In another promising development in the global race to find a coronavirus vaccine, U.S. drugmaker Moderna said its candidate has proven to be nearly 95 per cent effective in protecting people from the COVID-19 disease, according to preliminary results.
Monday’s announcement was based on interim data from its ongoing late-stage trial, raising hopes in the fight against the pandemic that has so far killed more than 1.32 million people worldwide.
“94.5 per cent efficacy and preventing COVID-19 is frankly well above the minimum thresholds that most of us had set for trying to stop a pandemic,” Moderna president Stephen Hoge told Global News on Monday.
Both U.S. competitors are now on track to file an emergency use application with U.S. regulators within weeks, as previously stated.
Here are five things to know about Moderna’s vaccine.
What do we know about Moderna’s results?
Moderna’s vaccine, which is administered in two shots 28 days apart, is being studied in 30,000 volunteers who received either the real thing or a dummy shot.
On Sunday, an independent monitoring board examined 95 COVID-19 cases that were recorded after volunteers’ second dose, and they discovered only five infections occurred in participants who received the mRNA-1273 vaccine.
The data also showed the vaccine prevented cases of severe COVID-19, a question that still remains with the Pfizer vaccine.
Of the 95 cases, 11 were severe and all 11 occurred among volunteers who got the placebo, but there were no significant safety concerns. The main side effects were fatigue, muscle aches and injection-site pain after the second dose.
The trial also included older adults age 65 and above, who are at the highest risk from the coronavirus.
“It seems to work well in older people and people that are from ethnically diverse background, which is good because you want it to work well for everybody,” Kerry Bowman, a bioethicist and assistant professor at the University of Toronto, told Global News.
What don’t we know about Moderna’s vaccine candidate?
While the results have been widely welcomed by the World Health Organization (WHO), experts and scientists, there are still several unanswered questions to determine the vaccine’s safety and efficacy.
Isaac Bogoch, an infectious disease specialist at the University of Toronto, said it still remains to be seen how effective the vaccine will be in real world settings outside of the clinical trial.
“There’s still a lot that needs to be addressed,” he said.
Bogoch said the final data should answer the following questions:
- What is the duration of immunity for people that have this vaccine?
- What is the safety profile of this vaccine?
- How effective would this vaccine be in different ages and populations and people with other underlying medical conditions?
- Can people who get this vaccine still transmit the virus or does it actually prevent them from getting the infection?
- Does the vaccine just prevent them from getting a symptomatic infection or does it actually prevent them from getting the infection altogether?
“We need the finer details to really nail down what the distribution plan will be,” Bowman said.
Can the Moderna vaccine be easily stored?
Moderna expects the vaccine to be stable at normal fridge temperatures of 2 to 8 degrees Celsius (36 to 48 degrees F) for 30 days and it can be stored for up to six months at -20 C.
In contrast, Pfizer’s vaccine must be shipped and stored at -70 C. It can be stored for up to five days at standard refrigerator temperatures, or for up to 15 days in a thermal shipping box.
Experts agreed this makes Moderna’s vaccine “a lot easier to accommodate and distribute”.
“There certainly will be logistical issues, but these can likely be overcome,” Bogoch said.
In the coming weeks, Moderna said it expects to file the full efficacy and safety data with the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) in the United States.
Hoge said the company will also submit its data with health authorities across the globe, including Health Canada.
Moderna already shared early safety and pre-clinical data from Phase 1 and 2 trials with Health Canada last month, he added.
“The good news is that we’ve actually started the rolling file application process in Canada. The process is up and running and through an interim order from Health Canada,” Hoge told Global News.
“They’re actually able to evaluate a conditional or accelerated approval of the vaccine. So, we’re already underway with Health Canada, maybe even a little bit ahead of where we are with the FDA.”
Meanwhile, the Data and Safety Monitoring Board, an independent group of experts that monitor the safety as well as the efficacy of the vaccine, has recommended continuing the Phase 3 trial.
Moderna plans to submit a full report of the Phase 3 trial to a peer-reviewed publication.
When will the vaccine roll out?
Moderna has been manufacturing its mRNA-1273 vaccine for several months and says approximately 20 million doses will be available by the end of the year.
The company also remains on track to manufacture 500 million to 1 billion doses globally in 2021, it said.
Canada signed a deal in September for 20 million doses to be delivered in the beginning of 2021, with the option of increasing the supply to 56 million doses.
Pending the review and approval from Health Canada, experts say Canadians can expect to get the vaccine early next year.
“It’s not quite clear because we have to let these independent government agencies do their job without any political pressure or external pressure,” Bogoch said.
“It wouldn’t be unreasonable to have the vaccine roll out in parts of Canada and the United States in early 2021,” he added.
— With files from Carolyn Jarvis, Global News , Reuters and The Associated Press.View link »