Virus Outbreak: Moderna vaccine ready for final trial

Cheryl Sanders
July 15, 2020

In an interview with Contagion a month prior, William Schaffner, MD, professor of Preventive Medicine and Medicine at the Vanderbilt University Medical Center, discussed the greater unknown factors of a would-be COVID-19 vaccine-how long would it last?

"The Moderna mRNA vaccine contains genetic material from the spike protein on the surface of SARS-CoV-2, the virus that causes COVID-19".

He suggested that such elements are "a bigger challenge than the science challenge of coming up with a safe and effective vaccine".

Phase 2 trials started in May and Phase 3 trials involving 30,000 volunteers is expected to start on July 27.

"This is an essential building block that is needed to move forward with the trials that could actually determine whether the vaccine does protect against infection", Dr. Jackson told The Associated Press.

USA biotech company Moderna said a vaccine it is developing has shown to induce a "rapid and strong" immune response against COVID-19, stating it will begin late-stage testing in less than two weeks.

Moderna had previously published "interim results" from the first stages of its trial, called phase 1 in May.

Moderna's vaccine trial is ongoing and supported by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institute of Health (NIH) in the U.S.

But some in the scientific community said they would reserve judgment until they saw the full results in peer-reviewed form. The phase III selected dose of 100 µg dose showed more than four times neutralizing antibody compared to reference convalescent sera.

Apparently the vaccine is generating the kind of antibody and T-cell (killer cell) response that the researchers would hope to see. The findings showed the levels of neutralizing antibodies appear during the trial were similar to those in COVID-19 patients who recovered.

During the trial, 45 healthy adult volunteers under 55 years of age were given two doses of the vaccine separated by 28 days with all participates who received doses of the drug in 100 micrograms or less reporting only mild, transient reactions such as fatigue, chills and headaches. Blood samples of participants will be evaluated regularly for one year following the second vaccination. They included one who developed a skin rash on both legs, and two who missed their window because they had COVID-19 symptoms, but their tests later returned negative.

However, Moody said the level of antibodies produced were "really encouraging".

He added, however: "You have to be very limited in how much you can extrapolate from a phase 1 clinical trial, because you want to see how this works when a person is exposed to the actual virus".

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