The reputed Biotech company Moderna is developing a potential coronavirus vaccine in partnership with the National Institute of Health. Its phase 1 trial is complete, and the results are entirely satisfactory. According to the published report, the vaccine was able to generate an immune response in the phase 1 trial volunteers.
The company published its results of the trial in the New England Journal of Medicine on Tuesday. According to their report, the vaccine was able to start an immune response with some regular side effects like fatigue, headache, muscle ache, chills, and pain at the injection site. It is one of the first US candidate COVID vaccines that published the results in a medical journal.
As per the reports, phase 3 trial will begin from the end of this month. It is the final stage of a clinical trial before the vaccine is placed before the regulatory committee for release.
The biotech company Moderna also organized a press release on Tuesday. The spokesperson said that if the reports are satisfactory, the company will start to deliver the vaccine to the masses from the beginning of 2021. As per their claim, they plan to make nearly 500 million to 1 billion doses of vaccines per year to accommodate the demand.
As per Dr. Lisa Jackson, the first stage’s objective was to check if the vaccine is safe for humans and if they can trigger the immune response in volunteers. Dr. Jackson is a senior researcher at the Kaiser Washington Health Reasearch Institute, performing the vaccine’s trial. The initial results were published in May.
According to her, the immune response is a positive and promising indication. But, there is still no clear information if the vaccine can protect people against infection in the real environment. The complete result will come out after the clinical trial is over. She also said that the team of researchers was conducting trials to get every possible answer to the questions.
Moderna will start the third phase of a clinical trial with a large section of volunteers on July 27. It is developing a candidate vaccine containing mRNA-1237. The vaccine is one of the first vaccines going through the third phase of the trial in the US.
As of now, the obtained information is enough to determine the dose for the next two clinical trials. According to Dr. Lisa Jackson, it is one of the critical decisions, and the availability of information is an excellent relief for researchers.
The phase 1 trial involves only a few volunteers. Scientists determine if a vaccine is safe enough for humans and can trigger an immune response in them.
Phase 2 involves people from different ages and physical health sections who mimic the condition of the intended recipients of the vaccine. The study suggests more number of volunteers to understand the effectiveness of the candidate vaccine. According to the US Center for Disease Control and Prevention, phase 3 involves many people, and the researchers test its efficiency and safety among masses in the real environment.
The safety and efficiency of the candidate vaccine
The phase 1 of the Moderna candidate vaccine involved 45 adults from ages 18 to 55 who are healthy. They received two doses of that mRNA vaccine with an interval of 28 days. The volunteers enrolled in the Kaiser Permanente in Seattle and Emroy University in Atlanta.
As per Dr. Jackson, the first dose of the candidate vaccine is called priming, and it prepares the immune sytem. After this, the body automatically triggers an immunity booster response as the volunteers receive another dose. The researchers used two doses to check the reaction among the volunteers for a clear picture.
The team did not find any trial-limiting safety conditions after the volunteers got two doses. But the mild side effects like headaches, muscle ache, fatigue, and pain at the injection site remained. It was familiar with the higher dose of vaccine.
The first phase involved a different group of volunteers who received different doses. As per the study, the adverse effect was reported in five volunteers receiving 25 micrograms of vaccines; the other ten received 100 micrograms and the last ten participants received 250mcg dose.
The second vaccination showed some different results. Around 13 people of the 25mcg group, 15 volunteers of the 100 microgram group, and 14 people from the 250 microgram group reportedly developed mild side-effects. Only three people reported having severe side-effects.
According to the reports, the adverse events after the 100 microgram dose were fatigue in 80% of volunteers, chills among 80%, headache in 60% participants, and muscle pain was present in 53% of participants. In general, the cases were mostly mild or moderate, and there were no serious issues.
The data obtained from the study showed that the COVID-19 vaccine could trigger an immune-boosting situation where the body produced proteins capable of fighting covid related infection.
On a precise note, all participants were able to develop neutralized antibodies similar to those who recovered from Corona Virus in recent times. The neutralizing antibodies connect to the virus and prevent them from attacking the body cells.
According to Dr. Lisa Jackson, the responses are identical. The vaccine can produce antibodies that can prevent the virus infestation. But a detailed research is still needed to check if it is safe and effective in real-life conditions. It was said by Dr. Paul Offit who is in the NH panel, but is not related to this vaccine trial. He is also the director of the Vaccine Education Centre. Currently, Dr. Offit is a physician working in the Infectious disease Divison of the Children’s Hospital of Philadelphia.
As per Dr. Offit, the main objective is to check if the virus is safe enough for 20 or 220 million people of the US. He also added that the vaccine is still safe. Still, the efficiency is unknown, and nothing is definite until the third phase of the clinical trial is over.
Mass scale trial of the US Covid -19 vaccine by Moderna may kickstart by the end of July.
As per Dr. Tal Zaks, the Chief Medical officer Moderna, phase 1 of this vaccine with mRNA-1273 was able to generate a reliable and effective immune response among the volunteers. The study indicated that the 100 microgram dose is best and optimal for the phase study.
On Tuesday, he also added that the company was aiming for the phase three trials for a precise result.
According to the team, researchers plan to gather more than 30000 adult participants from different locations, including high-risk areas for the phase 3 clinical trial.
A group of volunteers will receive 100 microgram dose each on a 28-day interval. The other group will receive a placebo vaccine (fake or empty vaccine) in the same style. It will help the researchers to check the efficiency of the vaccine with a clear comparison field.
The researchers will wait for 14 days after the second dose and will check if someone develops Covid-19. They also plan to keep a tab on the volunteers for two years to get more data.
As per the reports, the study is going to happen in more than 87 locations in the US. According to the World Health Organisation, the Moderna vaccine is among the 23 candidate vaccines undergoing a clinical trial.
According to Dr. Penny Heaton, CEO of Bill and Melinda Gates Foundation, the reports of phase 1 clinical trial is quite promising, and their foundation firmly supports the development of Moderna’s vaccine. She wrote in the editorial letter of the New England Journal of Medicine that published the report of Moderna’s vaccine trial. She also wrote that the development is utterly dependent on the resources and activity tracking. The pressure is immense, and the researchers worldwide are racing against time to develop a virus that can counter Covid-19.