Pharmaceutical giant AstraZeneca says it has not had discussions with the US government about emergency authorization for the COVID-19 vaccine it is manufacturing.
That vaccine is still undergoing late-stage human clinical trials at various sites around the world, including in the UK and the US, making for swift approval under criteria that the Food and Drug Administration the US has so far established itself as a long shot.
British newspaper The Financial Times reported on Sunday that the Trump Administration was considering a plan to accelerate approval of the vaccine, which has been developed by researchers at the University of Oxford in the United Kingdom and which AstraZeneca agreed to help test and manufacture.
The document cited three anonymous sources who it said had been briefed on the White House plan that it said included an option for the FDA to grant an “emergency use authorization” AstraZeneca’s vaccine if the results are successful positives from a late-stage UK clinical trial led by Oxford. That study involves about 10,000 people and is expected to announce the results next month.
The FDA has previously said that any vaccine applying for a license must show positive results in a much larger clinical trial, involving at least 30,000 people. AstraZeneca is starting a clinical trial of that size in the US for the vaccine, but results are not expected to be ready until later in the fall.
President Donald Trump is reportedly desperate for a COVID-19 vaccine to be approved before the November 3 presidential election to increase his chances of re-election. Some even speculate that he sees it as his “October surprise.” Trump is currently behind Democratic presidential candidate Joe Biden by about 10 points in national opinion polls.
“AstraZeneca has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility,” AstraZeneca said in a statement Monday in response to The FT story.
Despite the denial, investors sent AstraZeneca shares down 3.7% on Monday morning.
Vaccines you’ll be hearing about very soon
The FT report came on the same day that Trump held a press conference to announce that the FDA had granted an emergency use authorization for blood plasma from recovered COVID-19 patients for use in treating those currently suffer from the disease.
At that press conference, Trump hinted that a vaccine authorization could be imminent. “We are ahead of approvals in years than we would be if we followed the speed levels of previous administrations. We would be two years, three years ago ”, said the president. “That includes vaccines that you will find out about very soon.”
Leading Democrats have said the White House should not approve a vaccine before reliable results of safety and efficacy are available. Additionally, Peter Marks, who heads the FDA division responsible for evaluating vaccine candidates, told Reuters he would resign if the Trump Administration pressures the agency to approve a vaccine without adequate test data to show it is safe and effective. .
In addition to the Oxford-AstraZeneca vaccine, several other vaccines, including those being developed by the biotech company Moderna and the pharmaceutical giant Pfizer, are also now undergoing large phase III clinical trials with 30,000 people in the US.
Moderna began recruiting volunteers in July and has said it will complete registration by the end of September. Pfizer says it has recruited just over a third of its participants and will be “ready for regulatory review in October.” But even so, it’s unclear whether a vaccine could be approved under existing FDA guidelines before November 3.
On Saturday, an impatient Trump alleged in a tweet that anonymous individuals within the FDA were deliberately trying to delay enrollment in vaccine trials so that clinical trial results would not be available until after the election.
That tweet led to the condemnation of the Speaker of the United States House of Representatives, Nancy Pelosi, who called Trump’s tweet “a dangerous statement” that “went beyond pale” and could “endanger health and the welfare of the American people.”
