Editors' (re)View: Tornado hits Pfizer site; RSV prevention for infants, finally

July 21, 2023
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of July 17

Tornado hits Pfizer site

In a tweet earlier this week, Pfizer revealed that a powerful tornado severely damaged its pharmaceutical plant in North Carolina, which produces nearly 25% of its sterile injectable medicines.

Pfizer confirmed the extensive damage to the plant but reported no serious injuries, as all employees were safely evacuated. The tornado resulted in roofs being ripped open and medicine quantities being thrown about at the Rocky Mount facility. 

Pfizer gained control of the 1.4 million-square-foot factory in its 2015 acquisition of drugmaker Hospira. The site houses 22 packaging lines and employs 2,000 individuals. The plant's production includes anesthesia and other drugs, along with nearly a quarter of all sterile injectable medications used in U.S. hospitals.

According to the National Center for Environmental Information, the U.S. has already encountered 12 confirmed weather disaster events this year, resulting in losses exceeding $1 billion. All industries have been affected by climate-related impacts, and pharma is not immune. In 2017, when Hurricane Maria struck Puerto Rico, it caused significant damage to the island, which houses the manufacturing of 11 of the world's top 20 drugs, including Humira, Enbrel and Lyrica. 

Studies show that human-induced climate change is expected to increase the frequency and intensity of extreme weather events, such as heat waves and large storms. 

— Andrea Corona

RSV prevention for infants, finally

This week, we celebrated the first U.S. approved RSV preventive option for a broad infant population. AstraZeneca and Sanofi’s single dose long-acting antibody, branded Beyfortus (nirsevimab), was green lighted by the FDA for the prevention of respiratory syncytial virus in newborns and infants.

The U.S. already has two RSV vaccine approvals on the books. Back in May, the FDA gave the OK to GSK’s Arexvy for use in individuals aged 60 and older. A month later, the agency approved Pfizer’s bivalent RSV vaccine, Abrysvo, for the same patient population.(Abrysvo is also vying for approval for use in pregnant mothers, with a regulatory action date in late August.)

But it’s important to point out that the newest approval, Beyfortus, is not a vaccine.

Whereas vaccines encourage the body to develop its own long-term antibodies, nirsevimab is a monoclonal antibody that mimics natural antibodies. One advantage here is that while a vaccine typically takes a few weeks to generate an immune response, mAbs are effective almost immediately.

Vaccines typically offer more lasting protection, however, the single injection of Beyfortus protected against RSV for about five months in trials — which happens to be the length of a typical RSV season.

RSV vaccines in babies actually have a rocky history — which many say contributed to the delayed development of future RSV treatments. (Time ran a really interesting history of RSV vaccines a few months ago).

Back in the late 1960s, a formalin-inactivated vaccine against RSV was studied in infants and toddlers. Not only was the vaccine not effective, but when those who had been immunized became infected with the wild-type virus in the community, their RSV infection was worse. Many babies were hospitalized, and two immunized toddlers died after being infected with wild-type RSV.

Of course science and vaccine technology has advanced measurably since then. PATH,nonprofit global health organization, says there are five RSV vaccines designed to protect infants and children in active U.S. studies — so an infant RSV vaccine approval is likely on the horizon.

RSV is the leading cause of hospitalization for infants under the age of one in the U.S. The CDC estimates that each year, RSV results in around 58,000-80,000 hospitalizations and 100-300 deaths among children under five  — which means AstraZeneca and Sanofi’s preventive mAb and any future vaccines are a welcomed relief. 

 — Karen Langhauser 

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.' 

About the Author

Andrea Corona | Senior Editor

Andrea Corona serves as the Senior Editor of Pharma Manufacturing — a leading source of news and insights for pharma professionals — and is responsible for creation of editorial content, moderating webinars, and co-hosting the "Off script" podcast. Her editorial journey started as an as associate editor at Biocompare, an online platform providing product information, industry news, articles, and other resources to support scientists in their work. Before Biocompare, she was a digital producer at Science Friday, focusing on adapting radio segments for the web and social media management. Andrea earned her bachelor's degree in journalism and biology from the State University of New York, at Purchase College.