Respiratory Syncytial Virus Vaccine (GSK)

iStock, Magdalena Wygralak GSK’s dealmaking will be “cautious and disciplined” under the current trade war, but the pharma will focus on looking for “opportunities created” amid these tensions, according to CEO Emma Walmsley. The company also reported a 4% earnings bump for the quarter. GSK is choosing to look on the bright side of President Donald Trump’s trade war, focusing on “opportunities created,” even as tariffs escalate already-fraught geopolitical tensions. “I’m going to be more optimistic,” CEO Emma Walmsley said in the company’s first quarter earnings call on Wednesday. She noted that even as the Trump administration singles out China as its biggest biotech threat, GSK continues to “look at the opportunities out of China ,” pointing to “several good deals.” In December 2024, for instance, GSK inked a potential $1 billion deal with Shanghai-based DualityBio to license a novel antibody-drug conjugate (ADC) against a yet-undisclosed stomach cancer target. A year earlier, in December 2023, the pharma likewise entered into an ADC-focused partnership with Hansoh Pharma, putting $1.7 billion on the line. “About half” of GSK’s pipeline comes from dealmaking, Walmsley said during the call, while the other half is driven by its internal research efforts. “Since 2018, we’ve increased our investment in R&D by nearly 90%,” she added, “but we want to keep complementing that with [business development].” “We want to engage, we seek to move agilely, we are always focused on returns—and obviously you have to take a cautious and disciplined view in the current environment, but we still see opportunity here,” she added. Walmsley stands on the optimistic side, particularly as concerns grow around potential dealmaking problems that Trump’s trade war could pose. Roche CEO Thomas Schinecker, for instance, said during the pharma’s Q1 report last week that “it will be more difficult to make financial sense of any M&A deals” if tariffs get in the way. On the numbers side of the Q1 earnings call GSK reported that it made £7.52 billion in the quarter —approximately $10 billion—a 4% year-on-year increase. Its specialty medicines business emerged with the strongest performance, driven by its HIV portfolio, which grew 7% year-on-year to bring in £1.7 billion (nearly $2.3 billion). Its shingles vaccine Shingrix brought in £867 million (more than $1.1 billion) in the quarter, down 7% from the same period a year prior. GSK attributed the sales hit to the “slowdown in the pace of penetration” in the U.S., particularly in “harder-to-reach unvaccinated consumers.” The company’s vaccine division was a major topic of conversation on the earnings call. The pharma in its Q1 report revealed that it expects its vaccine portfolio to decrease by a low single-digit percentage this year, driven primarily by lower expected demand for Shingrix and its respiratory syncytial virus (RSV) shot Arexvy. One link to this downward forecast is macro-headwinds in the U.S., given the notable vaccine criticism from HHS Secretary Robert F. Kennedy Jr. To that point, Walmsley stands by vaccine technology, saying that “there is no better benefit than stopping disease before it starts.” Nevertheless, she said that “parents have questions, and [pharma] should answer those responsibly and transparently.” But for the most part, she said, GSK is insulated from Kennedy’s current rhetoric on vaccines, in particular the safety of childhood immunizations. “Pediatric vaccination is a relatively small part of our business in America,” Walmsley pointed out. Its highest-growth shots—Shingrix and Arexvy—are indicated for adults, as are its upcoming vaccines.

A CDC advisory group has expanded its recommendation for who should receive RSV vaccines. The broadened population is a potential boost for sales of RSV shots from GSK and Pfizer. The ACIP also voted to endorse a new meningococcal vaccine from GSK and a new shot from Bavarian Nordic which defends against the emerging chikungunya virus. A year after narrowing its recommendation for who should use vaccines to defend against respiratory syncytial virus (RSV), a panel of experts advising the Centers for Disease Control and Prevention (CDC) has expanded its endorsement.The reversal from the Advisory Committee on Immunization Practices (ACIP) is a potential boost for GSK and Pfizer. Both companies saw sales of their RSV vaccines for adults tumble last year after the CDC ruled that the shots should be limited to people age 75 and older and those ages 60-74 who are at risk of developing severe RSV-linked lower respiratory tract disease (LRTD).The ACIP’s new recommendation expands the eligible at-risk group to people ages 50 and older. The new guidance is pending final approval from the director of the CDC and the Department of Health and Human Services (HHS).After the FDA approved GSK’s Arexvy and Pfizer’s Abrysvo in 2023, the CDC recommended the shots for all people 60 and older, pending a doctor’s endorsement.From 2023 to last year, sales of Arexvy tumbled (PDF) 51%, from 1.2 billion pounds ($1.6 billion) to 590 million pounds ($754 million). Meanwhile, revenue from Abrysvo fell (PDF) 15% from $890 million to $755 million during the same stretch. The new direction from the ACIP comes after a review of positive results of a phase 3 trial evaluating the immune response and safety of Arexvy in adults ages 50-59, including those at increased risk for severe RSV-LRTD due to certain underlying medical conditions, compared to adults aged 60 and above.According to the CDC, between 15,000 and 20,000 RSV-associated hospitalizations occur annually (PDF) in the U.S. among adults ages 50 to 59. Those with chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk from an RSV infection.GSK’s Chief Scientific Officer Tony Wood said in a release that the new guidance would increase the RSV vaccine-eligible patient population by 13 million.Other ACIP vaccine guidanceThe CDC experts also endorsed GSK’s 5-in-1 shot Penmenvy, advising that it should be part of the adolescent meningococcal vaccination schedule for people ages 16 to 23. The recommendation also applies to kids ages 10 to 15 who are at increased risk.The ACIP also unanimously endorsed Penmenvy for the Vaccines for Children (VFC) program, which provides free doses for eligible children.The vaccine, which was approved by the FDA in February, is an alternative to separate administration of two shots that cover five meningococcal serogroups. Penmenvy will challenge Pfizer’s pentavalent option Penbraya, which hit the market in 2023. Because of their convenience, these vaccines are expected to increase immunization rates in the U.S.   The ACIP also signed off on Bavarian Nordic’s chikungunya vaccine Vimkunya for people age 12 and older who are traveling to a country where there is an outbreak of the mosquito-borne virus. The shot, which also was approved by the FDA in February, may also be considered for those traveling or moving to a country without an outbreak but with elevated risk for U.S. travelers. ACIP also recommends Vimkunya for laboratory workers with potential for exposure to the virus.According to CDC, there has been evidence of chikungunya virus transmission to humans in more than 50 countries within the last five years.The ACIP meeting was the first under new HHS Secretary Robert F. Kennedy Jr. On Tuesday, the panel discussed potentially narrowing the recommendations for COVID-19 and HPV vaccines. The ACIP will vote on its guidance for those shots at its next meeting, set for June 25-26.