Therefore, UK can start vaccination earlier than Norway – VG

The reason the UK can use the Pfizer vaccine for a whole month before FHI thinks it is possible to send doses to Norway is that the process in the country has been much faster. It is greeted with applause and skepticism.

“I consider this decision to be problematic and I do not recommend that EU member states repeat the process in the same way,” MEP Peter Liese told the German CDU about the decision, according to Reuters.

Health Minister Bent Høie doesn’t go that far:

– This is something that each country must take into account. As we assess the situation, it is only right that we analyze this data in depth and become part of the common system of which we are a part. Norway is also in a completely different infection situation in the UK, he tells VG.

While the European Medicines Agency (EMA) says according to Reuters that its process is better and is based on more evidence and research, the UK Medicines Agency (MHRA) has emphasized that its process has been thorough and that they have not been taken shortcuts.

This has happened:

• The EMA launched a so-called “ongoing review” of Pfizer’s candidate vaccine in early October. This means that the company continuously submits data to the EMA and has enough information to assess whether the vaccine should be approved. The UK launched its own such assessment of the Pfizer candidate in late October.
• On 23 November, UK authorities confirmed that the British Institute of Public Health MHRA had received the data they needed to assess whether the Pfizer vaccine could be used. Just over a week later, they have now announced yes. Vaccination can start next week.
• In the EU system, Pfizer delivered a large final data packet of its investigation on December 1. They have applied for conditional approval to use the vaccine in Europe. No later than December 29, once the data has been reviewed by the collaborating pharmaceutical companies, an extraordinary meeting will be held where the EMA will decide whether to recommend approval of the vaccine.

Read all about the vaccine processes in the special VG vaccine

No conditional approval or marketing authorization has been granted for the Pfizer vaccine itself, not even in the UK, explains Sigurd Hortemo from the Norwegian Medicines Agency.

– The UK has used the emergency procedure to use a vaccine prior to approval. This type of mechanism is present in all European countries. But in Norway we have made the decision that before using a vaccine in millions of people, it must have at least conditional approval, he says.

It emphasizes that conditional approval is also a procedure that is adapted to an emergency situation.

– To obtain conditional approval, a thorough evaluation of the clinical data must have been performed. What is not required for a conditional approval that is normally required is long-term data.

These vaccines are currently being considered for approval in the EU:

– Huge pressure

With over 59,000 deaths, the UK has the highest number of crown-related deaths in Europe. The country has also registered 1.65 million cases of infection. Hospitals have been under pressure and the economy has been hit hard.

Jan Helge Solbakk, professor of medical ethics at the University of Oslo (UiO), says he was surprised that the UK has progressed faster.

– Then you can ask if the evaluation process that they have carried out will be as complete as the process that the EMA is going to carry out. The problem is that you are in a situation where there is enormous pressure and the expectation that a vaccine will arrive as soon as possible, he says.

– But a three week difference in terms of approval may mean that quite a few deaths can be prevented, if the vaccine has the reported effect. In such a situation, there are no ideal decisions. There is no one sitting with the fasit now.

Preferably, he believes that the raw data from the vaccine studies should have been made public by now, and that greater transparency would increase confidence in the processes.

But it also emphasizes that the pharmaceutical companies of the different countries, which evaluate the raw data of the companies, are independent and more reliable.

– They have a huge responsibility. They have the pressure of time and uncertainty. But in such a situation, we must dare to trust someone, and then they would probably trust most of the anti-drug authorities.

– Reflects the situation in which we find ourselves

Stephen Griffin, a professor and virus researcher at the University of Leeds, believes the UK vaccine news is a big step forward.

– An emergency approval reflects the situation we are in. I cannot imagine that MHRA would approve the vaccine without good reason, and this will be followed up with ongoing evaluations. They may turn around before they give final approval, but they have a lot of data for this particular vaccine and it’s clear no serious side effects have emerged, he says.

At the same time, he emphasizes that he expects the MHRA to have good communication with the EMA also in the future, regardless of what happens politically, with reference to Brexit.

It recognizes that there is a strong political desire to get a vaccine out quickly.

– It’s the only realistic way out of this mess. We must not forget the people in the risk group who have been isolated since March. I think it is essential that we first get the vaccine to vulnerable groups.

These vaccine candidates are at the forefront of the EU process:

Anonymous EU countries assess

In the EMA assessment process, two countries are designated as having primary responsibility for reviewing the raw data submitted by pharmaceutical companies. Pharmaceutical companies in all countries, including Norway, contribute to the processes with advice, opinions and questions.

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It is not published outside the EU system which countries have the main responsibility for the assessment. This is, among other things, to avoid external pressure on who will do the work, according to Steinar Madsen of the Norwegian Medicines Agency.

– Two reports are produced, one from each of the countries, which are presented to the science committee. If the benefit outweighs the risk, the Scientific Committee may conclude that the vaccine should receive conditional approval.

This is what will happen at the extraordinary meeting on Pfizer scheduled for December 29. If the committee’s recommendation is positive, the EU Commission will make a decision within a few days and the vaccine can be implemented, also in the EU and Norway.