AstraZeneca plc (NYSE:AZN) reached skyward Monday, on word its COVID-19 vaccine may receive the Food and Drug Administration’s approval for emergency use in the United States, ahead of the impending presidential elections, the Financial Times reported Sunday.
Even so, AstraZeneca says it has held no talks with the U.S. government about emergency use authorization of its COVID-19 vaccine, currently dubbed AZD1222.
The FDA has stated that an approval of any COVID-19 vaccine will need to be supported by data from a trial involving at least 30,000 people. AZN is launching such a study in the U.S. but results may not be available until after the November 3 election.
At a press conference yesterday to announce emergency use authorization of convalescent plasma for the respiratory infection, President Trump hinted that a similar nod for a vaccine might be imminent.
Leading Democrats say the White House must not approve a vaccine with sufficient data to support approval. FDA division chief Peter Marks, whose group oversees vaccine approvals, told news media that he will resign if the Trump administration pressures the agency to approve a vaccine without adequate data showing its safety and effectiveness.
AZN shares jumped $1.74, or 3.1%, to $57.45.
