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GREEN LIGHT: The Pfizer vaccine is now approved for use in Europe. Medical Director Erik Hjelvin is satisfied. Photo: Helge Mikalsen
The Pfizer vaccine is the first to be approved for use in the EU and Norway. This means that the vaccine doses waiting at the factory in Belgium can now be loaded and shipped by truck.
The European Commission decided Monday evening to grant conditional approval for the vaccine to Pfizer and BioNTech. The Norwegian Medicines Agency immediately granted a marketing authorization for the vaccine in Norway, Pfizer writes in a press release.
This means that it has finally been confirmed that the first doses of the vaccine will be available in Norway during Christmas. The first vaccines will be delivered simultaneously across Europe and vaccination can begin immediately.
- Read more about this and the process that led to the decision, in this case.
Norway will get this
Norway will receive 10,000 doses of the Pfizer vaccine on the second day of Christmas and another 40,000 a few days later. Vaccination will begin in the Oslo area on December 27.
Norway will then receive 40,000 doses a week, until 2.5 million doses have been reached. Around 550,000 doses will arrive in the first quarter of next year.
– When the efficiency data was released in November, I understood the importance this would have, says Pfizer Norway Medical Director Erik Hjelvin to VG, adding:
– It feels completely unique to be a part of, I will probably only experience it once in my life.
Also Pfizer CEO Sissel Lønning Andresen is aware of how big this is:
– It is a victory for science and a great day on behalf of all those who work with research and science. We are now one step closer to winning the battle against the virus, he writes in the press release.
Ready to load doses
In principle, Pfizer can ship vaccines the same day as approval:
– We are ready to begin transportation immediately. We have a good dialogue with the Norwegian authorities on practical challenges such as transport, customs clearance, documents and the like. I’m sure we can send the first doses to Norway in a few days, says Hjelvin.
EFFICIENT: Pfizer has made several changes to the production chain to be able to produce as many vaccines as possible. Here’s Erik Hjelvin, medical manager. Photo: Helge Mikalsen
As it seems now, the first doses will arrive in Norway on the second day of Christmas and vaccination will be coordinated with the EU from December 27.
– It gives us a few days to coordinate all shipments to the entire continent.
The doses are distributed throughout the country and delivered directly from Pfizer to cold rooms in different parts of the country where they can be stored at minus 70 degrees, before leaving to the municipalities.
Vaccines distributed in Europe are manufactured primarily at Pfizer’s factory in Puurs, Belgium. Right now, there are several million vaccines ready for shipment and production is in full swing both here in Europe and in the United States.
BELGIUM: Worldwide, Pfizer can produce an average of more than three million doses per day. Here from the Puurs factory. Photo: Pfizer
The medical director says that Pfizer has put all its efforts into developing this vaccine and has invested enormous resources in time, money and people to administer it.
Pfizer’s ambition is to create 1.3 billion doses of vaccines by 2021. To achieve such a large volume, a lot needs to be done.
– At the same time, we are not entirely amateurs in the field, Pfizer is already one of the largest manufacturers of drugs and vaccines that are injected, and we have extensive experience with this type of production.
The lack of raw materials has been one of the challenges that has been known in the past, but it still does not worry the director:
– The shortage of raw materials occurs from time to time, but right now we do not have to worry.
Reduce bureaucratic wait times
In order to have the vaccine ready and approved as soon as possible, they have worked in collaboration with the pharmaceutical authorities to avoid all unnecessary interruptions in the processing of the case.
– To save time without reducing the quality of work, we have continually looked for opportunities to do different parts of development work in parallel, rather than stopping at each point in the process.
Side effects are collected in the database
Among other things, they have been able to submit study data on an ongoing basis rather than waiting until they are completed and then submitting all the documentation together. That way, you save a lot of time.
In addition, they have started the construction of large production and production facilities at the same time as the research is carried out.
When a vaccine is approved, the vaccine is clearly seen as more beneficial than harmful. Side effects must be reported in a database of the Norwegian Medicines Agency.
– So they are compiled with side effect reports from around the world to provide a good early overview of vaccine safety in addition to the good overview we have from clinical studies.
also read
Five new people have had an allergic reaction after the Pfizer vaccine: – Norway is well prepared
There is another company besides Pfizer that has gone so far in the process that it has applied for a so-called conditional approval in the European market: The Moderna candidate. In addition, there are two vaccine candidates that are still being evaluated and submitting data, a so-called “continuous review”, in the EU system.
Vaccine candidates for CureVac and Sanofi are also relevant for Norway, but they are further behind in the process.
Read more about the six candidates that are relevant to the EU and Norway, and where they are in the process, by clicking on them below:
