A top infectious disease expert is warning against approving a CCP (Chinese Communist Party) virus vaccine before it’s ready.
“The one thing that you would not want to see with a vaccine is getting an EUA [emergency use authorization] before you have a signal of efficacy,” Dr. Anthony Fauci told Reuters.
“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” he added.
Fauci heads the he National Institute of Allergy and Infectious Diseases and is a member of the White House Coronavirus Task Force.
A number of phase three trials for vaccine candidates are underway or scheduled to start soon.
Johnson & Johnson is planning to enroll 60,000 participants in a trial slated to begin on Sept. 5, according to a clinical trial database updated last week. Pfizer, Moderna, and AstraZeneca are also conducting trials on candidates against the virus, which causes a disease known as COVID-19.
AstraZeneca challenged a report on a possible EUA from the Trump administration this week, issuing a statement saying company officials have not discussed such authorization with the U.S. government.
“It would be premature to speculate on that possibility,” the company said.
Developing a vaccine by the end of the year is among President Donald Trump’s second-term priorities, his campaign said this week.
The president hinted at an upcoming announcement on a vaccine, telling reporters at the White House on Sunday: “If we went by the speed levels of past administration, we’d be two years, three years behind where we are today, and that includes in vaccines that you’ll be hearing about very soon, very shortly.
Over the weekend, Trump accused the Food and Drug Administration (FDA), the agency tasked with approving vaccines and treatments, of “making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.”
Workers at the administration “are hoping to delay the answer until after November 3rd,” the day of the presidential election, Trump said.
A few days later, Trump announced in a press briefing alongside FDA commissioner Stephen Hahn, the emergency use authorization of convalescent plasma to treat the CCP virus.
“I want to thank the FDA—all of the people that have been working very hard on this,” Trump told reporters.
“We’re removing unnecessary barriers and delays not by cutting corners, but by marshaling the full power of the federal government,” he added.
FDA scientists who reviewed data on the treatment concluded that it’s “is safe and shows promising efficacy, thereby meeting the criteria for an emergency use authorization,” Hahn said.
Critics said Hahn played up the potential benefits of the treatment, prompting him to issue a statement Monday calling the criticism “entirely justified.”
“What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” he said.
Hahn said last month that his agency would only greenlight a vaccine that is safe and at least 50 percent effective.
Operation Warp Speed, a federal effort, is aimed at delivering 300 million vaccine doses to Americans by January 2021.
Fauci is among the administration officials who said it may be possible to deliver a vaccine by early next year.
“To me, it’s absolutely paramount that you definitively show that a vaccine is safe and effective, both,” Fauci told Reuters. “We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective.”
