Press Release – Ministry of Health New Zealand’s medicines regulator, Medsafe has requested additional information from Janssen, ahead of making a decision about whether to approve the pharmaceutical companys COVID-19 vaccine. After receiving information from the US Food and Drug …
New Zealand’s medicines regulator, Medsafe has requested additional information from Janssen, ahead of making a decision about whether to approve the pharmaceutical company’s COVID-19 vaccine.
After receiving information from the US Food and Drug Administration (FDA) related to cases of blood clots reported in the US, Medsafe has issued a number of additional requests for data from Janssen. The pause of the rollout in the US and Europe has also been discussed with Janssen.
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Source: New Zealand Ministry of Health
New Zealand’s medicines regulator, Medsafe has requested additional information from Janssen, ahead of making a decision about whether to approve the pharmaceutical company’s COVID-19 vaccine.
After receiving information from the US Food and Drug Administration (FDA) related to cases of blood clots reported in the US, Medsafe has issued a number of additional requests for data from Janssen. The pause of the rollout in the US and Europe has also been discussed with Janssen.
Medsafe group manager Chris James says Medsafe expects to provide an update on the Janssen approval process in the next two to three weeks.
Medsafe calls for more data on Janssen vaccine before making approval call
Medsafe calls for more data on Janssen vaccine before making approval call Thu, 15 Apr 2021, 6:18PM
Medsafe has asked for additional Janssen Covid-19 vaccine data before making a decision on whether to approve it. Photo / AP
Medsafe calls for more data on Janssen vaccine before making approval call Thu, 15 Apr 2021, 6:18PM
The country s medicine regulator has asked for more information from pharmaceutical company Janssen before making a decision to approve its Covid-19 vaccine.
The US, European Union and South Africa have temporarily halted the rollout of the company s Covid jab due to fears over rare blood clots, the BBC reported this week.
Explainer: Covid-19 vaccine AstraZeneca is making headlines overseas due to a very rare side effect of blood clotting. This vaccine is not currently being used in NZ. Here s everything you need to know. Global Covid-19 vaccine roll-outs are poking holes in the efficacy of the doses on the market. The AstraZeneca vaccine, which has not yet been approved for use in New Zealand, has a “possible link” to potentially fatal blood clots. The clots, called cerebral venous sinus thrombosis (CVST), occur in the brain’s venous sinuses and can prevent blood from draining out of the brain.
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The AstraZeneca coronavirus vaccine has made headlines recently due to a possible link to blood clots.