Moderna, Inc. MRNA is unlikely to file a regulatory application seeking emergency use authorization (“EUA”) for its coronavirus vaccine candidate, mRNA-1273, before the U.S. presidential election scheduled on Nov 3, as reported in a Financial Times article.
An ongoing phase III study is evaluating mRNA-1273 in COVID-19 patients. The company has dosed 15,000 participants out of the total 30,000 enrollment target with mRNA-1273 in phase III study, as of Sep 25. The company will need additional two months for screening patients, which suggests that initial or preliminary data from the late-stage study will not be available before Nov 25. The U.S. presidential election is scheduled on Nov 3, much earlier than the expected availability of late-stage study data.
The company’s chief executive officer (“CEO”) stated that it will be not be able to file for EUA due to the FDA guideline, which states that at least half of study participants need to undergo two months of screening following their final injection before applying for EUA.
Moreover, Moderna has stated that it can file for an approval of mRNA-1273, which will allow it to serve the whole population of the United States, in January and anticipates an FDA approval by March, at the earliest.
Moderna’s statement has come as a disappointment for Donald Trump who has been actively pitching for availability of a vaccine before the elections, However, there are other companies developing a vaccine for COVID-19 in late-stage studies, which include AstraZeneca AZN and a collaboration of Pfizer PFE and BioNTech BNTX. J&J has rapidly progressed with its single-dose coronavirus vaccine candidate and launched a pivotal, phase III study last month.
Among these late-stage vaccine developers, Pfizer hopes to have enough data on its vaccine candidate, BNT162b2, before October-end for taking a decision on regulatory application filing for EUA or regular approval. Pfizer’s vaccine candidate’s shorter time period between two shots compared to Moderna and study design has helped the company to maintain an accelerated timeline. Meanwhile, AstraZeneca’s coronavirus vaccine study in the United States remains on hold though it has resumed the study in United Kingdom. Moreover, J&J anticipates to file for EUA for its vaccine candidate in early 2021.
Availability of a coronavirus vaccine has become the hot topic as it will likely have a major impact on the upcoming presidential election. However, its timeline is still uncertain and is highly debated.
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