I hope to vaccinate everyone 65 and older this spring.

The first Norwegians can receive the coronal vaccine as early as January. But the EU must first approve it. The elderly and other vulnerable receive it first. But it is not enough for everyone at once.

Pharmaceutical company Pfizer and BioNTech hope to obtain temporary approval for their vaccine in the US during November.

Geir Bukholm of the National Institute of Public Health assumes that Europe and the United States are quite similar in approval processes. He leads the work of providing Norway with a corona vaccine.

– Can we get some shots soon?

– It depends on when the European Medicines Agency EMA has finalized its approval. In the best case, there may be a conditional approval just before the New Year. So there is a theoretical possibility that the supplier can deliver the first doses during January.

950,000 over 65s

Pfizer’s vaccine should be 90 to 95 percent effective. Norway expects to receive more than two million doses during the first half of 2021. The vaccine must be administered twice. This means that a little over a million Norwegians receive this vaccine.

A group of ethics and prioritization experts recommends that the elderly receive the vaccine first. This group is those over 65 years of age. It amounts to approx. 950,000 Norwegians.

– In addition, there are those who are in medical risk groups and are younger, there are approx. 350,000. If medical risk groups are prioritized first, it will amount to approx. 1.3 million, says Geir Bukholm.

This means that if Norway receives two million doses of vaccine from Pfizer, it will probably not cover more than the risk groups for this first delivery. NIPH believes that 75 percent of those in risk groups will accept vaccine offers.

– What about Erna Solberg then? Won’t the Prime Minister be vaccinated until well into the fall?

– It depends on the extent to which it falls within some of the criteria.

Effect and duration are crucial

In the group “health personnel”, which is the second priority, there are approx. 300,000 people. The third priority risk groups are those defined in the group “socially critical functions”.

Who this is should be considered by others besides the health service. Both the Ministry of Finance and the Ministry of Justice will play important roles in this evaluation.

By December 1, NIPH will give its recommendation on prioritization to the government.

In addition to advice from the outside ethics group, NIPH should consider:

• What do we know about the most relevant vaccines?
• What kind of effect do they have?
• What kind of effect do vaccines have on different age groups?
• How long does the effect last?
• How do we think that different vaccines affect the spread of the disease in Norway?
• What do we know about the side effects of individual vaccines?
• To what extent will vaccines reduce the spread of the virus in the population?

– The United States has already secured 20 million doses of the manufacturer Moderna’s vaccines by the end of 2020. Now Astra Zeneca is also requesting conditional approval. When do you think they will offer us more vaccines?

– We hope that more vaccines will be offered to us in 2021 and perhaps already early next year. We are also likely to receive vaccines other than Pfizer at the beginning of the year.

If the Astra Zeneca vaccines are also approved, 3.3 million doses have been negotiated. It is also a two-dose vaccine. The number of people who receive it is, therefore, slightly more than 1.6 million.

Together with the Pfizer doses, it will be possible to offer 2.1 million doses.

– Can it be said then that ordinary Norwegians are offered a vaccine in the second half of the year?

– Yes, it can be done if one or more of the vaccines have a risk profile that makes them suitable for adults between 18 and 65 years old. Then we can also recommend them for this part of the population.

– What about children and young people?

– We do not believe that the vaccine will be approved in the first round for those under 18 years of age.

Bukholm says it’s too early to say anything about when everyone who wants has been vaccinated. But it assumes that if a large portion of the population has been vaccinated, many infection control measures can be eased over the next year.

– How confident can we be that conditional approval is secure enough? Is it going much faster than other approvals?

– The processes that are taking place now are basically as detailed as they would have been with a regular vaccine approval. They have followed the same rules, testing phases and procedures. Also, vaccines are tested in a fairly large number of people in very robust phase three studies. This number is certainly not less than in standard vaccine tests. Several phases of the trial have been carried out in parallel. You have the card up to the total time spent on trials, but each phase has been carried out according to the same rules as in other vaccine trials.

Bukholm explains that the biggest difference between regular approval and conditional approval is that people haven’t been observed for as long after phase three studies have been completed..

– On the other hand, there is a higher follow-up requirement in the observation phase after conditional approval. These are very robust studies on the efficacy and safety of vaccines.

However, Geir Bukholm cannot rule out very rare side effects.

– Also, side effects that occur after a long time are not detected in phase three studies.

– And what happened to narcolepsy after the swine flu vaccine?

– Yes, it is a rare side effect. The number of people tested was much less than the number of coronary vaccines that were tested. Norwegian and EU health authorities are planning a sensitive signaling system to detect rare side effects when vaccines are used. In Norway, we have a very good system to monitor the effect of the vaccine and monitor the side effects.