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One of the most anticipated vaccines is being developed in building number 200 of the Technological Square (Plaza de la Tecnología). Implemented in the North American city of Cambridge, Massachusetts, Moderna was the first company to test the SARS-CoV-2 vaccine in humans.
Now it is once again a pioneer in the public disclosure of the clinical protocol applied in research.
Facade of the Moderna headquarters | Photo: Brian Snyder- Reuters
In collaboration with scientists from the National Institutes of Health, the study reached phase 3, which corresponds to the last trial to test the effectiveness of the vaccine, before being approved and licensed. At this stage, Moderna has more than 25 thousand volunteers to receive the vaccine.
The higher the number of participants, the more results they will get to analyze and compare. If there are fewer Covid-19 patients among those vaccinated and there are no associated complications, we can talk about the reliability of future inoculations..
To ensure a competitive advantage, vaccine manufacturers often keep the details of clinical trials until they are completed. Currently, the anxiety of the population and the independent scientific community is pressing companies to be more transparent in communicating the methods used in research.
Photo: Dado Rubic – Reuters (Archive)
Peter Doshi of the University of Maryland argues that the widespread sharing of clinical protocols from different manufacturers “can help researchers together to answer questions about the behavior of the virus.”.
Doshi argues that it will be beneficial to companies if the research is evaluated by qualified scientists, as this “would increase its credibility.”
The World Health Organization believes in a global collaboration on multi-vaccine testing. According to the Spanish newspaper The countryFor WHO experts, the joint response would provide faster and more effective results.
By being the first to take this step, Zaks hopes to gain the trust of the scientific community, investors and the public. “I am proud to do this. I don’t think there is much more to reveal than has already been said, but for the public to judge, “said Tal Zaks, quoted by Hour.
The information exchange was applauded by clinical trials specialist Eric Topol, who identifies some weaknesses in the procedures. For Topol, Moderna should focus the investigation on people with moderate to severe cases, instead of also including mild cases of Covid-19.
The disclosed protocol also accounts for the diverse sample of participants. About 28 percent are black, Latino and from other communities that were most affected by the disease..
In this trial by Moderna, two doses of the vaccine are required at an interval of four weeks. Half of the volunteers receive the vaccine; the other half a placebo injection consisting of salt water. Neither the participants nor, subsequently, the attending physicians know who received the medicine.
Photo: Ueslei Marcelino – Reuters (Archive)
The group is monitored daily and, for the scrutiny of the effectiveness of the vaccine, counts the cases of Covid-19 that develop during the two weeks after the second injection. Some of the participants have already been given the second dose and, so far, the scientific director says there is no case.
According to Tal Zaks’ accounting, if a total of 151 cases develop, distributed between the two vaccine / placebo groups, the effectiveness of the vaccine could be 60 percent. The US drug regulatory authority (FDA) established that these 151 cases correspond to 50 percent effectiveness.
All of these data depend on the trajectory of the pandemic and exposure to the virus.
According to the protocol, Moderna estimates to have interim results at the end of December and final results in May 2021.
These deadlines are in line with the estimates of the other North American manufacturers, such as Pfizer or AstraZeneca, but the pressure is increasing on the date of distribution of the vaccine, with the Trump Administration contradicting the health and pharmaceutical authorities.
The president of the United States has promised the vaccine for the immediate future, in which his opponents see an attempt to withdraw dividends in the November elections.
