Imperial College London_Thomas Angus
Amid talk of vaccine nationalism, news of countries hoarding Covid-19 medication, and vaccine hesitancy, many fail to see the potential good news.
Currently, there are 165 viable vaccine candidates around the world, 26 of them are either in the process of or about to start human trials.
One of the manufacturers, French pharmaceutical giant Sanofi, has just struck a deal with the European Commission: According to the agreement, the EU has reserved 300 million doses of a possible vaccine.
The vaccine journey could take us to one of several destinations, which include: multiple vaccines being successful in the end, only one working or none of them could work.
Considering vaccine development usually takes more than 10 years and that the world is trying to squeeze those ten years into 12-18 months, there are a lot of ethical, scientific and logistical aspects at play.
Assuming that at least one vaccine is approved for the market, hundreds of millions, maybe billions of doses, need to be produced according to quality standards. They have to be distributed and priced fairly — how would Europe deal with that? What would the next steps be? And how much would it cost the average citizen to get vaccinated?
Vaccine distribution logistics
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In theory, the answers are simple, yet vague. Once a vaccine is approved and if the developer has made a deal with the EU beforehand, member states can put in their order for the vaccine.
But their access will be determined according to a population-based key. The European Commission told Euronews that it couldn’t say what exactly that key looks like and who determined its components. However, a spokesperson said all member states were involved in the decision-making process.
Once a member state has access to the vaccine, it will then individually decide the price and the prioritisation of the distribution among its citizens.
But before any of that can happen, the following questions need answering.
Will EU citizens get vaccines first?
The EU’s strategy uses the sheer number of member states for leverage in negotiations with vaccine-developing companies, but it also manages to pool money that can go into the development and production of a vaccine. Mostly, however, the union minimises the financial risk and the health risk for individual member states.
At the end of the day, it’s the EU’s way of making sure member states won’t draw the short straw once a vaccine is successful, considering the entire world will be vying for it.
When the European Commission announced its agreement with Sanofi, it also stated that it was “ready to explore with international partners if a significant number of countries would agree to pool resources for jointly reserving future vaccines from companies for themselves as well as for low and middle-income countries at the same time.”
The strategy is to have high-income countries “act as an inclusive international buyers’ group, thus accelerating the development of safe and effective vaccines and maximise access to them for all who need it across the world,” the Commission states.
In the beginning, Germany, France, Italy and the Netherlands decided to form an alliance and struck a deal with pharmaceutical company AstraZeneca. While that was happening, the European Commission was still devising a strategy on how to most efficiently ensure that EU citizens can have access to a vaccine as soon as possible.
On June 12, the health ministers of the EU member states gave the European Commission the go-ahead to negotiate advance purchase agreements — a form of down-payment — with vaccine developers on behalf of all member states.
The alliance of France, Germany, Italy and the Netherlands asked the European Commission to take on the AstraZeneca contract in order to fall in line with the joint strategy. That contract transferral is still in progress.
The Commission made an open call to all vaccine developers who have the capacity to manufacture vaccines in Europe and who are either currently conducting clinical trials or will start doing so in 2020.
The goal is to make deals for different vaccine development technologies and increase the chance that at least one of them works.
Stefan de Keersmaecker, a spokesperson for the Commission, told Euronews: “Let’s hope that the vaccine is developed by someone with whom we have an advance purchase agreement.” He added that the goal of the entire strategy is to make sure European citizens will receive fair, equitable and affordable access to vaccines within 12 to 18 months.
If a company with which the EU does not have one of these agreements develops a successful vaccine, a new strategy will have to be found that will prevent EU member states from competing with each other.
On a global scale, however, the World Health Organization has come up with a scheme called COVAX, which works to maximise the development, equitable access and fair allocation of vaccines across all countries.
The EU is part of that alliance, which aims to procure two billion vaccine doses by the end of 2021 at an economically efficient price. It also aims to ensure that the distribution of the vaccines will be “globally fair and equitable”. The key to achieving these goals is the advance purchase agreements.
High-risk business for vaccine developers
For companies who are choosing to try their luck at developing a COVID-19 vaccine, there is a lot to consider. Not only do they have to accelerate the process of trials while maintaining high scientific standards, but they also have to prepare for possible success.
That means they have to have enough raw materials in stock to start a giant production process. They have to set up all production facilities to be able to handle and produce large amounts of products. What’s more, they have to financially prepare for the case that their vaccine doesn’t work.
Particularly for smaller and medium-sized pharmaceutical companies, this is a huge challenge. To prevent a good idea not coming to fruition for these reasons, the EU has decided to chip in.
EU money is used to start production even if a vaccine hasn’t gone through the entire approval process yet. It’s a high-stakes wager, which could be a great success if a company develops the vaccine the world is waiting for.
If a firm’s vaccine doesn’t work out, the EU will try to use its European production facilities to produce the vaccine that does make it to market authorisation.
A down-payment for vaccines
There is a team of negotiators made up of representatives from all EU member states, which is right now in the middle of discussions with each vaccine developer. Some of these negotiations are quite far along.
Other than announcing its deal with Sanofi, the European Commission said it could not comment or reveal how many developers are in the final stages of finalising purchase agreements, who they are and how big the down-payments will be.
BioNTech SE is considered one of the frontrunners in vaccine development. It has signed an agreement with the European Investment Bank for €100 million. However, the Commission said it could not comment whether or not it is currently negotiating an advance payment agreement with the pharmaceutical company.
The advance purchase agreements could be considered a partial down-payment for vaccines that are in development. The money comes from the €2.7 billion Emergency Support Instrument for COVID-19.
According to the strategy, a “substantial” part of that instrument will be put towards funding vaccine development. However, an exact amount has not been determined, Keersmaecker noted.
He pointed out: “We support these companies with the development of their production capacity already at the stage where there may not necessarily yet be a developed vaccine.” Once a vaccine is developed, EU member states will be able to purchase the vaccine directly from the developer at a set price.”
The EU will put down a specific amount negotiated with each company under certain conditions. If one or several companies then develop a successful vaccine, each of the member states can put in an order and will have to pay the rest of the price separately.
What are the risks?
Financially, the EU is committing huge sums to these companies without a guarantee that any of them will develop a successful vaccine.
However, to soften the blow, part of the negotiation is to see if production facilities of companies whose vaccine hasn’t worked out can be used to produce a successful vaccine at some point.
According to Keermaecker, the EU doesn’t have financial loss at the forefront of its mind. “It’s not so much discussion about what we are going to lose. It’s more a discussion in terms of what is needed for this company to make the necessary investments, so that we, the European Commission, can make sure that when the vaccine is developed, we can distribute it easily to the member states. It’s a bit of a different approach.”
The EU’s strategy document states that there is a “very real risk that none of the supported candidates will be successful”. But “the value of earlier access to a vaccine is enormous, in terms of lives saved and economic damage avoided” makes “the risk worth taking”
Is more regulatory flexibility a good idea?
One of the ways the EU intends to speed up the vaccine discovery is to offer regulatory shortcuts without sacrificing the quality, safety and efficacy of a vaccine.
Those shortcuts range from getting rid of the necessity to translate everything into all the languages at each step and on each label, all the way to offering the scientific support of a task force from the European Medicines Agency during the development process.
The goal is to make use of flexible areas that already exist in European law. One of these points that allow for wiggle room is to the issue of a “conditional authorisation.” This means that a vaccine can be authorised based on less comprehensive data than usual, which does need to show positive benefit-risk results. The data can be completed later.
However, the Commission says this is not a case of bending the rules, but rather “the rules have been created sometime before this situation to allow for faster authorisation,” says Keersmaecker. “But this does not mean that the companies are off the hook. They still have to provide certain data within a certain period of time. But it does mean to be faster and more efficient, while still ensuring the public health,” he adds.
It is theoretically possible that a vaccine could be recalled later if data comes to light, which shows that it is unsafe or too risky. However, the vaccine that makes it to approval — meaning it will be allowed to go to market — “will have the usual excellent product quality as any vaccine,” Prof. Klaus Cichutek, President of the Paul-Ehrlich-Institute in Germany told Euronews.
Any vaccine that makes it to market “will have undergone extensive non-clinical and clinical testing, and the assessment of the Paul-Ehrlich-Institut and EMA will ensure that each product’s benefit-risk ratio will be positive.”
The Paul Ehrlich Institute (PEI) is a German research institution and medical regulatory body and is the German Federal Institute for vaccines and biomedicines. Currently, it is deeply involved in developing a national concept for vaccination against COVID-19 for the German Ministry of Health and the strategic advisory group of experts at the World Health Organization.
Once a COVID-19 vaccine is approved to go to market, the PEI will check each production batch for its safety and “provide an official governmental batch release for all Covid-19 vaccines to be marketed in Germany,” Cichutek points out.
Moreover, the research for the COVID-19 vaccine didn’t have to start from scratch. According to Chichutek, a lot of research had already been done during the development of a MERS coronavirus vaccine. “Only if the benefits outweigh the possible risks is it possible to grant a marketing authorisation,” he says.
The price of a vaccine
Neither the European Commission, nor representatives of pharmaceutical companies, nor scientists say how much a dose of vaccine would cost for a regular citizen in a European country or elsewhere.
Not even a price range can currently be determined since it is still unclear how many doses of a vaccine will be necessary to immunise someone. It is also unclear which technology — and hence production effort — will be used to develop the vaccine.
However, several sources told Euronews that those decisions will be made on a higher political level. Some institutions can give recommendations on factors like how much insurance companies would cover. While these recommendations are usually taken into account, they don’t guarantee anything.
Nevertheless, Keersmaecker says: “We want to make sure that this vaccine is affordable. It doesn’t have to be free. But it has to be affordable.”
Several pharmaceutical companies have committed that they will be offering the vaccine — if successful — on a not-for-profit basis.
However, such a promise is not as clear cut as it seems, as could be seen when Johnson & Johnson said it was offering the tuberculosis medication bedaquiline for a not-for-profit price in low and middle-income countries.
According to a Johnson & Johnson statement sent to Euronews, the TB drug bedaquiline “was the first novel TB medicine in nearly half a century. From 2015-2019, Johnson & Johnson provided more than 105,000 courses of the bedaquiline to more than 80 countries free of cost through a donation program [sic]”.
After pressure from rights groups, Johnson & Johnson found that it was indeed able to lower the price of the drug substantially. Up until July 2020, bedaquiline was offered at $400 (€337) for a six-month treatment in low- to middle-income countries. In July, the company announced it was dropping that price to $340 (€287) per treatment course for more than 135 countries.
In its statement, the firm says: “This price is on par with several decades-old generic medicines and enables us to support critical access-related activities, including quality manufacturing, responsible distribution, health systems strengthening, and antibiotic stewardship to protect the long-term effectiveness of the medicine.”
Johnson & Johnson also stated that it would offer an “escalating percentage” of free drugs if certain volume thresholds are reached annually.
Doctors without Borders had demanded that Johson & Johnson halve the price of $400 after researchers from the University of Liverpool calculated that the drug could be produced and distributed for as little as $1 (€0.84) per day.
Johnson & Johnson is one of the companies that pledged to market a COVID-19 vaccine as not-for-profit. Imperial College London, which is in the middle of clinical trials, said it will “waive royalties and charge only modest cost-plus prices to sustain the enterprise’s work, accelerate global distribution and support new research”.
It has established a social enterprise (VGH) to do so. The goal is also to distribute a possibly successful vaccine “as widely as possible in the UK and overseas, including low-and middle-income countries”.
Who would get it first?
There are no clear regulations as to which population group will get a vaccine first and whether it is dependent on your age or profession.
It is very likely that EU member states will individually determine which group will have first access to a vaccine once it becomes available.
Many assume the first people who need to be vaccinated are those in high-risk jobs, such as doctors and nurses. Second in line are likely those most vulnerable to infection due to their pre-conditions or age.
However, it seems to still be unclear who will be able to access the vaccine after that.