What is the vaccine that I will be given? This generic question seems to be the one asked by any person in the world who listens to the advertisements that for a week have been reported by those who point in the most frantic competition that pharmaceutical research has had in history: developing a vaccine that slows down the expansion of covid-19.
In fact, from the very declaration of the pandemic, pharmaceutical companies around the planet began an unprecedented race in pursuit of this goal, under the premise that projects of this type measure their progress in years and even decades, with a high degree of failure.
Today according to WHO, there are almost 170 proposals in the preclinical phase, fifty in clinical stage and 11 in phase 3, which claim to be almost ready for marketing.
Hence, the answer to this question – despite the wide offer – is not easy, because according to Pedro Cifuentes, an expert in public health, it depends on many factors that cross not only the essential levels of effectiveness and safety of biologicals, but also depends on their availability, price, large-scale production, distribution and unprecedented mass vaccination programs around the world.
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The truth is, that with full throttle, to date – this race points – Pfizer vaccines – BioNtech, Oxford-Astrazeneca and Moderna. They are closely followed by Johnson and Johnson, Glaxo, Curevac and Sanofi. And in that context, the three leaders are worth referencing.
In fact, this Sunday, November 21, Moncef Slaoui, head of the group that leads the efforts to face the pandemic in the United States government, said that a vaccination program against covid-19 is expected to begin at the beginning of December.
“Our plan is to be able to ship the vaccines to the vaccination sites within 24 hours of approval” by the Food and Drug Administration (FDA), Moncef Slaoui told CNN. “So I hope maybe the second day of approval, December 11-12.”
The North American pharmaceutical company and its German ally Biontech, gave a historic coup on November 9, when announcing, on preliminary data, that lThe effectiveness of their vaccine was 92 percent and 10 days later, with other final results, they announced that the effectiveness reached 95 percent, even in older people, in addition to not triggering serious side effects.
Although these data have not been published after a peer review, last Friday Pfizer submitted to the US Food and Drug Administration (FDA), an application for authorization for emergency use and it is expected that the response will be issue in a week.
But for the vaccine to reach the people, Pfizer and its partner have to overcome a series of challenges that, according to their own announcements, begin to prevent it from falling apart along the way.
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As this vaccine is based on a synthetic piece of genetic material of the virus (mRNA) that causes defense reactions in the human organism, it decomposes unless it is kept refrigerated at temperatures below minus 70 degrees Celsius, which in words of the health care worker Elizabeth Beltrán, requires a huge logistics never before deployed for its transport and storage.
Also, since there are two doses, ensure that people complete the scheme within 3 weeksHowever, in recent months, agreements have been signed to reserve large quantities of the vaccine.
Donald Trump separated 100 million doses for delivery in December for 1.9 billion dollars, and signed an option to purchase another 500 million doses for the first half of 2021. Japan contracted 120 million doses and the European Union, 200 million so far.
Today, according to the WHO, there are almost 170 vaccine proposals in the preclinical phase, 50 in the clinical phase and 11 in phase 3.
For this purpose, Pfizer and BioNtech expect to have 1,300 million doses ready by the end of 2021 and for this purpose, in parallel with the development of the project, they have already started mass production at their plants in Andover (Massachusetts), Kalamazoo (Michigan) in United States and in Puurs (Belgium), with the support of BioNtech in Germany, which will be part of the commercial supply network.
Although everything seems ready, there is no need to refer to the words of Professor Moisés Wassermann, in the sense that these will be the first synthetic RNA vaccines, which contain the genetic message so that the cells of the human being produce part of the protein on the surface of the virus, which is responsible for the initiation of the infection. “Thus, the patient becomes his own vaccine factory”, said Wassermann in his column of THE TIME.
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Harmless chimpanzee adenovirus
The Lancet magazine reported last Thursday that The experimental coronavirus vaccine, developed by Astrazeneca and the University of Oxford, is as effective in older adults as it is in young people, without producing major adverse effects, with the announcement, the project of the British-Swedish pharmaceutical company and the English academic center, rebound again after on October 23 the FDA authorized the restart of their trials in the United States, which had been detained, while investigating an adverse reaction, in one of his volunteers.
In essence, this vaccine is based on the viral-vector platform, which uses a designer virus to carry coronavirus genes and produce defense reactions in the body. In this case, a chimpanzee adenovirus called ChAvOx1 has been taken, which when tested in humans has been effective in terms of protection in people over 18 years of age.
The United States gave the project $ 1.2 billion, which separated 300 million doses, if approved. In the same sense, the European Union made agreements for 14 million doses and some countries, through collective strategies, have also negotiated. The truth is that, the CEO of Astrazeneca said in an interview with Bloomberg, that they expected the results of their tests by the end of December and at the same time it has been said that the annual manufacturing capacity of this vaccine, if approved, is 2 billion doses.
No extreme cold chain
Last Monday, Moderna assured that its experimental vaccine is 94.5 percent effective in preventing covid-19, according to provisional data obtained from an advanced-stage trial, which in turn turned it into a clinical trial in advanced stage, making it the second US company to report results at these levels in a week. “This is very good news. If you look at the data, the numbers speak for themselves,” said Anthony F: Fauci, director of the US National Institute of Allergy and Infectious Diseases.
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Like Pfizer’s vaccine, Moderna’s is based on new Messenger RNA technologyBut its advantage is that it reportedly does not need ultra-cold storage, making it easy to distribute. In fact, Moderna expects it to be stable, at standard refrigerator temperatures of 2 to 8 degrees Celsius for 30 days and that it can be stored at -20 degrees Celsius for 6 months. Adverse reactions were not significant.
The United States government supported Moderna’s project through the National Institutes of Health with an initial $ 1 billion and in August $ 1.5 billion were added in exchange for 100 million doses, if the vaccine shows that it is safe and effective. Moderna is known to have made similar agreements with other countries.
While these announcements are promising, according to health care practitioner Elizabeth Beltrán, you cannot fall into the false idea that the vaccines are already ready. “Although the urgency is extreme, processes that guarantee effectiveness and absolute safety in products that can be applied en masse cannot be ignored,” says Beltrán, warning that most of these data need scientific verification.
In this sense, the “Medicaments Information and Power” Thought Center of the National University of Colombia, in conjunction with the Informed Decisions on Medications Project (DIME), the Femeba Foundation and the Central American International Health Institute (IHCAI) stated in a bulletin that the data on these vaccines are part of preliminary analyzes with few patients studied and in fairly short observation periods, so there is the possibility that the efficacy data may vary, at the end of the established observation time ”.
“On the other hand, The information published, such as press releases, has enormous disadvantages, because it is not possible to consult in its entirety the data and analysis carried outs ”they say.
The Colombian Ministry of Health says it has the strategy and resources available to vaccinate 10 million people in the first phase
And in addition to other aspects such as the stability of biologicals and the ability to distribute prices, these experts consider that the access mechanism and the price at which they would be available is still uncertain and in this sense they end up saying that “an additional dose of patience of the final results, formally published on these and other vaccines under study, should be added,” they add in the note.
While this is happening, the Colombian Ministry of Health says that it has the strategy and resources available to vaccinate 10 million people in the first phase, with the vaccines that have the most guarantees and that will be acquired through the Covax multilateral strategy and in bilateral discussions with pharmaceutical companies when necessary.
“Beyond optimism, reality and prudence, they put the vaccine for Colombians on a horizon measured in months and not in days, as some think,” concludes Pedro Cifuentes.