This story originally appeared on Business Insider
One second experimental vaccine against coronavirus has managed to prevent COVID-19 in the final phase of clinical research, which means a victory in the fight against the pandemic.
Modern announced the success in a press release Monday morning, saying his vaccine was 94.5% effective at prevention COVID-19, the disease caused by the new coronavirus. An independent group of experts found clear evidence of effectiveness after reviewing preliminary data from an ongoing study of 30,000 people, Moderna said.
The Moderna injection is the second major vaccination program to announce the success of an advanced study. Pfizer and its German partner BioNTech said in a preliminary review of an ongoing study on Nov. 9th that their vaccine is more than 90% effective in preventing COVID-19.
Both announcements deliver much-needed good news as the pandemic spreads across the world. However, it can take weeks for regulators to review vaccines and decide whether to make them more accessible. The U.S. is currently reporting an average of 140,000 new coronavirus cases a day and the health system is showing worrying signs of stress as hospitalizations and deaths rise.
Moderna’s share price rose more than 10% before the market opened on Monday and was close to its all-time high. US stock futures also rose, with the SP 500 and Dow Jones Industrial Average rising between 1.4% and 1.8% to trade around session highs.
Pfizer and its German partner BioNTech said on Nov. 9 that their vaccine was useful in preventing COVID-19 / Image: NurPhoto | Getty Images is more than 90% effective
Couple of ‘excellent shots’
“These are two great vaccines that will help many Americans and many people around the world,” said Stéphane Bancel, CEO of Moderna, in a video interview with Business Insider.
Moderna’s publication shows that its vaccine is very similar to Pfizer’s. Moderna said his vaccine was 94.5% effective, while Pfizer said his injection was more than 90% effective. Moderna’s analysis was based on 95 COVID-19 cases, while Pfizer’s review included 94 cases. The data from neither company has been published in a scientific journal, and both are collecting even more information about the safety of their vaccines.
Moderna’s study begins counting coronavirus cases two weeks after receiving the second vaccine, while Pfizer’s study records illnesses one week after completing the vaccination course.
It would be “naive to compare 90% against 94.5%,” Bancel told Business Insider, saying it was too early to compare the footage.
Volunteers in the Moderna study were randomly given two-dose therapy with the experimental Moderna injection or placebo injections. The expert panel’s conclusion is based on 95 cases of disease observed in the study.
Of these 95 diseases, 90 people who took placebo got sick compared to five who received Moderna’s vaccine. The vaccine also appeared to prevent serious illnesses. The researchers found 11 cases of severe COVID-19 in the placebo group and zero in those who received the vaccine.
Moderna’s vaccine has one distinct advantage over Pfizer’s injection: it can be stored for a month at typical refrigerator temperatures (2 to 7 degrees Celsius), while Pfizer’s injection should be stored at -34 degrees Celsius, which requires dry ice and special containers .
Moderna’s vaccine has yet to be evaluated by the FDA
Both vaccines are still experimental and require regulatory approval before they can be released. Both companies plan to apply for emergency approval in late November. It is unclear how long it will take the U.S. Food and Drug Administration to evaluate the vaccines and decide whether to approve them.
Even if this is approved by regulators, vaccine supplies will be extremely limited at first, although it would be helpful to have two vaccines.
Moncef Slaoui, the senior advisor to the US government’s Operation Warp Speed vaccine initiative, recently estimated that if both vaccines were approved, 20 million Americans could be vaccinated in December.
Even if regulators approve, vaccine supplies will be extremely limited at first / Image: Depositphotos.com
Moderna was a key component of Warp Speed’s vaccination schedule. The U.S. government invested up to $ 2.48 billion to fund its development and ensure supplies.
Pfizer expects to produce up to 50 million cans by the end of 2020, and Moderna should have 20 million cans available in the US by the end of the year. Both injections are given in two doses.
Production will expand in 2021. Pfizer says it has enough vaccines to immunize up to 650 million people, and Moderna plans to produce enough injections for 500 million people worldwide. Vaccines from other drug companies may also be available next year if they are successful in ongoing clinical trials.
Bancel predicted that a coronavirus vaccine would be widely available in the U.S. by Memorial Day in late May, based solely on results from Pfizer and its company.
“Even if no other vaccine made it, in the worst case scenario, I think any American who wants a vaccine will get their hands on a vaccine by Memorial Day in late June,” Bancel said.
The early success should bode well for other vaccine pioneers
The effectiveness of the Moderna injection should bode well for other vaccine pioneers. All of these experimental injections target the same part of the new coronavirus, the spike protein.
Slaoui told Business Insider in October he expected three waves of approvals in the next few months.
Moderna and Pfizer would be the first wave. They were quickly followed by recordings from Johnson Johnson and AstraZeneca. Slaoui said he expected results from these companies in December or January.
The third wave contains two more takes, one from Novavax and one from Sanofi and GlaxoSmithKline. These programs are expected to enter the final phase of clinical trials in the US in the coming weeks.
Senior government scientists said a vaccine should be widely available to Americans in April. Slaoui predicted in August that if people agreed on the injections, we could be back to normal in the second half of 2021.
The announcement that both vaccines are effective is a validation of the new technology they both use called messenger RNA. The technology platform only uses the virus’ genetic code to create a vaccine. The approach is promising, but novel: So far, there are no state-approved mRNA vaccines.
Despite promising news, important questions remain unanswered
It is too early to draw any conclusions as to whether one vaccine is more effective or safer than the other. Although Moderna provided much more detailed results than Pfizer, neither has published data in medical journals from their ongoing studies.
Both companies are still collecting and analyzing data, which means the exact effectiveness of the recordings may differ from these preliminary results.
Moderna provided an overview of preliminary data on safety and side effects, while Pfizer did not provide this information.
Most of the side effects from Moderna injections were mild or moderate, but some volunteers had serious side effects that are medically significant but not life threatening. This mainly happened after the second injection. The most common serious side effects were fatigue (9.7%), muscle pain (8.9%), joint pain (5.2%), headache (4.5%), pain (4.1%) and injection site redness (2, 0%).
While Moderna said these side effects were “generally short-lived,” the details will be important, especially given how serious and long-lasting the side effects were.
Most of the side effects from Moderna Injections were mild or moderate / Image: Depositphotos.com
There are a few other unanswered questions
In terms of effectiveness, it is not clear whether any of the vaccines will prevent asymptomatic infections. Studies likely cannot definitively answer this question as volunteers were only tested for coronavirus if they developed symptoms.
No company has provided detailed results by age group. In the past, some vaccines were less protective in the elderly.
After all, we don’t know how long the protection could last. This information will only come in time as the study volunteers will be followed for many more months. People may need booster vaccinations, although no one knows if they will be needed six months, a year, or a few years later.
A transformative moment for Moderna
While Pfizer is a pharmaceutical company known for treatments like Viagra and Lipitor, Moderna is a much smaller biotech upstart that has never developed an approved drug.
Still, Moderna, which has only been around for a decade, has quickly become one of the most dynamic startups in the pharmaceutical industry.
Bancel, the CEO, has received great insight into the potential of mRNA to treat a wide variety of diseases. This has resulted in record levels of fundraising for Moderna, including the largest biotech IPO in history in December 2018.
The Cambridge, Massachusetts company is working on several other vaccine candidates for Zika, Influenza, Cytomegalovirus, and Respiratory Syncytial Virus.
Moderna hopes the success with the coronavirus shows that the company’s core technology is working, Bancel said.
“It’s copy and paste,” he said. “So the Zika vaccine, the CMV vaccine, if that vaccine shows high potency, they’re going to have high potency. It’s just science.”
The response to the pandemic has accelerated the company’s progress, and Moderna has been working closely with the US National Institutes of Health since January to develop and test a vaccine candidate for COVID-19. Moderna’s vaccine candidate was the first in the world to begin human testing in March.
Achieving positive efficacy results from an advanced study in less than a year is a scientific achievement that only Pfizer and BioNTech have so far achieved.
Moderna’s vaccine candidate was the first in the world to begin human testing in March / Image: Depositphotos.com
Investors have taken note. Moderna’s inventory has quadrupled this year due to advances in the coronavirus vaccine. The company has hired hundreds of new employees, particularly to keep the Norwood, Massachusetts manufacturing facility running 24/7.
“That’s just the beginning”
The company’s success has also drawn criticism. The company’s top executives and board members sold $ 236 million worth of shares in the first nine months of 2020 as some corporate governance pundits criticized insider sales as a poor estimate.
And some infectious disease experts criticized previous press releases on positive early data as “science through press release”. The data, if any, were later published in one of the leading medical journals and corresponded to Moderna’s original description.
Despite criticism, Moderna’s late success is the clearest confirmation of its technology to date.
“It’s just the beginning of a big wave of products,” said Bancel.
While fighting the pandemic presents significant logistical challenges, fighting the virus with effective vaccines will go a long way.