Moderna announces coronavirus vaccine prevents contagion in 94.5% of cases, a crucial victory in the fight against the pandemic: A second experimental coronavirus vaccine has managed to prevent COVID-19 in the final stage of Clinical Research, marking a victory in the fight against the pandemic.
The modern biotech just announced the success in a press release, saying that its vaccine was 94,5% effective in preventing COVID-19, the disease caused by the new coronavirus. An independent group of experts found clear signs of effectiveness after reviewing preliminary data from an ongoing study of 30,000 people, Moderna said.
Moderna's vaccine is the second most important vaccine program to announce success in an advanced trial. Pfizer and its German partner BioNTech said on November 9 that their vaccine was more than 90% effective in preventing COVID-19 in an early review of an ongoing study.
Both announcements are much-needed good news as the pandemic looms around the world, though it could be weeks before regulators review vaccines and decide whether to make them more accessible. The United States now has an average of more than 140,000 cases a day, and the health system is showing worrying signs of strain as hospitalizations and deaths increase.
"Two excellent vaccines
"Those are two great vaccines that are going to help many Americans and many people around the world," said Moderna CEO Stéphane Bancel in an interview with Business Insider.
Moderna's announcement reveals that its vaccine is broadly similar to Pfizer's. Moderna has assured that its vaccine appeared to have an efficacy of 94.5%, while Pfizer points out that its vaccine had an efficacy of more than 90%. Moderna's analysis is based on 95 cases of COVID-19, while Pfizer's review includes 94 cases. Data from neither company has yet been published in a scientific journal, and both companies continue to collect more information about the safety of their vaccines.
Moderna announces coronavirus vaccine prevents contagion
It would be "naive to compare 90% to 94.5%," Bancel has acknowledged to Business Insider, noting that it is too early to compare vaccines.
Volunteers in Moderna's trial were randomly given a two-dose regimen of Moderna's experimental injection or placebo injections. The conclusion of the expert panel is based on 95 cases of the disease observed in the study.
Of those 95 diseases, 90 people with placebo became ill, compared to five who received the vaccine from Moderna. The vaccine also seemed to prevent serious illnesses. The researchers found 11 cases of severe COVID-19 among the placebo group and zero among people who received the vaccine.
Moderna's vaccine has a crucial advantage over Pfizer's. It can be stored for a month at typical standard refrigeration temperatures (between 2.2 and minus 15 degrees Celsius), while Pfizer injection must be stored at 70 degrees below zero, which requires dry ice and special containers.
Modern vaccine still to be evaluated by FDA
Both vaccines are still experimental and need to secure regulatory clearance before being released to the public. Both companies plan to apply for an emergency use authorization by the end of November. It is unclear how long it will take the U.S. Food and Drug Administration to evaluate vaccines and decide whether to approve them.
Even if regulators approve, the supply of vaccines will be extremely limited at first, although having two vaccines will be useful.
Pfizer has said it expects to produce up to 50 million doses by the end of 2020, and Moderna should have 20 million doses available in the United States by the end of the year. Both injections are given as two-dose regimens.
Manufacturing will expand in 2021, with Pfizer saying it will have enough vaccines to immunize up to 650 million people and modern aiming to produce enough vaccines for 500 million people worldwide. Vaccines from other manufacturers could be available next year as well, if they are successful in the clinical trials that are being conducted.
Early success is hopeful for other vaccine manufacturers
The effectiveness of modern injection should be a good omen for other vaccine pioneers. All of these experimental injections target the same part of the new coronavirus called protein S.
Slaoui of Warp Speed pointed out to Business Insider in October that he anticipates three waves of approvals in the coming months.
Moderna and Pfizer make up the first wave. They could be quickly followed by vaccines from Johnson & Johnson and AstraZeneca. Slaoui has assured that he expects results in December or January from those companies.
The third wave includes two more candidates, respectively developed by Novavax and Sanofi / GlaxoSmithKline. These programs are expected to begin the final phase of clinical trials in the United States in the coming weeks.
The announcement that both vaccines are effective is a validation of the new technology they both use, called messenger RNA (mRNA). The technology platform uses only the genetic code of the virus to create a vaccine. The approach is promising but novel: there are no federally approved mRNA vaccines to date.
Key questions remain unanswered, despite promising news
It is too early to draw conclusions about whether one vaccine is more effective or safer than the other. While Moderna has provided much more detailed results than Pfizer, neither has published data in medical journals of its trials, which are still ongoing.
Both companies continue to gather and analyze more data, which means that the exact efficacy of vaccines could differ from these preliminary results.
Moderna has given an overview of preliminary data on safety and side effects, while Pfizer has not provided such information.
Most of the side effects of modern injections were mild or moderate, but some volunteers had serious side effects, which are medically significant but not life-threatening. These take place mainly after the second injection. The most common serious side effects were fatigue (9.7%), muscle aches or pains (8.9%), joint pain (5.2%), headache (4.5%), pain (4.1%) and redness at the injection site (2.0%).
While Moderna has said that those side effects are "generally short-lived", the specific details will be important, particularly with regard to the severity and duration of the side effects.
There are some other unanswered questions.
As for efficacy, it is unclear whether either vaccine prevents asymptomatic infections. Studies are unlikely to be able to definitively answer that question, as volunteers have not been tested for coronavirus unless they developed symptoms.
Neither company has provided detailed results by age group. Some vaccines have historically been less protective in older people.
Finally, we know nothing about how long the protection could last. That information will only come with more time, as study volunteers are followed for many more months. People may need booster injections, although no one knows if they will be needed within six months, a year, or several years.
A turning point for modern
While Pfizer is a pharmaceutical giant known for treatments like Viagra and Lipitor, Moderna is a much smaller biotech novice who has never developed an approved drug.
Even so, Moderna, which has only existed for a decade, has quickly become one of the most important start-ups in the pharmaceutical industry.
Bancel, the CEO, has had great visions of mRNA's potential to work on a wide range of diseases. That has driven record levels of fundraising for Moderna, including the largest IPO in biotechnology history in December 2018.
The Cambridge, Massachusetts-based company is working on several other candidate vaccines for Zika, influenza, cytomegalovirus or CMV, and respiratory syncytial virus or RSV.
Moderna hopes that its success with the coronavirus will prove that the company's fundamental technology works, Bancel has noted.
"It's copy and paste," he assured. "If this vaccine shows high efficacy, the others will have high efficacy. It's just science."
The response to the pandemic has accelerated the company's progress, and Moderna has worked closely with the U.S. National Institutes of health since January to develop and test a COVID-19 candidate. Moderna's candidate vaccine was the first in the world to begin human testing in March.
Being able to have positive efficacy results from a late-stage study in less than a year is a scientific feat only matched by Pfizer and BioNTech.
Investors have noticed. The value of Moderna's shares have more than quadrupled since the beginning of the year, driven by the progress of its coronavirus vaccine. The company has hired hundreds of new employees, particularly to help run its manufacturing plant in Norwood, Massachusetts, 24 hours a day.
"It's just the beginning"
The success of the company has also been criticized. Senior executives and members of the company's Board of directors sold 2 236 million in stock during the first nine months of 2020, while some corporate governance experts criticized internal sales as a bad strategy.
And previous press releases about positive initial data were criticized by some infectious disease experts as"science per press release." The data were eventually published later in a major medical journal and were in line with Moderna's initial description.
Despite the criticism, Moderna's success at the last stage is the clearest validation of its technology to date.
"It's just the beginning of a big wave of products," Bancel said.
Although there are major logistical challenges in the fight against the pandemic, having effective vaccines will go a long way in defeating the virus.
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