By Ciara Linnane, MarketWatch
The number of confirmed cases of the coronavirus that causes COVID-19 climbed above 27.3 million on Tuesday with the U.S. accounting for about a quarter of that total, as a group of nine drug makers pledged to “stand with science” in developing a vaccine.
The chief executives of nine drug companies that are working on vaccines — AstraZeneca PLC /zigman2/quotes/200304487/composite AZN +0.59% /zigman2/quotes/203048482/delayed UK:AZN +0.07% , BioNtech SE /zigman2/quotes/210293936/composite B -0.99% , GlaxoSmithKline PLC /zigman2/quotes/209463850/composite GSK -0.63% /zigman2/quotes/200381158/delayed UK:GSK -1.09% , Moderna Inc. /zigman2/quotes/205619834/composite MRNA +6.26% , Johnson & Johnson /zigman2/quotes/201724570/composite JNJ -0.40% , Merck & Co. Inc. /zigman2/quotes/209956077/composite MRK -1.55% , Novavax Inc. /zigman2/quotes/202614340/composite NVAX -2.12% and Sanofi SA /zigman2/quotes/206928357/delayed FR:SAN -1.13% /zigman2/quotes/201967021/composite SNY -0.54% — signed a pledge to follow the path toward approval required by a regulator like the U.S. Food and Drug Administration that involves Phase 3 clinical trials.
“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 CEOs wrote.
The move comes amid intensifying fears that the administration of President Donald Trump will attempt to rush out a vaccine before the Nov. 3 election. That comes after the head of the Centers for Disease Control and Prevention sent a letter to state governors in late August, urging them to have vaccine distribution centers ready by Nov. 1, just two days before the presidential election, and with Trump saying on Monday that a vaccine could arrive by a “very special date.”
Besides the logistical challenge of preparing centers at such short notice, experts fear that with clinical trials still recruiting participants, there will not be enough data by November to determine the efficacy or safety of a vaccine, and that a presidential pre-election push will imperil recruitment. Trump has at times appeared to tie his re-election chances to the arrival of a vaccine before the election and has accused the FDA of moving slowly to lengthen his odds against Democrat Joe Biden.
The CEOs titled the statement announcing their pledge: “Biopharma Leaders Unite to Stand with Science.”
The companies said they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”
Moncef Slaoui, a venture-capital investor and former GlaxoSmithKline PLC executive who heads up the government’s “Operation Warp Speed” program, told NPR last week that he cannot imagine trials producing data by the end of October.
“There is a very, very low chance that the trials that are running as we speak could read before the end of October, and therefore, there could be — if all other conditions required for an [EUA] are met — an approval,” he said. “I think it’s extremely unlikely but not impossible.”
Separately, Slaoui told Science that he would resign if he felt “undue” political pressure in the vaccine race.
In other news:
• Infectious-disease experts are concerned that the cold weather will lead to a surge in new coronavirus cases once winter begins, the Washington Post reported. Respiratory viruses typically start spreading a few weeks after schools reopen after the summer break, while the Labor Day holiday is expected to cause a spike in infections among people who gathered in large numbers. A model produced by the University of Washington’s Institute for Health Metrics and Evaluation that was published on Friday is forecasting that 410,000 Americans will have died by year-end under its “most-likely scenario,” the paper reported. That would be more than double the current death toll of 189,226, the biggest in the world.
• There was grim news for India on Monday, when it passed Brazil by case number. India now has more than 4.28 million confirmed coronavirus cases, and 72,775 people have died, the world’s third biggest death toll, according to numbers aggregated by Johns Hopkins University.
Lockdowns have been reimposed in the northern state of Punjab, but the measures are pushing people into poverty and adding to a long-running tragedy, that of farmer suicides, the New York Times reported. In 2019, 10,281 Indian farmers took their own lives, the paper reported, citing the National Crime Records Bureau. The number is expected to be understated as suicide is a crime in India.