The pharmacist behind one of the COVID-19 vaccines, in conjunction with the German biotechnology company BioNTech, published the first analyzes of the phase 3 of studies. What is the technology used
November 9, 2020 Share on FacebookShare Share on TwitterTweet Share on WhatsAppShare
Scientists and researchers work on the coronavirus vaccine at Pfizer's laboratory in Pearl River, New York (Reuters)
One of the most promising and advanced vaccines in the fight against COVID-19, being developed by the American pharmaceutical company Pfizer and the German biotechnology company BioNTech, returned positive data on Monday , according to what was published by the companies, which claimed that their vaccine against COVID-19 it is “90% effective “ , according to the first interim analysis of its phase 3 trial, the last stage before formally requesting its approval.
This protective efficacy against the SARS-CoV-2 virus was achieved seven days after the second dose of vaccine and 28 days after the first, the US pharmaceutical company indicated in a joint statement with the German firm BioNTech. Due to the recent start of studies, it is not possible to know how long the immunity lasts.
As Infobae announced, the vaccine is based on messenger RNA technology, which carries DNA instructions for the cells of the human body to generate certain protective proteins. It began its rehearsals in Germany in late April and in the United States in early May.
” Our objective was to demonstrate that the candidate messenger RNA vaccine is safe and effective (in this case immunogenic, that is, capable of producing antibodies that protect against the disease), two essential conditions in the production of any vaccine,” he commented at the time In dialogue with this medium, Dr. Alejandro Cané, chief of scientific and medical affairs of the vaccines division of Pfizer.
Regarding the doses and the number of days it takes to generate antibodies, the specialist indicated: “Vaccines that use the complete virus (attenuated or inactivated) with a single dose take 28 days to generate antibodies . This vaccine is used in two doses: one on day zero and another three weeks later . On the fourth, high and functional levels of antibodies are generated ”.
Regarding the doses and the number of days it takes to generate antibodies, the specialist indicated: “Vaccines that use the complete virus (attenuated or inactivated) with a single dose take 28 days to generate antibodies.
The first study by Pfizer and BioNTech included 45 adults between the ages of 18 and 55, and it tested different doses of the vaccine that, according to the companies, produced antibodies higher than those of patients who have recovered from COVID-19 . In a statement, Pfizer's head of vaccine research and development, Kathrin Jansen, said the clinical data is positive and work is being carried out with the utmost urgency.
The trials – which each have tens of thousands of participants – are double-blind, meaning that half of them receive a saline solution or another placebo and the patients do not know which treatment each is receiving.
The vaccine, as specified by the companies, was generally well tolerated, although in some cases it caused fevers and local pain where it was injected, but without any serious reaction being detected. The two companies used this collected information to carry out a much larger test, with up to 30,000 participants, which is still underway in the United States, Brazil, Argentina, Germany and distributed in 120 locations globally.
The deadlines given by Moderna are similar to those of Pfizer, which expects to know the efficacy of its vaccine in November and to have enough data to request authorization from the FDA by the end of the same month. EFE / EPA / WU HONG / Archive
Which are the steps to follow? The laboratory plans to request an emergency authorization from the Food and Drug Administration (FDA) this month, after two months of data collection, a minimum period recommended by the authorities. Based on projections, both companies said they expect to supply 50 million doses worldwide in 2020 and up to 1.3 billion in 2021.
“We are an important step closer to providing people around the world with a much-needed breakthrough to help end this global health crisis. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most, ”said Albert Bourla, CEO of Pfizer.
The laboratory plans to request an emergency authorization from the Food and Drug Administration (FDA) this month, after two months of data collection, a minimum period recommended by the authorities.
“ If that number (90%) really holds up, it's huge. It is much better than I expected and it will make a big difference, ”Ashish Jha, dean of the School of Public Health at Brown University, told Statnews. However, he cautioned that it is always difficult to evaluate the science through a press release and that researchers will need to see the full results.
Regarding the research work that is being carried out to find the vaccine against COVID-19 within the most important laboratories around the globe, Cane said: “We have to know that the new coronavirus is here to stay with us. They are working jointly, without competencies and sharing scientific information in real time among researchers, laboratories and also with regulatory agencies so that they can validate the processes and we can all save time ”.