Joining the countless experts and drug companies around the globe striving to prepare a coronavirus in time, in case the pandemic makes a comeback, Pfizer and the German pharmaceutical company BioNTech has begun its the human trials of its potential coronavirus vaccine in the United States on May 5. And if the tests are successful, the vaccine will be available throughout the U.S. as early as September this year.

The vaccine the two companies are creating is based on specially designed RNA, carrying instructions for cells to make spike protein of the coronavirus but without actually making a person sick. This, in turn, would instruct a healthy immune system to produce antibodies to fight off an infection. Compared to traditional vaccines, which use weakened virus strains, this new vaccine will be easier and faster to produce as well as prove to be more stable.

Pfizer and BioNTech began its experimental human trials last month itself when it injected 12 healthy human volunteers in Germany with their vaccine candidate, called BNT162, in Germany last month.

The vaccine will be tested on 360 healthy volunteers in the U.S. for the first stage of the study. Four variations of the vaccine will be administered to the volunteers divided into groups- a different format of messenger RNA with instructions on how to make a particular part of the spike will be injected, following which their antibody levels, liver enzymes, etc will be observed to detect any side effects. As the trials will progress to the second stage, the number of volunteers will be scaled up to 8,000.

“Vaccines are given to healthy people to keep them healthy, so they have to be very, very safe,” said Dr. Mark Mulligan, an infectious disease specialist at N.Y.U.

Pfizer and BioNTech have plans to distribute the first few million doses of the vaccine in the U.S. as soon as they receive the approval after proving that the vaccine they have created causes no severe effects.

“We need to think differently, we need to think faster,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer. “If we get hit with a second wave of coronavirus infections in October at the same time as the flu, things will be much worse than what we’ve already experienced.”

Coronavirus COVID-19 Laboratory Test, Cure, Vaccine
Andressa Parreiras, Biomedic, and Larissa Vuitika, biologist, work in a laboratory during the extraction of the virus genetic material on March 24, 2020 in Belo Horizonte, Brazil. The Ministry of Health convened The Technological Vaccine Center of the Federal University of Minas Gerais laboratory to conduct research on the coronavirus (COVID-19) in order to diagnose, test and develop a vaccine. According to the Ministry of Health, as of Tuesday, March 24, Brazil has 1.891 confirmed cases of the coronavirus (COVID-19) and at least 34 recorded deceases. Pedro Vilela/Getty Images

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