Good news about the vaccine, but when will it be in Norway?

Photo: Ole Berg Rusten / NTB scanpix
Pharmaceutical giants Pfizer and BioNTech have reported that they are testing a vaccine that has so far shown that it protects 90% of users against COVID-19 with no serious side effects reported.

MARIUS HELGE LARSEN
NTB

The world is rejoicing over good vaccine news. But what does that mean for Norway, and when can the COVID-19 vaccine be on the market there?

On Nov. 9, the pharmaceutical giants Pfizer and BioNTech brought good news that immediately sent stock exchanges all over the world upward at full speed. Their COVID-19 vaccine, which is still in testing, has so far shown that it protects 90% of users against COVID-19, and no serious side effects have been reported.

Steinar Madsen, medical director at the Norwegian Medicines Agency, was both happy and relieved when he heard the news.

“We basically assume that a joint European approval of the vaccine could come at the turn of the month between January and February. Based on the data we have gotten from the company, we are keeping all possibilities open,” he said to NTB.

Madsen also does not rule out that the vaccine may come sooner.

World Health Organization: A lot of work remains
Pfizer and BioNTech stated that they expect to be able to apply for approval for so-called emergency use of the vaccine in the United States during the third week in November.
They expect to be able to offer around 50 million doses in 2020, and up to 1.3 billion doses the following year. The vaccine must be taken in two doses administered over three weeks.

Bruce Aylward, head of vaccination work at the World Health Organization (WHO), believes the vaccine could be rolled out to the most vulnerable in March next year. He emphasized that this could lead to major, fundamental changes for the course of the entire pandemic.

“There is still a lot of work ahead of us, and these are only preliminary results. But these are very positive results that have come today, which hopefully is very promising for the whole world,” he told Reuters on Nov. 9.

The EU has ordered 300 million doses
Norway has joined the European Union’s (EU) program for coronavirus vaccines and will therefore receive the vaccines at the same time as other EU countries through an agreement with Sweden.

There are now at least 10 vaccines that have reached Phase 3, the last test phase before approval, and the EU has secured agreements with several of the manufacturers, including Pfizer and BioNTech.

On Nov. 9, the head of the European Commission, Ursula von der Leyen, announced that the commission would soon sign a contract with the two companies for deliveries of up to 300 million vaccine doses.

Next year
The European Medicines Agency (EMA) says they have not yet received test data from Pfizer and BioNTech. They are sticking to forecasts that the vaccine may be approved early next year. Norway is in a joint process with the EMA regarding approval of the vaccine.

As several vaccines are being developed in parallel, it is also possible that several vaccines could be available on the market at the same time.

“The EU has, for example, ordered up to 400 million doses of the vaccine from the manufacturer AstraZeneca (which is in Phase 3). It will initially come in small volumes while building capacity. In the first month, Europe may receive 10 million doses, but then it is envisaged that the entire delivery will be delivered within six months,” said Secretary General Bjørn-Inge Larsen of the Norwegian Ministry of Health and Care Services to NTB earlier this fall.

He stated that the infection will simply begin to die out on its own when more than 50% to 70% of the population has been vaccinated. It can take between six and 12 months to vaccinate that many people.

Broad studies
The new vaccine from Pfizer and BioNTech is a so-called mRNA vaccine.

This is a completely new technology that, in practice, has not been used on humans before. Unlike traditional vaccines, it is not based on the virus itself, which can make production more efficient.

“Many believe that this will have fewer side effects than previous vaccines. But precisely because this is new, there is a very heavy focus on large studies with many subjects, with 20,000 to 60,000 participants. This is how an enormous amount of data is collected on side effects, effects, and protection,” said Madsen at the Norwegian Medicines Agency.
Pfizer and BioNtech’s vaccine has been tested on over 43,000 people in the United States and other countries.

Translated by Lori Ann Reinhall

This article originally appeared in the Nov. 27, 2020, issue of The Norwegian American.