AstraZeneca's Coronavirus Vaccine Could Get FDA Approval For Emergency Use By October: FT

AstraZeneca plc’s AZN COVID-19 vaccine may be fast-tracked for approval in the United States, ahead of the impending presidential elections, the Financial Times reported Sunday.

What Happened: The Trump Administration is exploring multiple options, including the United States Food and Drug Administration allowing emergency use authorization in October to the British drugmaker’s vaccine being developed in partnership with Oxford University, according to FT.

The authorization may reportedly be based on a small study the drugmaker is conducting with 10,000 volunteers in the United Kingdom, whereas the U.S. requires the vaccine to be tested on 30,000 subjects.

A vaccine available before the election would allow Trump to lay claim on progress made against the COVID-19 disease that has claimed the lives of 170,000 Americans, FT noted.

White House Chief of Staff Mark Meadows told Democrats that the administration was considering fast-tracking a vaccine, possibly that of AstraZeneca, in September, people familiar with the matter told FT.

Why It Matters: The vaccine candidate’s Phase 3 trials are expected to be completed in November or December, according to the Wall Street Journal.

The drugmaker has inked a deal with governments of Argentina and Mexico to supply the vaccine to Latin American countries with the exception of Brazil.

The Cambridge, U.K.-headquartered company also has an agreement with the Serum Institute of India Pvt. Ltd. to supply the vaccine to middle-and-low-income countries, as well with the European Union.

Several other vaccine candidates are nearing or undergoing late-stage clinical trials, including those from Inovio Pharmaceuticals Inc INO, Moderna Inc MRNA, Pfizer Inc PFE and Johnson and Johnson JNJ.

Price Action: AstraZeneca shares closed nearly 1.4% lower at $55.71 on Friday.

Posted In: CoronavirusCovid-19COVID-19 VaccineThe Financial TimesVaccinesBiotechGovernmentNewsRegulationsRumorsPoliticsFDAGeneral