This week, the cabinet once again made it clear that there is no plan B: only a vaccine can end the corona virus crisis. That is why this summer five corona (covid-19) vaccines have been reserved by a European negotiating team; a sixth deal is in the making. The deals involve billions. Not much is known about the contracts and how well the vaccines will work will have to prove. This is what we do know.
The European Commission was in a hurry this summer. The Americans and British had already made agreements with major European companies and the companies themselves were keen to produce for the European market. A team of eight negotiators – including a Dutch civil servant – was formed to close deals.
Only large companies
The deals have been made with major pharmaceutical companies that have pledged to supply hundreds of millions of vaccines by next year, should the drug be successful, and to manufacture them in Europe. If all six reach the finishing line, there will be two vaccines for every Dutch citizen next year. It is up to the negotiators to assess whether the drug is really promising and to make sure that a mix of different types of vaccines are purchased.
The European Commission and the Ministry of Health don’t want to say anything about the content of the agreements. Only the number of vaccines that will be supplied is known. The Financial Times revealed in August that talks are being held with the companies about taking over part of the liability.
If a rare side effect is discovered after years, the countries will pay for the costs, should there be a claim for damages. A spokesman for Minister Hugo de Jonge confirms that this is the subject of discussion.
The deal with AstraZeneca is the only one fully completed. All European member states have also already agreed to purchase the drug when it enters the market. Production of the drug, including in the Netherlands, is in full swing and the first tests on humans were promising. However, a majority of the participants had mild complaints.
According to the Utrecht professor of vaccinology Cecile van Els, who works for the RIVM and is a member of the advisory panel that advises the Cabinet, such side effects are a point of concern: “Will enough people want the medicine? According to her, everything depends on the results of the third phase. In this phase tens of thousands of people will receive the drug in countries where the virus is still circulating.
These are the six vaccines ordered by the negotiating team. An explanation of the difference between vector, protein and RSA can be found in our previous vaccine update.
The second deal, with the French Sanofi and the British GSK, was the most surprising this summer. Sanofi is one of the biggest European players, but is lagging far behind in its research into a corona vaccine. No results have been published yet and research on humans has yet to begin. The preliminary agreements have therefore been made without scientists from the member states, including the Netherlands, being able to see the results.
Still, Cecile van Els thinks it’s a logical choice: “Other companies are still learning how to safely produce new vaccines on a large scale. Sanofi and GSK are using the same technology as for their flu vaccine, so they rely on proven technologies” Moreover, it’s the only one of the five that works according to the ‘protein method’. “Classic vaccines in the protein category should just be among them.”
After agreements with Curevac in Germany and Janssen in Belgium, the negotiators flew to Richmond in the United States for a fifth deal. The candidate vaccine from the American company Moderna is the hope of the Americans, and the only non-European company. Because it has declared itself willing to produce part of it in Europe, the team has reserved the vaccine. Besides AstraZeneca, the company is the only one of the five that has already started phase three.
The method is the same as for Curevac: a small piece of hereditary material (RNA) of the coronavirus is introduced. The method has not yet proven itself in humans, but the preliminary results are hopeful. “There is still a lot of experience to be built up, especially about side effects,” Van Els concludes That’s why the Phase Three study may be even more exciting for these companies. Another drawback is that RNA vaccines have to be stored very cold (at least -20), while protein vaccines can simply be stored in the refrigerator.
Notable absent is BioNTech, which is also working on an RNA vaccine. The German company has already started phase three and has already concluded deals with the United States and Hong Kong. Production for Hong Kong is even being done in Europe, at the expense of European production capacity. But according to Brussels sources, a European deal with the company is close by.
European countries can indicate to the European Commission whether they are participating in a deal. It is not allowed to negotiate with companies themselves. Once the deal is closed they are allowed to order extra vaccines from the companies. Sweden has already done so at AstraZeneca and France is also reportedly in talks with Sanofi. According to a spokesman for Minister Hugo de Jonge, the Netherlands is not doing so.
According to Van Els, it is important for confidence in the vaccines not to focus too much on getting the vaccines onto the market as quickly as possible, but to complete the major phase three trials and wait for the results.
Only after these studies have been published, the first of which will appear at the end of this year, can anything really be said about the efficacy and safety of a vaccine. In the meantime, the companies have started producing the vaccines in the hope that the results will soon be positive.
Moreover, the fact that very rare side effects of vaccines sometimes only come to light when they are on the market is something that Van Els believes should be properly explained. “You’d better be honest about this, you can’t rule this out beforehand. Honesty may also create more confidence in vaccination and lead to a greater willingness to vaccinate,” says the professor.
It is not yet clear who will be the first to receive it: in the Netherlands, the Health Council of the Netherlands will issue an advisory report this autumn.
In this video, we explains how it’s possible that a vaccine now seems to be so much faster – and what it all has to comply with: