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Argentina’s COVID-19 vaccine negotiations

An overview of negotiations with AstraZeneca, Pfizer, Russia and others

By | [email protected] | December 17, 2020 1:53pm

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The summer might have brought some relief to Argentina with regards to the COVID-19 pandemic, but the government knows the virus will inevitably strike again in a few months’ time unless something changes drastically when compared to 2020. And their biggest bet to prevent this, by far, is securing a massive amount of vaccines over the coming months, enough to at least immunize risk patients, doctors and other essential workers.

The world, however, is in scramble mode to get vaccines, and Argentina is no exception. The country was holding multiple simultaneous negotiations with laboratories across the world, but some of them have fallen through, others are suffering delays with regards to authorization, production or distribution logistics, and the only deal that looks likely to yield a significant amount of vaccines in the near-term is the one Argentina recently struck with the Russian Federation.

Here’s an overview of the talks Argentina has held with countries, companies and institutions, and the current state they are in:

Oxford-AstraZeneca

The government had first signed an agreement with the producers of the Oxford-AstraZeneca vaccine, according to which Argentina and Mexico would combine efforts to produce between 150 and 250 million vaccines doses to distribute in Latin America.

This was the first major vaccine-related announcement made by Argentina, midway through August when the pandemic in the country was at its worst. At the time, the government said this would help ensure that Argentina got 22 million doses ahead of time (enough for 11 million individuals), getting priority for distribution due to its role in manufacturing, although this would depend on whether its development proved to be ultimately effective.

The vaccine is moving forward, and it has shown good signs of creating immunity in preliminary Phase 3 trials, but it has also had its setbacks. According to the New York Times, AstraZeneca quietly halted tests after a participant in the UK fell ill, part of “a pattern of communication blunders that damaged the company’s relationship with regulators, raised doubts about whether its vaccine will stand up to intense public and scientific scrutiny and, in at least one instance, slowed the vaccine’s development.”

Earlier this week, the BBC reported that its developers are still optimistic about getting approval and starting distribution before the end of the year – but even if that happens on schedule, more time will still be needed to ready the doses that Argentina hoped to get before the start of its winter.

Pfizer-BioNTech

Argentina had also worked with Pfizer for several months, opening its Military Hospital facilities for its Phase 3 studies, and with several Argentines involved at a high level in the company, including infectious disease specialist Fernando Polack, who led the studies on the vaccine’s efficiency, and Alejandra Gurtman, another researcher and VP of Pfizer.

President Fernández met with Polack and Pfizer Argentina’s General Manager Nicolás Vaquer at the Olivos Presidencial Residency on July 10, and the Argentine Congress passed a law on November 10 to have the legal requirements that Pfizer wanted for the deal to take place, involving legal jurisdictions of potential lawsuits and confidentiality issues.

But when asked about the state of the negotiations with Pfizer during his press conference on Tuesday, Health Minister Ginés González García seemed very downbeat, almost cynical. “They asked us for a law giving them immunity, and the Congress gave them that law. But then Pfizer’s negotiators –not the local ones, but those in the US– started asking for more conditions. They wanted to pass a new law; they wanted the President to sign the contract instead of me. The conditions started getting somewhat unacceptable,” González García said.

The minister said he suspected that the real reasons behind the falling off in negotiations were that Pfizer “has half the production that they had initially hypothesized,” and so they couldn’t deliver on what they had discussed with countries across the globe, and had to shortchange some of them, although he did clarify that this was his own speculation based on press reports, and not on what the company told him.

What’s clear, in any case, is that Argentina’s possibilities of accessing this vaccine are presently a long shot, with others in the region such as Chile, which signed a deal with Pfizer earlier, getting priority.

Russia’s Sputnik V

Seeing how its deals with Western laboratories were showing signs of trouble, Argentina turned its sights eastwards a couple of months ago and began negotiations with Russia.

Last week, a relieved Alberto Fernández organized a press conference to announce that it had signed a preliminary contract with Russia for the provision of more than 10 million Gam-COVID-Vac (also known as Sputnik V) vaccines over the next three months: 300,000 in December, 5 million in January and 5 million in February.

The problem is that, just like with Oxford-Astrazeneca’s jab, the vaccine has not yet been approved by the regulatory bodies most trusted in the West, including the US’ Food and Drug Administration or the European Medicines Agency.

Argentina has sent local vaccine specialists to Russia to try to organize an evaluation of its own, but this will be complex too. Argentina’s regulatory equivalent to the FDA, the Anmat, usually takes time to make evaluation of its own (a year under normal circumstances), or takes cues from other international agencies. The developers of the Sputnik V have not yet published data of its Phase 3 trials in full, which Argentine regulators are waiting for before giving it the green light.

Although this vaccine has some advantages with regards to technology and logistics when compared to Pfizer’s, such as not needing to be stored in ultra-cold -70°C temperatures, the fact that its distribution began in Russia before the publishing of those results has caused international mistrust.

Earlier today, Vladimir Putin’s words about not having been vaccinated yet due to being over 60 years of age also caused a small uproar in Argentina, as the Argentine government expected to use the Sputnik V vaccine on risk patients, which include the elderly. Argentine Health Access Secretary and vaccine specialist Carla Vizzotti, currently in Russia to oversee the deal, responded that “the data analyzed so far includes people up to 60 years of age”, but “the last steps are being completed to authorize the vaccine for people over 60 as well.”

China, Johnson & Johnson, UN

Argentina has also collaborated in the development of China’s Sinopharm vaccine, with the local Huésped foundation being used as a center for Phase 3 testing in the country.

There are also volunteers being vaccinated at the Buenos Aires City’s Swiss Medical clinic for the clinical trials of the Johnson & Johnson vaccine. These might open the door for accessing these vaccines easier if they are rolled out for mass use in the future, but that is not the case at the moment.

Finally, the country also signed up for the United Nation’s COVAX vaccine distribution initiative, which tries to help bring the vaccine to less developed countries in order to reduce the massive distribution inequality that is likely to be seen under market conditions, but which is not distributing any vaccines as of yet.