To speed up the creation of a Covid-19 vaccine by election-time, the Trump administration is weighing going around traditional regulatory standards to "fast-track" a possible coronavirus vaccine being developed in the U.K., according to a report in the Financial Times.
According to the Financial Times, the Food and Drug Administration could give an “emergency use authorization” by as early as October to a vaccine under development by AstraZeneca (AZN) - Get Report and Oxford university.
"AstraZeneca has not discussed emergency use authorization with the U.S. government and it would be premature to speculate on that possibility," said AstraZeneca in a statement provided to TheStreet on Sunday.
The company added that late stage phase 2 and 3 trials for the candidate, dubbed "AZD1222," are ongoing in the U.K. and other markets.
"We do not anticipate efficacy results until later this year," the company added.
The study on the U.K. vaccine candidate so far has only looked at it in a third the number of people as required by the U.S. regulators, who say at at least 30,000 volunteers would have to be included in trial before any authorization.
AstraZeneca is planning a study with 30,000 participants, but that would come after the current trial.
The White House did not comment to the Financial Times.
"Unlike some commentators, I would not reject an October emergency use authorization out-of-hand," said Prof. Richard H. Ebright, the laboratory director at the Waksman Institute of Microbiology and a professor of chemistry and chemical biology at Rutgers University, in an email to TheStreet on Sunday.
Ebright -- who has been critical of the Trump administration's response to the outbreak -- said his views on the vaccine would "depend on the study design and study results of the human studies completed by the time of the decision."
But Dr. David N. Fisman, a professor of epidemiology at the University of Toronto, was more cautious.
"It's pretty important to know it's safe," he told TheStreet on Sunday by email. Fisman questioned the vaccine in development's ability to produce "herd" immunity, adding that the vaccine being developed is associated with "viral shedding in primates, so it appears to prevent disease rather than infection."
Fisman also said that mass vaccinations must be performed only after the medicines are proven free of major reactions, citing the Guillain-Barre cases in 1976 caused by the swine flu vaccine.
"It's really important to make sure pandemic vaccines are safe before they're used in millions of people," said Fisman.
This story has been updated with additional information.