Harvard scientists are developing a coronavirus vaccine specifically for those most vulnerable: the elderly
Various factors affect the effectiveness of a vaccine, including the age and sex of the person receiving it. Researchers at Boston Children's Hospital are working to develop an age-specific coronavirus vaccine to protect those most vulnerable: the elderly. They're testing different coronavirus vaccine formulations on human tissue outside of the body, which contains cells from people of different ages. Visit Business Insider's homepage for more stories.
More than 100 teams around the world are racing to develop a coronavirus vaccine. Dr. Ofer Levy and a group of Harvard Medical School researchers are among them, but the vaccine they're working on is a little different. It's specifically designed for those most vulnerable to the disease: the elderly. "Most vaccines are developed with a one-size-fits-all concept," Levy told Business Insider. "Academic centers and companies typically develop a vaccine assuming that you will respond to the vaccine the same way, whether you're a man or a woman, whether you're young or elderly, whether you live in the US or Africa, whether you give the vaccine in the summer or winter, whether you give it in the morning or the evening." But various factors can impact how much protection a vaccine confers, including age. Take the flu, for example, which is more deadly for older people with weaker immune systems. "Many elderly individuals, unfortunately, do not respond optimally to influenza vaccine," Levy said. "They should take it — it's safe and it has some effectiveness. But we wish it was more effective, because up to 30%, 40% of elderly individuals may be non-responders to the flu vaccine and that's because the immune system of the elderly weakens." Vaccine development is a long and expensive process, and that is all the more true for attempts to make targeted vaccines for specific groups. But Levy's lab is researching the concept by testing vaccine formulas on human tissue outside of the body, which is designed to model newborn, middle-aged, and elderly immune system responses. "In our minds, vaccines are not one-size-fits-all," Levy said. "They may be one-size-fits-none-particularly-well." As for a timeline, Levy said that a one-size-fits-all vaccine will become available before the one he wants to create. Several pharmaceutical and biotech companies have said they're aiming to have a shot ready for emergency use in the fall. "We're not going to be the first vaccine into trials," he said, but added, "we hope to have things that could go into humans, let's say, within a year or so." 'Modeling the human immune system outside the body' Levy works with the Precision Vaccines Program at Boston Children's Hospital, which is affiliated with the Harvard Medical School. His laboratory focuses on developing "next-generation" vaccines to protect specific populations. The lab uses a technology that builds human tissue outside of the body; it received a patent earlier this month. The researchers simulate age differences by collecting blood samples from people of all ages and adding their white blood cells to the tissue. They have already collected samples from elderly volunteers for their coronavirus vaccine research. The white blood cells recognize antigens like viruses and develop immune responses to them. Comparing this process across tissue samples enables the scientists to see how different immune systems respond to various vaccine formulations. That allows the lab to learn what might be most effective for whom before the clinical trial phase. "It's not going to be possible to do large, phase three, multi-thousand person studies of every single combination in every type of population," Levy said. "That's where modeling the human immune system outside the body could be key, because it may allow us to accelerate and de-risk vaccine development." A personalized medicine approach to vaccines
Before the coronavirus pandemic, Levy's lab was working on a vaccine for whooping cough that offered longer-lasting immunity and a vaccine for the respiratory syncytial virus, which is the number-one cause of infant hospitalization in the US. The researchers were also trying to develop an HIV vaccine that's more effective for newborns. "We anticipate that, in the future, there'll be different vaccine formulations for a baby, a man versus a woman, an elderly person," Levy said. "It's this whole notion of personalized medicine, but brought to vaccinology." After the coronavirus started spreading, the program switched its focus. "I was biking home from work, and there's a newspaper machine that dispenses the news in Chinese, and it had a headline, a very dramatic headline, big, bold letters, but I don't read Chinese," Levy said. "But it had the word SARS in it in English, and that caught my eye. And then, of course, it became more and more clear with the Wuhan outbreak, and so we said, 'Well, our entire program is really well positioned to help with this.'" Developing effective vaccines for the elderly Vaccines contain a weakened form of the antigen they're meant to protect the body against, so that the immune system can recognize the virus and neutralize it. Molecules called adjuvants can be added to a vaccine to improve the immune response it elicits. Levy offered four ways that pharmacological or immunological agents can help: They can convert an insufficient response into a more robust one; enhance the range of immune responses; make immunity last longer; or allow producers to include less of the antigen in each dose, thereby enabling them to make higher quantities of a vaccine more affordably. "We've screened hundreds and hundreds of thousands of molecules," Levy said. "We're screening them against elderly human cells, and you'll find different combinations of adjuvants are optimal in different age groups." The downside of adding adjuvants to a vaccine is that it makes the formulation more complicated. But Levy believes the benefits are worth it, and says the way his lab tests adjuvants in tissue minimizes risk.
In addition to the lab's own vaccine development, Levy added, companies and academic teams have been sending their coronavirus vaccine formulations for Levy's group to test. "We're natural partners for other groups because we have these unique systems to test vaccines outside the body, so everybody wants to send us their adjuvants, their formulations, to test, so we can compare, head-to-head," Levy said. He added that the lab has also ordered elderly mice to study, but said a vaccine "doesn't go into the mice until it first goes into a human system outside the body."Join the conversation about this story » NOW WATCH: Can you get the coronavirus twice?
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Leading US drugmakers will sign a pact to produce a safe coronavirus vaccine amid concerns about shots being rushed to market before the presidential election
Summary List Placement The race to develop a coronavirus vaccine has already shattered records. In March,...Summary List Placement The race to develop a coronavirus vaccine has already shattered records. In March, the biotechnology company Moderna entered its vaccine candidate in a clinical trial less than 70 days after the virus was sequenced, shaving a year off the development process. Since then, two US drug companies, Moderna and Pfizer, have published early data showing that their vaccines generated immune responses without causing serious side effects. That could put the companies on track to finish their human trials in October, under the most optimistic scenario. But scientists and public-health experts worry about the push to bring a vaccine to market before data clearly shows it's safe and effective. To assuage these concerns, Moderna and Pfizer — along with US pharmaceutical company Johnson & Johnson and French pharmaceutical company Sanofi — are preparing to release a joint statement that promises to put safety before speed. The statement could be released as early as next week, according to the Wall Street Journal, which obtained an early copy. In the draft, the companies pledge to only seek emergency FDA approval for their vaccine candidates after final human trials show "substantial evidence of safety and efficacy." A sentence from the draft reads: "We believe this pledge will help ensure public confidence in the COVID-19 vaccines that may ultimately be approved and adherence to the rigorous scientific and regulatory process by which they are evaluated." Most experts agree there's little hope of a coronavirus vaccine being ready before 2021. But President Donald Trump has suggested otherwise: On Friday, Trump said a coronavirus vaccine would probably be available for distribution next month, according to The Washington Post. Trump has previously said a vaccine may become available "right around" the presidential election on November 3. "I'm rushing it. I am. I'm pushing everybody," Trump told radio host Geraldo Rivera in an August 6 interview. The US Centers for Disease Control and Prevention is prepared for that scenario: The agency has asked public health officials in all 50 states to get ready for vaccine distribution by late October. CDC Director Robert Redfield said the goal was to be ahead of the game. The agency expects there to be one or more vaccines ready by November or December. Still, public-health experts fear that the Trump administration could rush the timeline before researchers know whether a vaccine produces adverse side effects. Some White House officials believe Trump's reelection prospects hinge on whether a vaccine comes to market, the Associated Press reported in July. "This timeline of the initial deployment at the end of October is deeply worrisome for the politicization of public health and the potential safety ramifications," Saskia Popescu, an epidemiologist at the University of Arizona, told The New York Times on Wednesday. "It's hard not to see this as a push for a pre-election vaccine." Under normal circumstances, vaccines take 10 years or more to develop and approve. The Trump administration's effort to accelerate and fund vaccine research, Operation Warp Speed, hopes to deliver 300 million doses of a safe, effective coronavirus vaccine by at least January 2021. The program is manufacturing six vaccine candidates in large quantities while clinical trials are still ongoing. "My concern is even with the name Operation Warp Speed, because it suggests that speed is the determining factor as opposed to science," Dr. Leana Wen, a public-health professor at George Washington University who previously served as Baltimore's Health Commissioner, previously told Business Insider. At an online press conference on Thursday, Dr. Jeanne Marrazzo, director of the University of Alabama at Birmingham's Division of Infectious Diseases, said it would take until at least early 2021 to know whether a vaccine was safe and effective. "People have been incredibly concerned about vaccine safety for decades and we've spent countless hours, countless press conferences, countless meetings, trying to assure them that we have done our absolute best to make sure that every vaccine we give is safe," Marrazzo said. "This is not that. This is exactly the opposite of that so it makes me very concerned."Join the conversation about this story » NOW WATCH: The White House has spent $12 billion on its Operation Warp Speed vaccine plan — but experts are worried about how the money's being used
Moderna's lead in the coronavirus vaccine race is slipping. Here's how pharma giants like Pfizer are threatening the biotech's frontrunner status. (MRNA, PFE)
Competitors are catching up to Moderna, which for months has been leading the race for a...Competitors are catching up to Moderna, which for months has been leading the race for a coronavirus vaccine. The New York pharma giant Pfizer on Wednesday released early human results for its vaccine candidate. Pfizer is using the same vaccine technology, called messenger RNA, as Moderna. Pfizer, a $190 billion drugmaker, is also planning to start late-stage efficacy trials this month, the same development timeline as Moderna. The stock market seemed to reflect these changing dynamics Wednesday. Pfizer and its German partner BioNTech saw their share prices increase by 5% and 7% respectively, while Moderna's stock dipped 6%. Visit Business Insider's homepage for more stories. Throughout the first months of the coronavirus outbreak, Moderna stood alone. From the beginning of the sprint to develop a vaccine, the upstart Massachusetts biotech was a leader. On January 23, it announced its plans to create a vaccine alongside US National Institutes of Health researchers. Moderna was the first company to start testing an experimental shot in humans in March and the first to detail human results a couple months later. It cemented its frontrunner status by building a vaccine in record time, using an unproven yet promising technology called messenger RNA. Investors pushed its stock to records. Despite having no federally approved drugs or vaccines, Moderna climbed to a $23 billion valuation, and its stock has tripled since the start of the year. Read more: The untold story of Moderna as the biotech's coronavirus vaccine faces a test that could make it one of the most consequential startups of all time But the landscape has changed dramatically six months into the outbreak. There are roughly 150 coronavirus vaccine programs, with 17 candidates in human testing, according to the World Health Organization. And Moderna isn't alone with its genetic platform. Four other programs already in human testing are also using mRNA vaccines. On Wednesday, Pfizer showed how intense the race for a vaccine has gotten, detailing early human results from its own vaccine candidate. The New York pharma giant announced its research plans the same week that Moderna dosed the first volunteers in March. But with the resources of a $190 billion pharmaceutical giant, Pfizer has caught up to Moderna. The stock market seemed to reflect these changing dynamics on Wednesday. Pfizer and BioNTech saw their share prices increase by 4% and 2.4% respectively, while Moderna's stock declined 5%. Pfizer and Moderna have equally fast development timelines for vaccines using the same technology Pfizer partnered with BioNTech, a German biotech specializing in mRNA, to develop a vaccine that uses the same technology as Moderna's. The timelines for the two vaccine programs are now basically the same. Both Pfizer and Moderna aim to start late-stage trials this month, testing the vaccines in thousands of volunteers to see whether they work. If they do, the companies have said their vaccines could be ready this fall for emergency use in limited quantities. Read more: A leading potential coronavirus vaccine just started human trials in the US. The top scientist at Pfizer told us it could be ready for emergency use this fall. In some ways, Pfizer is ahead of the buzzy biotech. Moderna gave a brief description of its data in May, opening it to criticism of "publication by press release." While CEO Stephane Bancel has said the data would soon be published by the NIH, that has yet to happen. Pfizer's release was accompanied by a scientific paper, albeit a version that has yet to be reviewed by other scientists or published in a journal. Given the limited data disclosed, Pfizer's vaccine could be "potentially more potent" than Moderna's vaccine candidate, SVB Leerink analyst Geoffrey Porges said in a Wednesday note to investors. He cautioned that it's difficult to make conclusions yet, given the preliminary nature of the early data. Jefferies analyst Michael Yee also said Pfizer's results "are consistent and at least as good (or higher)" than Moderna's description. Read more: Pfizer teamed up with a tiny biotech to make a coronavirus vaccine, and we just got our first look at some promising but early data To be clear, it's far from certain that either vaccine will work. These early-stage tests are designed to measure whether the vaccines are safe for people to take, and whether they generate a response from the body's immune system. Vaccines require massive trials to determine if they can actually prevent infections or disease. To be sure, company executives in the vaccine race have emphasized that more than one vaccine will be needed. Any successful effort is expected to face global demand that will outstrip supply. AstraZeneca, another pharma giant that dwarfs Moderna, is also working on a vaccine and aims to have one ready this fall for emergency use. Could there be a new frontrunner in the vaccine sprint? The next challenge facing Pfizer and Moderna is enrolling up to 30,000 people in massive clinical trials starting this month. To quickly sign up that many volunteers, the companies will need to work with dozens, if not hundreds, of trial sites around the world In that space, Pfizer seems to have an edge. As one of the largest vaccine makers in the world, carrying out the logistics of a large, global trial is nothing new for Pfizer. On a Wednesday call with investors, Pfizer's head of vaccine R&D, Kathrin Jansen, estimated it could take as little as four weeks to fully enroll a late-stage trial. Moderna, on the other hand, is going into uncharted waters. Since its founding in 2010, the company has yet to move any medicine into a Phase 3 study. Both companies are working with the US government as part of Operation Warp Speed, an initiative to have 300 million doses of a safe and effective vaccine by January 2021. It remains unclear how much support this program will bring to late-stage trials. Join the conversation about this story » NOW WATCH: Drugmakers are developing coronavirus vaccines in record time — but it will still be months before one is available