With the final results of the last stage of the trial of its vaccine against covid-19 on the table, the pharmaceutical Pfizer has assured this Wednesday that its product is 95% effective, and has added that it has the required two months of security data to request emergency authorization for use in the US in just a few days. Vaccine efficacy data have been consistent for all age and ethnic demographic groups, confirming that has had no major side effects, a sign that immunization could be widely used around the world. The efficacy in adults over 65, who are at particular risk from the virus, is greater than 94%.
The final analysis comes just a week after the initial trial results showed the vaccine to be more than 90% effective. “The results are finally better than expected and this messenger RNA (mRNA) technology is emerging as a weapon against the pandemic,” the statement said. Pfizer further reports that there were 170 cases of the disease in its trial, out of a total of more than 43,000 volunteers, of which 162 were seen in the placebo group and 8 in the vaccine group.
Ten people developed severe Covid-19, one of whom received the vaccine. He also adds that the vaccine was well tolerated and that the side effects were mostly mild to moderate and disappeared quickly. The only serious adverse event, affecting more than 2% of those vaccinated, was fatigue, which affected 3.7% of recipients after the second dose. If the results hold, this level of protection would put it on a par with highly effective childhood vaccines for diseases like measles.
Race for the express vaccine
Pfizer plans to ask the US Food and Drug Administration (FDA) for an emergency authorization for the two-dose vaccine in the next week. By the end of the year it will have manufactured enough doses to immunize 15 to 20 million people, company executives have said. “This is a historic moment,” said Kathrin Jansen, Pfizer’s senior vice president and head of vaccine research and development. “This was a devastating situation, a pandemic, and we have embarked on a journey and a goal that no one has ever achieved, to reach a vaccine within a year».
Pfizer becomes the first company to announce rpositive results of a vaccine test in its late stage, putting her at the forefront of a frenzied global race that began in January and has unfolded at record speed.
Pfizer ensures to respect the investigation times
The CEO of Pfizer, Albert Bourla, insists however that “we have never taken part of that maximum speed, we have worked as quickly as possible but respecting the times required by the investigation». “Our goal from the beginning has been to achieve the highest level of efficiency,” added Bourla, gaining scientific recognition. “If the final vaccine ends up with that level of efficacy, it would be higher than your regular flu vaccine, and this vaccine could have a serious impact on flattening the curve of this outbreak,” said Saad B. Omer, director of the Institute of Yale Global Health.
Work on the vaccine began in Mainz, Germany, in late January when Ugur Sahin, the CEO and co-founder of BioNTech, read in The Lancet about the virus, which frightened him. “Almost instantly I knew this would affect us,” Sahin said in an interview. That same day, the first European cases were detected, in France. Sahin assembled a team of 500 people to work on the vaccine. Many employees canceled their vacation and Sahin authorized overtime pay. They called it “Project Speed of Light.”
Messenger RNA technology
BioNTech used a technology that had never been approved for use in people. Takes genetic material called messenger RNA (mRNA) and injects it into muscle cells, which treat it as instructions for building a protein, a protein found on the surface of the coronavirus. The proteins then stimulate the immune system and are believed to result in long-lasting protection against the virus. 20 vaccine candidates were quickly identified, and he began testing them in rodents. But the company lacked the experience and resources to quickly conduct a large clinical trial. So Sahin called Pfizer. The two companies had worked together to develop a flu vaccine since 2018, and the day after Sahin called Jansen, the companies agreed to partner on a coronavirus vaccine, a partnership that was made public in mid-March.
After the first human trials, they determined that two vaccine candidates produced a robust immune response, including antibodies to the virus and powerful immune cells known as T cells. They chose the one with the fewest side effects to start a trial with more than 30,000 volunteers in the United States, Argentina, Brazil and Germany. In September the company expanded the trial to 44,000 participants. “The stakes are high for humanity,” Bourla says now, “if we can get it right, the world can be saved.”