Centre for Chronic Disease Control

GSK's Arexvy remains ahead of its Pfizer RSV rival and isn't concerned with the potential entry of a new competitor. Even with the threat of a potential new competitor in the respiratory syncytial virus (RSV) vaccine race on the horizon, GSK and its leading Arexvy shot aren’t sweating. Over the first quarter, the vaccine once again came out ahead of Pfizer’s rival Abrysvo with 182 million pounds ($227 million) and some two-thirds of the RSV market share, GSK reported. In other terms, more than 70 million of the addressable U.S. population of 83 million have so far received GSK’s shot. Pfizer, meanwhile, posted quarterly Abrysvo sales of $145 million. It’s becoming a familiar story after the two raced to the FDA finish line last year. Since then, Arexvy has already collected blockbuster sales of 1.2 billion pounds ($1.5 billion) in its first year on the market. The company previously predicted peak sales to hit $3 billion, an estimate that GSK is “very confident” still stands, CEO Emma Walsmey said on a quarterly press call. Still, the U.K.-based drugmaker isn’t stopping there in its Arexvy development. As Walmsey noted on the call, “There is plenty of room for growth.” The next checkpoint is an FDA decision on the vaccine’s use in those aged 50 to 59, which would add another 50 million U.S. adults to its potential reach. The shot is currently approved for adults aged 60 and older. That decision is expected in June and would make Arexvy the first RSV vaccine approved for the age group. While the next couple of quarters likely won’t collect as many sales, since the RSV season typically picks up in the fall and peaks in the winter, growth over this year’s fourth quarter will be telling. By then, a third competitor—Moderna’s mRNA RSV vaccine—may have also entered the market, as its FDA decision date is set for this month. The Arexvy maker “welcomes competition,” Walmsey said, and remains “very confident” in the underlying demand for its vaccine, Chief Commercial Officer Luke Miels added on a call with analysts. A clearer picture on the potential impact of Moderna’s entry will come when the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices makes its immunization recommendations. That decision will begin “a race to lock down contracts” ahead of the next RSV season, Miels added. In its Arexvy journey, GSK can look to its established shingles vaccine, Shingrix. That shot collected 945 million pounds ($1.2 billion) over the quarter, 50% of which came from global sales. Together, the vaccines led GSK’s wider vaccine profile to 16% growth. Elsewhere, specialty medicines demonstrated similar growth of 17%, while general medicines crawled up 1%. The three sectors brought in largely even hauls of 2.3 billion pounds ($2.8 billion), 2.5 billion pounds ($3.1 billion) and 2.6 billion pounds ($3.2 billion), respectively. All in all, the company garnered total quarterly revenues of 7.4 billion pounds ($9.2 billion) and boosted its 2024 guidance to the upper end of its 5% to 7% forecast range.

Dive Brief:Pfizer on Thursday gained U.S. approval of its newest pneumococcal conjugate vaccine for use in children and infants, helping it compete with a rival shot from Merck & Co. that won a similar OK last year.Pfizers vaccine, called Prevnar 20, is designed to protect against infection by 20 strains of the bacteria seven more than the companys prior Prevnar 13 version. It has been approved in adults since 2021.Last July, Merck won approval in children of its Vaxneuvance vaccine, which protects against 15 strains. Both companies could soon face more competition as the market has sparked interest from other drugmakers.Dive Insight:While vaccines for the bacterial infection are widely available, thousands of cases still lead to hospitalization and death in the U.S. each year. In response, Pfizer, Merck and others have worked to develop new shots that offer better protection, particularly against strains that werent previously covered by Prevnar 13.These second-generation shots are meant to improve upon older versions like Mercks Pneumovax 23, which was first launched in 1983. That companys follow-on, Vaxneuvance, gained clearance in adults in 2021 and a year later won expanded use in children aged 6 weeks through 17 years.Pfizers latest approval was supported by clinical testing that compared Prevnar 20 to Prevnar 13. The company reported positive Phase 3 results in August. The trial was one of several to indicate the shot worked just as well and was safe in infants and children. In the trial, immune responses were evaluated one month after a third and fourth dose of the vaccine. Immune responses were compared to those with Prevnar 13.Other vaccine developers aim to get involved, too. Biotechnology company Vaxcyte recently reported positive Phase 2 study results for an experimental vaccine its developing in older adults. The company said immune responses were comparable to Pfizers Prevnar 20, and that it will start Phase 3 testing later this year.Meanwhile, GSK is testing a shot it gained through a $2.1 billion acquisition of Affinivaxlast May.The Center for Disease Controls advisory committee on immunization practices is set to hold a meeting in June, when it could discuss immunization recommendations. '

CLEVELAND, April 12, 2021 (GLOBE NEWSWIRE) -- Four of Cleveland Clinic's 11 main health facilities in northeast Ohio are not currently administering the COVID-19 vaccine, according to research by Lucky Star Communications, a Cleveland-based research and communications firm. Cleveland Clinic spokesperson Alicia Real Cooney confirmed this in an email. "We selected various geographic locations throughout Northeast Ohio. Not all of our hospitals have vaccination clinics. We have a limited supply of vaccines, and that supply is determined by the state. We are distributing it according to ODH [Ohio Department of Health] guidelines at our designated vaccination clinics. We open up appointments based on supply. Individual doctors do not have the vaccine in their offices." ODH spokesperson Alicia Shouts confirmed in a statement that it was Cleveland Clinic's own decision for these four facilities to not participate in the COVID-19 vaccination drive during the pandemic. "The Ohio Department of Health reviews and approves vaccine administration sites based on applications for administration we receive for a given provider. The Ohio Department of Health does not determine which facilities a hospital system chooses to enroll." In an email, Dan Tierney, spokesperson for Ohio Gov. Mike DeWine, said the Governor had no comment on Cleveland Clinic's decision. In a televised press conference in March, the Governor had urged full participation in the vaccine campaign. "We have the ability to end this. We can drive this virus into the ground. But we all have to participate." Only 21 percent of Ohio residents have been fully vaccinated with two doses, according to the latest state figures. To reach herd immunity and put the virus out of business, a vaccination rate of 70 percent to 85 percent must be reached. According to a senior nurse at Cleveland Clinic's Lakewood Family Health Center, that facility does not have the low-temperature refrigeration unit necessary to store the vaccines. "It's sad to think that Lakewood Family Health Center is not participating in the vaccination drive because they are too cheap to pay for a refrigerator," said Jeff Barge, CEO of Lucky Star Communications. Elected officials for the four communities affected say they would welcome Cleveland Clinic's participation in the vaccination drive. "Absolutely," said Ohio State Senator Nickie Antonio, who represents Lakewood in the Ohio State Senate, in a phone call. "They’ve got the facilities. They’ve got parking. They’re equipped to do it, especially for their existing patients." But Mr. Barge's personal doctor at Cleveland Clinic Lakewood emailed him: "Might be quicker to go to CVS? I don't handle any of the vaccination stuff." According to the New York Times, there are huge groups of people — including 49 percent of Republican men and some ethnic groups with little reason to trust the medical establishment — who seem to refuse to be vaccinated, blocking the path to quick herd immunity. Without their cooperation, the pandemic might be greatly extended. For example, according to the New York Times, 49% of Republican males say they will refuse to be vaccinated. Participation by trusted doctors can be key to overcoming vaccination reluctance, as Pres. Joe Biden recently said in Deadline: "I discussed it with my team, and they say the thing that has more impact than anything Trump would say to the MAGA folks is what the local doctor, what the local preachers, what the local people in the community say." Director of the federal Center for Disease Control Rochelle Walensky has predicted "impending doom" under the present course of action. There is currently a surplus of the vaccine.