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3 vaccine executives say that after approval, distribution will be the main challenge

By adminvertexpublic / Published on Friday, 04 Dec 2020 04:35 AM / Comments Off on 3 vaccine executives say that after approval, distribution will be the main challenge / 94 views



The top executives of Pfizer, Moderna and Johnson & Johnson said in an NBC News interview that even after their companies developed potential Covid-19 vaccines at a breakneck pace, some of their biggest challenges still lie ahead, including quickly producing enough doses and ensuring fair distribution through the uneven U.S. health care system.

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

The executives — Gorsky, Pfizer CEO Albert Bourla and Moderna President 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 on the “Race for a Vaccine,” a network-wide, weeklong series airing across all programs and platforms, including “NBC Nightly News,” “TODAY,” “Dateline NBC,” MSNBC, NBCNews.com and NBC News NOW.

Gorsky said he was especially concerned about access to potential vaccines within Black and Hispanic communities, which not only have been hit especially hard by the coronavirus but in many cases also have been underserved by the health care system. He said governments and the drug companies would need to respond with massive distribution systems and education.

“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.

More than 274,000 people in the U.S. have died in the pandemic, which has shuttered businesses nationwide and put millions out of work. The winter months could be even more difficult, federal officials have warned.

Lester Holt interviews Pfizer CEO Albert Bourla, Moderna President Stephen Hoge and Johnson & Johnson CEO Alex Gorsky.Dateline

But the potential that Covid-19 vaccine shots will soon be available has spurred optimism, even before there’s a definite date for the first Americans who weren’t part of clinical trials to get them.

An advisory committee of the Food and Drug Administration is scheduled to meet Dec. 10 to consider whether to grant emergency use authorization to Pfizer for its vaccine candidate. The FDA itself would weigh in next. FDA scientists are also reviewing data about another vaccine candidate made by Moderna, and a third candidate from Johnson & Johnson is in a late-stage trial. Some states have said they also want to conduct their own reviews.

A member of an FDA advisory committee, 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: 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 move forward.”

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

Hoge said Moderna already faced a significant setback in September because of the lack of trust that some communities of color have in the health care system. He said the company realized that the people who had enrolled in its late-stage vaccine trial weren’t diverse enough to give Moderna the data it needed, so the company had to broaden its outreach.

“We said, ‘We’re going to take the time to do that now,'” Hoge said. “Because 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.

“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. But it was a hard decision and a lot of work,” he said.

The initial vaccine rollouts could be swift. If Pfizer receives approval, Bourla said, it has a logistics network in place, including specialized insulated boxes to keep doses cold “to send vaccines within 24 hours basically in any place in the U.S.”

Bourla said it’s still unknown whether people who’ve been vaccinated could still be carriers of the virus, able to transmit it to others.

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

Bourla said researchers and regulators ought to find a way to quickly vaccinate participants in clinical trials who received placebo doses, an idea Pfizer said it was exploring last month. “It is a moral and ethical dilemma and obligation, I think, that we have to these people,” he said.

The executives said many factors contributed to making the vaccine candidates possible on timelines never before imagined. In particular, they cited the willingness of governments to buy doses of unproven candidates, which sped manufacturing and freed the companies of some financial worry.

“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,” Hoge said. He said the standards of quality for the vaccine trials weren’t compromised.

The executives said they were kept in the dark as their companies collected data from the trials, in keeping with standard practice. Hoge said he didn’t sleep for the 24 hours from when he was told he would finally see the results to when he saw them.

“They notified us of the vaccine efficacy and the number of cases that had happened on placebo — and the very small number that had happened on the vaccine. And I don’t think I remember another thing for about 20 minutes,” Hoge said.

“From the moment of hearing that result, there was this overwhelming sense of relief for the past — for that 24 hours, for the past year, for the past 10 years of work,” he said.