Moderna tests 30,000 volunteers for its coronavirus vaccine phase 3 clinical trial on Monday, July 27. However, issues the biotechnological firm’s reliability clouded the clinical trial.
Moderna ‘s trial is the first phase 3 trial of the COVID-19 vaccine in the United States. It follows other pharmaceutical firms that are now examining the effectiveness of their vaccines outside the United States. AstraZeneca-University of Oxford, a separate vaccine candidate, is also under clinical trials.
Moderna currently has 87 test sites across the US to test the vaccine’s safety and effectiveness on a significant number of people at different locations for phase 3 trials, or the final stage.
Moderna Chief Executive Stephane Bancel said the biotechnology company’s goal is to deliver results through Thanksgiving. If those results are reliable, the FDA will easily recommend the vaccine for immediate use by people at high risk.
Phase 2 research for Moderna is still underway. Still, its Phase 1 tests revealed that the vaccine was healthy overall and activated immune responses in volunteers. The final stage will include participants divided to two categories. Half will receive the vaccine, and the other half will receive a placebo. A double-blind study will be carried out on the vaccine. Therefore, neither researchers nor people will know who’s having a placebo or vaccine. Each participant gets two shots 28 days apart.
Was the vaccine approved?
Moderna coordinated with the National Institute for Allergy and Infectious Diseases to develop the vaccine as Operation Warp Speed. They aim to produce 300 million doses of the vaccine by January 2021. The collaboration also involves collaborations with Pfizer and BioNTech and those between the University of Oxford and the AstraZeneca.
After its establishment in 2010, Moderna focused on using synthetic mRNA to establish immune responses. Other businesses find it dangerous as mRNA delivery systems can induce adverse effects. Moderna raised more than $600 million in its initial public offering in 2018, which is the largest pharmaceutical IPO history.
A 2016 editorial in the journal Nature accused Moderna of choosing “stealth over data disclosure” for not disclosing its methods. Nevertheless, Moderna recently published its observations on the coronavirus vaccine in the New England Journal of Medicine.
Damian Garde of STAT News has explained that Moderna is separate from Theranos, a troubled biotech firm. Garde said he spoke with several Moderna staff, stating that “there is some true research” in the company.
When this vaccine was approved, it will be the company’s first approved vaccine.
The mRNA vaccine: Pros and Cons
Moderna is currently competing against three other vaccine developers, which are all now in their phase 3 trials, including Sinopharm, Sinovac candidate vaccines, and the partnership between Oxford University and AstraZeneca.
Current technologies used which varies from current vaccines. The vaccine, called mRNA-1273, makes use of messenger RNA processing to create a vaccine from the genetic code of a virus.
According to reports, the mRNA provides the body with tools to “develop its own medication,” rather than just supplying the immune system with pieces of virus for target practice.
Despite its versatility and decades of research, the sole downside of this system is that it remains highly proprietary and has never been approved by the Food and Drug Administration.
Pfizer’s COVID-19 vaccine applicants use the same platform as Moderna’s vaccine. It will be the first mRNA vaccine on the market if either of them receives clearance.
The cells of volunteers will then build the proteins after receiving the vaccine, while their immune systems will learn to mount a defense after confrontation with the spike protein.