that drain blood from the brain, officials with the FDA and the Centers for Disease Control and Prevention (CDC) said this week.

Medsafe Group manager Chris James announced that the drug regulator was seeking additional information before making a decision on approving the Janssen vaccine.  (Photo file)

ROBERT KUCHIN / Sende

Medsafe Group manager Chris James announced that the drug regulator was seeking additional information before making a decision on approving the Janssen vaccine. (Photo file)

pause of spread in the US and Europe has also been discussed with Janssen.

Medsafe Group manager Chris James said Medsafe had issued Janssen a number of additional requests for data.

He expects to provide an update on the Janssen approval process in the next two to three weeks.

This will allow us time to investigate the data we receive so that when we make a decision, we can reassure the New Zealand public about the safety and efficacy of the vaccine, James said Thursday.

He said Medsafe continues to receive information from regulatory peers, including the FDA in the US and Good Therapeutic Administration in Australia, who are also evaluating the Janssen vaccine.

Medsafe has a strong system for evaluating the safety and quality of medicines and vaccines for use in New Zealand and will continue to make decisions based on the most up-to-date information.

University of Auckland vaccine specialist Dr. Helen Petousis-Harris said the benefit of continuing vaccine programs that include the AstraZeneca and Janssen vaccines far outweighs the risk in countries filled with Covid-19.  (Photo file)

Chris McKeen / Stuff

University of Auckland vaccine specialist Dr. Helen Petousis-Harris said the benefit of continuing vaccine programs that include the AstraZeneca and Janssen vaccines far outweighs the risk in countries filled with Covid-19. (Photo file)

Vaccine specialist Dr Helen Petousis-Harris said the current risk for the vaccine appears to be that one in a million people have a blood clotting problem.

People living in the US have a much higher risk of being struck by lightning during their lifetime, she said 65 times higher, she said.

Data on the AstraZeneca vaccine suggest that about four people in a million will experience blood clots.

In contrast, the risk of blood clots as a result of Covid-19 infection is about 165,000 people per million.

According to Medsafe, 150-800 women taking the oral contraceptive pill per million will experience blood clots.

With the 100 million doses given by each of the Pfizer and Moderna vaccines, there have been no signals of blood clotting issues so far, Petousis-Harris said.

New Zealand can afford the luxury of asking for more data, as we do not have high levels of the disease, she said.

That would not help trust the program if people thought Medsafe would not be careful, especially given the revelations about the Janssen vaccine are only a few days old, she said.

However, she said continuing to use the vaccine in countries with the disease was uninteresting, as the benefit outweighs the risk by miles.

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