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STUDY: Image shows Pfizer Company Vaccine Study Test Kits. Photo: Marco Bello / Reuters
Vaccine giant Pfizer estimates that they may be ready to apply for US approval in the third week of November. Conditional approval in Europe may be the next step.
The vaccine is now in the last and decisive phase of testing, and is one of the candidates that may be relevant for Norway, shows the special VG vaccine.
– They believe that they can have enough safety information and information on the effect of the vaccine in the third week of November, that they can request a call USA – Authorization for emergency use, says Steinar Madsen, medical director of the Norwegian Medicines Agency of VG.
Pfeizer itself stated how far they have come in the approval application process in a press release. The news was first reported by NRK.
The vaccine is being developed in collaboration between German BioNTech, American Pfizer, and Chinese Fosum Pharma. The EU negotiates a purchase agreement for up to 300 million doses of this vaccine, if it turns out to be safe and effective against Covid-19
May receive conditional approval in Europe
The EU system decides if it is safe and efficient enough for Norway. And that process began already on October 6.
In Europe, there is no authorization equivalent to emergency authorization in the US, but the so-called continuous evaluation of the candidate vaccine has started, explains Madsen.
– We rely on the same data in Europe. So we have already started a process with this vaccine in which it collects everything that is available from the data on an ongoing basis. When sufficient data is believed to be available, Pfizer may apply for approval in Europe. It will likely be a conditional approval, based on available data, but where the company is required to obtain more data over time.
If the vaccine is approved in Europe, it can also be purchased and used in European countries.
– It is not clear when the vaccine will be approved in Europe. We probably think a conditional approval can come in January at the earliest, says Madsen.
Put this on? When the corona vaccine is ready for use, the demand will be much greater than the number of doses we have access to. Therefore, a priority group of people will get it before others:
The vaccine cannot be approved in Europe until it has completed all three testing phases, but the EU Agency for Medicines has already started collecting research results. So the company must submit more research eventually. This is called “continuous review.” The hope is that it will go faster than shipping companies by waiting until all the research is done before applying.
This is the second corona vaccine for which the EU has started the approval process. Earlier this fall, they began searching for the vaccine for AstraZeneca / University of Oxford
– Large amount of data in a short time
When testing a new vaccine, two things are more important: safety (that the vaccine does not have unacceptable side effects) and efficacy (how well it protects against coronavirus).
– It is clear that here Pfizer has made a great effort to obtain a large amount of data in a very short time. It is estimated that this vaccine will be tested in 38,000 people. It’s a larger trial than many other drugs and vaccines, Madsen says.
It also emphasizes that what Pfizer is saying is that the data could be ready in the third week of November. The company then has to apply for emergency approval in the US, which can probably go into effect a bit later.
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– Good news
Gunnveig Grødeland researches immunology and vaccine development at the Department of Immunology at the University of Oslo. She says this is good news, also for Norway.
– Although this vaccine is not first in line for Norway, it also points in the direction that there is a possibility that more vaccines will be approved, he says.
He notes that Pfizer is one of the companies that has come out and emphasized that political pressure will not affect their work with developing a candidate vaccine, and that they will follow standard procedures.
– They have taken the time they needed naturally. Then it must be safe and secure.
Furthermore, Grødeland points out that the candidate vaccine for Pfizer is the so-called RNA vaccine. It’s a new vaccine format that has been researched for a long time, he says.
– It’s great, because it will actually also mean that if approved, this is the first RNA vaccine that is approved for use in humans.
