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For the second time in as many weeks, there is promising news from the race for a COVID-19 vaccine as infections rise in the United States and Europe.
US biotech company Moderna Inc said on Monday that preliminary data from an ongoing phase three study of its experimental COVID-19 vaccine showed it was 94.5 percent effective.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” said Stephane Bancel, Moderna’s CEO, in a statement. “This positive interim analysis of our Phase 3 study gave us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease.”
The news follows the announcement last week by US pharmaceutical giant Pfizer that the results of the phase three trial for the COVID-19 vaccine it is developing with Germany’s BioNTech showed it is over 90% effective.
The results of both trials put Moderna and Pfizer on track to seek permission from the U.S. Food and Drug Administration in the coming weeks for emergency use of their vaccines.
If they get the green light from the FDA, stocks of both vaccines would be limited and rationed by the end of the year. Both vaccines require people to get two shots, several weeks apart.
Moderna expects to have approximately 20 million doses, destined for the United States by the end of 2020. Pfizer and BioNTech plan to have approximately 50 million doses globally by the end of the year.
US Secretary of Health and Human Services Alex Azhar responded to the Moderna news on Twitter, writing, “This news is another remarkable result of President Trump’s leadership and his unwavering support for #OperationWarpSpeed, an incredible tribute to scientists and American innovators, and another remembers that there is light at the end of the tunnel. “
This news is another extraordinary result of President Trump’s leadership and unwavering support #OperationWarpSpeed, an incredible tribute to American scientists and innovators, and another reminder that there is light at the end of the tunnel.
– Secretary Alex Azar (@SecAzar) November 16, 2020
Pfizer CEO Albert Bouria said on Twitter he was “thrilled” with the result of Moderna’s process, adding, “Our companies share a common goal – to defeat this dreaded disease – and today we congratulate everyone at Moderna and share. the joy of their encouraging results. “
I am excited to hear the good news coming out of @modern_tx‘S #COVID-19 vaccine development program. Our companies share a common goal – to defeat this dreaded disease – and today we congratulate everyone at Moderna and share the joy of their encouraging results.
– AlbertBourla (@AlbertBourla) November 16, 2020
Moderna’s study, known as the COVE study, enrolled more than 30,000 participants in the United States and is conducted in collaboration with the National Institutes of Health.
Moderna’s first interim analysis included 95 participants who had confirmed cases of COVID-19. Of those, 90 cases of the disease were seen in the placebo group versus five cases seen in the group that received its two-dose vaccine, with an estimated efficacy of 94.5 percent, the company said.
The 95 participants included 15 adults aged 65 and over and 20 participants from different communities, including 12 people who identify as Hispanic, 4 African Americans, 3 Asian Americans, and one multiracial person.
Moderna and Pfizer’s vaccine announcements are falling against a grim backdrop of skyrocketing infections.
Over the weekend, confirmed cases of COVID-19 surpassed 11 million in the United States, according to Johns Hopkins University.
US hospitalizations of people with COVID-19 are also breaking records, says the coronavirus monitoring project.
There are more than 54 million confirmed cases of COVID-19 globally, and restrictions have been increased in the United States and Europe to curb spiral infections. But these measures will also likely weigh on an economic recovery that is widening inequalities within and between nations.
The candidate vaccines from Moderna and Pfizer-BioNTech are so-called mRNA vaccines, a new technology. Vaccines aren’t made with the coronavirus itself, so there’s no chance anyone could get it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.
Pfizer-BioNTech vaccine must be shipped and stored at -70 degrees Celsius (-94 degrees Fahrenheit) – arctic winter temperatures – and can be stored for up to five days in standard refrigerator temperatures or for up to 15 days in a thermal box for shipping.
Moderna’s vaccine has an advantage in that area because it expects its vaccine to be stable at normal refrigerator temperatures of 2-8 ° C (36-48 ° F) for 30 days and can be stored for up to six months at -20 ° C (-4 ° F).
Moderna, which went public in 2018, has received nearly $ 1 billion in research and development funding from the US government and has a $ 1.5 billion deal to provide 100 million doses.
The US government has an option for another 400 million doses, and Moderna also has supply agreements with other countries.
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