In promising news, US biotech company Moderna on Monday said that early data suggests that its COVID-19 vaccine is 94.5% effective. Moderna’s vaccine is being tested upon more than 30,000 participants in the United States and this data is from a first interim analysis that included 95 participants with confirmed cases of COVID-19.
“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,” said Stéphane Bancel, Moderna's Chief Executive Officer. “We look forward to the next milestones of submitting for an EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic,” he added.
On Sunday, an independent monitoring board broke the code to examine 95 infections that were recorded starting two weeks after volunteers' second dose and discovered all but five illnesses occurred in participants who got the placebo. The study is continuing, and Moderna acknowledged the protection rate might change as more COVID-19 infections are detected and added to the calculations. Also, it's too soon to know how long protection lasts. Both cautions apply to Pfizer's vaccine as well.
But Moderna's independent monitors reported some additional, promising tidbits: All 11 severe COVID-19 cases were among placebo recipients, and there were no significant safety concerns. The main side effects were fatigue, muscle ache and injection-site pain after the vaccine's second dose, at rates that company President Dr Stephen Hoge characterised as more common than with flu shots but on par with others such as shingles vaccine.
The Cambridge, Massachusetts company's vaccine is among 11 candidates in late-stage testing around the world, four of them in huge studies in the US.
The news from Moderna comes a week after Pfizer Inc. announced that its own COVID-19 vaccine appeared similarly effective — news that puts both companies on track to seek permission within weeks for emergency use in the US.
Both Moderna's shots and the Pfizer-BioNTech candidate are so-called mRNA vaccines, a brand-new technology. They aren't made with the coronavirus itself, meaning there's 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 strong results were a surprise. Scientists have warned for months that any COVID-19 shot may be only as good as flu vaccines, which are about 50% effective.
Another steep challenge: distributing doses that must be kept very cold. Both the Moderna and Pfizer shots are frozen but at different temperatures. Moderna announced Monday that once thawed, its doses can last longer in a refrigerator than initially thought, up to 30 days. Pfizer's shots require long-term storage at ultra-cold temperatures.
With AP inputs