Biotechnology company Moderna said on Monday, November 30 that it was filing that day with the Food and Drug Administration (FDA) to request an Emergency Use Authorization (EUA) for its vaccine candidate that has been demonstrated to have a 94.1% efficacy in protecting against COVID-19.
“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Stéphane Bancel, Chief Executive Officer of Moderna, said in a press release on Monday.
“We will file today for an Emergency Use Authorization from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe.”
According to the FDA, the agency may issue an EUA for an unapproved drug that can be “used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions… when there are no adequate, approved, and available alternatives.”
It will still be several weeks before the FDA will decide whether to issue the EUA for the Moderna vaccine.
In a press release also issued on Monday, the FDA said that it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for December 17 to discuss Moderna’s EUA application. The FDA noted that while the VRBPAC will provide advice to the agency on the vaccine candidate, the decision of whether to issue the EUA ultimately lies with the FDA.
FDA Commissioner Stephen M. Hahn, M.D. said that his agency aims to ensure that the public can trust any potential approved vaccine.
“The FDA understands there is tremendous public interest regarding vaccines for COVID-19. We remain committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves,” the commissioner said.
More than 30,000 participants enrolled in Moderna’s Phase Three trial. During the trial, 196 participants tested positive for COVID-19. Of those cases, 185 were observed in the placebo group compared to just 11 cases in the vaccinated group.
Additionally, of the 30 severe cases of COVID-19 which occurred among the participants, zero of those cases occurred with those who received the actual vaccine.
Moderna announced in its press release that it expects to have 20 million doses of the vaccine available by the end of 2020, with another 500 million to 1 billion available in 2021.
For Americans who want things to get back to normal as soon as possible, this is welcome news.
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