Moncef Slaoui, chief advisor to Operation Warp Speed (OWS), the public-private partnership to hurry along a vaccine for COVID-19, cited tough going in the early days of development, as researchers met “a real challenge to engage the population.” During a panel discussion at the virtual 39th J.P. Morgan Healthcare Conference, he pointed to “a double-edged sword, to talk about what a vaccine can do, when we don’t know – and then once you know, you’re going to have to change your message. For quite a period of time, it was very difficult to have a concrete conversation that is relevant to people [who could] understand it, feel it and sense it.” The situation eased “once we had data on efficacy and safety, and once discussions happened at the FDA.” Hurdles remain, with some of the public still skeptical, but the picture has grown brighter.
Stephane Bancel, CEO of Cambridge, Mass.-based Moderna Inc., which designed one of the vaccines, also spoke. “Our thesis as a company is that SARS-CoV-2 is not going away,” he said. “We are going to live with this virus, we think, forever.” In the months ahead, officials must “stay really close to the mutations and to be able to very quickly find a regulatory pathway to evolve the product.” Regarding durability of the vaccine, “we just don’t have enough data,” he said, but findings continue to accumulate. “The U.S. will probably be one of the first countries of size to get its population protected,” he said. “Europe is going to be much later. I would not be surprised if it takes Europe potentially until the end of the year to get good immunization” across the territory.
“The nightmare scenario that was in the media in the spring that the vaccine might not even work is off the table,” Bancel said. Current questions involve frequency of vaccinations – whether one shot might eventually be enough – and the strains against which to protect people. Karen Lynch, vice president of CVS Health and president of Aetna, stressed the need for vigilance as a society with regard to mask wearing, hand washing and social distancing. “We’re in the heat of it right now,” she said. “My hope is that we can at least slow the pace.” Brian Tyler, CEO of Irving, Texas-based McKesson Corp., said he was “incredibly encouraged by what the industry has accomplished in a relatively short period of time,” but “I don’t want us to get overconfident in the science and let go of those social behaviors.”
‘We cannot forget’
Angela Hwang, group president of Pfizer Biopharmaceuticals, noted that the virus is plainly mutating, but “whether it’s changing a little or a lot, that is something we’re anticipating, so we may be in a place where we need a new vaccine.” At the moment, her firm is “bullish about what our vaccine is going to be able to do,” in terms of tackling variants, although this could change. “That’s where the beauty of mRNA technology comes in,” she said. “With the sequence, we’re going to be able to make a vaccine in very short order, as little as six weeks.” Pfizer, which developed its vaccine in partnership with Mainz, Germany-based Biontech SE, is satisfied with “the data that we have now, in terms of where we are with our phase III,” but the trial’s extension, which follows the patients for another two years, will be crucial in understanding the course of the disease. “What’s clear is that [the pandemic] won’t be the crisis that we are in today forever,” she said, calling for “vigorous surveillance and response” as COVID-19 evolves. “We see this as a durable business.”
Meanwhile, OWS’s Slaoui said, manufacturers need to streamline and optimize the supply chain for existing vaccines even as drug companies achieve “more variety of platform technologies underpinning” new ones. A one-dose fix will be important, especially in the context of a pandemic. “It’s a development that could take place, frankly, with the current mRNA vaccines, given the performance observed over a short period of time with one dose,” he said, also mentioning New Brunswick, N.J.-based Johnson & Johnson’s work on a single-shot vaccine. “What people need to realize is that in real life, a very large percentage of people immunized with the first dose will not get their second dose, for various reasons,” he said. “Maybe at the height of the pandemic, this will not be so,” but they are likely to slack off later.
As the panel concluded, Slaoui offered an upbeat observation. “I want to remind us that SARS-CoV-2 is only one of the very many deadly viruses” floating around, and without vaccines “we would be living all our lives in a confined environment, much more than we have experienced over the last 11 months.” As COVID-19 vaccines are used globally, “the circulation of this virus, the intensity of this mission, will by definition decrease.” He noted that with respiratory syncytial virus (RSV) as with COVID-19, gradual exposure from a young age can build immunity without much harm. “Once you’re primed, usually your protection from the virus will last your life, until you become frail or co-morbidities interfere with your immune system,” he said. “I do think that we will get to that stage with this virus – thanks to the vaccination, we will get there quickly,” maybe in two or three years. The World Health Organization, he said, offers “a very long list of potential pandemic agents” of which to be wary. “We need to be even faster and better equipped for the next one,” he said. “We forgot with Ebola, we forgot with Zika. We cannot forget. We should be ready.”