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Expedite Pfizer’s EU approval meeting until December 21. Photo: Paul Sancya / AP
An extraordinary meeting for the approval of the Pfizer vaccine in the EU system was scheduled on December 29. The meeting is accelerating to December 21, confirms the Norwegian Medicines Agency.
– Our experts, along with the other experts, have analyzed the data and are working hard. They have had questions and seem to get satisfactory answers to them.
Therefore, EMA considers it so that it can be ready for a committee meeting where 21, tells the director of the Norwegian Medicines Agency Audun Hågå to VG.
This is also stated by the EMA in a press release.
If there is a thumbs up, final approval can come on December 23 at the EU Commission.
– We must trust that there is now a good basis to be able to say that the benefit of the vaccine is clearly greater than the risk. Our goal is to provide the population with good vaccine coverage.
– Was there disagreement between the EMA countries on this?
– I have also seen in the media that it is claimed. It is a very serious pandemic situation, and in Germany it is very serious, says the director, adding:
– Every time we approve new drugs, we find ourselves in a difficult balance between being fast and that fast. We choose to trust the evaluation carried out by EMA.
Erna: The first installment may arrive in December.
Prime Minister Erna Solberg (H) says it is good news that the first approved vaccine can arrive before the turn of the year.
– We are well on track with planning this in Norway, he says.
In addition, it says that national and local authorities are in full preparation for vaccination and points out that all municipalities must have a vaccination plan by December 18.
– Vaccination equipment has been ordered and is on the way; both syringes, tips, sanitizing wipes and freezers are on the way, she says, and more:
– The first delivery may arrive at the end of December and Norway is ready to implement vaccination. It will probably be a minor delivery; the exact number of doses must be confirmed later.
In the agreement that Norway has on the resale of the Swedish vaccine, it is established that there will be at least 500,000 doses of the Pfizer vaccine in the first quarter of 2021, depending on whether the vaccine is approved.
Good news for the EU
German Health Minister Jens Spahn confirmed early Tuesday that approval can take place on December 23 to the German daily Bild, adding that vaccination can start between two and four days after approval.
– This is good news for the whole EU, says the minister.
NRK reported that the acceleration may take place from December 21.
Pfizer’s candidate vaccine is the one at the forefront of the EU approval process, and it is now taking it one step further.
The United Kingdom, Canada and the United States have already started vaccinating with the Pfizer vaccine.
The pharmaceutical company has applied for conditional approval for the vaccine in Europe. When they did this on December 1, they delivered one last big data packet on their research. Pharmaceutical companies in the EU collaboration are now working to review this.
According to the plan, after the December 29 review, an extraordinary meeting was to be held at the EMA, where they should conclude whether they recommend the approval of the vaccines. It is this meeting that will now move to December 21.
Nursing home residents prioritize first
– It is not very likely that it will happen before Christmas, but it can happen faster than it was supposed recently, says Health Minister Bent Høie at Tuesday’s press conference.
– If the vaccine is approved on December 21, should municipalities rush even more?
– We can keep the same plans. If we receive vaccinations before the New Year, the number will be limited. It will be residents of nursing homes who will be vaccinated first. There they have a good overview of who should be vaccinated and the health personnel available, Høie tells VG.
Bild experiences that vaccination can begin two to four days after approval.
Once the EMA has made a decision, the EU Commission will quickly follow up with a formal decision: Steinar Madsen from the Norwegian Medicines Agency has previously said that if the EMA’s conclusion is positive, there may be a formal approval in a few days.
Sweden’s vaccine coordinator Richard Bergström told VG that at least 500,000 doses of the Pfizer vaccine will arrive in Norway in the first quarter of 2021.
This is the process
Approval of a conditional vaccine is based on sufficient but not completely finished data.
The Moderna company has also requested conditional approval for its vaccine. According to the plan, an extraordinary meeting on its vaccine will be held in the EU on January 12.
The vaccine study at EMA is led by two European countries, but all countries can contribute advice, opinions, and questions to the process. Norway is also actively contributing to this process, Steinar Madsen, medical director of the Norwegian Agency for Medicines, previously told VG.
No other vaccine, other than the Pfizer / BioNTech and Moderna candidates, has gone so far in the process that they have applied for a so-called conditional approval in the European market.
Four candidate vaccines are currently being considered, a so-called “continuous review”, in the EU system. These are the vaccines that Norway can access.
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