The Massachusetts biotechnology firm, Moderna, Inc. has developed a potential coronavirus vaccine and shipped its first sample vials to the National Institute of Allergy and Infectious Diseases (NIAID) for human testing. The experimental vaccine will be tested on 20 to 25 healthy volunteers by April to test if it is safe and if it produces a response in the immune system against COVID-19 infection.
In a statement by Moderna, Inc., the firm announced that they developed a potential coronavirus vaccine named mRNA-1273 and sample vials have been shipped to the NIAID for human testing. The vaccine developed maximizes messenger RNA molecules that bring instructions to reprogram cells in the body to function differently and beneficially.
In the company’s announcement, Moderna’s chief technical operations and quality officer Juan Andres emphasized that the collaboration of Moderna, NIAID and the Coalition for Epidemic Preparedness Innovation (CEPI) has allowed the company to deliver a clinical batch of potential vaccine in 42 days from sequence identification. Such accomplishment, he revealed would not be possible without the Moderna’s manufacturing site in Norwood which uses leading-edge technology that allows them to conduct flexible operations and meet high-quality standards for clinical-grade material.
Dr. Anthony Fauci, the Director of NIAID revealed that this is the first time that a phase one trial is conducted within three months of developing a sequence. Previous outbreaks, Fauci pointed out, such as SARS and influenza, affected the globe for 11 to 20 months before human testing of its vaccines. The coronavirus or COVID-19 vaccine, on the other hand, took only four months since the disease outbreak to be developed and tested.
Human Testing by April
The NIAID will begin a clinical trial on 20 to 25 healthy volunteers by the end of April to assess if the doses are safe, and if the vaccine can induce an immune response against the novel virus, NIAID director Anthony Fauci explained. The expected release of results of human testing will be done by July or August. Fauci admits that it is still uncertain if Moderna batch will work as the genetic technology firm has yet to yield an approved vaccine for humans. Should the first clinical trial yield positive results, the vaccine will be available next year, taking into consideration additional studies and regulatory clearance, the NIAID Director said.
The announcement of the potential vaccine is a positive development as the confirmed cases of coronavirus in the US have reached 60 and top officials of the Center for Disease Control Prevention (CDC) warned about a potential community spread of coronavirus in the country. Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases said it is not an issue if it will happen anymore, but rather an issue of when this may happen and how many of us will have a severe illness.
There are no available vaccines and no specific medicines approved by the US Food and Drug Administration to treat novel coronavirus yet. A recent study by the Chinese Center for Disease Control and Prevention reports that 2% of those infected with the virus have died. Fauci warns that a similar incidence may happen in the US because of the lack of antiviral drugs.
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