3 vaccine managers say after approval distribution will be the biggest challenge



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Executives at Pfizer, Moderna, and Johnson & Johnson said in an interview with NBC News that even after their companies developed potential Covid-19 vaccines at a breakneck pace, some of their biggest challenges remain, including the rapid production of sufficient doses and the guarantee of equity. distribution through the uneven US health care system.

“We’ve never done anything like this,” Johnson & Johnson CEO Alex Gorsky said of the logistics for reaching billions of people with potential vaccines.

The executives – Gorsky, Pfizer CEO Albert Bourla and Moderna Chairman Stephen Hoge – spoke in an exclusive joint interview with NBC News’ Lester Holt. The interview is scheduled to air Thursday on “Dateline NBC” at 10 p.m. ET.

This report is part of NBC News’ in-depth coverage of “Race for a Vaccine,” a week-long network-wide series on all programs and platforms, including “NBC Nightly News,” “TODAY,” “Dateline NBC,” MSNBC, NBCNews.com and NBC News NOW.

Gorsky said he was particularly concerned about access to potential vaccines among black and Hispanic communities, which not only have been particularly affected by the coronavirus, but in many cases have also been underserved by the system. health. He said governments and pharmaceutical companies should respond with massive distribution systems and education.

“How do we make sure we can get the distribution [and] administration safely, efficiently, and logistics to try to reach hundreds of millions, not to mention billions, of people around the world? Gorsky asked.

More than 274,000 people in the United States have died in the pandemic, which has closed businesses across the country and put millions of people out of work. The winter months could be even more difficult, federal officials have warned.

Image: Lester Holt interviews executives (Dateline)
Image: Lester Holt interviews executives (Dateline)

But the potential for Covid-19 vaccines to be available soon has fueled optimism, even before there was a specific date for the first Americans who were not in clinical trials to obtain them.

A Food and Drug Administration advisory committee is set to meet on December 10 to consider whether to grant emergency use authorization to Pfizer for its vaccine candidate. The FDA itself would then weigh in. FDA scientists are also reviewing data on another vaccine candidate made by Moderna, and a third candidate from Johnson & Johnson is in an advanced stage trial. Some states have said they want to conduct their own reviews as well.

A member of an FDA advisory board, Dr Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said in a separate interview, “The standard we’re going to hold this to is this: Would I give this vaccine to myself or my own family? And if the answer to that question is “I’m not sure,” then we’re not going to go ahead. “

The UK officially approved the vaccine from Pfizer and its partner BioNTech on Wednesday, becoming the first country to have done so.

Hoge said Moderna had already suffered a major setback in September due to the lack of trust some communities of color have in the healthcare system. He said the company realized that the people who signed up for its advanced stage vaccine trial were not diverse enough to give Moderna the data it needed, so the company needed to expand its reach. .

“We said, ‘We’re going to take the time to do it now,’” Hoge said. “Because it is absolutely essential that this trial provides data that gives confidence to all of these communities, especially those disproportionately affected by Covid, and ensures that they can have confidence that the vaccine is working. also for them.

“Ultimately, we were able to work with investigators to build that confidence and recruit the trial over the next six to eight weeks. But it was a difficult decision and a lot of work,” he said.

The first vaccine deployments could be rapid. If Pfizer receives approval, Bourla said, it has set up a logistics network, including specialized insulated boxes to keep doses cold “to send vaccines within 24 hours to virtually anywhere in the United States.”

Bourla said it is still unclear whether people who have been vaccinated might still be carriers of the virus, able to pass it on to others.

“I think this is something that needs to be looked at. We’re not sure at the moment,” he said.

Bourla said researchers and regulators should find a way to quickly vaccinate clinical trial participants who received doses of placebo, an idea Pfizer said it was exploring last month. “It’s a moral and ethical dilemma and an obligation, I think, that we owe to these people,” he said.

Executives said many factors helped make vaccine candidates possible in times never imagined before. In particular, they cited governments’ willingness to buy doses of unproven candidates, which has sped up manufacturing and freed companies from some financial worries.

“What is really the ingredient that has been pulled over the past year is some of the financial and commercial prudence that normally slows drug development,” Hoge said. He said the quality standards of vaccine trials were not compromised.

Executives said they were kept in the dark as their companies collected trial data, in line with standard practice. Hoge said he had not slept for the 24 hours between when he was told he would finally see the results and when he saw them.

“They informed us about the effectiveness of the vaccine and how many cases have happened with placebo – and the very small number of cases with the vaccine. And I don’t think I remember anything else for about 20 minutes,” a Hoge said.

“From the moment I heard this result, there was this overwhelming sense of relief for the past – for those 24 hours, for the past year, for the last 10 years of work,” he said. declared.

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