Address by the Minister of Health and Care Services to the Storting regarding Norwegian authorities’ work on vaccines against Covid-19

Address by the Minister of Health and Care Services Bent Høie to the Stortingon 18 January 2021, regarding Norwegian authorities’ work on vaccines against Covid-19.

President,

Through the EU cooperation of which Norway is a part, we have commenced immunisation against Covid-19 faster than many had dared hope for. On Boxing Day, the first delivery arrived in Norway, and the following day, the first nursing home resident was vaccinated. Initially, the number of doses is limited. Most municipalities began to immunise their residents just after New Year’s. This morning, a total of 48,680 Covid-19 immunisations were registered in the national immunisation register, SYSVAK.

We are expecting large deliveries of vaccines in the coming weeks and months. Once high-risk groups are immunised, fewer will develop serious disease, but we may continue to see big and small outbreaks. The epidemic must still be contained so that the capacity of the healthcare services is not overwhelmed. We are following the situation closely and are adapting the infection control measures according to the development in infection numbers.   

Vaccine agreement

It was not a given that Norway’s population would receive access to vaccines against Covid-19 as early as we did. When vaccines are a scarce commodity, even purchasing power is no guarantee of rapid access. Norway is a small market of limited interest to the major actors on the market, and we do not have our own manufacturing of vaccines for humans. Several countries notified of restrictions on exporting of vaccines, and the work of securing access to personal protective equipment in the early phase of the pandemic had shown us the vulnerability of the global market for pharmaceuticals and medical equipment. In a global vaccine market with considerable uncertainty, Norway is therefore dependent on cooperation with other countries in similar situations. That we have now commenced immunisation in Norway, is because of the fact that we, in cooperation with the EU, were able to invest risk capital at an early stage in the vaccine development and manufacturing and that the European Commission and member states have facilitated in order for Norway to also be covered by the EU’s procurements via resale agreements with Sweden.

It has now been clarified that Norway will receive at least 3.4 million vaccine doses from Pfizer-BioNTech, 1.89 million vaccine doses from Moderna and more than 3.3 million vaccine doses from AstraZeneca. Approval of the latter is pending and is expected to arrive in late January. We are also expecting a considerable volume from the EU’s newly agreed additional agreement with Pfizer-BioNTech. We will also gain access to a considerable volume from Janssen. Furthermore, we will be able to receive large volumes from the EU’s agreements with Curevac, Sanofi-GSK, Novavax and Valneva, if these vaccines are approved. The EU has entered into binding supply agreements with five manufacturers, an option agreement with a sixth manufacturer, as well as a letter of intent with a further two companies.

If all of the vaccines for which the EU has agreements are approved, Norway will gain access to three times as many vaccines as we need. The vaccines that we do not need for ourselves will be given to other countries that need vaccines. We are planning to do this in cooperation with other European countries.

CEPI is the global coalition for epidemic and pandemic preparedness. It was established following the Ebola virus epidemic in West Africa in 2014–2015 to develop vaccines against the disease. Norway played an important role in this establishment, and CEPI, as you know, is headquartered in Oslo and London. Since then, CEPI has contributed with funding of vaccine development, including to the University of Oxford and AstraZeneca, as well as Curevac, which has likely contributed to the rapid development of vaccines against Covid-19. The two companies AstraZeneca and Curevac are expected to deliver a total of 565 million vaccine doses to Europe in 2021. This is enough to be able to immunise 62 per cent of EU and EEA residents.

Norway is one of the biggest contributors to CEPI. In March, the Norwegian Government decided to increase funding to CEPI by NOK 2.2 billion over several years. The purpose of the increased funding was to strengthen CEPI’s work in developing a vaccine against Covid-19.

ACT-Accelerator, which is the global cooperation for development, production, and equitable access to new diagnostics, treatments, and vaccines against Covid-19, was launched in April, with support from, among others, Prime Minister Erna Solberg. COVAX, the vaccine pillar in this cooperation, was developed as a collaboration between the organisations WHO, Gavi and CEPI. At an early stage, COVAX defined the goal that up 2.2 billion vaccine doses should be made available in 2021, for equitable distribution between countries – irrespective of their purchasing power.

The distribution key that was proposed by COVAX and which remained in place for a long time, entailed that countries would not receive vaccine coverage for more than 20 per cent of their own populations. This was not enough to flatten the curve. Therefore, the Norwegian Institute of Public Health was tasked with modelling how various scenarios for immunisation and vaccine access could affect the spread of infection and the necessity of continuing other infection control measures. The models showed that in case of widespread infection, it would be necessary to immunise significantly more than 20 per cent of the population before seeing an acceptable reduction in the number of hospitalisations – even with an effective vaccine. It then became clear that COVAX alone would not be able to cover Norway’s need for vaccines.

The work of securing access to vaccines against Covid-19 has been highly political in nature. Therefore, it is the Ministry of Health and Care Services – not the Norwegian Institute of Public Health – that has led these efforts. There has also been extensive cooperation between the Ministry of Health and Care Services and the Ministry of Foreign Affairs. In May and June, we had extensive deliberations regarding vaccine cooperation with colleagues in other Nordic and European countries and with the European Commission. We also had meetings with representatives from vaccine manufacturers. The manufacturers clearly stated that they wanted to enter into agreements with Europe as a whole, not with individual countries. In early June, there was contact between the Ministry of Health and Care Services, the German Federal Ministry of Health and the office of the Prime Minister of France. The topic was Inclusive Vaccine Alliance, IVA, which is a European initiative for development, manufacturing and procurement of vaccines against Covid-19. This alliance was launched by Germany and France, in cooperation with Italy and the Netherlands on 5 June. In this period, I also had extensive political contact regarding vaccines with my European colleagues, including conversations with Germany’s Federal Minister of Health, Jens Spahn on 12 June and the European Commissioner, Stella Kyriakides, who is responsible for health in the European Commission, on 2 and 17 June, respectively.

On 11 June, Prime Minister Erna Solberg sent a letter to President of the European Commission, Ursula von der Leyen regarding Norwegian participation in IVA, at the request of, among others, France. Two days later, on 13 June, the IVA countries signed an agreement with the pharmaceutical company AstraZeneca regarding the delivery of up to 400 million vaccine doses to the countries in Europe. It was then clear that the EU would take over the work that had been commenced by the IVA countries.   Therefore, on 2 June, the Norwegian Government formally decided that close cooperation with the EU should be Norway’s main strategy for gaining access to vaccines for its own population. In July and August, we had regular conversations with Sandra Gallina, who was the EU’s chief negotiator during the vaccine procurements, and with Sweden’s vaccine coordinator, Richard Bergström regarding Norway’s connection to the EU’s vaccine procurements.

It was not a foregone conclusion that Norway, an EEA country, would be part of the EU’s agreements. We consistently received positive verbal feedback to this request, both from the European Commission and the individual EU member states that we were in contact with. The United Kingdom entered into its own bilateral agreements outside of the general European cooperation. Therefore, we were concerned that this would lead to scepticism in the EU to having to include countries outside of the EU. The EU used the Emergency Support Instrument (ESI) for risk investment in vaccine development. They did this, among other things, to cover start-up costs for upscaling manufacturing capacity for vaccines. Norway was not part of ESI, and no mechanism has been found that allows for direct payments from Norway to ESI. This, despite several offers of payment from Norway. We were thereby prevented from directly taking part in the agreements which the EU and its member states entered into with vaccine manufacturers. We received clear feedback from the Commission that the legal hurdles for Norway to become a part of ESI were absolute, but at the same time, there were clear political commitments that we would jointly find solutions to work around these legal hurdles.

Therefore, we worked hard to find models that solved the legal problems. It was the Swedish vaccine coordinator, Richard Bergström who in August proposed a model for resales to the EEA countries and Switzerland. This solution entails that all EU countries waive a volume of up to three per cent, in order to cover the needs of Norway, Iceland, Switzerland and Liechtenstein and that the vaccine doses will be resold from one of the EU’s member states at a price that also covers the ESI contribution. Thereafter, it is this EU country that pays this ESI contribution to the European Commission. On 14 August, the EU signed an agreement with AstraZeneca entailing that the EU took over the vaccine agreement that the IVA countries had entered into two months prior. On the same day, Prime Minister Erna Solberg had a conversation with Commission President von der Leyen, who subsequently posted on Twitter that the EU’s agreements with pharmaceutical companies under the EU’s vaccine strategy also covers the needs of Norway and the other EEA countries.

The solution arrived via Sweden. On 20 August, I had a conversation with my colleague Lena Hallengren regarding possible resales from Sweden’s procurements. In a press conference on vaccines the same day, Swedish Prime Minister Stefan Löfven, together with Lena Hallengren and Richard Bergström, stated that Sweden would ensure redistribution of vaccines from the EU’s procurements to Norway and Iceland. A third-party agreement between Sweden, Norway and AstraZeneca was entered into regarding Norway’s connection to the EU’s agreement with AstraZeneca, and a resale agreement between Sweden and Norway was concluded on 15 October. To date, the EU has signed agreements regarding vaccine deliveries with eight different vaccine companies, and Norway’s connection is ensured through the same mechanism under all of these agreements.

The work of manufacturing vaccines against Covid-19 is moving at a fast pace, and a large number of vaccine candidates are being developed worldwide. There is still uncertainty as to how many and which of these candidates will prove to be safe and effective. Vaccine development is associated with a high risk, and the probability of succeeding in bringing a vaccine candidate to the market is approximately 20 per cent. No one has known if such an estimate is transferrable to Covid-19 vaccines. On the one hand, we saw promising data from studies at an early stage of the vaccine development. On the other hand, there were no approved vaccines against any coronavirus, and several of the vaccine candidates are based on new technology. To be reasonably certain that at least one of the vaccine candidates would succeed, the EU and its partners invested at an early stage in the development and production of a portfolio of various vaccine candidates. This has contributed to the development of a number of vaccines that are now nearing formal approval, and to securing large production volumes that will benefit the populations of Europe and the rest of the world.

Our connection to the EU’s agreements have secured Norway rapid access to approved vaccines. What now remains is the considerable effort of ensuring that immunisation can be implemented in a sound manner.

Immunisation in Norway

On 15 September, the Norwegian Institute of Public Health was tasked with organising the necessary planning efforts in order to be able to immunise the population against Covid-19, once one or more vaccines were approved. The Norwegian Directorate of Health coordinates these efforts in cooperation with the Norwegian Medicines Agency, the Norwegian Directorate of eHealth and the Norwegian Directorate of Health. The regional health authorities, the Norwegian Association of Local and Regional Authorities (KS), county governors and other actors are involved as needed. This work was ongoing throughout autumn. The Ministry has held weekly meetings with the Norwegian Institute of Public Health, the Norwegian Directorate of Health, the Norwegian Medicines Agency and the Norwegian Directorate of eHealth, regarding immunisation, in order to ensure that matters that are unresolved or experiencing insufficient progress, receive sufficient attention. Sub-projects are followed up more closely, if needed.

On 15 and 19 November, the Norwegian Institute of Public Health delivered the assignment. These deliveries provided a solid basis for decision making by the Norwegian Government.

On 12 October, the Norwegian Government decided that immunisation against Covid-19 shall be offered as part of the national immunisation programme. Immunisation is optional and free of charge for each individual.

The goal of the corona immunisation programme is to safeguard health, reduce disruptions in society and protect the economy.

The municipalities are responsible for organising immunisation in the manner they deem appropriate in order to achieve the highest possible immunisation coverage.

The Norwegian Government’s main priority in the immunisation effort is early immunisation of the entire population. In the initial phase, there will be limited access to vaccines, and there will therefore be a need to prioritise between groups. The entire population over 18 years of age will be offered the vaccine once we have a sufficient number of doses and this is indicated by the properties of the vaccine, if there is a professional basis for recommending such immunisation.

It is the groups that are at highest risk of developing serious disease and death that will benefit the most from being protected against Covid-19. The Norwegian Government has prioritised the very elderly and individuals in nursing homes early in the immunisation process. Next are elderly individuals over 65 years of age and individuals between 18–64 years of age who have specific underlying diseases and conditions. The oldest individuals in the high-risk group have been considerable impacted by the infection control measures in order to protect them against infection. This has resulted in increased loneliness. We hope that it will be possible to allow for fewer visitation restriction, in line with the immunisation of this group. I have requested the Norwegian Directorate of Health to consider this.

The order of priority can be adapted to the course of the pandemic, the properties of the vaccine, the level of infection in society and the degree of control and pressure on the healthcare services. 

Such an adaptation has already been made in the prioritisation. Approximately 20 per cent of the doses to the municipalities can now be given to healthcare personnel. Furthermore, hospitals will receive enough doses to immunise 15,000 healthcare personnel in January and February. This change has been made to avoid critical healthcare personnel becoming sick, and thereby ensuring that treatment is available.

The immunisation programme is premised on 75 per cent of the high-risk groups and health personnel with patient contact, and 50 per cent of the rest of the population accepting the vaccine offer. Norwegian orders of vaccines through the EU also accommodate for a far higher participation rate.

Fortunately, it appears that we will manage that percentage, and more. Currently, 83 per cent of the population say they are very likely or likely to accept taking a vaccine against Covid-19. According to the Norwegian Directorate of Health’s weekly surveys, it is the elderly who are the most positive. In this age group, 91 per cent say they will take the vaccine. We are pleased to see these figures. We had both hoped and believed that support would grow, as knowledge about the vaccines gradually reached the population. Good information and openness about the effectiveness and side effects of vaccines is key to achieving a high level of support in the population. The surveys also show that we have succeeded in the message that a joint effort is required to end the coronavirus pandemic.

The Norwegian Institute of Public Health is responsible for purchasing vaccines and shall cooperate with the distributor on a plan for the handling and distribution thereof. The plan shall ensure the right vaccine to the right place, at the right time, in the right amount and of the right quality.

The Norwegian Directorate of Health is responsible for ensuring the availability of sufficient vaccination equipment. There are now 11.4 million syringes and 14 million needles in storage, in addition to other necessary equipment.

The Norwegian Directorate of Health has purchased 615 freezer transport containers with a power-driven compressor to transport the Pfizer vaccine to the municipalities. Up to 3000 electronic temperature gauges have been procured for use in containers and other storage units where vaccines will be stored. Distribution and implementation of immunisation using the Pfizer vaccine must be planned in detail because the vaccine must be stored at minus 70 degrees Celsius, and it only has a shelf life of five days at refrigerator temperature if the ultra-cold freezer chain is broken. The manufacturer, Pfizer, has in the contract stated that they shall manage the physical transportation from their own factories and to the final stage of the ultra-cold freezer chain, i.e., to the regional health authorities and hospital pharmacies. There, the vaccines will be repackaged and distributed to the municipalities. The hospital pharmacies have the freezer capacity, necessary permits and authorised personnel to handle this.

Other vaccines that do not have to be stored in special freezer conditions, will be sent to the Norwegian Institute of Public Health, which will ensure onward transportation to the municipalities.

The Norwegian Government tasked the municipalities with creating plans for the implementation of immunisation. The time limit was 18 December. The plans include preparations prior to receipt of the vaccine, receipt, storage and internal redistribution of the vaccines, identification of high-risk groups, scheduling of appointments and implementation of immunisation. Long transport distances mean that the municipalities must have all equipment, personnel and vaccine recipients in place when the vaccine arrives, so that the immunisation is as effective as possible, and waste is avoided. This requires careful planning from each individual municipality.

The county governors had a time limit of 23 December to review the plans and follow up with the municipalities that required advice and guidance. The county governors have appointed coordinators who will contribute to all municipalities in the county having satisfactory plans for immunisation against Covid-19 and communicating information between the authorities and the municipalities.

It is the municipalities themselves that are responsible for immunising their own residents. Adaptations have been made to the regulatory framework in terms of duties and fees, in order to facilitate for regular general practitioners to be able to participate in the municipalities’ immunisation efforts.

The regional health authorities shall ensure the offer of a vaccine against Covid-19, mainly for their own healthcare personnel, but also for some patients. The Norwegian Institute of Public Health is drafting recommendations regarding which patients should be vaccinated at hospitals.

Recently, there has been a discussion about why it is apparently taking longer to implement immunisation in Norway than in some other countries.

Vaccines from the two manufacturers that have been approved to date and delivered to Norway, consist of two doses. In order for the vaccine to be fully effective, dose number two must be given three and four weeks after dose number one, or shortly thereafter. In order to be certain that a person who has received dose number one receives dose number two at the right time, this dose is stored on an intermediate basis in case of manufacturing problems. This means that we initially only administer half of the doses we receive. Placing vaccines in a preparedness inventory ensures that we have a buffer in case there are problems with manufacturing or distribution. This is also how it is being done in many European countries. The size of this buffer may be adjusted depending on what is considered necessary. The manufacturer of the Moderna vaccine recommends that we reserve half of the doses we receive. Thanks to the preparedness inventory, the dispatching of vaccines in Norway will proceed as planned, despite that fact that Pfizer, on Friday 15 January, reported that Norway will receive reduced deliveries of vaccines for a period.

Some countries are experiencing so much pressure from infection that they want to give as many as possible protection as quickly possible. They have decided that it is better that many have protection than some having full protection. The first dose probably provides protection for a certain period of time. But these countries are taking a risk by choosing such a strategy, when dose number two is not administered within the recommended time frame. Neither the manufacturers nor the European health authorities are currently recommending such an approach. As long as there is a scarcity of vaccines, these countries will also have to reduce the pace of immunisation for dose number one, once new deliveries are only sufficient for administering dose number two. To the extent these countries do not significantly postpone dose number two, the pace of immunisation of the entire population will even out among the EU countries.

Some countries have chosen to use an emergency procedure for more rapid approval of the vaccine and have thereby been able to commence immunisation earlier. Norway, in cooperation with the EU, has chosen to follow the established plan for approval, in order to be certain that the effectiveness, safety and quality of the vaccine has been thoroughly evaluated.

In Norway, we have chosen to distribute the vaccine equally to all municipalities. Because we have a short time to act once the freezer chain is broken, we must ensure that the municipalities are ready to receive the vaccine, before they are sent. Particularly in the early stages, we will have to expect that immunisation will take a bit longer. However, we are expecting that we will quickly make up for any lag, and that the delivery of vaccines to Norway will determine how quickly we are able to immunise.

The European Medicines Agency has approved an application from Pfizer for the vials to contain 6 and not 5 doses. In practice, this will increase the number of available doses from this manufacturer by 20 per cent.

The vaccines that are delivered to Norway protect against Covid-19. Currently, we do not know if the vaccines also protect the immunised individual from transmitting the infection to other people. If this vaccine also protects against transmission to other people, this will be significant to the prioritisation of the vaccine going forward. For instance, it may be relevant to prioritise areas with high rates of infection. We are following these developments closely.

Some have advocated for Norway to directly enter into agreements with manufacturers, in addition to what we are receiving through the EU cooperation, in order to get the population immunised faster. To our knowledge, the manufacturing capacity of the manufacturers is fully utilised. If Norway were to secure additional vaccine delivery, in addition to what we have already agreed, this will likely be vaccines that arrive in Norway once we have fully immunised all Norwegians who want it. Otherwise, we will have to attempt to purchase vaccines that have already been delivered to others. Fortunately, the pharmaceutical industry does not want the vaccines to be sold on the open market, on the contrary. My impression so far is that the industry has taken considerable social responsibility, both in terms of pricing and distribution of vaccines to the countries.

There are continuous efforts regarding measures to ensure a good flow of information relating to who has received the vaccine, what vaccine they have received and possible side effects. Electronic registration in the national electronic immunisation registry, SYSVAK, will contribute to quick updating of important data. A portal has been established (SYSVAK nett) which can be used for those who do not have integration between the electronic patient medical records and SYSVAK.

Unfortunately, we must be prepared for occurrences of rare side effects once the vaccine is put to use on a large scale, even though it has been tested and approved for use. The Norwegian Institute of Public Health recommends that pros and cons of immunisation are considered carefully for patients who have a very short life expectancy. On a weekly basis, it is common that between 300 to 400 individuals to die in Norwegian nursing homes. It is expected that some will die shortly after being immunised, without there necessarily being any connection between the death and the vaccine. Nevertheless, this will be reported and reviewed in accordance with established routines.

What will happen once we immunise?

Throughout the immunisation process, measures must be maintained and adapted on an ongoing basis to the infection situation and the vaccines administered. The infection situation may change if we are unable to comply with the infection control measures, or if a significantly changed virus spreads in Norway.

We now hope that a large share of the high-risk groups will be vaccinated by Easter. Once the high-risk groups are immunised, we can expect that fewer will develop serious disease, and that the risk of overcrowding of intensive care units will diminish somewhat. The pressure from infection will likely be reduced, but the pandemic will remain capable of getting out of control. We will probably be able to discontinue some measures.

If all goes to plan, we believe we will be able to offer the vaccine to everyone over 18 years of age this summer. We believe this will entail that approximately 70 per cent of all adults will have accepted taking the vaccine. At best, this will happen in June.

Even if all adults have been offered the vaccine, local outbreaks may still occur, especially among individuals who have not been immunised. Such outbreaks will generally have less serious consequences, but serious disease, hospitalisation in intensive care and fatalities may still occur.

We will continue to monitor the infection situation and outbreaks. The immunisation programme will continue.

Once the immunisation programme has reached a sufficient stage, we can discontinue the most intrusive measures, but we must be prepared for new measures if needed. The most lasting measure will be that individuals with symptoms will have to stay home and be tested. The same applies to practicing cough etiquette and good hand hygiene. This also helps prevent other infectious diseases.

Conclusion

As the Prime Minister just said, we are seeing the light at the end of the tunnel. However, it is quite some time until we can relax.

On the contrary, it is essential that we continue to observe the infection control rules, practice physical distancing, stay home if we become sick and keep our hands clean.

Immunisation is well underway and must not be delayed. It is precisely a high rate of infection that can delay immunisation.

We must persist!