MANILA, Philippines – US-based biotech company Moderna announced today, May 18, the "positive interim clinical data" of mRNA-1273, its vaccine candidate against novel coronavirus (COVID-19), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID).
Moderna reported that in eight patients who had been followed for a month and a half, the vaccine at low and medium doses triggered blood levels of virus-fighting antibodies that were similar or greater than those found in patients who recovered. This suggests that the vaccine triggers some level of immunity.
"Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera," Moderna said in a statement.
The company assured safe use of the vaccine in the clinical trial. "mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies."
Meanwhile, preclinical results from a viral challenge study in mice conducted in collaboration with NIAID and its academic partners are also available. In this study, vaccination with mRNA-1273 prevented viral replication in the lungs of animals challenged with SARS-CoV-2.
“When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials,” the company said.
With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start pivotal Phase 3 study in July.
“We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2,” Moderna said.
SEE ALSO: COVID-19 vaccine: Oxford's ChAdOx1 could be ready in September, remdesivir possible in January
US top infectious disease expert Dr. Anthony Fauci early this month announced that the Trump administration is ramping up efforts to produce a vaccine against coronavirus.
The initiative called “Operation Warp Speed” aims to reduce the usual development time for a vaccine.
— The Summit Express
Moderna reported that in eight patients who had been followed for a month and a half, the vaccine at low and medium doses triggered blood levels of virus-fighting antibodies that were similar or greater than those found in patients who recovered. This suggests that the vaccine triggers some level of immunity.
"Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera," Moderna said in a statement.
The company assured safe use of the vaccine in the clinical trial. "mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies."
Meanwhile, preclinical results from a viral challenge study in mice conducted in collaboration with NIAID and its academic partners are also available. In this study, vaccination with mRNA-1273 prevented viral replication in the lungs of animals challenged with SARS-CoV-2.
“When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials,” the company said.
With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start pivotal Phase 3 study in July.
“We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2,” Moderna said.
SEE ALSO: COVID-19 vaccine: Oxford's ChAdOx1 could be ready in September, remdesivir possible in January
US top infectious disease expert Dr. Anthony Fauci early this month announced that the Trump administration is ramping up efforts to produce a vaccine against coronavirus.
The initiative called “Operation Warp Speed” aims to reduce the usual development time for a vaccine.
— The Summit Express
