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Pfizer has administered the first US patients. USA With its experimental vaccines to combat the disease caused by the new coronavirus, it is part of an attempt to reduce years of the typical time it takes to develop a new inoculation.
The trials are taking place at NYU Grossman School of Medicine and the University of Maryland School of Medicine, the drug maker said Tuesday.
“The short period of less than four months in which we have been able to move from preclinical studies to human testing is extraordinary,” Chief Executive Albert Bourla said in a statement.
Preclinical studies are what companies do in animals or in the laboratory before testing vaccines in humans. Drug makers have been working with regulators to compress development times to stop the spread of the virus, which has infected more than 3.5 million people worldwide and killed more than 250,000.
New York-based Pfizer is working with BioNTech SE of Germany. The companies began testing the vaccines on patients in Germany in late April. Vaccine trials typically start by looking at safety, but to accelerate the development of a Covid-19 vaccine, drug makers are looking at both the safety and the immune system response of experimental injections.
Pfizer and BioNTech are in a race with companies like Johnson and Johnson, Moderna, and dozens of other biopharmaceutical teams and academic groups to devise a safe and effective vaccine against the disease within the next 18 months.
There are already a handful of human trials, including those from Moderna and those from CanSino Biologics, the Beijing Institute of Biotechnology, and Inovio Pharmaceuticals.
The Pfizer trial in the USA USA It will include 360 patients in two age groups: 18 to 55 and 65 to 85, although trials in the older population will begin only after safety and immune response are established in the younger group.
The University of Rochester / Rochester Regional Health Medical Center and the Children’s Hospital of Cincinnati Medical Center will also eventually provide test sites for the vaccines.
“In an early vaccine trial, you actually control many possible reactions, you launch a very wide network, you actually ask people to report to you everything they feel,” said Phil Dormitzer, director of viral science at Pfizer. vaccines. “You don’t know for sure until you’ve seen a very large number.”
Given what happened with the development of other vaccines in the past, there is a risk that the new inoculation may make patients more susceptible to serious illness.
“Knowing that there is a potential risk, we are going to proceed as if it were a real risk,” Dormitzer said. “If it happens, we will detect it as soon as possible”
Pfizer and BioNTech are looking at four different injections, and at a variety of doses and schedules, and will decide which one is most effective as the trials progress. The goal is to have a shot ready for emergency use in the fall.
Companies also share data with regulators in real time, rather than analyzing it themselves before submitting it and requesting regulatory approval.
Pfizer and BioNTech’s potential vaccine takes advantage of a new type of RNA technology. After being injected into the body, RNA slides into human cells and tells them to make viral proteins, which then cause the body to develop protective antibodies.
The use of technology has not yet been approved. The advantage is that RNA technology can advance faster in assays because it does not involve making batches of inactivated proteins or viral particles in living cells, which can take months.
Moderna is following a similar approach and began testing its vaccine on patients in March. One of the main challenges, beyond finding a safe and effective vaccine, will be to increase production fast enough to meet the needs of the world.
Pfizer says it should be able to make millions of doses this year and hundreds of millions by 2021, if it were to succeed with one of its candidate vaccines. The RNA method is “actually a more natural imitation of what happens with a natural immune response to an invader,” said Mark Mulligan, director of the NYU Langone Vaccine Center, where the trials are being conducted.
“Certainly, there are things that I think are favorable in terms of the speed with which they can be produced and this idea that this is a natural type of vaccination.”
New York City has been an epicenter for Covid-19 in the United States. The boroughs of Queens, Brooklyn, and the Bronx rank as the three highest death counties in the nation, according to data from Johns Hopkins University. At NYU, the evaluation began last week, with the first 10 to 15 people volunteering. The first person was vaccinated on Monday.
“We have had a tremendous response from interested people,” Mulligan said. “I think it speaks volumes for New Yorkers’ desire to fight back.” – Bloomberg
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