Moderna’s COVID-19 vaccine shows almost 95% effectiveness in Phase 3 of clinical trials
Drug maker Moderna’s COVID-19 vaccine candidate proves to be nearly 95% effective against the coronavirus, exactly one week after Pfizer and BioNTech’s big reveal. The company said that its trial “has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.”
Moderna’s result is based on its first interim analysis from Phase 3 of its clinical trials (which is the final stage before going through the licensing process). The study which is also known as the COVE study was based on 95 participants with confirmed cases of COVID-19. The company’s trial was carried out on 30,000 participants in the US, of which half of them were given a placebo and the other half were given the company’s mRNA-1273 vaccine. Over the course of the trial, 90 participants who got placebo developed COVID-19, with 11 of them being severe cases, while only 5 people who got the mRNA-1273 vaccine developed COVID-19, and none of them were severe cases or side effects.
Although, Moderna did say some participants who received its mRNA-1273 vaccine experienced symptoms like headaches and body-aches, which is not really something to worry about because they were short lived, according to Moderna. “This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” Moderna’s CEO, Stéphane Bancel, said in a press release.
The company’s mRNA-1273 vaccine also uses the mRNA technology, which is a “promising alternative to conventional vaccine approaches because of their high potency, capacity for rapid development and potential for low-cost manufacture and safe administration,” according to Nature. That’s the same mRNA technology used to develop Pfizer and BioNTech’s vaccine which also proved to be 90% effective against the coronavirus. While these vaccines may seem to have very similar attributes, Moderna’s mRNA-1273 vaccine has an advantage over Pfizer and BioNTech’s vaccine in the sense that Pfizer’s vaccine requires to be kept under a temperature of -75 degrees Celsius, while Moderna’s vaccine only requires -20 degrees Celsius (which has been used to store vaccines in the past), according to CNN. Also Moderna’s vaccine can be stored in that temperature for 30 days, while Pfizer’s will only last 5 days in its preferred temperature.
The company’s next plan now is to inquire for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in coming weeks, and also plans to have its EUA informed by the final safety and efficacy data in 2 months time. The company will also apply for authorisation to global regulatory agencies. Lastly, Moderna expects to ship about 20 million doses of its vaccine before the end of the year in the US, with hopes to manufacture and ship 500 million to 1 billion doses globally in 2021. Mind you, Moderna is a startup that has never gotten any vaccine approved before for human use, so we anticipate.