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Mexico's quest for a homemade vaccine

The Boss 30 November 19, 2020

Thousands of such containers, called ampoules, are already being sorted, labeled, and made ready to ship every hour in a mock production of a national vaccine developed by Mexicans, right here in Mexico.
These are the trial runs of a Covid-19 vaccine production line in Mexico City, to which CNN was recently given exclusive access. The ampoules we saw were only filled with water. But if all goes to plan, officials hope to be producing millions of vaccine doses this way by the end of 2021.
For Mexico, the development of its own vaccine is not just a matter of public health. While the first vaccines will be produced much earlier by some of the world's richest countries, a nationally produced vaccine is Mexico's failsafe—its best bet to ensure that if vaccine supplies from other countries prove difficult to obtain, its roughly 130 million citizens will still be protected.
Researchers have been working on the vaccine project for several months.
Mexico's government is fully aware that, at least to start, any widespread vaccination campaign will have to rely on foreign developed vaccines.
Its foreign ministry has taken an accordingly aggressive stance in proactively trying to secure up to 116 million vaccine doses from outside the country.
First, it says 25.2 million of those doses will come from agreements Mexico has secured within the COVAX program, the WHO-backed initiative that aims to secure vaccines for developing countries.
Second, purchase agreements for up to 90.9 million doses have also been secured with vaccine producers, specifically with UK-headquartered AstraZeneca, China's CanSinoBIO, and the US' Pfizer, which recently announced its vaccine is more than 90 percent effective.
"That's why international cooperation has this interesting role right now because we don't feel alone," said Martha Delgado Peralta, Mexico's Undersecretary for Multilateral Affairs and Human Rights, to CNN. "We are looking out for a good that doesn't yet exist, that everyone wants...that is about quality of life. It is a really, really tough, hard thing to do."
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Mexico has a reasonably well-developed public health system and broad experience in immunology, and is hosting a number of Phase 3 trials within the country for internationally developed vaccines. Though technically that should not influence its ability to eventually procure those vaccines, it certainly doesn't hurt to generate the good will.
Mexico has so far been successful in securing promises of access to future vaccines, say officials.
But the first round of vaccines will be the most sought-after products in the world. And an initial round of purchase agreements does not safeguard a population long-term against the virus.
"We are at high risk if we cannot find a solution that can be permanent in the near future," said Delgado Peralta.
Which is where prong three comes into play—a nationally developed vaccine.
At least a half-dozen trials of domestically developed vaccines are currently underway in Mexico.
CNN gained exclusive access to one such trial in its beginning phases on the sprawling campus of the prestigious National Autonomous University (UNAM) in Mexico City.
Lead researchers Edda Sciutto and Juan Pedro Laclette have been working on the project for months.
Their vaccine candidate uses a protein fragment that they say has been shown in animal studies to produce antibodies and a strong cellular response.
"We think it's very [safe], and is only the part essential to trigger an effective immune response," said Sciutto, as opposed to, say, a vaccine that would require the injection of a whole, dead virus.
The group, which involves dozens of members across multiple divisions at the university, plans to take its vaccine into Phase 1 trials in January.
At that pace, the group lags far behind other vaccine trials worldwide. But Laclette points out that first doesn't necessarily equal best and that we still don't know how well the first round of vaccines will work.
"Considering the situation of the pandemic all over the world, though, it's not going to be too late," Laclette said.
Getting billions of doses around the globe might be the logistical challenge of the century. And each vaccine is different, perhaps working better in certain populations than others.
"It is important to have many alternatives and select the best," said Sciutto.
Developing a vaccine is just the first part. Producing hundreds of millions of doses is another challenge entirely.
Sciutto and Laclette's team have partnered with Mexican drugmaker Neolpharma to produce the vaccine at scale.
In an exclusive tour of the Mexico City-based company's production facilities, industrial manager Diego Ocampo said the production process has been streamlined in an unprecedented way.
Normally, once a vaccine is developed, it would take years before his facility could be ready to produce it en masse. Neolpharma is trying to speed things up by using an existing platform -- in this case, a system for producing proteins with genetically engineered E. coli bacteria.
Neolpharma employees have also been working more and longer shifts and simplified their supply chain to help speed up the process.
Mexico's government, much like others around the world, will also loosen some of the regulations that normally surround vaccine development.
Authorities say they will review each vaccine candidate on a case-by-case basis, though Neolpharma is expecting "expedited review, close follow up with the evaluating committee, and expedited approval of Clinical Trials," among other changes, says Ocampo.
Ocampo believes those factors combined will allow the company to produce millions of vaccines shortly after a candidate is approved, though he couldn't say exactly when.
The two enormous, German-made production machines in his facility can each produce roughly 500,000 doses of a vaccine each day, depending on the final size of each dose.
"As a Mexican I feel that we're helping out in some way...it feels like I am on the front line," said Ocampo.
This entire process is far from a guaranteed success, with significant unknowns in each step of the process.
Mexico's foreign ministry could hit major roadblocks in its procurement of foreign-made vaccines. It's also possible, though perhaps not very likely, that all six of Mexico's domestic-made vaccine trials fail. And safely and effectively producing and distributing hundreds of millions of doses will be extremely difficult.
Mexico is not a country with a highly developed vaccine production industry. Vaccine timelines are usually discussed in terms of years, not months. But these are unprecedented problems that demand different kinds of solutions. And Mexico is giving it a shot.