The CEOs of nine leading developers of vaccine candidates against COVID-19 today signed a statement pledging “a united commitment to uphold the integrity of the scientific process” by pursuing approvals or emergency use authorizations (EUAs) only for vaccines that pass muster in Phase III trials by proving safety and effectiveness.
The CEOs’ statement comes as their companies race to bring the therapeutics to market, and as President Donald Trump said Friday that the U.S. “remain[s] on track to deliver a vaccine before the end of the year and maybe even before November 1st.”
“We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” according to the statement, signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline (GSK), Johnson & Johnson (J&J), Merck & Co., Moderna, Novavax, Pfizer, and Sanofi.
The CEOs pledged to “always make the safety and well-being of vaccinated individuals our top priority,” as well as:
- Continue adhering to “high scientific and ethical standards” in the conduct of clinical trials and the rigor of manufacturing processes.
- Submit their vaccine candidates for approval or EUA only after they show safety and efficacy through a Phase III clinical study “that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”
- Ensure a sufficient supply and range of vaccine options, including those suitable for global access.
“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” the statement added.
That confidence appears to be shaky, according to one survey made public last week. A USA TODAY/Suffolk Poll taken August 28-31 and released Friday showed that of 1,000 respondents identified as voters, 67% would either not take the vaccine until others have tried it (44%) or not take it at all (23%). The poll surveyed registered voters by cellphone and landline and has a margin of error of plus or minus 3.1 percentage points.
The CEO statement is designed to position the biopharmas as resisting pressure for election-timed approvals or EUAs. At a press conference Friday, Trump not only said his administration was on track to deliver a COVID-19 vaccine before year’s end, possibly before November 1, but added: “We think we can probably have it sometime during the month of October.”
Playing into forecasts
Some of those companies whose CEOs signed the statement have played into those optimistic forecasts by announcing timeframes for releases of Phase III data that fall before election day, or soon after.
Pfizer and BioNTech, for example, have said that if their up-to-30,000 patient Phase II/III trial succeeds for BNT162b2, the lead candidate of their BNT162 program, they expect to be ready to seek an EUA or other regulatory approval as early as October. Upon such authorization or approval, the companies plan to supply up to 100 million doses by the end of this year, and approximately 1.3 billion doses by the end of 2021.
Moderna CEO Stéphane Bancel told CNBC’s Squawk Box that results from the approximately 30,000-patient Phase III COVE trial (NCT04470427), evaluating the company’s vaccine candidate mRNA-1273 and launched in July, could come as soon as October in a “really optimistic” scenario.
However, AstraZeneca said only that results are expected “later this year” from Phase III trials assessing AZD1222, the vaccine it is developing with the University of Oxford and a spinout company, in up to 50,000 patients globally—including a 30,000-patient U.S. trial (NCT04516746) whose estimated primary completion date is December 1.
J&J’s Janssen Pharmaceutical Cos. has set March 10, 2023, as the estimated primary completion date for its planned up-to-60,000 patient Phase III trial of Ad26.COV2.S titled ENSEMBLE (NCT04505722)—though preliminary data will be available much sooner, a Janssen spokesperson told The Wall Street Journal.
All five vaccine candidates are “Front Runner” candidates among the nearly 300 COVID-19 therapeutics included in GEN’s updated “COVID-19 DRUG & VACCINE CANDIDATE TRACKER.” The five are among 34 vaccine candidates that are in clinical trials–a subset of the 178 vaccines in development worldwide by companies, academic institutions, and independent research institutions as of today, as of the World Health Organization.
After mentioning J&J, Moderna, and Pfizer as three examples of “great companies” in late-stage clinical development of COVID-19 vaccines, Trump added at his press conference: “I think you’re going to see results that are shockingly good.”
FDA Commissioner Stephen M. Hahn, MD, told the Financial Times that his agency was prepared to grant an EUA allowing use by subgroups of patients of at least one COVID-19 vaccine candidate before the conclusion of a Phase III trial, as long as the FDA concluded that the benefits of a vaccine outweighed its risks.
Hahn insisted an FDA decision would not be rushed to improve Trump’s prospects for re-election on November 3—“This is going to be a science, medicine, data decision. This is not going to be a political decision”—though Trump tweeted August 22 that FDA career officials he has labeled as “Deep State, or whoever” were attempting to delay decisions on COVID-19 vaccines until after Election Day: “Must focus on speed, and saving lives!”
In a letter dated August 27, Robert R. Redfield, MD, director of the U.S. Centers for Disease Control and Prevention, told governors that their states will receive applications for permits to distribute vaccines at state and local health departments and hospitals from McKesson under a contract with CDC.
“CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020,” Redfield urged.
Moncef Slaoui, PhD, chief scientific adviser to Operation Warp Speed—the Trump administration’s program committing the nation to deliver 300 million doses of a COVID-19 vaccine by January 2021—defended the heads-up to states in an interview with NPR. Slaoui, a former head of pharma R&D and chairman of vaccines at GSK, asserted that an EUA before the end of October was “extremely unlikely but not impossible, and therefore, it’s the right thing to do, to be prepared in case.”
Anthony S. Fauci, MD, director of the NIH’s National Institute of Allergy and Infectious Disease (NIAID), has been more cautious about the potential timing of a COVID-19 vaccine, saying that talk of its availability by late October or November were unlikely, but not impossible, “guesstimates,” telling CNN: “Most of us project that that’s going to be by November and December, by the end of this year.”