The National Institute of Allergy and Infectious Diseases declared that the first testing in humans of an experimental coronavirus vaccine started on Monday. The primary goal of the first set of trials is to find if the vaccine is safe in humans. If it is safe then the future studies will decide how well it is working.

Dr. Anthony Fauci, the institute’s director, said in a statement that the trial has been “launched in record speed.” The speedy development of a potential vaccine is exceptional and it was only possible as the researchers already knew about the related coronaviruses that had caused other outbreaks such as SARS and MERS. Even with the fast progress, if the vaccine is proved to be safe and effective against the virus, it will not be available for no less than a year.

The trials are being conducted at Kaiser Permanente Washington Health Research Institute in Seattle by using a vaccine made by Moderna Inc. Seattle was already chosen as a trialplace before the United States had any reported coronavirus cases. Washington State has been hit by the virus severely with more than 670 cases so far.

Moderna uses genetic material that is messenger RNA — to produce vaccines and the company has nine others in several stages of development that includes several for viruses that can cause respiratory infections. However, no vaccine made with this technology has reached the market yet.

The Dr. Barney Graham, the deputy director of the institute’s Vaccine Research Center said that the infectious disease institute has been working with Moderna and the RNA method can produce vaccine rapidly. Other companies are using different methods to manufacture coronavirus vaccines but Moderna is the first one to reach a clinical trial.

The trial will enroll 45 healthy adults ages 18 to 55 and each will receive two shots, 28 days apart. Moderna has called the vaccine mRNA-1273. Three different doses will be verified — each in 15 people and the participants will be studied to evaluate whether the vaccine is safe and it stimulates the immune system to make antibodies that can halt the virus from replicating and control the disease.

On Monday, 4 participants were vaccinated and 4 more are to receive shots on Tuesday. They will pause to monitor these participants, before more participants receive injections. The participants will be followed for almost a year, but Stéphane Bancel, the chief executive of Moderna, said in an interview that safety informations would be obtainablein few weeks after the vaccine is injected. If the vaccine appears safe, Moderna will ask the Food and Drug Administration for approval to move forward to the next phase of testing before the first stage is finished. The second round of trials is to measure efficacy and verify safety, which will include more participants.

Trials and making of the vaccine started in January, immediately when the Chinese scientists posted the genetic sequence of the new coronavirus on the internet. Researchers at Moderna and the National Institute of Allergy and Infectious Diseases has identified a part of the sequence that codes for a spike-like protein on the surface of the virus and attaches to human cells allowing the virus to enter them.

A nonprofit group, the Coalition for Epidemic Preparedness Innovations has helped to pay the manufacture of the vaccine for the trial. The spike sequence is the basis for the vaccine and Moderna does not require the virus itself to produce the vaccine: The Company synthesizes the stretch of RNA needed for the vaccine and inserts it in a lipid nanoparticle.

On 4th March, the Food and Drug Administration has given permission for the trial to begin for coronavirus vaccine.

Source: New york times