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What will it take to develop a Covid-19 vaccine?

The most important vaccination in recent history is progressing in record time. Here’s what you missed in this week’s episode of The Road to a Vaccine.

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A new live weekly show called The Road to a Vaccine, created by Johnson & Johnson, explores the Covid-19 crisis and the global scientific community’s efforts to develop a working vaccination in record time. In this weekly eight-part video series, journalist Lisa Ling searches for answers from leading scientists, researchers, and healthcare professionals involved in the journey to a coronavirus vaccine, asking the questions on everyone’s minds.

Read on to catch up on the latest episodes, and tune in live on Tuesday, July 7 for the premiere of season two of The Road to a Vaccine; until then, find replays of season one at JNJ.com/roadtoavaccine.


Episode 8: The unequal battle against Covid-19

As the global community enters another month of uncertainty in the pandemic, the world continues to seek answers. In episode eight of The Road to a Vaccine, host and journalist Lisa Ling wrapped season one with a series of interviews around the current state of the pandemic, including perspectives from a global humanitarian relief expert and two world-renowned virus hunters.

Rt Hon. David Miliband, former foreign secretary of the UK and currently president and CEO of the International Rescue Committee (IRC), has seen the effects of Covid-19 in developing countries. Miliband lent his perspective on the worldwide experience with the virus, as the IRC estimates the world is at risk for up to 1 billion coronavirus cases and 1 ½ to 3 million deaths in fragile countries where the underlying healthcare infrastructure is very weak.

“Our great fear is that the disease is marching,” Miliband said. “First of all, from China to Europe and from Europe to the U.S. then from the U.S. down to Latin America, where we’re seeing the most exponential growth at the moment.” A second wave of Covid-19 cases is possible without certain preemptive measures and collaboration. “I’m afraid at the moment, the global response has been utterly feeble,” Miliband said.

How exactly does Miliband imagine a better global response? To start, increased testing. Then there’s the opportunity of increasing the amount of community health workers, who Miliband says are “the future of healthcare” in developing countries. Miliband and his teams work together to train community members in Yemen, Nigeria, Kenya, and other countries to act in place of doctors. “There’s enormous scope for ordinary people who are not trained as doctors and nurses, but can be trained to do basic tasks, diagnosis, and provision,” he said.

Even with these actions, the developing world remains at risk during the pandemic. The IRC works in countries where the underlying health conditions of the populations are very weak, in addition to their health care systems. Just look at Yemen, with only four ventilators to serve a population of 18 million who are dependent on humanitarian aid. “It’s the holes in the global safety net that imperil lives and livelihoods,” Miliband said. “Just as within the United States, it’s holes in the domestic safety net.”

First-world countries are not immune to these systematic weaknesses. The U.S. has acutely felt the effects of a failing system, especially over the last several weeks. Dr. Cato T. Laurencin returned to The Road to a Vaccine to provide his perspective on another crisis plaguing underrepresented communities in America: the disease of racism. “In many ways, blacks in America are experiencing a double pandemic,” he said. The recent and ongoing events of police brutality, violence and systemic racism, Laurencin said, “is an American problem that has to be tackled by all.”

In episode three of the series (recap below), Laurencin elaborated on the disparity of Covid-19 care among communities of color. If a second wave of Covid-19 is on the horizon, it is up to the country as a whole to protect minority groups from unequal provision and treatment. In addition to better testing and tracer technology, “we have to have appropriate medical care,” Laurencin said. That means early medical intervention in black and brown communities, better access to healthcare, and training to prevent unconscious bias in physicians.

“Racism and discrimination are at the root and at the heart of all the [issues] we’re seeing,” he said. “And so I hope that Americans — not just black Americans, but all Americans — now stop and say ‘enough is enough.’ We have to make the types of changes that will make this country better.”

People have the power to make change, and in the battle against Covid-19, collaboration could save populations. Two scientists and virus hunters in particular know this all too well. Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels and Dr. Peter Piot, director of the London School of Hygiene & Tropical Medicine and a Handa Professor of Global Health, have been diligent in their work fighting Covid-19, among other viruses. Their working relationship has strengthened over many years, beginning when they met as student and professor. Today, they are working together toward a vaccine for Covid-19 while Piot confronts his personal struggle with the virus.

“The irony is that, after having tried to make the life of viruses as miserable as possible for them for decades now, the virus got me,” Piot told Ling. He warned of the complexities of the virus, including the fact that some individuals are asymptomatic and therefore can spread Covid-19 without showing any symptoms. “It’s a big lesson for everybody,” Stoffels added. “Don’t take this lightly. … This is not a simple disease and we have to get through this before we can get back to full comfort and normal living again.”

Getting through the pandemic could very well mean navigating additional outbreaks. “There will be some more waves,” Piot cautioned. “But let’s make sure it kills far fewer people than now. That’s why the development of a vaccine is such an emergency.”

The global community is working toward a Covid-19 vaccine at a record pace, and much is still unknown. Head to JNJ.com/roadtoavaccine to watch all eight episodes of season one of The Road to a Vaccine, and tune in for season two premiering July 7th.


Episode 7: Preparing for a new “normal”

Summer is officially on the horizon — and with it, the natural desire to socialize. “Normalcy” might feel like a thing of the past, but can the world realistically return to a version of everyday living in the face of Covid-19? On episode seven of The Road to a Vaccine, host and journalist Lisa Ling interviewed experts on how to safely reopen the United States and what recent vaccination progress could mean for a new “normal.”

With parts of the U.S. already opening their doors, the question is now how to do it safely. Ling spoke to Dr. Mark McClellan, director of the Margolis Center for Health Policy at Duke University, to offer his insight on the process. “We can reopen, but we have to take the pandemic very seriously,” said McClellan. “The rate of transmission of this virus is much higher than a typical flu.” And it is not only the frequency of spread that has experts concerned about reopening. The fact that a patient with Covid-19 is contagious without showing symptoms is a warning in itself. “Even if you’re not worried about protecting yourself, what you do has a big impact on all of those around you,” McClellan said.

Despite the progress that’s been made in flattening the curve so far, it’s possible that reopening the country could cause a backslide. McClellan warned of the potential resurgence of cases, stating that a country-wide reopening should focus on awareness of three key factors:

Proximity: Keeping people a safe distance from each other is crucial.

Time: People spending shorter durations in one place is better than longer durations.

Type of activity: Avoiding longer activities that make it harder for people to maintain safe behavior

“Now we’re moving into [a new normal] — not going back to normal, but more limited versions [of normal],” McClellan said. “That means businesses need to do things differently: more space between individuals, lots more people continuing to work from home. For schools, [it’s] maybe shifts with fewer students in the classroom.” Some businesses or activities, he said, aren’t ready to reopen at all now — like “super-spreader” events, where the spread of a virus can happen quickly. That would include sporting events, concerts, parades, and other gatherings packed with people.

Reopening any part of the world also will require a level of global preparedness. Dr. Jonathan Quick M.D., MPH, who works as managing director of pandemic response, preparedness and prevention at The Rockefeller Foundation, has spent his career working to prevent global epidemics. “There’s some magical thinking that because we stayed indoors for three months, the virus has changed somehow: It hasn’t,” Quick cautioned. “The virus is exactly the same virus as it was in January ... in terms of its contagiousness and its deadliness.” With the majority of the country yet to be infected, most individuals are still vulnerable.

“It will be a long time before we get back to something like normal, but some things probably won’t go back,” Quick said. “We’re going to be cautious about touching, hand-shaking. Some of that may stay with us for a while.”

While communities begin adjusting to new day-to-day changes, scientists around the world are hard at work in the labs. New developments toward a Covid-19 vaccine are giving hope to the idea of returning to a new normal more quickly. Johnson & Johnson’s Dr. Paul Stoffels, who also joined this week’s episode live from the vaccine development lab in Beerse, Belgium, oversees the team working around the clock to develop a Covid-19 vaccine. In recent tests, the team has found that one month after an initial infection, they cannot re-infect animals that have already recovered from the Covid-19 virus. “Most likely, if you get infected, there is a way that you can be protected for longer,” Stoffels said. Although animal testing cannot provide concrete evidence for human reaction, he said, it can be used to predict what will happen in people.

Despite a seemingly unpredictable future for the general public, there are many optimistic predictions within the scientific community. Stoffels and his team are working toward large-scale clinical trials of a Covid-19 vaccine, where they will need to test 30,000 to 100,000 people in a region with high transmission. “The preparation to do clinical trials ... is huge work,” Stoffels explained. “We still predict that by the end of the year, or early next year, we’ll have efficacy data hopefully proving that [the vaccine candidate] works. We’re looking forward to a great year of multiple steps that we need to take.” The best news of all? “So far, no hiccups,” he reassured viewers.

Watch the full episode to learn more about the scientific progress toward a Covid-19 vaccine, as well as one artist’s mural dedicated to medical workers on the frontlines.


Episode 6: How is a vaccine transported safely — and fairly — around the world?

What does it take for a vaccine — as many as 1 billion doses — to be distributed around the globe? That was the key question on episode six of The Road to a Vaccine, during which host and journalist Lisa Ling interviewed experts on the global collaboration it will take to achieve this ambitious goal.

As Covid-19 has spread across the globe, it has become obvious that certain groups are more at risk than others, like those in underdeveloped countries and with underlying health conditions. This was a key topic for Jane Halton, chair of the Coalition for Epidemic Preparedness Innovations (CEPI), who believes a vaccine must be distributed in an equitable manner. In fact, her focus is to distribute to the most vulnerable populations in each country first. “What we don’t want is a vaccine nationalism, which sees one country or one geography preferenced if and when there is a vaccine produced.”

Protecting these vulnerable populations is a global responsibility. Halton believes Covid-19 will remain a threat until the world has mastered two things: effective treatments and changes in behavior. “I think the message to all of us is [that] we all have a part to play in protecting everybody in our community,” she explained. “In the short term, [we need] great hygiene [and] thoughtful interaction with others … If you’re not well, stay home. Don’t go to work.”

Even industries outside of health and science are responsible for this kind of collaboration. Seema Kumar, Johnson & Johnson’s vice president of innovation, global health and science policy communication, explained that the Covid-19 crisis could take even wider cross-industry support than that of past pandemics. “What we’re seeing in the Covid[-19] situation is how much more we need to take this collaboration … across the globe, across the scientific community, but also across the public and policy makers,” said Kumar. “I think what we’re seeing now is collaboration at an unprecedented scale, because that’s what we need to end the global pandemic.”

In the effort to meet Johnson & Johnson’s 1 billion vaccine dose goal, collaboration might be most essential in the global supply chain. “This will take a village,” vice president of Janssen Supply Chain Remo Colarusso explained, who credited collaboration as the sole reason for success in a pharmaceutical supply chain. Colarusso is working with his team to create an efficient, effective, and global distribution process for the Covid-19 vaccine. “It’s going to require great collaboration with multiple, capable partners all over the world to make [the 1 billion vaccine goal] happen,” he said.

Colarusso seemed confident in the process, due largely to his company’s constant progress in the manufacturing space. Still, the 1 billion vaccine goal will take participation from multiple companies around the world. “The way you get to something so large, 1 billion doses — that’s 30 times more than all of our other products combined — it’s highly unlikely that one company will have all of that capacity, sitting around waiting for a pandemic.” But companies may already have the pieces to the puzzle — they just need to find ways to work together to solve it. “We’re going to collaborate with the best people out there that know what they’re doing, and we’ll piece this together and get to our billion doses,” he said. “Great partners [and] collaboration, that’s what will make this a success.”

Watch the full episode to learn more about how vaccines are distributed around the world, including the perspective of UPS’s president of global public affairs, Laura Lane, on shipping during a pandemic. Also, one young female activist told her story of hope and how she’s making a difference in her Nigerian community during the Covid-19 crisis.


Episode 5: The mental health crisis of Covid-19

The scientific community’s journey toward a Covid-19 vaccine is well on its way, but there’s a parallel crisis that’s hitting both frontline workers and communities worldwide: mental health issues. On episode five of The Road to a Vaccine, host and journalist Lisa Ling discussed the pandemic’s mental health footprint with experts, and how the world can take steps to fight this often-overshadowed emergency, which could outlast Covid-19.

The uphill battle in facing this struggle now, in the midst of a global pandemic, is that mental illness rates pre-pandemic were already substantial. Johnson & Johnson’s Husseini K. Manji, MD, FRCPC, addressed the challenges of pre-coronavirus mental illness, noting: “We really are starting against the backdrop of a mental health crisis that already exists both in the United States and globally. ... In the U.S. alone, 1 in 5 adults suffered from a mental illness in 2018.” The number of adults affected by mental illness is expected to rise thanks to the toll of the pandemic; one new study shows that 70 percent of American adults experienced moderate to severe mental distress in the last month.

The threat of Covid-19 has become part of daily life, resulting in a longer-term “over-activation of the system” — one that could outlast the pandemic itself. Simply put, mental health is more at risk now than before because of the sustained nature of the pandemic. Normally, the brain’s “fight or flight” response is only temporary and should subside after feeling threatened, Dr. Manji explained. But the ongoing stress of the pandemic and subsequent lockdowns has activated that response without an outlet for proper release.

Dr. Manji outlined three ways we can help fight the looming global mental health crisis:

- Acknowledgement: “We collectively need to increase awareness of mental health, dispel the stigma of mental illness, and use the best science to help individuals and families.”

- Adequate treatment: “It’s more important than ever to ensure that mental health conditions are treated the same as physical health.”

- Vigilance: “We should recognize that while everyone is experiencing distress, we need to identify and deliver evidence-based treatments to those who are going to suffer even more consequences, like PTSD or depression.”

The impact of mental health issues is already sweeping in nature, but Arianna Huffington joined the show to advocate acute care for frontline workers, who might face even more intense mental trauma. Huffington, Thrive Global Founder and CEO, spoke with Ling to spotlight the #FirstRespondersFirst initiative, a partnership created to support and sustain the health and well-being of frontline workers amid the Covid-19 pandemic, leveraging expertise from Thrive Global, the Harvard School of Public Health, Creative Artists Agency, and Johnson & Johnson. “We have tried to provide a whole, human solution for first responders during this crisis,” Huffington told Ling. “Obviously, we need to do everything we can to help provide protective equipment, but also they have other needs: child care, accommodations, and mental health support.”

According to The International Council of Nurses, as Ling referenced, 90,000 healthcare workers have been infected by Covid-19 worldwide, killing more than 260 nurses so far. Nurses have seen the trauma of watching their own being infected and killed, yet they’re finding creative ways to make sure that they — and their patients — are staying mentally strong. In honor of International Nurses Day, Ling also zeroed in on real nurses’ stories for their perspective. She spoke to Nicole Lincoln MS, RN, FNP-BC, CCNS, about her experience working on the frontlines in the ICU; and nursing innovator and President of SONSIEL Rebecca Love RN, BS, MSN, FIEL, on her grassroots initiative to provide life-saving PPE for nurses.

“Nurses are the most courageous people I know,” Lincoln said, when Ling asked what ran through her mind when entering the room with a Covid-19 patient. “They’re not thinking of themselves at that point; they’re thinking of the patient and being there for this patient that’s obviously frightened to death.” She called out creative ways that nurses are still connecting with patients — like using baby monitors — at a time when visitors are not allowed and nurses have to limit time with patients. “In all of the sadness around us, we look for the little pieces of joy, and we share them with each other,” Lincoln added. “We celebrate each time a patient is discharged; we play a song. Everybody gets excited for the success we’re having in all of this — the teamwork and the togetherness.”

Watch the full episode to learn more about nursing innovation and mental health effects of Covid-19, including one woman’s story of surviving the virus and her advice for those in fear.


Episode 4: What doctors on the frontlines say about Covid-19

Like a hurricane, the Covid-19 pandemic looks different from its center — and in the eye of this storm are frontline doctors, nurses, and emergency responders. On the latest episode of The Road to a Vaccine, journalist and host Lisa Ling focused on the healthcare professionals on the frontlines. From New Orleans to the labs and hospitals of Brooklyn, Ling interviewed doctors and professionals who not only have seen the worst of past pandemics, but also those who are experiencing the worst of Covid-19 right now.

For Dr. Adaora Okoli, an internal resident physician at the Tulane University School of Medicine, Covid-19 is not the first pandemic she’s experienced. Okoli worked to fight Ebola in Lagos, Nigeria, and, in turn, contracted the disease while treating patients. Okoli credited her survival of the Ebola virus as the reason she’s treating patients today. “It was like a rebirth for me. Adversity birthed my purpose to be here today and be able to continue to do what I’m doing.”

Today, Okoli noticed that her patients in New Orleans are asking similar questions to those she asked herself in Lagos: “Who is this doctor treating me? How long am I going to be here for? Am I going to survive this disease?” Her experience fighting Ebola made her more empathetic in her practice, she explained, among other important lessons. She explained that when it comes to those largely affected by infectious diseases, she noticed it is “usually the marginalized, disenfranchised. … The African American population, for instance, is more affected in New Orleans than other populations. So, infectious diseases are here to stay if we do not address the underlying issues, such as health disparities, that affect so many people.”

Okoli also emphasized the need for a strong healthcare system in order to properly fight Covid-19. “We have a habit of treating pandemics and outbreaks in such an emergent way. We raise money, we try and pump in billions into the outbreak, but as soon as the outbreak is over, we don’t actually do the work of building and strengthening our healthcare systems. And it’s a global thing,” Okoli said. “We don’t even have enough primary healthcare centers that can take care of the rural population and even the urban population. ... We’re reactionary, we’re not preemptive. It’s in times of peace that we should actually look to strengthening our system, building the infrastructure that we need to be able to combat outbreaks. We should expect outbreaks. We shouldn’t be surprised that outbreaks are happening.”

Ling also interviewed renowned epidemiologist Dr. Larry Brilliant, who has first-hand experience from the eradication of one of the biggest pandemics of the 20th century: smallpox. “That was the end of an unbroken chain of transmission that went all the way back to Pharaoh Ramesses ... and it ended,” he explained. “When you’ve seen that, you can never be a pessimist. I’m optimistic that we will throw this disease into the dustbin of history.”

Ling’s final guests had a particularly unique story. After discovering mutual friends and similar work histories, Johnson & Johnson’s Chief Medical Officer Dr. Ed Kuffner and Certa Dose founder and CEO Dr. Caleb Hernandez headed to the frontlines to volunteer together at one of the busiest hospitals in Brooklyn, N.Y.. Ling asked about the status of improvement in their Coney Island emergency room. “I can tell you that the social distancing and the stay-at-home orders have worked,” Hernandez answered. “When we first started out, the volumes were just so large and so crazy.” But within four weeks, “these insane volumes — 400% of what you would expect an ER to handle — went down to a more manageable amount.”

“We all need to respect this virus,” Kuffner explained. “We really, as a society, need to continue to hang together. The onus is on us to protect others in society and protect those healthcare workers who are on the frontlines every day.”


Episode 3: The truth about testing, safety, and Covid-19’s impact on minorities

In episode three of The Road to a Vaccine, journalist Lisa Ling called out a universal concern in this pandemic: the uncertainties. Are we where we need to be with testing? How can we ensure a vaccine is safe? And why are certain communities, specifically black and Hispanic/Latinx, more affected than others?

Speaking with Dr. Margaret Hamburg, an internationally recognized leader in public health and former FDA commissioner, Ling questioned if there were any similarities to the Covid-19 pandemic and the fight against HIV/AIDS. Hamburg, who worked directly with Dr. Anthony Fauci to slow the spread of HIV in the 1980s, said: “There are lessons to be learned [from the HIV/AIDS epidemic], and I think it gives us reason for optimism.” Hamburg, who helped curb New York City’s tuberculosis outbreak as the city’s health commissioner in the 1990s, seemed motivated by the opportunity for improvement, particularly with Covid-19 testing. “We’re a country with enormous resources and huge scientific and technological capacity,” she said. “We can and must do a better job, and I think we will.”

According to Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels, the process of upscaling is crucial in manufacturing a Covid-19 vaccine. Johnson & Johnson’s goal of 1 billion vaccine doses for Covid-19 would be a record-breaking first, and Stoffels is confident in their ability to reach it. “We’ve done 300 million vaccines already, so we know we can do it. Because we were focused on pandemics before, we are particularly focused on an extremely high productivity cell line, which allows for extremely high output,” he said. “That’s where we have been able to respond so fast to this epidemic and previous epidemics. This type of cell line, and the manipulations you do to such a cell line, is one of the most advanced types of biological inventions.”

When asked about the safety and reliability of a Covid-19 vaccination, Stoffels explained: “The vaccine is not a virus. We have tested this vaccine technology in four or five different diseases already. We now have 60,000 people who have been vaccinated with the technology already, with minimal side effects. Overall, vaccines are probably the most effective way to protect from diseases. All types of diseases are out of our lives because of vaccines. There’s no polio anymore, because we had a vaccine. There’s no cowpox anymore, because we have a vaccine.”

Another devastating aspect of the Covid-19 pandemic is its impact on minority groups. In episode three, Ling also interviewed Dr. Cato T. Laurencin, a surgeon, professor, and expert in health disparities who recently published a study on Covid-19 in the black community.

Upon discovering false internet claims about people of color being immune to the virus, Laurencin said he set out to stop the spread of myths and misinformation. His study found that compared to the overall population, communities of color had higher rates of infection and death.

The lack of data on race and ethnicity makes it almost impossible for black and brown communities to understand the severity of the spread of Covid-19; Laurencin said his team had a difficult time finding any available data for the study. “We must demand that we have adequate data on race and ethnicity,” Laurencin said. “Having adequate data to track [Covid-19 infections] now, and to track it in the future, is very important.”

“We know that there are a number of contributing factors that take place in the black community, making individuals more susceptible to disease and death by the coronavirus,” he said. “These are all under the general area of discrimination and racism over hundreds of years and continue today.”


Episode 2: The ultimate way to end a pandemic

No virus is exactly like another. However, there might be vital similarities. In the second episode of The Road to a Vaccine, host Lisa Ling interviewed experts and scientists who’ve been on the frontlines of outbreaks such as Zika, malaria, and HIV. In comparing other viruses to Covid-19, a strain of the coronavirus, a key question emerged: Is a vaccine the only way to rid the world of this pandemic?

Dr. Hanneke Schuitemaker, global head of viral vaccine discovery at Johnson & Johnson, said yes. The difference between a vaccine and a treatment is that a vaccine has the ability to stop the transmission of the virus, she explained to Ling. Since Covid-19 can be transmitted before symptoms even arise, it’s that much more important for a vaccine to build immunity.

Reflecting on the malaria vaccine, Dr. Dan Carucci, global medical director at McCann Health, seemed optimistic about the development of a Covid-19 vaccine. “The challenges that we’re seeing with Covid are likely less substantial than they would be for malaria,” he said. Modern technology and the ability to replicate a vaccine through it is also on our side. “Biology is hard, but technology is relatively easy,” said Carucci. “That suggests we have a good chance of success for developing a Covid vaccine.”

History tells us that a vaccine is the ultimate goal for ending this pandemic, but what is noticeably different about this particular moment is the global effort to create one. “Vaccine development is intrinsically collaborative,” said Dr. Dan Barouch of Harvard University’s Center for Virology and Vaccine Research. The greater scientific community is working toward a vaccine candidate — and they’re working with one another, too.

Johnson & Johnson expects to initiate human clinical studies of its lead vaccine candidate by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use in early 2021, a substantially accelerated time frame in comparison to the typical vaccine development process.

In the meantime, “I wonder if the focus should be on our appreciation for the things that we’ve taken for granted,” said Carucci. “I think maybe what we have now is a greater sense of community.”


Episode 1: What are we waiting for?

Scientists must consider many factors when developing a vaccination, from choosing the right vaccine candidate to taking proper time for testing. During the ever-changing fight against Covid-19, the disease born of the coronavirus, the question is not only can we get a vaccine, but how soon can we get one? What needs to happen next? On the first episode of The Road to a Vaccine, host Lisa Ling spoke to Dr. Paul Stoffels, chief scientific officer at Johnson & Johnson, Dr. Rinke Bos, principal scientist for vaccines at Johnson & Johnson, and Dr. Tom Inglesby, director of the Center for Public Health at Johns Hopkins University, about the reality of a potential — and successful — coronavirus vaccination.

As this unpredictable virus continues to alter the lives of a global population, the answers to these questions are not so simple. According to Stoffels, the world will need billions of vaccine doses to properly protect our population, “and that’s where there’s a huge transformational change,” he said.

But before we have a working vaccine, containment is going to be difficult, said Inglesby. “What we should think about in the meantime is what we can do to mitigate the spread and the impact of this disease,” he told Ling.

The good news is that a Covid-19 vaccination is already in the works. Johnson & Johnson has chosen a lead vaccine candidate, as Bos explained, and the clinical studies have begun.

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