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Argentine scientists take first steps in developing an oral formulation to prevent infection from SARS-CoV-2. It will be the first initiative of its kind in Latin America.
It's now commonplace to say that "little is known about the coronavirus," just five months from when it was first identified that Covid-19 was responsible for the host of infections and deaths that have now swept the world.
However, experts continue to be surprised by the fact that – even though not even 180 days have passed since its genome was discovered –– 115 different vaccines are already under development across the globe. Among them is an idea being developed by Argentine scientists at the CONICET (National Scientific and Technical Research Council) government agency, who have just won a US$100,000 grant from a research agency that reports to the Science, Technology and Innovation Ministry.
Under the coordination of Dr. Juliana Cassataro, who is leading a team of experts from the University of San Martín (UNSAM), the funds will be used to develop an original idea based on preventing infection from the novel coronavirus.
“Ours would be the first initiative to develop a vaccine of this type in all of Latin America. We are moving forward with a new concept, [and] now completing the preclinical studies phase,” Cassataro, who is also a professor at the Unsam Institute for Biotechnology Research, explained to Perfil.
Cassataro's team is trying to combine various coronavirus proteins and antigens with other compounds that they have already managed to fine-tune in their laboratory and that are internationally patented.
"We have already successfully tested oral formulations against other pathogens in mice and poultry. From what we know so far, our products achieve a combination that can unleash an effective type of immunity for the coronavirus, since it causes the creation of IgA [salivary anti-influenza] antibodies in the immune system, which are also generated in the best place in the body: respiratory mucosa. These molecules also managed to generate T-helper 1 [cell that play an important role in the immune system] and T CD8 lymphocytes [a type of white blood cell]," said the professor.
The researcher added another key detail: "For our formulation, we plan to use antigens from the SARS-CoV-2 specific strains and viral lineages that circulate in Argentina and were sequenced at [the] Malbrán [Institute]." Finally, "If the resulting vaccine, in addition to being effective, could be delivered orally, it would be a bonus because that would help facilitate the distribution and the vaccination process."
According to the immunology expert, four different biotechnological strategies have been developed in global laboratories to create this vaccine: working with inactivate viruses (such as vaccines for Hepatitis A and rabies), adenovirus-based, based on DNA, and designs based on viral RNA (Ribonucleic acid).
To these four platforms that are in phases one or two, a fifth was added last week, with candidates made on the basis of recombinant or subunit proteins, such as the current ones against HPV or Hepatitis B.
Each of these options ha advantages and disadvantages, including safety for the person who will receive it and technological novelty or difficulties to produce them in the necessary quantity and guarantee their accessibility.
“This is not a minor issue because the WHO experts say that we would need to manufacture at least one billion doses in the shortest time possible,” said the Unsam expert, referring to the World Health Organisation.
“This is why it is important that there are several options in development, because in addition to not being able to know which will work and which will not, it is also possible to have more options to manufacture the successful ones. This also explains why the WHO has registered no less than 115 different projects,” the expert continued.
He added that "some may be very efficient and others less so, but the idea is that if we bet on more options, we are more likely to get one, or several, that work."
Finally, Cassataro warned against a desire to achieve concrete results quickly.
“It is incredible, everything that we advance in a very short time. But we cannot categorically affirm that in 12 or 18 months we will have a vaccine. I would love to, but science advances in another way. We will have vaccines, but not before testing them on thousands of people to be sure that they do not cause more damage than they prevent and that they are effective in protecting us,” she added.
“When will it arrive? We still can't know for sure."
How to guarantee global access
One of the great barriers that future vaccines must overcome is not immunological, but industrial and economic: that they reach all the people who need it in an accessible way and in the shortest possible time. It is not a minor issue, and the WHO itself is concerned about this issue.
"We have to promote the vaccine and that everyone has access to it," said WHO Director General Tedros Gebreyesus recently. “The world needs it and fast. Past experiences have taught us that even when vaccines exist, they have not been available equally to everyone. We cannot allow that to happen.”
The problems needed are many: from who will have the patent for these molecules to the cost at which they will be marketed and which groups of people or nations will have priority to be vaccinated with the first batches produced. It should be remembered that in the AH1N1 influenza pandemic in 2010, only developed countries had first access to vaccines and the poorest countries only had access six to eight months later.
Among the more than 100 potential vaccines – so far all the initiatives are based in laboratories in China, the US, and Europe – at least 10 have already been tested on humans, something totally unprecedented in the pharmaceutical industry, where these times are usually measured in decades.
The amount of money that is being committed is also unprecedented. For example, the British government has allocated £93 milion to build the UK's first dedicated vaccine manufacturing and innovation centre.
Why is it so important to have an effective vaccine?
"Because it is the only way to ensure that the population has adequate defences against this disease without paying very high costs in lives," Cassataro explains.
"For example, in France and Spain more than 27,000 people died and it is estimated that only between four and five percent of the entire population achieved some immunity. To achieve what is called 'herd immunity,' protection should cover more than 60 percent of the people," she concluded.
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