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Vaccination against Covid-19 is now fast approaching.
– This has been a great demonstration of what modern medicine and biotechnology can achieve, it has been absolutely impressive, says the chief physician of the Norwegian Medicines Agency, Sigurd Hortemo.
Three of the vaccines Norway has access to are now on the rise in the intense vaccine race.
– The time frame here is highly controlled by companies. As soon as they deliver data documenting that the vaccine is effective and safe, EMA professionals are ready to jump into it, Hortemo says.
Norway is part of the joint European collaboration on vaccines, where the European Medicines Agency (EMA) decides which vaccines are approved. Professionals from the Norwegian Medicines Agency also participate in this work.
– When a vaccine is approved in the EU, it is also automatically approved in Norway, says Hortemo.
– It takes four weeks
The European Medicines Agency (EMA) is waiting for the various companies to collect enough data from their studies. As soon as the studies that have been started have been given some scope, the EMA will have access to this data.
“The EMA will probably have access to this in early December, and then we estimate that they will need around four weeks to evaluate the effect and safety of the vaccine, and if it is produced safely,” Hortemo says.
Now it is these three companies that are closest to surrendering to EMA:
– At best, we can have a vaccine with conditional approval in Norway in January, says Hortemo from the Norwegian Medicines Agency.
Høie: – Closer now
Over the past 24 hours, authorities in both the UK and Germany have signaled that they hope to start vaccinating in early December.
– Why do you bet on starting before us?
– Every country in Europe can choose to approve a vaccine, so if Germany does not want to wait for European approval and make a national approval, then it can, says Health Minister Bent Høie.
Norway will wait for EMA approval before vaccination starts here. However, Høie doesn’t think there are big differences within Europe.
NIPH: must be ready for vaccination during the new year
– When it comes to access to the vaccine itself in Europe, it will probably be relatively similar in different European countries, he says.
The best scenario of the Minister of Health is identical to the stable advice of the Norwegian Medicines Agency.
– It is that we can have a vaccine approved in Europe before the new year, which may be available for the start of vaccination in Norway in January, says the Minister of Health.
– How many will we get?
– It depends on the number of agreements concluded by the EU. Currently, we work with ten different companies and eleven different vaccines. If all are approved, we will be in a situation where we will have much more than we need, says Høie.
You get just over one percent
According to Høie, Norway will have access to just over one percent of the vaccines included in the EU cooperation.
OPTIMIST: – We are getting a little closer every day, says Health Minister Bent Høie. Photo: Terje Bendiksby
– Because we represent a little more than one percent of the total population of the EU, he says.
The EU has already concluded agreements with the three companies Pfizer / BioNTech, Moderna and Oxford / AstraZeneca.
The deal with Pfizer / BioNTech brings 200 million doses to the EU, with the possibility of another 100 million doses. If the vaccine is approved and goes well, Norway will receive two million of these doses.
According to Høie, the calculation is the same in the agreements with the other two companies. The EU has reached an agreement with Moderna for 80 million doses, with the possibility of another 80 million at a later date.
From Oxford / AstraZeneca, the order is for 300 million doses, with the option to order another 100 million at a later date.
Broadly speaking, this means that Norway through the three companies can access just over 5.8 million doses, if the three mentioned vaccines are approved.
But this is more complicated than that:
5.8 million doses does not mean that 5.8 million people can be treated. The Pfizer / BioNTech and Moderna vaccine appears to require two doses to protect against the virus. The Oxford vaccine is designed to work after just one dose.
The exact decision about when the vaccine is ready, how many doses will be produced and how many of them will end up in Norway, no one has done yet.
