Reason to celebrate – E24

The European Commission has formally approved Pfizer’s vaccine for use in Europe and Norway.

This was decided by the Commission on Monday night, a few hours after the European Medicines Agency (EMA) voted in favor of approval of the vaccine. They have reviewed and evaluated company data.

The Norwegian Medicines Agency confirms to VG that the vaccine has also obtained a marketing authorization in this country.

It was the head of the commission, Ursula von der Leyen, who presented the news at a press conference on Monday night.

– This is our first shot. More will be approved soon, if it turns out to be effective, says von der Leyen.

She says she is proud that BioNTech pharmaceutical company is behind the vaccine that was first approved.

– We are now writing a new chapter in the pandemic. This is a true European success story.

Over the next few days, the first doses will be shipped from Pfizer’s factory in Belgium. They will be available to all EU countries at the same time, under the same conditions, and vaccination can start between December 27 and 29.

– A happy day

The director of the Norwegian Medicines Agency describes the approval as “an impressive scientific endeavor”.

– This is a happy day. A very good certificate of what modern science can achieve. Here’s a colossal directed effort behind the fact that this can happen in no time, he says.

– This has gone very fast, of course we are very happy about that. The vaccine can now be administered throughout Europe.

– In addition, it is important that doctors and health personnel report everything about the effect and side effects. We know a lot about vaccines, but not everything, he explains. Among other things, you can learn more about rare side effects and how long the vaccine will last.

– But there are reasons to celebrate today. It has been an impressive effort.

Unanimously Recommended

Ursula von der Leyen announces on Monday that the EMA will present its evaluation of the Moderna vaccine on January 6.

On Monday, the EMA evaluated the Pfizer vaccine and recommended that it be approved for people 16 years of age and older. They wrote this in a press release on Monday.

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

Later on Monday, he confirmed that the result of the vote in the EMA scientific committee was unanimous.

Now that the EU Commission has considered the case, it has been formally approved for use in the EU and Norway.

– 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.

See FHI’s list of which groups should take priority in the vaccine queue here.

The European Commission meeting was scheduled for Tuesday morning, but Ursula von der Leyen, president of the European Commission, wrote on Twitter that she expected 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 corona vaccine be approved in the EU. This is good news for the days and months to come, Prime Minister Erna Solberg writes to 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.

– I am glad that the first corona vaccine is now approved for use in the EU and Norway. We will start vaccination at the same time as the other European countries, says the Minister of Health and Care Services, Bent Høie.

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

– 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.

Read more about why this is so here.

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.

All EU countries have had the right to vote on the Pfizer vaccine decision at the EMA, while what the EEA countries have meant is also recorded, according to Madsen at the Norwegian Medicines Agency.

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.

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)

Read more about it here.

Read more about the six candidates that are relevant to the EU and Norway, and where they are in the process, by clicking on them below:

http://api.int.vgnett.no/enrichments/top_object/17872