Moderna Vaccine Granted Conditional Marketing Authorisation In Iceland Skip to content
COVID-19 vaccine vaccination Iceland
Photo: Almannavarnir/Facebook. The first COVID-19 vaccines are administered to healthcare workers in Iceland, December 29, 2020.

Moderna Vaccine Granted Conditional Marketing Authorisation In Iceland

Yesterday afternoon, Iceland’s medicines Agency issued a conditional marketing authorisation to the vaccine “COVID-19 Vaccine Moderna” in Iceland. The vaccine protects individuals against COVID-19 and is intended for use on people aged 18 years or older. The marketing authorisation is based on the European Commission’s conditional marketing authorisation for the Moderna vaccine, the second COVID-19 vaccine to be authorised for use in the EU. According to the European Commission’s press release, the vaccine “authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA), and is endorsed by the Member States.”

This is also the second COVID-19 vaccine to be granted conditional marketing authorisation in Iceland, in addition to BioNTech/Pfizer’s Comirnaty. Icelandic translation of the vaccine’s package information sheet is ongoing and will be published as soon as the final version has been approved. A special information website on the vaccine will be issued soon at the Medicine Agency’s website.

Authorities hope that the first shipment of the Moderna vaccine will arrive next week. While the Pfizer vaccine needs to be kept at a temperature of -80°C (-112°F), the Moderna vaccine is easier to handle. Director of Iceland’s Medicines Agency Rúna Hauksdóttir told RÚV “It’s a little simpler to use. It needs to be transported at a temperature of -20°C (-4°F), and can be left longer in coolers or at room temperature.” As with the Pfizer vaccine, people need to be injected twice with the vaccine to receive immunisation, and the waiting period between injections is longer, four weeks instead of Pfizer’s three.

While the Moderna distribution schedule is yet to be released, Chief Epidemiologist Þórólfur Guðnason told RÚV he hoped that the first shipment might arrive next week. “We haven’t received any confirmation, but they have a distribution plan, so we know that we’ll get 10,000 doses before the end of March,” Þórólfur told RÚV.

More vaccine producers are requesting marketing authorisations. “AztraZeneca is also undergoing a rolling review with the European Medicines Agency, and those data are being reviewed now and in the next few days,” Rúna stated. When asked if she considered it likely that the vaccine is granted marketing authorisation in January, she responded. “I can’t exactly comment on that now but I do think it’s more likely than unlikely.”

The Chief Epidemiologist changed the prioritisation for vaccines yesterday as Iceland is receiving less of the vaccine than was expected. People over the age of 70 are next in line to be vaccinated, paramedics who transport COVID-19 patients and some healthcare workers. “There are still some people remaining. We’re going over the list again, and it’s clear that many healthcare institutions want to redefine their lists and get more of their staff vaccinated, which would mean that we would need to take older individuals of the list,” Þórólfur stated.

Companies that consider themselves to be of national importance have also applied pressure to the Chief Epidemiologist. “I know there will continue to be complaints, but it will simply have to be so,” Þóróflur stated. The next shipment of the Pfizer vaccine is expected to arrive in about two weeks. “That will be around 3,000 doses. What we know now is that we will receive a vaccine for 30,000 people before the end of March,” stated Þórólfur.

There are 34,000 people in Iceland over the age of 70. Pfizer has not replied to a request to vaccinate the entire nation for research purposes. Þórólfur is expecting an answer in the next few days.

 

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