There is no signed contract yet. In addition to Russia’s Sputnik V, Pfizer, AstraZeneca and Janssen offered doses.
Nine of the 200 vaccine candidates against Covid-19 are being tested in thousands of volunteers from different countries in the framework of phase 3 studies, the last instance prior to authorization and marketing, key to determining if they are safe and effective. In parallel, with the aim of speeding up the steps if they are approved, pharmaceutical companies face production at risk – if the results are not favorable, they are discarded – and governments negotiate contracts, also at risk. Although there are still no signed agreements, Argentina received offers for four of the most advanced and could – once again: it is a fundamental requirement that they successfully pass phase 3 – have a “vaccine mix” available during the first half from 2021.
“We always believed that this is going to be a mix of vaccines. No producer will have the capacity to produce all the necessary ones. How we do not know which of them will be approved and which will notAlthough we have confidence in all of them, we have to ensure different vaccines in such a way as not to be left with a disability related to one that goes wrong or its approval is delayed, “said Health Minister Ginés González García in the framework of an interview joint conducted by the Argentine Network of Scientific Journalism (RADPC), in which the Clarion.
Russia’s touted offer to access 25 million doses of the Sputnik V candidate that could arrive between December and January is not the only one in dance. Pfizer offered one to three million of its messenger RNA-based candidate (developed in conjunction with BioNTech). “At Covax – a global purchasing mechanism – we have already paid the advance for 9 million vaccines. And by paying a little more, you can choose which vaccines. We made use of that option and they told us that by February we would have vaccines available,” he said. González García, although did not specify which candidates they chose. And he added: “As soon as the law is promulgated (which declares the purchase and distribution of vaccines against Covid-19 of public interest), we will sign with AstraZeneca, with production capacity from March, which will last until the end of June-July by 22.4 million doses of vaccine“They all need the application of two doses per person.
“Of course, they all have to be approved“Before being marketed, she stressed and stressed that” any massive introduction of a product or drug needs to meet world standards. “She also said that there is dialogue for other candidates:” In the case that the ROC costs a lot. Today I made another request, linked to how, how much and at what price. And we also have other promising ones, but that come a little later in their development, such as Janssen, which has the huge advantage of being a single dose, which logistically means a very important resolution of the problem “.
When do you think the doses will be ready, how much availability do you estimate and at what price: these are the three questions that, according to González García, all potential suppliers at the negotiation table. And an order: the transfer of technology to produce locally, a step in which progress was made with the candidate from Oxford and AstraZeneca, whose active substance will be produced by the local biotechnology laboratory mAbxience for distribution in Latin American countries. The British company is also systematically sending information on the progress of its research to the National Administration of Medicines, Food and Medical Technology (ANMAT), which allows real time analysis that could speed up the regulatory process.
The “added value” of the Russian offer, said the Minister of Health, is “the opportunity to mass vaccination from the start and make it as timely as possible, end the queue that we are still having with these levels of pandemic in Argentina and, above all, lower circulation and mortality, which are the two things that interest us centrally. “And he added that” although we had Pfizer vaccines available as of December, they were not large. “
However, he stressed that no agreement has been signed yet with none of the candidates. The enactment of the law passed last week would give the green light to move forward. “This law is requested by the Covax mechanism. In the same way that they (the laboratories) are producing at risk, what they want is dilute some of the risks and share them with countries. It is universal and there is no way to enter the circle of vaccines if you do not have those guidelines. That’s why we did it, “he said.
As for Sputnik V, he announced that a representative will arrive in the next few days to face commercial management.
“The bilateral actions are to see if there is any strategy that can improve the opportunity: have more doses before“said the Secretary of Access to Health, present at the meeting with the RADPC.
The four candidates for which specific offers were received (those from Pfizer, AstraZeneca, Gamaleya and Janssen) were presented to representatives of the National Immunization Commission (CoNaIn), who gave their endorsement to the Ministry of Health to advance the contracts with the four producing laboratories.
According to the minutes of the meeting held on October 22, Dr. Mirta Roses, president of the CoNaIn, recalled “that purchase contracts are at risk, and it may happen that they are not marketed or that the required quantities are not available in each production and distribution cycle, and aspects such as the results of phase 3 studies and the incorporation of people with comorbidities will be taken into account, among others. In addition, producers will be asked to constantly update the information as it becomes available. “
When it comes to closing deals, in terms of costs, come into play not just the price per doseBut rather the timely delivery and logistics issues, including presentation (single or multi-dose), storage temperature, the place they occupy and what is the vaccination strategy, Vizzotti said.
The Pfizer and BioNTech candidate, for example, needs refrigerate to -80 degrees. That will not be an option for the most remote vaccinations, estimate from the Ministry of Health. “These are issues that are part of the challenge that this vaccination campaign will imply in relation, not only to the number of people to be vaccinated, but also there are two doses and different vaccines with different types of storage (only Janssen’s is a dose). Some will be for more central locations, others for more decentralized areas. Each of the jurisdictions is working to expand the cold chain and strengthen the ultra-cold capacity, “said Vizzotti, and said that the provinces are already working on the definition of the target population and the design of vaccination strategies.
“In Argentina we have the procedures for the registration of all vaccines. In these vaccines, obviously due to the emergency situation worldwide, the evaluation processes are being accelerated, but no registration step is being skipped. The technical parameters to be approved are from the regulatory entities. Based on them, the approval and the vaccination strategy are defined: in all vaccination procedures the safety of the vaccines is evaluated from the first moment (in each of the research phases) and permanently, even after authorization. , in phase 4 “, highlighted Vizzotti.
When asked about whether advance authorizations are evaluated, before the end of the phase 3 trials, the Secretary of Access to Health replied that “what is done in the world -not only in Argentina- in the context of emergency sanitary, are interim analysis, without waiting for the recruitment of 100% of the volunteers. If at some point those interim analyzes show that the vaccine does not generate benefits, they are interrupted, and if they show that it does, the regulatory agencies can evaluate it. “In that sense, he said that” the regulatory agencies may receive partial information to go analyzing in real time. When that information is sufficient, a decision can be made from the regulatory point of view to define moving forward with the approval of the vaccine. “