The U.S. Food and Drug Administration approved the world’s first vaccine to prevent the respiratory infection RSV, short for respiratory syncytial virus, on May 3, 2023. The new shot represents six decades of starts and stops in the hunt for a vaccine to curb one of the most common winter respiratory viruses. RSV leads to around 14,000 deaths in older adults every year and can cause severe illness in infants and children as well.

The vaccine, called Arexvy, made by the biopharmaceutical company GSK, is approved for use in adults ages 60 and over. Now that it is FDA-approved, it must still be endorsed by the Centers for Disease Control and Prevention, a move that’s expected in summer 2023.

The Conversation asked Annette Regan, an epidemiologist and vaccine specialist, to discuss the significance of the first vaccine against RSV and the other RSV vaccine candidates that are in the pipeline.

1. How does the new vaccine protect against the virus?

The vaccine targets a protein known as RSV F glycoprotein, which is found on the surface of the virus. The F protein enables the RSV virus to enter host cells.

By stimulating antibodies against this protein, the vaccine should protect against infection. Clinical trial data suggests this is the case, since Arexvy was 80% effective at protecting against RSV-related disease and 94% effective at protecting against severe disease.

The vaccine also includes an adjuvant, a substance that helps amplify the effect of the vaccine by boosting the immune system’s response.

2. When and for whom will it be available?

The RSV vaccine has been developed for and tested in adults age 60 and older. While the FDA has approved the vaccine – which means it has deemed it safe and effective – the shot will not be administered by health care professionals until it is reviewed by an independent expert group coordinated by the CDC called the Advisory Committee on Immunization Practice, which makes vaccine recommendations to the CDC.

The committee’s recommendations will cover how the vaccine should be used – including the ages at which the vaccine should be given – the number of doses needed, the time between doses and precautions and contraindications.

The committee is expected to meet in June 2023 to make a recommendation on the new RSV vaccine, after which the CDC would officially endorse it. The vaccine could be rolled out to the public as soon as late summer 2023, well before the typical RSV season, which usually starts in the fall and peaks in winter.

It’s hard to say what the committee’s recommendation will be. It could recommend the vaccine for all adults 60 and older, or a subset of older adults. While the clinical trial showed the vaccine was 81% effective among adults ages 60 to 69 and 94% effective among adults ages 70 to 79, it was only 34% effective among adults 80 and older. Given the lower efficacy for adults ages 80 and older, the committee could place an age cap on the recommendations.

3. Why has the first RSV vaccine been so long in coming?

A vaccine against RSV has been in the works for decades. One problem that has plagued vaccine manufacturers is the difficulty of identifying an antigen – the piece of the virus that the vaccine targets – that doesn’t change, or shape-shift. The F protein of the RSV virus is notorious for changing its shape once it fuses with a host’s cell.

In 2013 and 2014, the National Institutes of Health worked out how to “freeze” the F protein into a fixed shape before fusing with a cell so that a vaccine could target it well. This was a game-changer that allowed the development of effective vaccines using this target.

In addition to challenges in identifying a good antigen, there were earlier setbacks. Early attempts to create an inactivated RSV vaccine in the 1960s were stalled after they caused an enhanced form of RSV disease. Children who had never had RSV before and received the vaccine experienced very severe illness when they encountered the virus in the community, and two children died. This tragic outcome sidetracked vaccine development for decades, as researchers needed to investigate the cause and ensure that the problem wouldn’t occur again for future vaccines.

4. What other RSV vaccine candidates are coming down the line?

In addition to Arexvy, many other promising RSV candidates are under development, some of which are likely to become available later this year or in early 2024.

The next RSV vaccine under review with the FDA is Pfizer’s RSV vaccine. It is similar to the recently approved vaccine except that it has no adjuvant and is bivalent, meaning that it targets both RSV A and RSV B – the two strains of RSV. This vaccine is meant not only for adults ages 60 and older, but also for pregnant people – with the aim of protecting young infants through maternal antibodies.

Data from a phase 3 clinical trial – the last stage of clinical trials before a company would apply for a license – shows that when given during pregnancy, the Pfizer vaccine was 82% effective in protecting infants less than 3 months old against severe RSV infection. The FDA will be making a determination on the Pfizer vaccine for older adults later in May 2023 and for pregnant people in August 2023. The CDC advisory committee is scheduled to discuss vaccine recommendations in October 2023, making this the likely next possible vaccine available.

A few other biopharmaceutical companies have developed alternative RSV vaccines, some of which are in phase 3 clinical trials. For example, Moderna has an mRNA vaccine against RSV with promising preliminary results. Regardless of which companies make it to the finish line next, it is clear that in the near future there will be a variety of new tools to help protect against RSV infection.

Annette Regan, Associate Professor of Epidemiology, University of San Francisco

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Heavy downpours and a thick snowpack in the Western mountains and Upper Midwest have put communities in several states at risk of flooding this spring – or already under water.

Flooding is the costliest type of natural disaster in the U.S., responsible for about 90% of the damage from natural disasters each year. It happens almost every day somewhere in the country.

Yet, much of the aging infrastructure meant to protect U.S. communities is in bad shape and, in some cases, failing. The American Society of Civil Engineers gave the nation’s dams, levees and stormwater infrastructure a D grade in its latest report card, in 2021.

Help is coming. Congress authorized billions of dollars for infrastructure projects under the Infrastructure Investment and Jobs Act in 2021. But there’s a problem: New infrastructure planning frequently relies on historical flood patterns for its benchmarks rather than forecasts of changing risks as the climate warms.

We study flood risks and mitigation strategies as civil and environmental engineers. As federal funding for infrastructure rolls in, communities run the risk of spending millions of dollars on systems that weren’t built to handle the flood risks ahead.

Infrastructure is failing

Much of the nation’s flood control infrastructure was designed for 20th century storms and flooding. And in many cases, stormwater systems, levees and dams are now approaching the end of their useful life, or are already well beyond it.

The nation’s river levees are 50 years old on average. Retention ponds are meant to last 20-30 years on average. Stormwater systems are also aging, and retrofits in cities like Chicago and Philadelphia are getting expensive.

Midland, Michigan, saw the risks in 2020 when heavy rainfall caused the Edenville Dam, built in 1925, to collapse. The rush of water overwhelmed a second downstream dam, creating a disaster that drained two lakes and damaged or destroyed more than 2,000 homes. The dams’ owner had lost its hydropower license for the Edenville Dam two years earlier, in part for failing to widen its spillway for safety.

Increasing damage like this has pushed federal flood insurance costs higher – more than three times higher in parts of coastal Louisiana and Florida under the Federal Emergency Management Agency’s new risk-based premiums, newly released FEMA data show. At the same time, many of the people most at risk are low-income families who can least afford the costs of recovery without help.

Old data won’t protect against future flood risk

The Infrastructure Investment and Jobs Act, the most significant U.S. infrastructure law in recent years, includes $55 billion in new spending for water infrastructure – money that is making its way to communities. But that’s barely an eighth of what the American Society of Civil Engineers estimates is needed for drinking water, wastewater and stormwater infrastructure improvements.

And another problem arises when the money arrives.

Often, new infrastructure is designed using historical data, such as past high-water marks and storm intensity, to determine future flood risk. However, climate change is moving those baselines.

Years of satellite observations have shown that, globally, both extreme wet and extreme dry conditions have increased in extent, duration and severity. A warming atmosphere can hold more moisture, leading to stronger downpours. As heavy precipitation intensifies, more frequent and severe flooding events have hit the U.S.

The Federal Emergency Management Agency currently estimates that approximately 13 million Americans – around 4% of the population – live in 100-year flood zones, meaning the area has at least a 1% chance of flooding in a given year. But FEMA’s maps often overlook smaller streams that frequently run through heavily populated areas.

Federal flood maps also take years to update. Many still rely on decades-old data and fail to consider the rising risks from climate change. That can lead to complacency for community leaders and residents – until it’s too late.

There are alternatives that communities can use to help align their planning with a more likely future.

Researchers working with the nonprofit First Street Foundation developed some of the first U.S. flood maps that account for future flood risk at the local level. They estimate that climate change alone will increase flood damage in the U.S. by 26% by 2050 and expand into areas that rarely saw severe flooding in the past. With people continuing to build in high-risk areas, the costs and number of people at risk rise even higher.

What can communities do?

Protecting communities starts with changing the status quo, including incorporating climate change into infrastructure planning and developing innovative policies for better flood management.

Stopping construction of new homes in flood-prone areas can help avoid future damage and the need for expensive infrastructure, though political pressure and housing shortages can make these measures difficult.

Buyouts of flood-prone homes to prevent rebuilding are expensive and slow, but they have been used in over 1,100 counties in almost every state to avoid repeated flooding. In some cases, moving away from coastlines and riversides is the only option. Known as managed retreat, it is gaining interest, particularly in communities at risk from sea level rise, but it’s also controversial. Success largely depends on whether the effort is community-led.

Nature-based solutions, such as bioswales, wetlands and rain gardens, can be relatively affordable methods to help capture and absorb rainwater, reducing the amount of runoff that flows into rivers and exacerbates flooding.

But for many communities to remain unchanged, building and maintaining large-scale infrastructure will be necessary. Designing structures like levees or seawalls so they can be expanded or raised in the future is one strategy that can ultimately save money.

Innovative and sustainable funding mechanisms will likely be needed to support flood resilience efforts. One option is establishing local dedicated funds to finance flood resilience initiatives, supported by government grants, private donations and small local taxes. Managed well, these funds could invest in long-term solutions and sustainable land practices that can reduce the frequency and severity of flooding.

Many communities are making an effort, often pushed by residents lobbying officials to prioritize flood initiatives and investments designed to stand up to the future. Changes won’t happen overnight, but taking proactive measures and supporting innovative solutions will benefit communities in the long run and is the fiscally responsible thing to do.

Antonio Arenas Amado, Assistant Professor of Civil, Construction and Environmental Engineering, Iowa State University and Lu Liu, Assistant Professor of Civil, Construction and Environmental Engineering, Iowa State University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

The World Health Organization declared on May 5, 2023, that the COVID-19 pandemic is no longer a public health emergency. Although the virus is still causing hospitalizations and deaths, many travelers who were reluctant to go abroad because of the pandemic now feel freer to travel internationally again.

That’s going to be a whole lot easier to do this summer if you already have a valid passport. The wait times for getting one are soaring. The State Department says it can take up to 13 weeks for it to process passport applications, and up to nine weeks for expedited service that requires the payment of extra fees. It’s getting about 500,000 passport applications a week, which is at least 30% more than last year, Secretary of State Antony Blinken said in March. And delays in processing were already aggravating in 2021 and 2022.

I’m among the many Americans who have had to cancel or delay trips because of the long wait times. I was hoping to fly to London for a weeklong break between teaching economics courses. Unfortunately, renewing my passport took so long I couldn’t go.

The government says staffing issues are contributing to the delays. As an economist who researches the everyday experiences of consumers, I wondered if there was more to the story, since international travel is a big business. U.S. residents spent around US$17 billion in just the month of March 2023 going abroad.

Origin of passports

Passports have been around a long time. They became more widespread about four centuries ago during the reign of the French King Louis the XIV. The king gave people with royal connections letters asking foreign officials to let the traveler “passe port” – French for pass through – the port or border of another country safely.

You can find a similar statement in the front of every U.S. passport, which “requests all whom it may concern to permit the citizen/national of the United States named herein to pass without delay or hindrance.”

One reason for the passport bottleneck in the United States is a long-term increase in demand for those official blue booklets. Back in 1989, there were three valid passports for every 100 people in this country. Today there are more than 45 passports for every 100 Americans. More recently, many Americans who let their passports expire because they were avoiding international travel when the pandemic began are eager to travel again.

Changes after 2000

The U.S. population has increased about 1% each year over the past three decades. During that same period the number of people holding a valid passport has jumped an average of 10% each year, 10 times faster than population growth.

Part of the rising demand for passports followed a policy change in the early 2000s. Before then no passport was required for U.S. citizens to travel to Canada, Mexico or the Caribbean. A driver’s license or an official document like a birth certificate was suitable documentation to visit countries that shared a common border with the U.S. By 2009, however, a passport was needed to visit those nearby countries by air, land or sea.

But the new rules don’t fully account for the surge in passport issuance. In 2010, about 100 million people had valid U.S. passports. Today, over 150 million do.

Lost, stolen and damaged passports

Another reason for the passport boom is that the State Department is fielding more requests than before for reissued passports to replace lost or stolen documents.

One problem while traveling is keeping your passport safe. While so far no one has ever stolen my passport, I have spilled food on it while climbing mountains, gotten it soaked in a monsoon and crushed it in my luggage on the world’s longest flight.

If your passport is ever lost, destroyed or stolen, you need to file a DS-64 form with the State Department. Filing this form prevents a thief from using that passport. The data is not just kept in the U.S. but is also sent to Interpol’s Stolen/Lost Travel Document database, which prevents worldwide travel by someone posing as you when traveling with your stolen passport.

The government periodically releases the number of DS-64 forms filed. In 2005 a bit more than 100,000 were submitted. This jumped fivefold to over 500,000 people who reported losing their passports in 2021.

Who gets passports?

Where do passport applications come from?

Not surprisingly, states with more people tend to get more passports. For example, Californians got the highest number of passports, about 2.7 million, in 2022.

But some states have more wanderlust than others. After adjusting for population, over the past few years the top two sources for international travel are the high-income states of New Jersey and Massachusetts. Around 1 out every 17 residents in those places applied annually for a passport.

The states where residents are the least likely to apply for a passport are the low-income states of Mississippi and West Virginia. In those places only about 1 out every 65 residents applied on average each year.

What can be done?

One of the reasons passport processing times have gotten so long is that many people are taking trips they put off in the spring of 2020. What can be done?

I suggest two things.

First, the Caribbean is one of the most popular U.S. tourist destinations. U.S. travelers today can visit the U.S. Virgin Islands and Puerto Rico without a passport because they are U.S. territories. I believe that expanding this access to a small number of Caribbean countries, as was possible before the 2009 policy change, would boost tourism and reduce passport demand.

Second, citizens with a current passport should be able to use it while waiting for a renewal. Right now old passports must be submitted with renewal forms, which blocks international travel. The State Department doesn’t really need the old documents. It recently ran a trial allowing people to renew passports online without asking for their current passport books.

Once a new passport is issued, the old one becomes invalid. This could present a problem for people traveling abroad while their passport renews. There is a simple solution for this. At the beginning of the COVID-19 pandemic the State Department allowed U.S. citizens who were abroad when their passports expired to reenter the country.

Extending this policy would mean people could continue traveling no matter how long it takes to renew their passport.

Jay L. Zagorsky, Clinical Associate Professor of Markets, Public Policy and Law, Boston University

This article is republished from The Conversation under a Creative Commons license. Read the original article.