> POTENTIAL VACCINES: ARGENTINA’S FIVE FRONTRUNNERS

A quick rundown on the five frontrunners, in order of their appearance on the scene.

OXFORD- ASTRAZENECA

Already with positive results in producing antibodies in July, followed up by President Fernández proudly announcing in August that the Argentine lab mabxience (belonging to the Argentine-spanish pharmaceutical group Insud Pharma dating from 2009 and specialising in monoclonal antibodies) will produce the Oxford-astrazeneca vaccine with packaging in Mexico, the British vaccine has since progressed to signing an agreement to supply Argentina with 22 million doses of A ZD1222 against the Covid-19 pandemic. The lab hopes that they can publish their Phase III clinical studies before this month is out. AZD1222 is based on a diluted version of adenovirus (which causes common colds) infecting chimpanzees with the aim of preparing the immune system for the novel coronavirus. Last month AZD1222 became the first vaccine against Covid-19 to be accepted by the European Medicines Agency (EMA) for “continuous evaluation.”

Astrazeneca Argentina has been working with ANMAT since October 5 among various other regulatory authorities around the world with more than 5,000 people participating in their tests globally.

Apart from the Oxbridge vaccine (since Astrazeneca is Cambridgebased), the British Embassy relayed information this week about an Anglochilean international seminar last Wednesday on access to vaccines against Covid-19, including their financing and distribution, with Argentine participation among 30 countries of the region.

The United Kingdom has pledged up to 829 million pounds towards the worldwide distribution of vaccine among aid packages against the pandemic topping a billion pounds.

PFIZER

The Pfizer connection also goes back to July when Argentina was selected as part of an expansion of Phase III vaccine testing beyond the United States, a process beginning in mid-may and arousing the interest of many countries.

Fernando Polack, the researcher in charge of clinical testing, commented: “If you have the scientific privilege of participating in the evaluation of a vaccine, it often contributes to positioning your country potentially better in the waiting-list for distribution. Otherwise you have to wait for the vaccine [if it proves to be effective] to be manufactured on a certain scale, waiting behind countries with greater commercial or strategic force.”

The testing, which began in August at the Central Military Hospital, takes the usual form of the volunteers being tested blind – half receive the vaccine and half a saline solution or some other placebo without either knowing which.

Colonel Sergio Maldonado, the director of the Central Military Hospital, commented that his staff welcomed the experience. The participants had some aches and pains with temperatures rising but no serious reactions. The information has been used for testing on a much broader scale with up to 30,000 participants in 120 locations across the globe including Brazil and Germany, as

well as the United States and Argentina.

The lab is requesting emergency authorisation from the FDA this month. Pfizer have this month announced that their clinical tests have shown their vaccine to be 90 percent effective against coronavirus, which prompted their Russian rivals to claim an even higher 92 percent for Sputnik V.

Experts are sceptical about such percentages – thus an intermediate analysis of Pfizer’s first 94 cases showed 85 or 90 percent to be asymptomatic while there are various parameters for measuring effectiveness such as mortality or confirmed cases. Other variables include previous exposure to respiratory diseases and the degree of protection against Covid-19 in its most serious manifestations.

Furthermore, previous tests have shown that immunity can take almost a month to arrive, according to a data monitoring committee independent of the pharmaceutical companies developing these vaccines.

SPUTNIK V

Argentina’s purchase of 25 million doses of Sputnik V is due in two batches, with the first arriving in about six weeks.

President Fernández has requested that the necessary information be fed as rapidly as possible to ANMAT so that Sputnik V can be approved for use here once all the testing stages have been completed in Russia.

Sputnik V has been on the horizon ever since August when Putin surprised the world by announcing that his country had available a registered vaccine against Covid-19 after very advanced research, promising “lasting immunity” as against as short a period as six months in some other projects.

But suspicions became aroused when it emerged that after three months, it had been tested on only 76 volunteers with the results of that testing and other pre-clinical studies yet to be published.

Russian officials assured that despite their own domestic market being given priority, the millions of doses due in Argentina as from next month would be available because agreements had already been signed with five companies in Brazil, India, China and South Korea to produce on a massive scale.

Russian officials are promising preliminary results within a fortnight and definite results by early December at

the latest.

SINOPHARM

In late August the Health Ministry agreed with Beijing to test the vaccine of China’s Sinopharm lab here. This vaccine, developed by the CNBG (China Na- tional Biotech Group) and the BIBP (Beijing Institute for Biological Products), is being pushed by Fundación Huésped, which is headed by Pedro Cahn, a leading member of the presidential team of epidemiologists.

Phase III testing, stretching over 12 months with 3,000 volunteers (all required to be over 18 and in good health), takes the usual form of administering the vaccine or a placebo at random.

The local vehicles of the studies are the Elea-phoenix laboratories (founded in 1939) and Fundación Huésped, whose head Cahn pronounced himself satisfied with the vaccine’s effectiveness in producing antibodies.

JANSSEN-JOHNSON & JOHNSON

Almost simultaneously with Sinopharm Argentina was selected for Phase III clinical studies by the prestigious pharmaceutical company Johnson & Johnson.

Three months later the vaccine has 60,000 adult volunteers lined up around the world, the biggest global testing until now. The US multinational giant has the manufacturing capacity to produce a billion doses annually by the end of 2021.

The first local volunteers (all aged over 18) were vaccinated at Swiss Medical centres this week with the usual blind testing. Former City Health deputy minister Gabriel Novick highlighted that this vaccine has the advantage of not needing freezing for transportation or storage (whereas the Pfizer vaccine is harder to distribute since it must be conserved at temperatures of between minus 70 and 80 degrees Centigrade).

Dr Paula Barreyro, Janssen Latinoamérica Sur’s scientific affairs director, told Infobae that the vaccine had a non-replicating adenovirus vector, which meant that it did not produce infection or disease in the organisms into which it is inoculated with only the minimal amount of coronavirus introduced to generate a response from the immune system.

The technology on which the vaccine was based also lent itself to rapidly increasing the scale of production – the same technology which had been used to develop vaccines against ebola, zika and AIDS (all of which are still in Phases II or III).