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, a 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
