Although the trials have not been completed, the pharmaceutical companies are already negotiating with governments and advancing sale prices. A Conicet expert requests “caution with bombastic announcements”.
Pfizer and BioNTech, two of the most powerful biotech companies on the planet, announced the start of the final trial of their experimental vaccine to combat the coronavirus. It was proposed as a challenge to present results in October that, by that date, will be evaluated by regulatory entities (FDA, Food and Drug Administration, the equivalent of Anmat in the US). At the same time, they stipulated a selling price: $ 20 maximum per dose delivered (a two-dose regimen is planned over time). As a result, companies headquartered in the US and Germany, respectively, advance in the race to achieve technology that can slow the spread of the pandemic worldwide. Last week, the Donald Trump government secured 100 million doses after disbursing $ 2 billion.
“The value of $ 20 arises from the companies’ agreement with the US government for 100 million doses. The numbers are not haphazard: this power has a population of 75 million citizens over the age of 60, so with this contract it could cover the supply to its risk groups and would give them a margin, a plus, to immunize the personnel of health ”, explains Mario Lozano, molecular virologist at Conicet and former rector of the National University of Quilmes. Then he completes: “Argentina should carry out similar accounts: we have approximately 7 million people over the age of 60, a tenth of the United States in that age group. Similarly, with 10 million vaccines we would be good to cover this portion of society and do the same with our doctors, nurses and other groups that are on the front lines of combat. “
For this so-called “final phase”, Pfizer and BioNTech will carry out tests on more than 30 thousand people (between 18 and 85 years old) in 120 clinical centers scattered around the world. The efficacy of the candidate vaccine will be tested in the US, Brazil, Germany and, as this newspaper reported days ago, in Argentina. According to the companies, at the domestic level, phase 3 clinical trials would begin between August 3 and 4 at the Military Hospital (CABA). It is important to underline that this is a phase that cannot be skipped and that it should be as rigorous as possible. To do this, both companies partnered with the Infant Foundation, which, under the supervision of the infectious medicine doctor Fernando Polack, will coordinate the studies in Argentina.
In the context of the emergency imposed by the coronavirus, the WHO established a condensed phase scheme for clinical trials. “Pfizer has already done 1 and 2 together and are now in a 2/3 stage. In principle, they obtained promising results but with few people and this must be taken into account, because it is one thing to test from the laboratory and another is to manufacture billions of doses, as is necessary in this case. It was successful, therefore, it generated very few adverse side effects and caused many antibodies in the people who received the drug, ”says Lozano.
The challenge, in this sense, will be when the sample expands and more heterogeneous groups participate in the tests: from health professionals, to young people and older adults from different territories, with different socioeconomic backgrounds and with different clinical backgrounds. Only in this way, the methodology will be strengthened and the statistical panorama will become more complex and more related to “people’s realities”. In phase 3 – which will take place in Argentina – nations with greater viral circulation are required as an essential requirement. This is what the specialist points out: “In this case, the companies try to establish the counterpoint between vaccinated and unvaccinated people. Those who belong to the second group receive a placebo and then, each of the participants in the experiment is followed up to know if, in fact, the vaccine prevented the contagion or if it did not do so as expected. ”