Pharmaceutical firm Moderna said it will apply to the drug regulators in the United States and the European Union for emergency use authorisation of its coronavirus vaccine on Monday, after full results from a late-stage study showed its vaccine was 94.1% effective with no serious safety concerns.
The drugmaker said in a press release that the Phase 3 study with 30,000 participants has met the scientific criteria needed to determine whether the vaccine works.
“Today [Monday], Moderna will submit for an EUA [Emergency Use Authorisation] with the United States Food and Drug Administration and an application for Conditional Marketing Authorization with the European Medicines Agency [of the European Union],” the company said.
The new data also showed that the vaccine was 100% effective in preventing severe illnesses due to the coronavirus. According to the press release, 30 out of the 196 volunteers developed severe Covid-19 illness, but all 30 were among the group of volunteers who got the placebo shot. This, according to the company, means that the vaccine was 100% effective at preventing severe cases.
Although Moderna’s latest efficacy result is slightly lower than an interim analysis released on November 16 that found the vaccine to be 94.5% effective, company’s Chief Medical Officer Tal Zaks told Reuters in an interview that the difference was not statistically significant. “We believe that we have a vaccine that is very highly efficacious,” he added. “We now have the data to prove it.”
“We are going to have a vaccine that can stop Covid-19,” Moderna President Stephen Hoge told the news agency.
Moderna said it has reported no new side effects since its interim analysis on November 16. Based on that analysis, the most common side effects were fatigue, redness and pain at the injection site, headache and body aches, which increased after the second dose but were short-lived.
Zaks said the vaccine caused significant flu-like symptoms in some participants, which, he said, “goes hand-in-hand with having such a potent vaccine.” But it has not caused any significant safety concerns so far, he said.
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Moderna is the second vaccine maker in the world to apply for emergency use authorisation. Pfizer and German partner BioNTech SE on November 15 said their vaccine, which also uses a new technology called synthetic messenger RNA (mRNA), was 95% effective. Pfizer applied for emergency use authorisation on November 21. Its vaccine also requires two doses per person.
However, the distribution of the vaccine developed by Moderna is expected to be easier than Pfizer’s because it can be stored at normal fridge temperatures and does not require the ultra-cold temperature needed by the Pfizer vaccine. The is a critical factor for countries like India, which do not have the required infrastructure for ultra-cold storage.
Independent advisers to the US Food and Drug Administration are scheduled to meet on December 17 to review Moderna’s trial data and make a recommendation to the FDA. They will meet on December 10 to review Pfizer’s data.
More than 70 coronavirus vaccines are being developed around the world, including 11 that, like Pfizer’s and Moderna’s vaccines, are in large-scale trials to gauge effectiveness, according to The New York Times.
India has not yet signed a deal for a coronavirus vaccine so it is unclear when it will be available for use in the country, despite some leaders promising it will be available from as early as January. Availability of the vaccine in India will be subject to approval by domestic regulators, and the Indian government agreeing to purchase them. So far, many other nations including the United States, United Kingdom, the European Union, Australia and Israel have made deals to buy millions of doses of the vaccines.
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