With all eyes on the prize for a COVID-19 vaccine, researchers are setting aggressive timetables that might be too good to be true. Despite hopes that a shot could be available this year, Novartis' CEO is pumping the brakes––and given his past vaccines experience, he should know.
Novartis CEO Vas Narasimhan forecast Thursday that a potential COVID-19 vaccine could take until the end of 2021 to reach an approval, throwing some cold water on drugmakers with aggressive timelines for their candidates, Bloomberg reported.
In an opinion piece published in Germany's Heraldszeitung, Narasimhan said a vaccine would be "the ultimate way to deal with this pandemic," Bloomberg reported, and would take anywhere from "one and a half to two years."
Narasimhan's take comports with the pharmaceutical industry's consensus view that a COVID-19 vaccine, which must pass human trials and prove both safety and efficacy, will likely take time to succeed despite hope that a shot might be available by year's end.
For instance, researchers at Oxford University, which has partnered with British drugmaker AstraZeneca to commercialize a possible vaccine, said it could conclude human testing by the fall––putting its candidate on a rapid pace for emergency authorization by the end of the year.
President Donald J. Trump has repeatedly expressed hopes that a vaccine may be on the near horizon, tweeting Thursday that "vaccine work is looking VERY promising, before end of year."
Good numbers coming out of States that are opening. America is getting its life back! Vaccine work is looking VERY promising, before end of year. Likewise, other solutions!— Donald J. Trump (@realDonaldTrump) May 14, 2020
Of course, Narasimhan, Novartis' former head of North American vaccines, is uniquely suited to provide a timeline for a vaccine, having previously spearheaded the drugmaker's response to the 2009 H1N1 pandemic.
Novartis at the time was the largest producer of H1N1 vaccines in the world and still lagged behind the most aggressive timelines for a vaccine. Novartis later offloaded its vaccines unit in a 2015 asset swap with GlaxoSmithKline.
Ahead of approvals—and even ahead of definitive data—drugmakers across the board are boosting manufacturing capacity for their own vaccine candidates as worry continues to grow about the industry's ability to supply the billions of doses needed.
Moderna CEO Stephane Bancel, whose company is pursuing an mRNA vaccine for COVID-19, told a CNBC virtual conference he is rooting for “three, four, five vaccines” against COVID-19 to succeed, “because no manufacturer can make enough doses for the planet.”
Moderna, for its part, agreed to a 10-year supply partnership with Lonza aiming to produce up to 1 billion vaccine doses per year. Still, with a global population of more than 7.6 billion, there likely won’t be enough vaccine doses to reach herd immunity for “several years,” the Washington Post reported. That’s why experts are hoping multiple vaccines show they can work.
The helmsman at Regeneron––a drugmaker, like Novartis, that isn't pursuing a COVID-19 vaccine––also cast doubt earlier this week on whether the pharma supply chain could produce enough potential vaccines or therapies to keep up with demand.
CEO Len Schleifer called manufacturing capacity "limited' in an interview with CNN, a troubling assessment of the industry's production capabilities as dozens of companies seek to answer the novel coronavirus pandemic.
However, drugmakers are attempting to rise to the challenge with expansive manufacturing deals aimed at boosting production into hyperdrive.
Pfizer, which is developing a candidate with partner BioNTech, said Monday that it was considering outsourcing production of some its drug portfolio to make way for a massive COVID-19 vaccine effort in the coming months.The drugmaker will lean on its 200-strong network of contractors as part of a plan to "build a robust U.S.-based supply chain as well as one based in Europe," a Pfizer spokesperson said.
Johnson & Johnson, meanwhile, struck multiple manufacturing deals to hit its own billion-dose goal, including with Emergent BioSolutions and Catalent. AstraZeneca, in parallel, has signed on to produce and distribute vaccines for the University of Oxford's promising program, which is speeding ahead.