COVID-19 Vaccine: How Long Will It Take Before It Gets Approved?
Biopharma companies around the world are now in a race to develop vaccines that will help treat COVID-19 patients.
China's CanSino Biologics and Massachusetts-based Moderna Therapeutics are the frontrunners in developing vaccines that will cure COVID-19 patients.
In a recently published article, CanSino along with its collaborators at the Academy of Military Medical Sciences' Insitute of Biotechnology is doing everything to secure quick human testing of the vaccine with the approval of the Chinese regulatory group.
The company said that they are going to test its recombinant to humans. Chairman and CEO of CanSino Suefeng Yu said in a statement that he is so thankful to the company's collaborators and diligent team who worked night and day since late January to develop vaccines that will treat COVID-19 patients.
He also said that at the moment, they have developed a vaccine that has scientific data to support the IND filing. He also stressed that the vaccine they developed is a candidate among the vaccines developed around the world that has the potential to help treat patients.
GREENLIGHT TO TEST THE VACCINE
CanSino company said that they already received a green light from the Chinese regulatory to test the vaccine that they developed. This is the fastest approval so far because the company just filed the pre-IND application on Tuesday.
The vaccine developed by the company is named as Ad5-NCov. It uses an adenovirus-based viral vector platform. The company has already earned its name and integrity in developing a vaccine because the company developed the Ebola vaccine in 2017 which was approved.
Phase 1 of human testing will be conducted in Wuhan, China for healthy individuals age 18 to 60 years old. This is where COVID-19 patient was first confirmed.
According to the information posted on the Chinese Clinical Trial Registry, they are going to divide the subjects or human participants into three groups who will receive different doses of the vaccine.
The main objective of Phase 1 of human testing is to determine the safety of the vaccines, evaluate the efficacy measures, determine the levels of antibody against the spike protein, and to determine if the vaccine neutralize the antibody against COVID-19.
HUMAN TESTING OF VACCINE IN UNITED STATES
The U.S. FDA has approved the first phase of Moderna's mRNA vaccine even without animal data. This is because the number of COVID-19 cases and the death toll in the country continues to spike and there is a need for an immediate vaccine that will stop the virus.
The vaccine developed by Moderna is named as mRNA-1273. During its first trial, there will be 45 health adults who will be tested and they will be divided into three groups. Each group will receive different doses of the vaccine.
The main objective of the test is to determine the safety of the vaccine and immunogenicity. Each group will have the vaccine twice and this will be done in 28 days apart.
The company has already secured enough funds for the second trial of the vaccine which will take place in few months from now. If it's proven that Modernas mRNA-1273 is effective in stopping and curing COVID-19 patients, they said that they will ramp-up manufacturers to produce millions of vaccines.
HOW LONG A VACCINE WILL BE APPROVED?
According to the Sabin Vaccine Institute, there are three clinical trials that a candidate vaccine will undergo. The first phase includes few dozen healthy volunteers and this stage aims to monitor the safety of the vaccine and its adverse effect. The second phase involves hundreds of individuals that usually came from the different parts of the world that have positive cases of COVID-19. The third phase is the same with the second phase but this time it will involve thousands of volunteers.
Looking at the three stages of three phases above, this means that before a vaccine will be approved to be used for public it might take a year or more depending on the pace of their action.
Subscribe to Latin Post!
Sign up for our free newsletter for the Latest coverage!