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The laboratories Pfizer and BioNTech announced this Monday, November 9, that according to the preliminary results of phase III -which have not been reviewed by peers- the vaccine they develop “is 90% effective” against the coronavirus, generating optimism about the possibility of stopping a pandemic that has left more than 50 million infected and 1.25 million dead worldwide.
The vaccine is one of more than 40 candidates developed at this time, but no other laboratory has provided results as advanced as these.
(In context: Pfizer says its coronavirus vaccine gives 90% protection)
American expert Anthony Fauci called the results “extraordinary” and the director of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus, celebrated “encouraging” news. Others noted, however, that Pfizer and BioNTech had not specified the age of the participants in their vaccine trials.
“If a vaccine is going to reduce serious illness and death, and allow the general population to return to normal life, it will have to be effective in the elderly in our society “warned Eleanor Riley of the University of Edinburgh.
For now, what is known is that the studies of this vaccine against covid-19 showed an efficacy of more than 90% in participants with no previous evidence of infection. In other words, it prevented more than 90 percent of infections in one group in the study.
This level of efficacy was achieved seven days after the second dose, that is, 28 days after the start of vaccination, that has two doses, although both companies warn that the final effectiveness could vary as the study progresses.
(Also read: First 10 million covid vaccines will be for the population at risk)
The data analysis presented does not include any severe cases of COVID-19 among the volunteers, but they are expected to occur as the study continues, said Pfizer Senior Vice President William Gruber.
The companies plan to supply 50 million doses in the world in 2020 and up to 1.3 billion in 2021. If these results are confirmed by peer review and independent evaluation, Pfizer and BioNTech could request an emergency use authorization from regulators, something that could happen next week.
About the study
To understand the advertised data you have to understand exactly how the study design works. According to the initial protocol, 44,000 people participate in the research divided into two groups: those who receive the vaccine and those who receive a placebo.
(See: 80% of Colombians fear that the pandemic will not be controlled)
Then, you have to wait for the participants to become infected or not in their daily lives and with these data the efficacy of the vaccine is compared with the placebo. Meanwhile, an independent committee analyzes the data to check that everything is in order.
To make the announcement, the company used the committee’s reports analyzing the first 94 cases of covid-19 that were detected among the 44,000 participants. The “more than 90 percent efficacy” means that of the 94 infected who participated in the trial, less than 10 percent received the vaccine, explains health care worker Elizabeth Beltrán. The rest of them received the placebo. However, much information is missing.
The questions
Following the announcement came a series of questions related to lto production, distribution, and most importantly, the performance and capacity of the vaccine. To begin with, it must be said that the Pfizer trial began less than four months ago and precisely one of the biggest questions is how long the vaccine will confer protection and which age groups will benefit.
(Also: ‘Is a new quarantine possible in Colombia?’)
“The key question still centers on time,” said Michael Kinch, a drug development expert and associate vice chancellor at the University of Washington.
Few details are currently available on efficacy in key subgroups, such as the elderly. Those analyzes have not been carried out. And it is not known if the vaccine prevents severe forms of COVID-19, as none of the participants who received doses in this round had complications.
Pfizer’s vaccine also poses some significant challenges, as it is based on messenger RNA, which requires freezing to avoid inactivation, it must remain refrigerated before being injected at -70 ° C, which would require the use of special containers.
“It is a hopeful result, as it was done in an important group of volunteers and it shows that there is early and good immunity. We await complete results for a better analysis “said Carlos Álvarez, national coordinator of covid-19 studies for the WHO.
(We recommend: Mass vaccination against covid could be in mid-2021: WHO)
And he landed: “You have to be careful. Just because it has been shown to be effective in the short term does not mean that it provides long term immunity. The efficacy may be lower at the end of the study. And there is still a long way to go before it can be distributed worldwide ”.
Claudia Vaca, pharmacoepidemiologist, made it clear that many details of this vaccine project need to be known, such as the duration of immunity, the effect in people over 55 years of age and protection against serious forms, since “In the study protocol, this was not an outcome to evaluate, which is highly questionable.”
“Without knowing the effectiveness is an adventure, the cold chain becomes an immense barrier and can generate a stampede of countries buying specific freezers and setting up another fictitious market. Most importantly, Pfizer stated that it has not done a safety assessment; in other words, the risk-benefit balance is unknown “, he finished.
Carlos Eduardo Pérez, infectologist at the National University, asserted that in any case it is excellent news that the production of antibodies is greater than 90 percent, taking into account that the WHO recommendations place expectations of 50 to 60 percent.
(See: The reasons why they will no longer ask for a PCR test to enter the country)
“What he knows is that it requires a demanding cold chain and at least two doses a few weeks apart. Which implies a very special and complex logistics. On the other hand, the expected production of 50 million initial and 1,300 in one year there are few units for world demand, which will mean an important prioritization “, he pointed out.
Healthcare worker Elizabeth Beltrán pointed out that the study is still underway “And this means that the data is anything but definitive”. “These are promising data, but very preliminary. It takes time to really know all the data derived from the 44,000 participants in the tests, “he said.
“Here we must bear in mind,” says Beltrán, “that this data is also used as a commercial strategy and to promote effects that have already occurred in the stock market. Now, we must wait for the scientific analysis of the data because the 94 infected are actually people with symptoms and you need to know what the real behavior of the vaccine is in real spaces, it does prevent serious cases and if it really reduces the transmissibility of the virus ”.
The expert lands, in other words, that for now what we have are press reports and not details of a scientific report endorsed by peers and published in scientific journals.
Finally, it is worth noting that the progress of this project was achieved without funding from the American vaccine accelerator known as ‘Operation Warp Speed’.
HEALTH UNIT
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