Vaccines for Millions Ready This Year: The Impossible Dream?

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The race is on to be the first developer of a coronavirus vaccine, with global drugmakers and the White House seeking to compress into just months a process that normally takes several years. Whether it can happen remains an enigma.

For the Trump administration, news of a successful vaccine could calm the virus’s toxic effects on the U.S. economy in the midst of an ongoing presidential campaign. Donald Trump’s goal with “Operation Warp Speed,” a covert push reported on this week, is for hundreds of millions of doses to be produced by year’s end.

“I’m not over-promising,” Trump said in a White House meeting with New Jersey Governor Phil Murphy on Thursday. “You know who’s in charge of it, honestly? I am.”

The White House initiative aims to compress research, testing and manufacturing of a vaccine by as much as eight months, pulling in health agencies, military resources and drugmakers. The plan, which could result in billions of dollars in government spending, hasn’t been rolled out in full.

The idea is that the government would bear some of the financial risk that would normally fall to individual drugmakers, according to people familiar with the plan. The administration would facilitate the running of multiple processes in parallel to build out manufacturing for vaccines, some of which could fail, said the people who asked not to be identified because the specifics aren’t yet public.

Mimic or Incorporate

But many parts of the Trump administration push appear to mimic, or incorporate, individual initiatives already underway by large drugmakers and others. And while the Trump plan involves U.S. drugmakers and assets, it isn’t reaching across borders for global assistance.

Johnson & Johnson, which has been working on its vaccine for months, has said it plans to produce 1 billion doses by the end of 2021, if it is successful in trials that kick off this September. And it’s not alone among drugmakers moving as quickly as they can. More than 100 experimental vaccines against the virus are in development. Those who can flex their resources muscle — like J&J, Pfizer Inc., Sanofi and Moderna Inc. — are already buying, building and scaling up manufacturing capacity, even before their vaccine candidates are evaluated by U.S. regulators. In some cases, production gears are already cranking.

Not all productions sites are created equal, however. Depending on the scientific approach taken, facilities must be fitted with different equipment. The speed in which they’re able to make the product can vary as well. And everything is contingent on the facilities surpassing the red-tape of regulatory requirements. While the U.S. Food and Drug Administration is likely to focus on expediting its review of clinical trial data during an emergency use approval process, the bottom line is that making a product that can be quickly deployed to millions of healthy individuals can be cumbersome.

New York-based Pfizer, which just dosed its first dozen patients with its experimental mRNA vaccine, said it will be ready to immunize patients with tens of millions doses this fall, should it get an emergency use authorization, and hundreds of millions of doses by early 2021. Pfizer is jointly developing the vaccine with BioNTech Se, a German biotechnology company.

Moderna, a leader among U.S. companies testing experimental coronavirus vaccines, said Friday htat it had entered a pact with Swiss company Lonza Group AG aimed at manufacturing 1 billion doses a year. The companies expect the first batches to be produced in the U.S. in July.

Trade-Offs

“I’m not certain we’ll have an approved vaccine by the end of the year, but depending on the actual manufacturing process, producing that scale of doses can be done,” said Nicolette Louissaint, executive director of the nonprofit Healthcare Ready, which facilitates public-private partnerships to protect the health-care supply chain.

There are big-time trade-offs the industry must make in order to mass-produce a Covid-19 vaccine, according to Louissaint, a former senior adviser to the State Department’s Special Coordinator for Ebola during the 2014 crisis.

“How do we maintain production for other products?” she said. “We have limited capacity, globally, so we’re going to have to acknowledge those trade-offs as we pivot to making hundreds of millions of doses.”

If the government or business community did it alone, it couldn’t be done, she added. “Meeting this timeline requires dual investment because of the sheer amount of risk, and the volume and scale that’s needed.”

While the Trump Administration promises to ramp up efforts among major drugmakers in the U.S., companies in other countries, and even Bill Gates, the Microsoft co-founder, are also pushing to get vaccines out quickly.

Two Candidates

French drugmaker Sanofi has two Covid-19 vaccine candidates in the works. One uses technology already employed in a flu vaccine, which could speed up both R&D and production. The company is using facilities in New York, Pennsylvania and Japan to that end, and it’s also turned to GlaxoSmithKline Plc for additional manufacturing power.

Together, they have enough existing capacity for as many as 600 million doses per year, Sanofi CEO Paul Hudson said on April 24. “For the record,” Hudson said, “we have 10,000 people producing over billion doses right now of our own vaccine portfolio.”

Sanofi’s other candidate with Translate Bio Inc. uses messenger RNA to prompt the body to make a key protein from the virus, creating an immune response. It could be produced at up to 350 million doses per year. Two shots on goal gives the French drugmaker better odds in the fight against Covid-19.

Even if Sanofi’s two assets prove successful, the company likely can’t serve global demand alone, said John Shiver, Sanofi’s senior vice president of global vaccine R&D, in an interview. “The call is big enough that we actually do need several vaccines to succeed” and move into mass-production, he said. “We need for more than one company to supply a vaccine.”

Processes in Parallel

The key to all of these efforts is pretty much the same: Launch several processes in parallel rather than in sequence, even at the risk that its candidate may not prove effective.

For J&J, which hasn’t yet put its vaccine into human trials, that means signing two deals to secure manufacturing capacity at facilities in Baltimore and Bloomington, Indiana. It’s begun preparing to produce the vaccine at one of its own sites in the Netherlands, and is looking for additional facilities across Europe and Asia. J&J CEO Alex Gorsky, like many others, said he’s committed to bringing the vaccine to the public on “a not-for-profit basis for emergency pandemic use.”

Not all Covid-19 vaccine candidates have the backing of the drug industry to make these risky manufacturing plays. But scientists working at smaller companies with no marketed products or at highly-accredited research labs without production infrastructure are scrambling to get it.

The University of Oxford’s Jenner Institute, for example, has turned to AstraZeneca Plc. The London-based drugmaker announced it has agreed to manufacture its vaccine, with a goal of 100 million doses before the end of the year. It’s one of the most ambitious near-term production goals that’s been set by a manufacturer.

Gates is also putting his resources toward manufacturing well before a proven vaccine is ready for the public. The billionaire has said the Bill & Melinda Gates Foundation will build new facilities for seven potential vaccines from the ground-up, despite the fact that it’s likely to only settle on two candidates.

“It will be a few billion dollars we’ll waste on manufacturing for the constructs that don’t get picked because something else is better,” Gates said on The Daily Show on April 2. “But a few billion in this situation we’re in, where there are trillions of dollars” being lost economically is worth it.

Through this kind of effort, Gates believes a vaccine could be ready in as fast as nine months — one of the most optimistic predictions to-date.

“We can save months,” Gates said, “and every month counts.”

— With assistance by Jennifer Jacobs

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