Moderna announced that it will file for US and European emergency use of its COVID-19 vaccine candidate on Monday, after its late-stage study showed efficacy against the virus was 94.1%. Shares jumped 13% in Monday’s pre-market trading session.
Specifically, Moderna (MRNA) will apply for emergency use authorization (EUA) with the US Food and Drug Administration (FDA) and submit an application for Conditional Marketing Authorization (CMA) with the European Medicines Agency. Furthermore, the biotech company disclosed that the FDA expects to hold a meeting to review its mRNA-1273 vaccine on December 17.
The announcement comes after Moderna released full results of the Phase 3 study of mRNA-1273 conducted in 196 cases, which demonstrated vaccine efficacy of 94.1% against COVID-19. In addition, the primary analysis showed 100% success in preventing severe COVID-19, the company said, adding that mRNA-1273 continues to be generally well-tolerated with no serious safety concerns identified.
“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,” said Moderna CEO Stéphane Bancel. “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.”
Moderna has initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), Ministry of Health in Israel, and Health Sciences Authority in Singapore and intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO).
The Phase 3 study, also known as the COVE study, enrolled more than 30,000 participants in the US and is being conducted in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA).
By the end of 2020, Moderna expects to have about 20 million doses of mRNA-1273 ready to ship in the US. The company confirmed that its manufacturing capacity is on track for the delivery of about 500 million vaccine doses per year and up to 1 billion doses per year, beginning in 2021.
Shares in Moderna have surged 89% over the past month and are up a staggering 551% so far this year. Meanwhile, Wall Street analysts still have a Moderate Buy consensus on the stock’s outlook. Looking ahead, the average price target stands at $108.62, indicating 15% downside potential lies ahead.
Among the bears, Leerink Partners analyst Mani Foroohar recently reiterated a Sell rating on the stock with a $60 price target, as he believes that “significant competition, and a likely eroding revaccination market over time” will negatively impact the vaccine’s commercial potential.
“As we are in the midst of a global buildout of capacity analogous to a Manhattan project for vaccines, we see excess capacity, high competitive intensity, and limited pricing power as likely long-term structural features of vaccine end-markets, presenting secular challenges to a sub-scale player such as MRNA,” Foroohar commented in a note to investors. (See MRNA stock analysis on TipRanks).
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