2020-12-21T14:27:38Z

Voted for Pfizer vaccine to be approved in EU and Norway – VG

12/21/2020 Norway, Science

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THE VACCINE: In a research laboratory in Puurs, Belgium, ampoules with the candidate vaccine are sorted for Pfizer and BioNTech.

The European Medicines Agency (EMA) has concluded after an extraordinary meeting that they believe that the Pfizer vaccine should be approved. It can be formally approved on Monday night.

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They write in a press release on Monday. They believe the vaccine should be approved for people over 16 years of age.

– It has been voted and there was a clear majority for approval, says Steinar Madsen of the Norwegian Medicines Agency to VG.

For the vaccine to be formally approved for use in the EU – and Norway – the EU Commission must assess the case and make a formal decision.

– The Science Committee gave a positive attitude. It’s the case that the commission almost always follows the recommendation of the scientific committee, says Madsen.

The European Commission meeting was scheduled for Tuesday morning, but Ursula von der Leyen, president of the European Commission, writes on Twitter that she expects a decision to be made on Monday night.

Only when there is formal approval, doses can be shipped from the Pfizer factory.

–- The corona vaccine is closer than ever. On the same day the sun sets and we move towards brighter days, the EMA recommends that the first coronary vaccine be approved in the EU. This is good news for the coming days and months, Prime Minister Erna Solberg tells VG about the news.

About 10,000 doses are expected to arrive in Norway on December 26, while another 40,000 will arrive on December 28, according to FHI. It is the 10,000 doses that will be used in the Oslo area on Christmas Eve, while the rest are stored in freezers and distributed throughout the country.

Read all about vaccines and approval. in the special of VG vaccines.

Norway has secured vaccinations for 3.9 million Norwegians

– The first doses will go to the elderly in nursing homes in the Oslo area, where the infection pressure is high. The reason for this is that the manufacturer can only deliver to one location in Norway on the first delivery, and it is practically not feasible to distribute these doses across the country, says Solberg.

This is how they have worked

Conditional approval of a vaccine is based on sufficient but not completely finished data. The companies that have requested this have had to submit a large final data packet for their investigation, something that Pfizer did on December 1.

It is this data package that has been reviewed in the EU system and which the EMA believes shows good enough results for the vaccine to be used.

The vaccine study at EMA is led by two European countries, but all countries can contribute to the process with advice, opinions and questions. Norway is also actively contributing to this process, Steinar Madsen, medical director of the Norwegian Agency for Medicines, previously told VG.

Two vaccines have gone so far in the process that they have applied for so-called conditional approval on the European market and have submitted a final data package for study: the Pfizer / BioNTech and Moderna candidates.

This is happening in the future

Furthermore, there are two vaccine candidates that are still being considered, a so-called “continuous review”, in the EU system. Therefore, they are considered for approval, but have not gotten so far that they have formally applied for conditional approval yet.

What does “continuous review” mean?

The EMA accepts vaccine applications on behalf of all EU / EEA countries. To speed up the process, applicants can submit information as they conduct more research on the vaccine. It’s called “continuous review.” The EMA will then continuously watch what you input, until they have enough information to make a decision. Most commonly, pharmaceutical companies in two countries have primary responsibility for reviewing the application.

Once the two countries have reviewed all the documentation, they make a recommendation, an advice, whether to approve or reject the vaccine. They send the recommendation to the scientific committee of the EMA. The committee is made up of representatives from all EU / EEA countries, including Norway. They must vote on whether the vaccine should be recommended for approval. The approval may be temporary, so the manufacturer is obliged to send more information in due course.

The candidate vaccines for CureVac and Sanofi are also relevant for Norway, but they are further behind in the process and have not yet been taken up for “rolling review” in the EU.

Enough to vaccinate 3.9 million Norwegians

Norway has so far completed three agreements on the purchase of vaccines through the EU system, via Sweden. The Pfizer, Oxford and Moderna agreements are ready and the Moderna agreement is the last to be completed. The agreements mean that Norway can get:

2.5 million doses of Pfizer vaccine (approximately 550,000 in Q1)
3.3 million doses of Oxford / AstraZeneca (approximately 1.5 million doses in February and March)
1.9 million doses of Moderna vaccine (approximately 150,000 in the first quarter)

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Voted for Pfizer vaccine to be approved in EU and Norway – VG

Norway has secured vaccinations for 3.9 million Norwegians

This is how they have worked

This is happening in the future

Enough to vaccinate 3.9 million Norwegians

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