FILE PHOTO: Employee Philipp Hoffmann, of German biopharmaceutical company CureVac, demonstrates research workflow on a vaccine for the coronavirus (COVID-19) disease at a laboratory in Tuebingen, Germany, March 12, 2020. Picture taken on March 12, 2020.
Clinical trials for a potential vaccine for SARS-CoV2 or COVID-19 began its first phase as the first human to enroll for trial received the first dose of the vaccine in Seattle, Monday.
Biotechnology company, Moderna developed the vaccine which is now referred to as mRNA-1273 alongside researchers from the National Insititute of Health. The trial is being performed in Seattle at the Kaiser Permanente Washington Health Research Institute (KPWHRI).
With hopes to recruit 45 healthy adults who are willing to submit themselves to the clinical trials, phase 1 of the study seeks to test three different doses of the mRNA-1273 vaccine. Those who elect to participate in the trials will be monitored to evaluate the immunogenicity and safety of the vaccine, upon receiving two shots, 28 days apart. Immunogenicity will be evaluated in order to see how well the vaccine can stimulate an immune response to the novel coronavirus or SARS-CoV2.
First person to subject to human trials
Forty-three year-old Jennifer Haller who hails from Seattle is the first person to ever get the vaccine. In an interview with TIME, Haller said that she has her hopes that the vaccine can be developed as soon as possible so that lives can be saved and that people can go back to their normal life in the soonest possible time.
Experimental COVID-19 vaccine test begins as U.S. volunteer receives first shot https://t.co/z2IGGS78BB pic.twitter.com/LtCfQCsWsZ — TIME (@TIME) March 17, 2020
Moderna's Chief Medical Officer, Dr. Tal Zaks said that the study and clinical trials are the first steps in the clinical development of a viable mRNA vaccine against the SAR-CoV-2 and that they are expecting to gather relevant and important safety and immunogenicity information from the human trials. Furthermore, he also said that Moderna is already working with the Food and Drug Administration (FDA) and other organizations in preparing for phase 2 of the trials which will involve a larger number of volunteer test subjects.
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The clinical trials started just over two months after the Chinese researchers have sequenced the genetic build-up of coronavirus. Only two days after having access to the sequenced SARS-CoV-2, the design for the vaccine was already finalized by researchers at the NIH's Vaccine Research Center. On the same day, they also began manufacturing it and finished the first batch of vaccines last February 7. By the February 24, the company was able to ship the vaccines to the NIH post-analytical testing.
According to Dr. Anthony S. Fauci, head of the National Institute of Allergy and Infectious Diseases, finding and developing a vaccine for COVID-19 is an urgent public health authority. He also noted that Phase 1 of the study being launched in record speed was an important leap towards the achievement of the goal.
Does the Vaccine contain Coronavirus?
Unlike other vaccines, mRNA 1273 does not contain trace amounts of the virus, thus, it cannot cause COVID-19. Instead, it contains a small part of the virus's genetic code or mRNA (messenger ribonucleic acid) which scientists extracted and then expanded in a laboratory. After this, scientists used the genetic code in order to encode the viral "spike" protein which is vital in allowing the coronavirus to gain access to the human cells. Upon access to human cells, scientists predict and hope that the viral "spike" will stimulate the immune system to initiate and attack the virus in order to prevent the development of COVID-19.
However, despite the production of the vaccine was done at an incredibly fast pace, the evaluation will take some time. All participants in the study will be monitored for a year after the second dose of the vaccine was administered in order to collect data and conclude if the vaccine is safe and effective.
As of the moment, the study is still looking for people aged 18-55 within the Seattle area who are willing to enroll as test subjects for the new vaccine.
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