For the second time in as many weeks, there is promising news from the race for a COVID-19 vaccine as infections surge across the United States and Europe.
US biotech firm Moderna Inc on Monday said preliminary data from a continuing phase three study of its experimental COVID-19 vaccine showed it to be 94.5 percent effective.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” said Moderna’s CEO Stephane Bancel in a statement. “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.”
The news follows on from last week’s announcement from US drug giant Pfizer that phase three trial results for the COVID-19 vaccine it is developing with Germany’s BioNTech showed it to be more than 90 percent effective.
The results of both trials place Moderna and Pfizer on track to seek authorisation from the US Food and Drug Administration in the coming weeks for emergency use of their vaccines.
If they get the green light from the FDA, supplies of both vaccines would be limited and rationed before the end of the year. Both vaccines require people to get two shots, several weeks apart.
Moderna expects to have about 20 million doses, earmarked for the US by the end of 2020. Pfizer and BioNTech expect to have about 50 million doses globally by the yearend.
US Secretary of Health and Human Services Alex Azhar responded to the Moderna news on Twitter, writing: “This news is another stunning result of President Trump’s leadership and his unwavering support for #OperationWarpSpeed, an incredible tribute to American scientists and innovators, and one more reminder that there is light at the end of the tunnel.”
This news is another stunning result of President Trump’s leadership and his unwavering support for #OperationWarpSpeed, an incredible tribute to American scientists and innovators, and one more reminder that there is light at the end of the tunnel.
— Secretary Alex Azar (@SecAzar) November 16, 2020
Pfizer’s CEO, Albert Bouria, said on Twitter that he is “thrilled” by Moderna’s trial result, adding: “Our companies share a common goal – defeating this dreaded disease – and today we congratulate everyone at Moderna and share in the joy of their encouraging results.”
I am thrilled to hear the good news coming out of @moderna_tx’s #COVID19 vaccine development program. Our companies share a common goal – defeating this dreaded disease – and today we congratulate everyone at Moderna and share in 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 US and is being 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 observed in the placebo group versus five cases observed in the group that received its two-dose vaccine, resulting in an estimated efficacy of 94.5 percent, said the company.
The 95 participants included 15 adults aged 65 or above, and 20 participants from diverse communities including 12 people who identify as Hispanic, 4 African Americans, 3 Asian Americans and one multiracial person.
The vaccine announcements from Moderna and Pfizer are falling against a grim backdrop of soaring infections.
Over the weekend, confirmed cases of COVID-19 topped 11 million in the US, according to the Johns Hopkins University.
US hospitalisations of people with COVID-19 are also breaking records, says the coronavirus tracking project.
There are more than 54 million confirmed cases of COVID-19 globally and restrictions have been ratcheted up across the US and Europe to curb spiralling infections. But those measures will also likely weigh on an economic recovery that is widening inequalities within and between nations.
The vaccine candidates of both Moderna and Pfizer-BioNTech are so-called mRNA vaccines – a new technology. The vaccines are not made with the coronavirus itself, so there is no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognise the spiked protein on the surface of the virus.
The 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 at standard refrigerator temperatures or for up to 15 days in a thermal shipping box.
Moderna’s vaccine has an advantage in that area because it expects its vaccine to be stable at normal fridge temperatures of 2-8C (36-48F) for 30 days and it can be stored for up to six months at -20C (-4F).
Moderna, which went public in 2018, has received nearly $1bn in research and development funding from the US government and has a deal worth $1.5bn to supply 100 million doses.
The US government has an option for another 400 million doses and Moderna also has supply deals with other countries.