Governments, companies, health systems and citizens scrutinize with great interest to know when a vaccine against Covid-19 will arrive that can give a respite to the economy, health and a certain normality similar to the lives before the pandemic. Policy makers, research bodies and the pharmaceutical industry know this and in an unprecedented race they are moving rapidly towards a solution. At the moment, they are 45 the developed candidates by R&D centers, universities and pharmaceutical laboratories that are already tested in clinical trials with humans, according to the latest public list of the World Health Organization.
In the vast majority of these 45 projects there is private initiative participation. Specific, 33 of these candidates (almost 75% of cases) are driven by companies alone or in collaboration with research centers or universities. In this range there are companies of all kinds: from large multinationals to thriving biotech companies listed on the Stock Market and small companies specialized in vaccines that have seen their great opportunity in this pandemic.
The most advanced vaccines for the European region are those led by the British company AstraZeneca, in collaboration with the Oxford University, and that of the American Pfizer, in alliance with the German BioNTech and the Chinese Fosum. For these two candidates, the European Medicines Agency (EMA) has begun what it calls “continuous review”, a process in which the health authority verifies the data from the tests with volunteers simultaneously as they are obtained. In this way, when the community body based in Amsterdam has sufficient figures on the effectiveness, it will give the go-ahead for its commercialization and distribution in the countries.
In almost 75% of cases, vaccines have private sector participation
Both companies believe that their product is very close to having the conclusive data that allows them to know if they pass the cut of the health authority. In the US, Pfizer reported in mid-October that it expects to have such evidence by the end of this month of November. The US government has admitted that the US drug agency (FDA, in its acronym in English) will give authorization within 24 hours when the efficacy is proven in the final phase of the trials. That would mean that in December, if the scientific evidence is met, the first vials could be distributed.
In Europe the calendar can be very similar. The EMA’s ongoing evaluation of Pfizer and AstraZeneca research means that as soon as the data is available, it can begin to be distributed. It will be a matter of weeks or at most the beginning of 2021. In fact, Salvador Illa, advanced last month that it expects Spain to receive its first 3.1 million doses of AstraZeneca this December, out of a total of 31.5 million that are expected to arrive in 2021.
Distribution in Europe
These two initiatives are not just the only two most advanced. In total, 10 are in the last stage of clinical trials (human trials), according to the World Health Organization (see graph). Of those, that of Janssen, Novavax and Moderna They also have opportunities to be distributed in Europe, since the other four Chinese and the Russian Sputnik V have very little probability of reaching EU citizens because the tests are not carried out on the continent under the supervision of the EMA.
Europe has already signed three supply agreements for these experimental products for distribution among its Member States, specifically with AstraZeneca (300 million vials), with the consortium formed by Sanofi y GSK (300 million) and with Janssen (200 million plus another 200 million optional). Spain has shown its interest in joining these three agreements, which gives it reserves of a minimum of 83 million doses, according to the proportional distribution by population, as it has been advancing in recent weeks Five days.
The Executive of Ursula Von del Leyen also maintains advanced negotiations for the supply of the experimental options of the companies CureVac, BioNTech-Pfizer y Moderna.
Due to the unprecedented health crisis caused by the SARS-CoV-2 virus, the processes to obtain the vaccine have been shortened as never before. It is the cause that global science has focused on finding a quick solution. In addition to the 45 initiatives in clinical trials, WHO details that there are another 156 in preclinical tests (corroborating hypotheses at the laboratory level and in animals). This number of initiatives has accelerated the process to obtain a conventional vaccine, which can usually exceed a decade from the laboratory stages to its authorization.
On this occasion, organizations and companies have had sufficient financial support to rapidly undertake the tests. The US Administration of Donald Trump launched Operation Warp Speed (maximum speed) endowed with 10 billion dollars to fund research on therapies and vaccines. Even so, the speed has not been so fast as to see a vaccine approved before the presidential elections that are held today in the US, as his president had suggested to score a point in a health crisis that has left more than 236,000 deaths in that country.
Moderna, Pfizer, AstraZeneca, Novavax, Janssen (Johnson & Johnson group) and Sanofi are some of the companies that have been showered with hundreds of millions of dollars to move quickly. Likewise, the European Union, its member states and the United Kingdom have endowed hundreds of millions of these investigations or through grants to institutions that have centralized resources such as CEPI (Coalition for Innovations in Preparedness for Epidemics).
USA (14 candidates), China (11) and Europe (11) lead the trials
The think tank Policy Cures Research reports that funding for the R&D of this vaccine has been announced in the world that reaches 5,451 million dollars (4,688 million euros), both by the public sector and the pharmaceutical industry and donations .
By geopolitical poles, Chinese companies or institutions are behind 11 of the 45 clinical trials, 14 in the case of the United States, and another 11 of European participations (Germany, United Kingdom, France and Italy). At the propaganda level, Russia authorized the first vaccine, Sputnik V from the Gamaleya Institute, in August, but in reality it is still in testing with volunteers.
The clinical trials that are being carried out also include those of large vaccine manufacturers, on which the great weight of distribution in Western countries will fall, although somewhat more delayed than the 10 in phase III (final tests in thousands of volunteers). The consortium of Sanofi and GSK is currently conducting Phase II trials (for efficacy on hundreds of participants) and Merck Sharp & Dhome (MSD) has two Phase I candidates (testing for safety on dozens of volunteers). Although it is still expected that there may be more alliances as research centers or small biotech companies need financing or production capacity.
For example, within these alliances, the Spanish company Rovi has become the partner of the American company Moderna to do the filling and packaging of vials to distribute all over the world (except the US).
Distribution. The director of the oncology research and development area of the British pharmaceutical multinational AstraZeneca, the Catalan Josep Baselga, announced yesterday that at the end of the first quarter of next year, “if all goes well, the vaccines will be in an advanced distribution phase ”. Speaking to RAC1, Baselga indicated that, in his case, AstraZeneca estimates that by early 2021 it will have about 3 billion doses. For the Spanish scientist and manager, the complicated thing will be to design how to distribute them given the demand that will exist, which is why he has said that he calculates that until “the end of the first quarter” of next year the vaccines – if they work – would not be in “phase advanced distribution ”.
Manufacturing. Unlike the conventional in the development of a vaccine, in the case of the coronavirus, companies are advancing in industrial plans simultaneously with research, so that when they receive approvals from the health authorities they can manufacture and distribute in a very fast from day zero. In this effort, they have allied with major producers such as the Indian company Serum, such as AstraZeneca.
Unknowns. Among what is not yet known is to what extent these first vaccines will be effective (for example in more than 50% of the population) or we will have to wait longer for a second wave of more sophisticated products or for there to be a therapy (for example monoclonal anti-overlaps that the industry investigates). The price is also unknown in most cases. Spain has only communicated what it will pay for AstraZeneca, at 5.8 euros per citizen (two doses).