The United States, the leader in both confirmed coronavirus cases and deaths linked to the disease, has helped aid the launch of two significant potential vaccine trials on Monday, as well as taken more efforts to expand its domestic manufacturing capacity to be able to deliver a vaccine to the public as soon as regulation will allow. On Monday, the late-stage trials for Moderna's (NASDAQ: MNRA) and Pfizer (NYSE: PFE)/ BioNTech's (NASDAQ: BNTX) experimental vaccines began with 30,000 participants. The Trump administration also awarded Fuijifilm (OTC: FUJIY) a $265 million contract to expand its vaccine manufacturing capacity for the production of Novavax's (NASDAQ: NVAX) potential coronavirus vaccine.
Vaccine Testing
Two of the world's biggest COVID-19 vaccine studies began in on Monday, with two sets of 30,000 volunteers receiving two doses of either experimental vaccine as the world races for a cure.
Moderna, in partnership with the U.S. National Institutes of Health (N.I.H.), was first to announce the beginning of its late-stage trial for its mRNA-1273 vaccine. After a couple hiccups with reports that the biotech was having issues in developing its large-scale trial, the company kept its timeline to begin in July. The N.I.H. Coronavirus Prevention Network, which is aiding companies in conducting late-stage clinical trials, will help with the trial.
The biotech also announced that it has received an additional $472 million from the U.S. government in support of its development of the pontential vaccine, bringing its total funding to a whopping $955 million. Furthermore, the company is now partnering with SAP to help distribute the vaccine when approved.
Moderna, a frontrunner for the development of the COVID-19 vaccine since the beginning of the pandemic, has never released a vaccine for public use. However, the company has shown positive early-stage effectiveness and safety of its vaccine candidate. The company reaffirmed that it is on track to deliver 500 million doses of the vaccine a year, with the possibly of manufacturing 1 billion.
Pfizer (NYSE: PFE), in partnership with the German biotech BioNTech, was the second company to launch a 30,000 participant trial of its potential vaccine on Monday, taking place at 120 sites globally. The company predicted that it will have enough data to apply for the necessary regulatory approval by October. The company also anticipants to have 100 million doses of the vaccine available by the end of 2020, with 1.3 billion expected to be made throughout 2021. The two have received $1.95 from the U.S. government to produce and deliver 100 million doses.
Both trials will test the safety and effectiveness of the potential vaccines, with participants receiving two doses of either the vaccine or a placebo about 28 days apart. The two vaccines use a new technology called messenger ribonucleic acid, or mRNA, which is designed to train the immune system to recognize and attack the novel coronavirus. Although the technology has not been approved for use in humans before, but allows for faster development and manufacturing.
"It's novel technology. We are certainly aware of the fact that there's not as much experience with this type of platform as there are with other standards," Dr Anthony Fauci, the nation's top infectious disease expert, told reporters on a conference call, quoted by CNBC. "I'm not particularly concerned. But I don't want a lack of severe concern to get in the way that we are keeping an open mind to look for any possible deleterious effect as we get into and through the phase-three trial."
Manufacturing Expansion
The U.S. Department of Health and Human Services (H.H.S.) awarded Fuijifilm Texas A&M Innovation Center in College Station, Texas $265 million to expand the nation's vaccine manufacturing ability. The contract will also help manufacture Novavax's coronavirus vaccine candidate, which has received $1.6 billion from the Trump administration.
"To ensure we have the need capacity, we are engaging domestic centers fro advance manufacturing that H.H.S. has helped build in recent year," H.H.S. Secretary Alex Azar said in a statement. "Securing more manufacturing capacity here in American will help get a vaccine to Americans without a day wasted and prepare our nation for future emergencies."