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This story originally appeared on Business Insider
- The Moderna coronavirus vaccine candidate entered the next phase of human testing on Monday.
- The company expects results for Thanksgiving (November).
- The candidate is an mRNA vaccine that can be produced faster than most conventional vaccines.
- However, some researchers are warning that mRNA vaccines are new and could have side effects.
Moderna’s coronavirus vaccine entered an important new test phase on Monday: the Phase 3 clinical trial, which involved 30,000 volunteers at 87 sites in the United States.
It is the first late-stage study of a possible coronavirus vaccine to begin in the United States. Moderna’s CEO said the company is expected to deliver results on Thanksgiving Day (late November). If these results are good, the FDA could quickly approve the vaccine for high-risk emergencies, considering full approval.
Modern, based in Massachusetts, has partnered with the National Institute of Allergy and Infectious Diseases to develop the vaccine. His candidate is one of several funded by the United States government under Operation Warp Speed, an initiative that aims to deliver 300 million doses of a safe and effective vaccine by January 2021.
Other vaccines supported by Warp Speed include a collaboration between Pfizer and BioNTech and a partnership between the University of Oxford and AstraZeneca. The Oxford vaccine has already started phase 3 trials with participants in the UK, Brazil and South Africa. The researchers plan to test it in the United States in August.
What does phase 3 mean?
A phase 3 trial is usually the final test of a drug or vaccine before it can be sold to the public. Phases 1 and 2, in which the drug is usually administered to smaller groups of volunteers, are designed to show that a vaccine candidate will produce an antibody response and is generally safe.
Phase 3 studies test the safety and effectiveness of a vaccine in more people in multiple locations.
For the Moderna test, the volunteers receive two injections that are 28 days apart. Half of the participants receive the candidate vaccine and the other half a placebo. It is a double-blind study, in which neither the researchers nor the volunteers know who received which dose.
Sister Kath Olmstead gives Melissa Harting from Harpersville, New York an injection when the phase 3 trial of the Moderna vaccine candidate begins on July 27, 2020 in Binghamton, New York / Picture: AP Photo / Hans Pennink
Moderna’s Phase 2 tests are still ongoing, but the results of the Phase 1 tests released earlier this month showed that the vaccine was generally safe and triggered immune responses in volunteers.
Betting on an mRNA vaccine
The Moderna vaccine called mRNA-1273 differs from other existing ones. It uses a technology called messenger RNA to create doses that use only the genetic code of a virus. As a result, the development of the mRNA vaccine can take less time.
However, there are still no mRNA vaccines on the market, primarily because the science behind them is new. If approved, the Moderna vaccine would be the first mRNA vaccine. Candidates for the Pfizer coronavirus vaccine are also based on mRNA.
Conventional vaccines rely on various other methods, e.g. B. the use of live samples of a weakened virus or a killed virus.
However, experimental mRNA vaccines have successfully triggered immune responses in cancer patients. In fact, some research suggests that mRNA vaccines can trigger a stronger immune response than ordinary vaccines by stimulating our innate immune system – the parts of our immune system we were born with, such as the skin and mucous membranes. Most vaccines stimulate the parts of our immune system that are activated when we come into contact with pathogens such as T cells.
If Moderna’s bet pays off, it could revolutionize vaccine development. However, there are still many unknowns: The researchers still do not know whether mRNA vaccines generate long-term immunity, produce adequate immune responses, or have no harmful side effects.
The potential cost of the vaccine has also not yet been determined. Stephane Bancel, CEO of Moderna, said recently Business insider The company is considering setting two prices at lower costs during the pandemic. However, the startup lost a patent litigation last week, which means that Moderna may have to pay to use basic mRNA technology. This could force you to set a higher vaccine price.
Moderna has never had an approved vaccine
Moderna raised over $ 600 million during its December 2018 IPO, the largest biotech IPO in history.
The company was founded in 2010 and has since used only synthetic mRNA to reprogram living cells and develop immune responses. Other large pharmaceutical companies consider this bet risky because mRNA delivery systems have the potential to create adverse side effects.
On May 25, 2020, bottles of a mRNA-type vaccine candidate developed for COVID-19 will be displayed at Chulalongkorn University in Bangkok, Thailand / Image: Athit Perawongmetha / Reuters
In 2016 an editorial in the magazine nature He even compared Moderna to the failed biotech startup Theranos and accused the company of choosing “stealth instead of data disclosure” because Moderna had not yet described his methods in a peer-reviewed journal. Since then, however, he has published results related to his coronavirus vaccine in the EU New England Journal of Medicine.
Moderna’s board of directors includes prominent and respected scientists such as Robert Langer, an award-winning professor of chemical engineering at MIT, and Betsy Nabel, president of the Brigham Health network associated with Harvard.
“After speaking to many Moderna employees, including those who are skeptical about the future of the company, almost everyone says: ‘This is not Theranos. There is real science here,'” said Damian Garde STAT news to WBUR.
The vaccine faces many obstacles
Even if the Moderna vaccine is successful in its autumn Phase 3 trial, approval could take longer, and approval of a coronavirus vaccine by January 2021 would be an unprecedented achievement.
Even then, other factors could undermine its ability to end the pandemic: antibody protection could quickly fade and require booster shots; Mass production and distribution of the vaccine could pose logistical and supply-related challenges. And some people may choose not to get vaccinated at all.
Of course, there is a possibility that the vaccine candidate will not be successful at all. A 2016 study with 640 phase 3 studies found that 344 failed, about 54%. Another study found that out of 302 new drug applications submitted to the FDA after phase 3 trials, 50% of these drugs were initially rejected. However, almost half of the rejected drugs were finally approved.
Who is Moderna against?
Including Moderna, four vaccine candidates have so far developed in phase 3 studies. The other three are being developed by Sinovac, Sinopharm and the University of Oxford in collaboration with AstraZeneca.
The Sinovac test in Brazil and the Sinopharm test in the United Arab Emirates are expected to take three to six months. The Oxford study did not specify the duration of the phase 3 study, but the researchers hope to have a vaccine available by Christmas.
There are a total of 24 potential coronavirus vaccines in human trials and at least 18 others that may be ready to start clinical trials this year.