Moderna to Ask FDA to Release COVID Vaccine, Expects 20 Million Doses to Be Ready by End of 2020

Biotechnology company Moderna has announced that its ongoing study of its COVID vaccine candidate suggests it is highly effective.

Moderna said it will apply for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on Monday, and expects around 20 million doses of the vaccine called mRNA 1273 to be available in the U.S by the end of 2020.

The drug-maker said a phase 3 study of mRNA-1273 involved 30,000 participants and included 196 cases of COVID-19, of which 30 were severe. The efficacy rate against COVID-19 was 94.1 percent, and 100 percent against severe cases.

Moderna also confirmed that it remains on track to manufacture approximately 500 million to one billion doses for the international markets in 2021. The information was announced via press release and the data has not yet been peer-reviewed.

Stéphane Bancel, CEO of Moderna, said in a statement: "This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 percent efficacy and importantly, the ability to prevent severe COVID-19 disease.

"We believe our vaccine will provide a... powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death."

Moderna said the FDA's meeting to review the safety and efficacy data package for mRNA-1273 is likely to be scheduled for Thursday, December 17.

It expects shipping of mRNA-1273 to "designated distribution points throughout the U.S. will occur shortly after an Emergency Use Authorization is granted."

Moderna announced on November 16 that its initial phase 3 study showed a vaccine efficacy of 94.5 percent and pledged doses would soon ship to the U.S.

Reacting to the fresh press release published today, experts not involved in the research said the information appeared promising.

Dr. Michael Head, the senior research fellow in global health at the University of Southampton, U.K., said in a statement: "These revised findings are very much in line with those previously announced by Moderna. This is essentially good news.

He added: "There continues to be a very high level of observed effectiveness, with this effectiveness was consistent across older populations and ethnic minorities.

"There were also no serious adverse events caused by the vaccine. We must... reserve a little caution as we await the final published results, but for now we can retain the existing optimism that [new] vaccines may be deployed in the near future."

Moderna said its reviews of safety data during the latest round of testing did not identify any new serious safety concerns, but noted safety analysis is ongoing.

Prior analysis had found common adverse reactions included injection site pain, fatigue, muscle and joint pain, headache, and redness at the injection site. Adverse reactions to mRNA-1273 increased in severity after a second dose.

Dr. Alexander Edwards, associate professor in biomedical technology at University of Reading, said in a statement: "This is great news, the more trial data we have the greater confidence we have that vaccines can be used to blunt the human cost of COVID-19.

"We still need to see full data sets published in reviewed journals, and regulators will pore over every detail. Vaccine rollout remains a mammoth exercise but... the more trial data we have, the closer we are to a major new phase in the pandemic."

This article has been updated with additional information from Moderna.

Moderna
This picture taken on November 18, 2020 shows a syringe and a bottle reading "Vaccine Covid-19" next to the Moderna biotech company logo. Moderna said today it was applying for an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). JOEL SAGET/AFP/Getty