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DECISIVE TESTING: It is only in the third and final phase of testing that companies receive answers about whether the vaccine actually has an effect against the coronavirus. Here, the Moderna vaccine trial is organized in Hollywood in August. Once the latest data packet is entered, the approval decision can be made. Photo: CHANDAN KHANNA / AFP
At any moment, what remains for an approval in Norway and the EU can come. It is a data package and it can decide everything.
At the Norwegian Medicines Agency, the tension is mounting. An application has been submitted for approval for three vaccines in the EU and Norway, and all are in good condition. But what are we really waiting for?
Yes, the companies behind all three vaccines must turn in one last big data packet on their research. This is what the European Medicines Agency (EMA) needs to approve and approve vaccines for the EU and Norway.
– This is when EMA can make the final assessment: stick with it or not. Now we are waiting for the companies to deliver a complete data package, says Chief Physician Sigurd Hortemo of the Norwegian Medicines Agency to VG.
This can happen at any time, and this is where the excitement lies. All estimates of when a vaccine can arrive in Norway depend on this.
– Now these data are what we are waiting for, says Hortemo.
VERY EXCITED: Much of what Sigurd Hortemo and the Norwegian Medicines Agency ask about corona vaccines will be answered in this data packet. Photo: Norwegian Medicines Agency
Herein lies the emotion
These data packages will answer much of what the Norwegian Medicines Agency is now considering.
– What we want to know is whether the vaccine protects against the disease, which is the absolute requirement. We need to know what side effects have occurred in the first weeks after vaccination, says Hortemo from the Norwegian Medicines Agency.
- What three vaccines are these? Click on each one to read more about them.
- What are these data packets? To be approved, companies must demonstrate that their vaccine protects against Covid-19 disease and has no unacceptable side effects. When they think they have enough data to prove this, they send this data packet with the research. So they actually say “now we think we have enough research to get an approval,” a kind of final, formal request. And this can be delivered at any time.
- What happens when they arrive? The European Medicines Agency can then decide whether the vaccine can get temporary approval in the EU and Norway.
– And none of the three have complied yet? As much as you know
– No, none of the companies has delivered a complete data package so far, Hortemo responds.
– It is very far?
– No, we don’t think it’s very far. We think the first one will be delivered during December, perhaps early December, he says.
It takes several weeks to process
All three vaccines are now in the final and crucial testing phase, with each vaccine being tested in tens of thousands of people.
For example, Pfizer’s preliminary results have received a lot of attention:
The companies have released press releases stating that all three vaccines appear to work, but the research itself needs to be followed up.
– When the European Medicines Agency receives the data package, it will contain a full overview of the results of the phase three studies, on efficacy, side effects and production data. If this is good, EMA can give conditional approval, Hortemo notes.
- How long does it take to process the request? Application processing may be faster than we think. The Norwegian Medicines Agency estimated for the first time that EMA would go from three to four weeks. “But now so many resources are being invested that we no longer dare to say how long it may take. We do not rule out that it could go faster,” says Hortemo.
- So how long does it take in total? If these data packets are delivered soon, a vaccine can be approved starting in December.
– The most optimistic believe that we will get conditional approval before Christmas. But we still think the most realistic thing is a little over New Years, says Hortemo of the Norwegian Medicines Agency.
This happens when a vaccine is approved.
After the request is processed, this happens:
- The final decision: If the European Medicines Agency (EMA) grants conditional approval to one or more vaccines, the matter goes to the European Commission. They give final approval for the EU and Norway. The Norwegian Medicines Agency believes that it will only take days after the EMA approves a vaccine until it is formally approved in Norway.
- The manufacturer sends doses of vaccines to countries that have reserved them. Norway has reserved doses of all three vaccines in this case through the EU alliance.
- FHI takes the doses in its central warehouse.
- FHI resends doses to your municipality and hospitals. The NIPH has estimated that it can take two to three weeks from the time vaccines are received in their warehouse until the first groups are vaccinated.
- Who are the first? It has not yet been decided who will be given priority. It is the government that decides, but both an expert group and the NIPH advocate putting groups at risk first.
The latest news on the vaccine race can always be found at General description of the VG vaccine.
