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GSK's RSV Vaccine Candidate Shows High Efficacy in Older Adults
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GSK plc (GSK - Free Report) recently announced that positive data from the pivotal phase III study — AReSVi 006 — evaluating its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above were presented at the IDWeek 2022.
In the study, the RSV vaccine candidate showed an overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease (RSV-LRTD), thereby meeting the study’s primary endpoint.
The vaccine also demonstrated consistent high efficacy against LRTD in severe disease (94.1%). In adults aged 70-79 years vaccine efficacy was 93.8% while in adults with underlying comorbidities such as cardiorespiratory and endocrinometabolic conditions, vaccine efficacy was 94.6%. The vaccine’s efficacy against LRTD was also consistent across both RSV-A and RSV-B subtypes.
Treatment with the vaccine was generally well tolerated with a favorable safety profile.
GSK plans to file regulatory applications seeking approval of its RSV vaccine candidate for older adults in the second half of 2022.
Shares of GSK have plunged 44.4% in the year-to-date period compared with the industry’s decrease of 27.3.
Image Source: Zacks Investment Research
Currently, there are no FDA-approved vaccines against RSV infections — a disease that leads to more than 420,000 hospitalizations and 29,000 deaths worldwide each year.
A potential approval for the RSV vaccine for older adults will boost GSK’s vaccine portfolio as it may become the first FDA-approved vaccine for this patient population. However, GSK is likely to face competition from other companies that are developing their respective vaccine candidates for RSV.
Pfizer (PFE - Free Report) is also developing its bivalent RSV vaccine candidate, RSVpreF, in a phase III study to prevent lower respiratory tract illness caused by RSV in individuals aged 60 years and above.
Pfizer plans to file a biologics license application seeking approval of the vaccine from the FDA in fall 2022.
Pfizer is also conducting a phase III study on RSVpreF in healthy pregnant women to help protect their babies from RSV after birth.
Loss per share estimates for Acadia narrowed 0.8% for 2022 and 11.7% for 2023 in the past 60 days.
Earnings of Acadia surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ACAD delivered an earnings surprise of 6.83%, on average.
Loss per share estimates for ORIC Pharmaceuticals narrowed 5.9% for 2022 and 7.3% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the other occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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GSK's RSV Vaccine Candidate Shows High Efficacy in Older Adults
GSK plc (GSK - Free Report) recently announced that positive data from the pivotal phase III study — AReSVi 006 — evaluating its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above were presented at the IDWeek 2022.
In the study, the RSV vaccine candidate showed an overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease (RSV-LRTD), thereby meeting the study’s primary endpoint.
The vaccine also demonstrated consistent high efficacy against LRTD in severe disease (94.1%). In adults aged 70-79 years vaccine efficacy was 93.8% while in adults with underlying comorbidities such as cardiorespiratory and endocrinometabolic conditions, vaccine efficacy was 94.6%. The vaccine’s efficacy against LRTD was also consistent across both RSV-A and RSV-B subtypes.
Treatment with the vaccine was generally well tolerated with a favorable safety profile.
GSK plans to file regulatory applications seeking approval of its RSV vaccine candidate for older adults in the second half of 2022.
Shares of GSK have plunged 44.4% in the year-to-date period compared with the industry’s decrease of 27.3.
Image Source: Zacks Investment Research
Currently, there are no FDA-approved vaccines against RSV infections — a disease that leads to more than 420,000 hospitalizations and 29,000 deaths worldwide each year.
A potential approval for the RSV vaccine for older adults will boost GSK’s vaccine portfolio as it may become the first FDA-approved vaccine for this patient population. However, GSK is likely to face competition from other companies that are developing their respective vaccine candidates for RSV.
Pfizer (PFE - Free Report) is also developing its bivalent RSV vaccine candidate, RSVpreF, in a phase III study to prevent lower respiratory tract illness caused by RSV in individuals aged 60 years and above.
Pfizer plans to file a biologics license application seeking approval of the vaccine from the FDA in fall 2022.
Pfizer is also conducting a phase III study on RSVpreF in healthy pregnant women to help protect their babies from RSV after birth.
Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Acadia Pharmaceuticals Inc. (ACAD - Free Report) and ORIC Pharmaceuticals, Inc. (ORIC - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Acadia narrowed 0.8% for 2022 and 11.7% for 2023 in the past 60 days.
Earnings of Acadia surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ACAD delivered an earnings surprise of 6.83%, on average.
Loss per share estimates for ORIC Pharmaceuticals narrowed 5.9% for 2022 and 7.3% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the other occasion. ORIC delivered an earnings surprise of 8.85%, on average.