Preparing to Deliver: We’re Ready to Help Protect Babies This Winter Virus Season

Thomas Grenier, Head of Vaccines, North America

When my children were born, we received all the wonderful gifts—soft blankets, cozy hats, and an abundance of parenting advice. Each thoughtful gesture helped us prepare for those precious first days. But as I eased into parenthood, I quickly realized that the most valuable gift we could give our kids was something you can’t quite purchase from a registry: protection.

Sanofi recognizes this truth, which is why we’re committed to showing up for families through the development and deployment of immunizations, including for serious lung infection caused by respiratory syncytial virus (RSV). Although severe RSV is uncommon, it is the leading cause of hospitalization in babies under age 1; many parents are surprised to learn that babies are 16 times more likely to be hospitalized with serious RSV lung infection than with the flu. Last year, when the U.S. Food and Drug Administration (FDA) approved our monoclonal antibody to help protect babies - whether born before or during RSV season, at term or preterm, healthy or with existing medical conditions - against serious RSV lung infection, we helped transform the RSV prevention landscape as we knew it.

November marks the start of winter virus season, a time when cases of RSV typically begin to rise, and parents and providers alike are on high alert. We know what is at stake right now, which is why we planned accordingly.

Working to get here.

We did not wait for winter virus season’s start to initiate our efforts to help protect babies from severe RSV lung infection. We have spent all year preparing for delivery—expanding manufacturing capacity, planning for supply resiliency, and refreshing how we collaborate with providers and health systems. I’m proud to say that all this work has given us the ability to supply enough doses of Beyfortus^® (nirsevimab-alip) 50 mg and 100 mg Injection to every baby in the U.S. today who may benefit.

Beyfortus is a prescription medicine used to help prevent a serious lung disease caused by RSV in newborns and infants born during or entering their first RSV season, as well as children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Beyfortus should not be given to children with a history of serious allergic reactions to nirsevimab-alip or any of the ingredients in Beyfortus. Beyfortus may not protect all children. See below for additional Important Safety Information.

A core objective of our work this year has been offering equitable access to Beyfortus—and we continue to make progress towards this through collaboration. We are grateful for the partnership of the White House, Centers for Disease Control and Prevention (CDC), the U.S. FDA, and healthcare providers across the country, all of whom played a critical role in helping us make Beyfortus widely available. Doses began shipping in September to healthcare providers and hospitals, including those within the CDC’s Vaccines for Children program, which provides immunizations at no cost to children that are Medicaid-eligible, underinsured, uninsured or American Indian/Alaska Native.

Making a real difference on arrival.

In addition to the efforts outlined above, we had a particularly busy October preparing for winter virus season’s arrival—which also happened to be RSV Awareness Month. Helping educate new and expectant parents about RSV remains a significant priority for Sanofi; in that spirit, we partnered with Olympian Shawn Johnson East and a number of influential parents and physicians to share their RSV and Beyfortus stories with their respective communities. I feel confident entering winter virus season with a strong alliance of partners and voices helping to underscore urgency to immunize babies who may benefit from Beyfortus.

One reason we are so proud to support widespread adoption of Beyfortus is that doing so allows us to collect real-world data. This information complements the pivotal trial data and adds to the already growing body of evidence supporting Beyfortus’ impact, as seen at the IDWeek and American College of Allergy, Asthma, and Immunology (ACAAI) conferences last month.

We’ll continue collecting and sharing data because information like this helps us all make informed decisions. We’ll also continue our efforts to make Beyfortus as accessible as we can. As a company, we know this is how we can best help families prepare for their special arrival(s). And as a parent, I know firsthand that no gift is greater than having tools available to help protect our children's health.

IMPORTANT SAFETY INFORMATION

Your child should not take Beyfortus if your child has a history of serious allergic reactions to nirsevimab-alip or any of the ingredients in Beyfortus.

Before your child receives Beyfortus, tell your healthcare provider about all of your child’s medical conditions, including if your child:

• has ever had a reaction to Beyfortus.
• has bleeding or bruising problems. If your child has a problem with bleeding or bruises easily, an injection could cause a problem.

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your infant should not receive a medicine called palivizumab if they have already received Beyfortus in the same RSV season.

Serious allergic reactions have happened with Beyfortus. Get medical help right away if your child has any of the following signs or symptoms of a serious allergic reaction:

• swelling of the face, mouth, or tongue
• difficulty swallowing or breathing
• unresponsiveness
• bluish color of skin, lips, or under fingernails
• muscle weakness
• severe rash, hives, or itching

The most common side effects of Beyfortus include rash and pain, swelling, or hardness at the site of your child’s injection. These are not all the possible side effects of Beyfortus. Call your healthcare provider if you have questions about side effects.

INDICATION

Beyfortus is a prescription medicine used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV) in:

• Newborns and babies under 1 year of age born during or entering their first RSV season.
• Children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season.

Please see full Prescribing Information, including Patient Information, for more details.