Pfizer (PFE) RSV Vaccine Candidate BLA Gets FDA's Priority Tag
Zacks Equity Research
8 December 2022, 10:48 am ·2-min read
Pfizer PFE announced that the FDA has accepted its biologics license application (BLA) seeking approval of its bivalent respiratory syncytial virus (RSV) vaccine candidate, RSVpreF for the prevention of lower respiratory tract disease (LRTI) caused by RSV in older adults (aged 60 and above). With the FDA granting priority review to the BLA, a decision is expected in May 2023.
The FDA grants Priority Review to regulatory applications for vaccines that, if approved, would offer better safety or effectiveness for the treatment or prevention of some serious conditions in comparison to standard applications.
Currently, there are no FDA-approved vaccines against RSV infections anywhere in the world. Older adults are at maximum risk to get RSV disease. The LRTI-RSV disease causes a high rate of morbidity and mortality in older adults and young kids.
Pfizer's BLA was based on data from a phase III study called RENOIR on the RSV candidate. The study's primary objective was to assess the safety and efficacy of the vaccine for the prevention of moderate-to-severe LRTI-RSV during the first RSV season.
Data from the interim analysis of the RENOIR study demonstrated vaccine efficacy of 66.7% in participants with two or more RSV-associated symptoms. However, the vaccine efficacy was 85.7% in participants with the more severe disease having three or more symptoms. In the study, the vaccine was well-tolerated, with no safety concerns.
Pfizer is also conducting a phase III study on RSVpreF infants through maternal immunization.
Pfizer's stock is down 14.3% this year so far against an increase of 10.8% for the industry.
Image Source: Zacks Investment Research
GSK's GSK RSV vaccine for older adults is also under FDA priority review with a decision expected on May 3, 2023. Regulatory applications seeking approval of GSK's RSV vaccine are under review in Japan and Europe as well.
AstraZeneca AZN and Sanofi's SNY RSV vaccine called Beyfortus/nirsevimab was approved in Europe for protection against LRTI caused by RSV in newborns and infants in November. A similar application is under review in the United States. The approval for Beyfortus was based on data from the MELODY phase III and other phase IIb studies conducted jointly by AstraZeneca and Sanofi.
Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Sanofi (SNY) : Free Stock Analysis Report
AstraZeneca PLC (AZN) : Free Stock Analysis Report
GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report
Pfizer Inc. (PFE) : Free Stock Analysis Report
Enterprise Storage Market Size (by Technology, Geography, Sector, and Size Band), Trends, Drivers and Challenges, Vendor Landscape, Opportunities and Forecast, 2021-2026
Summary. The global enterprise storage market research report provides an executive-level overview of the current storage market worldwide, with detailed forecasts of key indicators up to 2026.New York, Jan. 26, 2023 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Enterprise Storage Market Size (by Technology, Geography, Sector, and Size Band), Trends, Drivers and Challenges, Vendor Landscape, Opportunities and Forecast, 2021-2026" - https://www.reportlinker.com/p063127
Here's how I built a second income (and a third) for life!
After decades of working, I'm looking forward to banking this new second income without effort. I'm also working on building my second second income! The post Here's how I built a second income (and a third) for life! appeared first on The Motley Fool UK.
National Grid stands down coal power plants readied to help France
Drax and one EDF unit had been warmed up in response to request over strike concerns and not cold snap
Royal Mail reveals mounting losses after £200m strike hit
Operating losses have reached £295 million in the first nine months of its year so far.
Three in four people prefer better-connected public transport over driving, new global study reveals
Smart mobility interface Hitachi Rail is digitising public transport to create better connected services Delivering better connected public transport Hitachi Rail's new report explores how cities can better connect their public transport More than half of North American respondents would accept increased road taxes to fund better-connected public transport Hitachi Rail publishes first-of-its-kind major study into attitudes towards public transport across eight global cities – including Washingto
Broadband customers trapped by choice between huge mid-contract price hikes or exit fees of over £200, Which? warns.
Robotic Surgery Services Global Market Opportunities And Strategies To 2031
The Business Research Company provides the strategists; marketers and senior management with the critical information they need to assess the global robotic surgery services market as it emerges from the COVID 19 shut down.New York, Jan. 26, 2023 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Robotic Surgery Services Global Market Opportunities And Strategies To 2031" - https://www.reportlinker.com/p06413411/?utm_source=GNW Description:Where is the largest and fastest-
Local papers need new support to survive, say MPs
Local newspapers have been among those hit hardest by the drastic changes in the news industry, with many forced to close in recent years.
Microsoft issues latest: Outlook, Teams, Xbox and more go down in major outage
Microsoft has been hit a major outage, taking down Outlook, Teams and more. The issues also appeared to affect Microsoft Azure, its cloud services platform, meaning that other websites could also be affected. Microsoft recognised some of the issues on its social networks and server status page, and indicated that it was searching for the cause of the problem.
Holcim CEO wants to further expand in North America -report
Holcim's North American business is on track to represent half of the cement maker's sales, CEO Jan Jenisch said in a media interview, with the Swiss company considering more acquisitions to boost its products and solutions business there. Holcim wants to grow its solutions and products division to around 30% of group sales by 2025, Jenisch told financial website The Market. "We're well on track there, and it can grow further," The Market cited Jenisch as saying in an interview published on Wednesday.
Ethereum posts lukewarm response to 'Shanghai upgrade' ⁠— The Crypto Mile Weekly Update
Ethereum posts a lukewarm response to this week's successful test of the blockchain's upcoming Shanghai upgrade.
American Airlines bullish on demand as Southwest reports loss
American Airlines offered a confident outlook on 2023 travel demand Thursday after reporting record quarterly revenues, while Southwest Airlines continued to suffer the effects of recent operational problems."We expect a strong demand environment to continue in 2023 and anticipate further improvement in demand for long-haul international travel this year."
Britain to challenge China with £1bn subsidies for computer chip makers
Ministers are preparing to invest at least £1bn in Britain's computer chip industry in a challenge China's dominance of the sector.
A hidden feature of this stock allows us to predict a 100pc rise in the share price
Some readers, Questor suspects, will wince at this striking fact about today's stock: it has made 17 acquisitions over the past decade or so.
$45.6 Billion Worldwide Cellulose Fibers Industry to 2027: Featuring China Bambro Textile. Daicel, Eastman Chemical and Grasim Industries Among Others
Global Cellulose Fibers Market Global Cellulose Fibers Market Dublin, Jan. 26, 2023 (GLOBE NEWSWIRE) -- The "Cellulose Fibers Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.The global cellulose fibers market size reached US$ 27.6 Billion in 2021. Looking forward, the publisher expects the market to reach US$ 45.6 Billion by 2027, exhibiting a CAGR of 8.73% during 2021-2027. Keeping in mind the un
Commercial Printing Global Market Report 2022: Featuring Quad/Graphics Inc, Acme Printing, RR Donnelley, Dai Nippon & More
Commercial Printing Market Commercial Printing Market Dublin, Jan. 25, 2023 (GLOBE NEWSWIRE) -- The "Commercial Printing Market" report has been added to ResearchAndMarkets.com's offering.The global commercial printing market size is expected to reach USD 574.12 billion by 2030, according to a new study. The report gives a detailed insight into current market dynamics and provides analysis on future market growth. The global increase in instances of commercial printing may be responsible for the