A top coronavirus vaccine candidate, developed by Massachusetts-based biotech company Moderna, will be submitted for regulatory approval on Monday – the second largest drug to hit the milestone this month.
Moderna said it would ask the US Food and Drug Administration for emergency approval after the Phase 3 trial is complete. The vaccine is 94.1 percent effective against Covid-19.
In addition, Moderna said the vaccine was 100 percent effective in preventing severe cases of the disease.
These results were the same across all age, race and gender categories, the company said in a statement. So far, no serious security concerns have arisen. The most common side effects are fatigue, muscle and joint pain, and headache.
“We believe our vaccine will provide a new and powerful tool that can transform the course of this pandemic and help prevent serious illness, hospitalization and death,” said Stéphane Bancel, CEO of Moderna, in a statement.
Ten days ago, another vaccine candidate developed by US pharmaceutical giant Pfizer and its German partner BioNTech also filed for regulatory approval after finding similar efficacy.
As with Moderna’s drug, they’re also about inserting a special code called mRNA into the body to develop an immune response. No mRNA-based drug has ever been approved before.
The Moderna study enrolled 30,000 people, half of whom received the vaccine candidate and the other half received a placebo. Of this group, the scientists recorded 196 cases of Covid-19, of which only 11 were from the group that received the vaccine. There were 30 cases of serious illness – all in the placebo group.
Of the 15,000 people who were given the vaccine, none were seriously ill with Covid-19 during the trial period, the company said.
Last week, AstraZeneca and Oxford University campaigned for their own promising results, only to later admit that a technical error had occurred during the trial and some additional testing was planned. As with the others, there was no evidence that the vaccine was unsafe.
These developments have met with widespread optimism among scholars and stock markets. However, experts also advise caution until more data is released beyond the various companies’ triumphant, untested press releases. While these vaccine studies are primarily aimed at preventing symptomatic disease, the question remains how effective they are in stopping transmission.
President-elect Joe Biden has also warned that vaccines, which will take some time to approve and launch, will not mitigate the harsh winter in the US, Europe and elsewhere.
Coronavirus cases continue to rise, with more than 267,000 Americans dead, fearing Thanksgiving could bring even more deaths. Europe was hit by a similar wave until widespread lockdowns began to turn the tide. More than 1.4. Millions have been killed worldwide.
Even if these drugs get regulatory approval, drug adoption will pose a Byzantine supply chain challenge to billions of people around the world on an unprecedented scale.