Recruitment for clinical trial volunteers of Moderna’s COVID-19 vaccine has started in Seattle, USA.
Researchers have begun recruiting a total of forty-five healthy volunteers to take part in a clinical trial for the preliminary safety of an investigational COVID-19 vaccine, developed by Moderna Therapeutics, the Wall Street Journal reports.
Moderna Therapeutics, which sent it’s investigational COVID-19 vaccine candidate to the National Institute of Allergy and Infectious Diseases (NIAID) in Maryland, back in February is now advancing to the next stage of its clinical trials.
Forty-five healthy Seattle-area volunteers between the ages of 18 and 55 will be enrolled in the preliminary trial, which attempts to determine whether the vaccine triggers an immune response and whether the administered dose causes adverse side effects, according to a description on ClinicalTrials.gov.
Moderna’s investigational COVID-19 vaccine does not contain the virus
Notably, Moderna’s investigational vaccine does not contain the virus that triggers COVID-19, called SARS-CoV-2, and cannot, therefore, cause an infection, Kaiser Permanente reported. The new vaccine does not use a dead or processed virus as its basis, unlike vaccines produced for other viruses, such as measles. Instead, the vaccine includes a short segment of a laboratory-generated genetic material called messenger RNA, or mRNA.
Messenger RNA, or mRNA, transfers the instructions stored in DNA to make the proteins required in every living cell. Moderna’s approach is to use mRNA drugs to instruct the patients own cells to produce proteins that could prevent, treat, or cure disease.
According to the Kaiser Permanente study, the artificial mRNA organic structure administered as a vaccine into the human body, releases programmed instructions prompting the cells to produce a protein found on the surface of the virus and to trigger an immune response.
It is expected that the immune system should react to the new vaccine proteins by producing specific antibodies targeting the elimination of the viral proteins and eventually the elimination of the virus if it appears in the immune system of one who has had the vaccine. It will enable the vaccinated person to be better prepared to battle SARS-CoV-2 should they ever come across it.
The NIAID Director Anthony Fauci told the Wall Street Journal, that the department expects a clinical trial will be funded by the Kaiser Permanente Washington Health Research Institute and that the testing will be initiated by the end of April 2020.
The 45 volunteers will be split into three groups, with each group receiving twice a specific dose of the vaccine as an intramuscular injection in the upper arm. The administration of the second dose of the vaccine will be done with a 28-day gap.
For this 14-month study, participants are required to attend eleven times in person and will receive $100 for each appointment they attend, earning up to $1,100 by the end of the trial.
After this initial safety trial, the efficacy of the vaccine needs to be tested in several additional studies in wider groups of individuals before it is widely distributed.
How much will the COVID-19 vaccine cost?
U.S. health officials stated earlier this week that they cannot guarantee that a COVID-19 vaccine will be affordable although the development of the vaccine is encouraging. Forbs reported that Health and Human Services Secretary Alex Azar has angered Democrats by suggesting that a COVID-19 vaccine might not be affordable for all Americans and that the Trump administration could not cap its price because of the need for private sector investment in research of the vaccine. Congressional reporter Michael Mc Auliff tweeted:
Alternative COVID-19 treatment
So even if the COVID-19 vaccine product is approved, there may be a difficult balance to strike, when determining the price. For the meantime, patients with COVID-19 will receive supportive care to tackle disease symptoms. A handful of repurposed drugs, ranging from medications treating Ebola to HIV, have already shown promise. A 35-year-old COVID-19 sufferer with severe symptoms received the unapproved antiviral medication named remdesivir, which was initially developed by Gilead Sciences to treat Ebola. The patient, who was released from hospital recently, did not appear to suffer any side effects from the remdesivir antiviral drug treatment. The Food and Drug Administration (FDA) for “compassionate use” allows experimental drugs to be administered to people outside of clinical trials, usually in emergency situations.
Read more about COVID-19 vaccine development.