Coronavirus: Pfizer testing possible vaccine on 360 U.S. patients; what does that mean; what is mRNA

Coronavirus: Pfizer, BioNTech, testing possible vaccine in human trials

Pfizer pharmaceutical company announced this week that it has begun human trials for a vaccine for the COVID-19 virus.

On Monday, Pfizer, along with Germany pharmaceutical company BioNTech, began trials of the vaccine on 360 volunteers in the United States. According to the companies, another 200 patients have enrolled in the trials in Germany.

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The drug has shown great promise, its makers said.

“With our unique and robust clinical study program underway, starting in Europe and now the U.S., we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most,” Albert Bourla, chairman and CEO of Pfizer, said in a statement.

“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19.”

Here is what we know about the potential vaccine:

How does this type of vaccine work?

The vaccine, called BNT162, is a messenger RNA (mRNA) vaccine. That means the vaccine contains the instructions for cells to make certain kinds of viral proteins. In the case of COVID-19, the vaccine instructs the cells to make the virus’ spike protein.

The COVID-19 virus uses that spike to penetrate cells in the lungs and to infect a person. Once it pierces the cell, it replicates then invades more cells making the person sicker until their body either fights the virus off or the person dies from the infection.

The BNT162 mRNA vaccine would teach the cells to create the spike, then instruct the body’s immune system on how to produce antibodies to fight off the COVID-19 virus.

How is the study conducted?

The program is in the Phase ½ study. In Phase ½, the vaccine is tested to determine its effectiveness, safety and the dose level needed.

The tests will look at the four mRNA vaccine candidates the two companies are working on.

The first participants are healthy adults between the ages of 18 to 55.

The very first test on humans began last month in Germany where 12 adults were given a shot of the vaccine. Tests in Germany will eventually include 200 volunteers as the study progresses.

As of Monday, the vaccine was injected into healthy tests subjects in the United States where the first phase of testing will include 360 volunteers. By the end of the second phase of the study, some 8,000 people will be given the vaccine.

In the U.S., the study will be conducted at New York University’s Grossman School of Medicine, the University of Maryland School of Medicine, the University of Rochester Medical Center and the Cincinnati Children’s Hospital Medical Center, The New York Times reported.

Each of the four centers where the testing is taking place will monitor one of the four variations of the vaccine.

What happens if the testing shows success?

Because of the way Pfizer is testing the vaccine – testing the four groups at one time in parallel studies – it is cutting the time it would normally take to get approval from the U.S. Food and Drug Administration.

Once Pfizer can show the benefits of the drug, it can apply for emergency-use approval by the FDA. Pfizer and BioNTech could distribute the first few million doses of the vaccine after the approval is given.

The companies are planning to have that volume of the vaccine because they are betting the drug will work and ramping up the production of the vaccine now.

More studies would be needed for the drug to be routinely given as a vaccine.

Are any other potential vaccines being looked at?

Yes, there are currently 108 vaccines being developed around the world. Only eight of those have been approved for clinical trials, according to the World Health Organization.

News reports came last week about a vaccine being developed at Oxford University in England. Researchers working on that vaccine hope to have the first few million doses of their vaccine available in September.

The biotech company Moderna along with the National Institute of Allergy and Infectious Disease is also working on an mRNA vaccine. A DNA vaccine being developed by Inovio began human trials last month.

President Donald Trump has mentioned one vaccine being developed by the Johnson & Johnson company.

When does Pfizer think this vaccine will be ready?

Company officials say that if trials prove the vaccine is effective and safe for humans, it could be ready for emergency use in the U.S. as early as September.

BETHESDA, MD - More than 100 companies are working on a vaccine against the COVID-19 virus.
BETHESDA, MD - More than 100 companies are working on a vaccine against the COVID-19 virus. (Photo by Allison Shelley/For The Washington Post via Getty Images /The Washington Post via Getty Im)