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The mourning of having the most effective coronavirus vaccine It has exploded this week with pharmaceutical companies making various announcements.
The American Pfizer -which has one of the three tested in the country- assured that your product is 90% effective.
Less than 48 hours later, the Russian government declared that the Sputnik V – which Argentina will receive in December – reaches 92%. Then: What is the best vaccine?
According to Argentinian infectologists, both lack final results and are based on preliminary data. In both cases, pharmaceutical companies reported what happened to a specific group of people, at a specific time and after a dose, although the presumed immunity occurs after a second injection.
Therefore, to date, there is no better vaccine because, to be exact, there is no vaccine for the coronavirus. There are methods for testing efficacy and effectiveness, which are not the same thing.
In the history of vaccines, we have gone from preparation under a microscope to genetic decoding of the virus to isolate a protein, in the case of covid19, modify it and generate antibodies. But still it must be proven to be effective and to have a real impact on the community.
According to Edgardo Bottaro, infectologist in the infectology department of Santojanni hospital and a member of the staff Helios Salud: “fr In double-blind, randomized clinical trials, neither investigators nor recruited subjects know what was given to them. This modality aims to avoid any bias in the inclusion of people in one group or another, which would interfere with the correct result of the study ”.
In short, a population that has not had the disease is defined and divided at random to give part of the vaccine and part of the placebo.
From now on, work with the biological data of the volunteers then an evaluation of the preliminary results is made to find out whether the vaccine is working or not.
“The assessment times, the number of subjects to include, the number of expected events (Covid disease) and the percentage of expected efficacy depend on complex calculations which take into account statistical and biological variables, ”commented Bottaro.
“When you evaluate a vaccine versus a placebo, you are evaluating the disease incidence rate in each of the groups. If in one group there are 100 people who have covid disease and in the other there are only 5, you have an efficiency of 95%, for example. But HOh, what is the clinical specification of these volunteers?: whether they are clinical cases of Covid, cases confirmed by PCR or suspected cases by close contact. It can be very different in the Sputnik V and Pfizer protocols. Although, in general, in vaccine studies confirmed cases of covid after injection are used, “ added Omar continued, president of the Argentinian Society of Infectology (SADI).
What we know about Sputnik comes from preliminary data from a phase III clinical trial where 40,000 volunteers participate. 16,000 of them have already received the second dose which constitutes the vaccine. The answer was “Calculated on the basis of 20 confirmed cases of Covid-19 divided between vaccinated individuals and those who received the placebo. Efficacy was demonstrated on the basis of a first interim analysis obtained 21 days after the first injection“, according to a statement from the Gamaleya Center in Moscow. Now we will have to see what happens after the second dose.
“In the announcement of Pfizer, mentioned that in 90% of the cases, the volunteers were asymptomatic. It’s different from talking about efficacy, meaning that the vaccine does not prevent the infection from entering. But when infected, they don’t cause symptoms, they don’t cause complications, and they don’t die. This is good news, but we have to see how comparable it is with Sputnik V. Today we cannot find out because the two studies are not published with the final results.“said Sued. It should be clarified that thThe Sputnik V protocol has not yet been published.
According to Bottaro: “At this time, we don’t have hard data to tell which of the COVID-19 vaccines currently in development is the best?.
The effectiveness of a vaccine is given by the reduction in the incidence of disease among those who received the vaccine compared to those who were not vaccinated. Efficacy is the ability of an approved vaccine to protect previously vaccinated people against disease.
As well efficacy can be measured by the reduction in the incidence of severe forms, hospitalizations or deaths.
“The main difference is that the conditions under which the vaccination is performed in the clinical study are somewhat “ ideal ” , while the results obtained in the community are “real” results influenced by variables absent from the clinical study. The setting for a clinical research study is somewhat “artificial” because it does not accurately reflect what is going on in people’s daily lives. “added For follow-up.
Knowing the efficiency, for Bottaro,“will allow us know the impact of the vaccine – another important concept – that is, the reduction in the incidence of a disease due to vaccination compared to the incidence of this disease before vaccination“.
So wellThe effectiveness will be the data that the Ministry of Health and the ANMAT will take into account to approve the vaccine, the effectiveness will be the result that matters.
“Efficacy and impact data will not be available at the time of vaccine approval. To obtain them, it will be necessary to monitor the effects of the vaccine on the population in order to define its effectiveness and carry out actions aimed at solving the emerging problems that threaten it. “ comments from specialists.
??That is to say: if a vaccine was very effective in phase III studies, but when it was applied massively “there were unfavorable situations in the population“- either by mistrust, unfavorable geography for traveling in ultra-cold conditions, economic problems, etc.The efficiency will be lower than its efficiency and the impact will be less than expected“, they add.
Another point that raises doubts is not knowing how long the immunity of the two vaccines lasts, another of the aspects that make efficiency.
According to Bottaro, the objective is the same in both cases: to generate a significant efficiency by reducing the possible undesirable effects which worsen the cure compared to the disease.
Source: Clarin
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