indica News Bureau-
With COVID-19 spreading to more than 150,00 patients across the world, scientists and doctors are working day in and day out to find a vaccine and a cure for the deadly virus. In a breakthrough, Moderna, Inc.,a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the first participant has been dosed in the Phase 1 study of the Company’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) on Monday. The vaccine was administered to the volunteers at Kaiser Permanente Washington Research Institute in Seattle on Monday.
As part of the first phase of the study, 45 patients will be administered with a two-dose vaccination schedule, given 28 days apart. Participants will be followed through 12 months after the second vaccination. The study focuses on evaluating the safety and reactogenicity of a two-dose vaccination schedule and to evaluate the immunogenicity to the SARS-CoV-2 S protein..
“This study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2, and we expect it to provide important information about safety and immunogenicity. We are actively preparing for a potential Phase 2 study under our own IND,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “We are grateful to NIH for their ongoing collaboration and to CEPI for funding the initial manufacturing of mRNA-1273 and are proud to be included with the many companies, worldwide health agencies and NGOs working on a possible response to the novel coronavirus outbreak.”
On January 11, 2020, the Chinese authorities shared the genetic sequence of the novel coronavirus. On January 13, 2020 the VRC and Moderna’s infectious disease research team finalized the sequence for the SARS-CoV-2 vaccine and Moderna mobilized toward clinical manufacture. The first clinical batch was completed on February 7, 2020 and underwent analytical testing; it was shipped on February 24, 2020 from Moderna and delivered to NIH from the Company’s manufacturing facility in 42 days from sequence selection.
“We’re team coronavirus now,” study leader Dr. Lisa Jackson said on the eve of the experiment. “Everyone wants to do what they can in this emergency.”
“We all feel so helpless. This is an amazing opportunity for me to do something,” a volunteer Jennifer Haller, 43, of Seattle, said as she awaited the shot. She’s the mother of two teenagers and “they think it’s cool” that she’s taking part in the study. After the injection, she left the exam room with a big smile, “I’m feeling great”, she said to Associated Press.
Monday’s milestone marked just the beginning of a series of studies in people needed to prove whether the shots are safe and could work. Even if the research goes well, a vaccine wouldn’t be available for widespread use for 12 to 18 months, said Dr. Anthony Fauci of the U.S. National Institutes of Health.
Still, finding a vaccine “is an urgent public health priority,” Fauci said in a statement Monday. The new study, “launched in record speed, is an important first step toward achieving that goal.”
The Company is actively preparing for a potential Phase 2 study under its own IND to build on data from the ongoing Phase 1 study being conducted by the NIH for which it will work closely with FDA and other government and non-government organizations. The second phase of the study may begin a few months’ time.
