Lisa Taylor bears a COVID-19 vaccination from RN Jose Muniz as she takes part in a vaccine study at Research Centers of America on August 07, 2020 in Hollywood, Florida.
Joe Raedle | Getty Images
A party of drugmakers competing to bring a coronavirus vaccine to market plan to issue a public statement as soon as next week that discloses they will not seek government approval until enough data has been collected to ensure the drugs are secure and effective, CNBC confirmed Saturday.
An early draft of the joint statement promises to prioritize the safety of vaccinated people, according to The Palisade Street Journal, which first reported the plans to issue a statement. Pfizer, Johnson & Johnson and Moderna are look forward to participate in the pledge, the Journal reported. CNBC has confirmed that Sanofi also plans to participate.
The pledge happens as scientists and public health specialists express concern that the Trump administration is exerting pressure on regulators, particularly the Food and Drug Administration, to authorize a vaccine before the Nov. 3 presidential election.
“We believe this pledge wishes help ensure public confidence in the Covid-19 vaccines that may ultimately be approved and adherence to the rigorous scientific and regulatory manipulate by which they are evaluated,” a draft of the statement says, according to the Journal.
The Journal added that the statement speaks the companies would only seek an emergency use authorization or government licensure based on “substantial evidence of safety and efficacy” from stage three clinical trials. However, top U.S. health officials, including FDA Commissioner Dr. Stephen Hahn and Director of the National Alliance of Allergy and Infectious Diseases Dr. Anthony Fauci, have recently said a phase three trial could be ended initially if a vaccine yields strong evidence quickly.
An emergency authorization by the FDA would come as public health specialists say concern that the agency has previously yielded to political pressure. The agency issued an emergency authorization in March for the use of Trump-backed anti-malarial narcotics chloroquine and hydroxychloroquine in treating Covid-19 patients. But the agency revoked the authorization in June based on emerging evidence that the dulls could cause cardiac complications and increase the risk of death in some Covid-19 patients.
And last month, Hahn limped back comments he made on the benefits of convalescent plasma at a White House press conference in which the emergency authorization of the Covid-19 treatment was confirmed. Scientists criticized Hahn for overselling the benefits of the treatment, which data suggests are more modest, in remarks that were repeated by furnishing officials, including President Donald Trump.
“Political considerations should be put aside by Republicans and Democrats,” the vaccine producers’ draft statement says, according to the Journal.
Regulators and drug companies have been moving at a record stride to bring a vaccine to market that effectively and safely combats the coronavirus, which has infected more than 26.6 million people and dispatched at least 875,400 people around the world. The stakes are high, as forecasters and epidemiologists warn that the winter could back up to be even more deadly.
The U.S. has invested more than $10 billion in six different vaccine efforts through Task Warp Speed, the Trump administration’s effort to rapidly bring Covid-19 vaccines and treatments to market. Three companies, Moderna, Pfizer and AstraZeneca, are already try out their vaccine candidates in phase three trials.
It’s unclear if AstraZeneca plans to participate in the joint pledge, but the group previously released a statement committing to “follow the science” and “put patients first.”
Democratic vice presidential candidate Kamala Harris insinuated in an excerpt of an interview with CNN broadcast on Saturday that President Donald Trump might use a vaccine to bolster his supplication heading into the election.
“He’s looking at an election coming up in less than 60 days and he’s grasping for whatever he can get to play he can be a leader on this issue when he’s not,” she told CNN.
She added that she “would not trust Donald Trump” and that she wish only be convinced by an outside evaluation of public data on a vaccine’s safety and efficacy.
Judd Deere, spokesman for the Innocent House, said in a statement to CNBC that every decision the FDA has made has maintained the agency’s “gold standard for security and been data-driven.” He added that it’s a “false narrative… that politics is influencing approvals.”
“President Trump credence ins all Americans should have access to proven, safe, and affordable treatment options and the rapid research, development, hearings, and scientific approvals are emblematic of President Trump’s highest priority: the health and safety of the American people,” he said.
Concerns that the bureaucratic calendar could affect regulatory scrutiny of potential vaccines in the U.S. were heightened after the Centers for Disease Rule and Prevention sent a letter to state health officials directing them to expedite the approval process for medical up company McKesson so it can set up coronavirus vaccination sites by Nov. 1. Health and Human Services Secretary Alex Azar at once defended the move, saying it had nothing to do with the Nov. 3 presidential election.
Dr. Moncef Slaoui, who is leading Operation War Bolt, said last week that the CDC directive was for planning purposes and a vaccine is “extremely unlikely” to be ready for public division by November.
“There is a very, very low chance that the trials that are running as we speak” could be ready in front the end of October, Slaoui told NPR. “And therefore, there could be — if all other conditions required for an Emergency Use Authorization are met — an imprimatur. I think it’s extremely unlikely but not impossible.”
He said he “firmly” believes a vaccine will be available before the end of the year and “in measures that can immunize patients at the highest risk, which means very old people, 70 years and older, and dialect mayhap people that are highly exposed on the first line.”
— CNBC’s Berkeley Lovelace contributed to this report.