Pfizer, Moderna and J&J execs say an FDA vaccine go-ahead is far from the finish line: NBC

A triumvirate of top vaccine execs say snaring a COVID-19 shot approval is really just the beginning. Next, Pfizer, Moderna and Johnson & Johnson face the monumental tasks of scaling up manufacturing to quickly produce doses and locking down equitable access across the U.S.’ spotty healthcare system.

“We have never done anything like this,” Johnson & Johnson CEO Alex Gorsky told NBC News of the road ahead, in a joint interview alongside Pfizer chief Albert Bourla and Moderna President Stephen Hogue.

Of particular concern, Gorsky said? Access to an authorized vaccine in Black and Hispanic communities. The COVID-19 pandemic has hit those groups especially hard in the U.S., and that fact, coupled with inequities that have long plagued the domestic healthcare system, puts the onus on governments and drugmakers to respond with massive distribution systems and better education, Gorsky said.

"How do we actually make sure that we can get distribution [and] administration safely, effectively, and do the logistics of trying to reach hundreds of millions, let alone billions, of people around the world?" Gorsky asked.

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Diversity and trust in the healthcare system among communities of color has dominated Moderna’s attention in recent months, too, Hogue said. In September, the company concluded that enrollment in its late-stage vaccine trial lacked the diversity needed to show whether its shot was effective across a wide range of people—prompting efforts to broaden recruitment.

“[It's] absolutely essential that this trial provide data that provides confidence to all of those communities, particularly those that are disproportionately impacted by Covid, and make sure they can have confidence that the vaccine works for them, as well,” Hogue told the news outlet.

“In the end, we were able to work with the investigators to build that trust and recruit the trial over the subsequent six to eight weeks,” he said.

As for Pfizer, the company is grappling with the “ethical dilemma and obligation” of how to quickly get vaccines to people who received placebo in the drugmaker’s phase 3 trial, CEO Albert Bourla said. 

Asked whether Pfizer’s mRNA vaccine, developed with German biotech BioNTech, could stop individuals from spreading the virus to others, Bourla admitted the company wasn’t yet sure.

“I think that’s something that needs to be examined. We are not certain about that right now,” he said.

The trio of execs all agreed on one thing: The unprecedented speed at which Moderna, Pfizer and Johnson & Johnson developed their shots would not have been possible without the willingness of governments to invest in unproven products, which hastened manufacturing work and took some of the financial risk off the companies.

"What's really the ingredient that's been taken out over the course of the past year is some of the financial and business caution that normally slows the development of drugs," Hogue said, adding that clinical trial standards hadn’t been compromised in the push for speed.

Pfizer in July bagged a 100 million-dose order from the U.S. for a whopping $1.95 billion—and just last month picked up a distribution deal with the European Union to supply upward of 300 million doses at an undisclosed price.

Moderna has itself received just under $1 billion in funding from the Biomedical Advanced Research and Development Authority (BARDA) and committed to deliver 100 million doses to the U.S. in a deal worth up to $1.525 billion. J&J, for its part, also has a $456 million deal with BARDA, and has pledged to scale up manufacturing alongside R&D.

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Meanwhile, a U.S. rollout for one or more of the companies’ trio of vaccine hopefuls is within reach. Pfizer and Moderna have both filed their shots for potential emergency use authorizations with the FDA. Pfizer’s candidate will go before the FDA’s independent vaccines advisory committee and the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP) on Dec. 10, with Moderna’s mRNA prospect due for a review on Dec. 17, Moncef Slaoui, head of the government’s Operation Warp Speed vaccine program, said recently.

The goal, Slaoui said at the time, is to ship vaccines to distributors within 24 hours of authorization and potentially start getting the shots into patients’ arms within two days of the advisory panels’ decisions.

Pfizer, for its part, relying on its own just-in-time delivery system rather than the U.S.’ chosen distributor, McKesson, plans to start shipping doses “within hours” of a positive phase 3 decision, Bourla said in late November.

One such decision came this week when Pfizer and BioNTech’s BNT162b2 became the first COVID-19 vaccine cleared in the Western world following an emergency use authorization in the U.K. The first doses would be delivered immediately, the companies said, while a spokesperson at the U.K.’s Department of Health and Social Care said the vaccine would be made available across the country starting next week.

Meanwhile, Pfizer is open to enlisting other drugmakers to expand production, Bourla told Sky News in November. He said it would be “very challenging” to transfer the company’s tech, but added that Pfizer will “explore any possible avenue.”