FDA Blocks Publication of Vaccine Safety Studies Amid Controversy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Should l Buy GSK?
Source: CNBC
- Vaccine Study Publication Blocked: The FDA confirmed it has blocked the publication of several studies supporting the safety of Covid and shingles vaccines, reflecting the Trump administration's ongoing skepticism towards vaccines, which may hinder patient access to these shots.
- Vaccine Recommendation Policy Shift: Under Secretary of Health and Human Services Robert F. Kennedy Jr., federal health agencies have reduced recommendations for Covid shots, indicating a weakening support for vaccine development research that could impact public trust in vaccinations.
- Withdrawal of Studies Explained: FDA scientists analyzed millions of patient records and found rare side effects of the vaccines; however, they were directed to withdraw two accepted Covid vaccine studies, highlighting the agency's commitment to maintaining the integrity of its scientific process.
- Shingles Vaccine Research Concerns: An HHS spokesperson stated that the design of the shingles vaccine study fell outside the FDA's purview, further emphasizing the strict standards and policies governing vaccine research oversight.
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Analyst Views on GSK
Wall Street analysts forecast GSK stock price to fall
6 Analyst Rating
1 Buy
2 Hold
3 Sell
Moderate Sell
Current: 50.500
Low
20.15
Averages
38.72
High
55.60
Current: 50.500
Low
20.15
Averages
38.72
High
55.60
About GSK
GSK plc is a United Kingdom-based biopharma company. The Company’s segments include Commercial Operations and Research and Development. The Company is focused on the science of the immune system and advanced technologies, investing in four core therapeutic areas-respiratory, immunology and inflammation; oncology; human immunodeficiency virus (HIV), and infectious diseases. Its specialty medicines prevent and treat diseases, from asthma, cancer and HIV to autoimmune diseases like lupus. General medicines include inhalers for asthma and chronic obstructive pulmonary disease (COPD) with antibiotics. Its portfolio also includes Efimosfermin, a fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development. The Company also engaged in ozureprubart, a long-acting anti-immunoglobulin E (IgE) monoclonal antibody. The Company also owns HS235, a potential molecule for the treatment of pulmonary hypertension (PH).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Clinical Trial Initiation: Under the agreement, the companies plan to initiate their first clinical trial this year, focusing on developing injectable versions of antibody-drug conjugates, which is expected to accelerate the market introduction of new therapies.
- Future Development Options: Halozyme will provide GSK with an option to develop Enhanze-based therapies targeting other drug targets in the future, indicating the potential for long-term collaboration in innovative drug development.
- Financial Terms Undisclosed: While the agreement includes undisclosed upfront payments and royalties on net sales of Enhanze-based products, specific financial terms remain confidential, which may affect market expectations regarding the collaboration.
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Focus on Oncology: The partnership aims to develop subcutaneous formulations targeting multiple promising oncology therapies.
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FDA Blocks Publication of Vaccine Safety Studies Amid Controversy
- Vaccine Study Publication Blocked: The FDA confirmed it has blocked the publication of several studies supporting the safety of Covid and shingles vaccines, reflecting the Trump administration's ongoing skepticism towards vaccines, which may hinder patient access to these shots.
- Vaccine Recommendation Policy Shift: Under Secretary of Health and Human Services Robert F. Kennedy Jr., federal health agencies have reduced recommendations for Covid shots, indicating a weakening support for vaccine development research that could impact public trust in vaccinations.
- Withdrawal of Studies Explained: FDA scientists analyzed millions of patient records and found rare side effects of the vaccines; however, they were directed to withdraw two accepted Covid vaccine studies, highlighting the agency's commitment to maintaining the integrity of its scientific process.
- Shingles Vaccine Research Concerns: An HHS spokesperson stated that the design of the shingles vaccine study fell outside the FDA's purview, further emphasizing the strict standards and policies governing vaccine research oversight.
See More
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- Cancer Treatment Breakthrough: GSK's prototype targeted cancer drug Mo-rez shows breakthrough potential, with preliminary data indicating that 62% of patients with platinum-resistant ovarian cancer and 67% with endometrial cancer achieved at least a 30% reduction in tumor size, laying a foundation for GSK's further development in cancer treatment.
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- Career Background: Szarama joined the FDA in December 2022, previously serving as the deputy director of CBER and having worked at the U.S. Centers for Medicare and Medicaid Services from 2016 to 2019, providing her with a robust foundation for her new role.
- Leadership Transition: Her appointment follows the departure of Vinay Prasad in April 2023, who faced criticism for several controversial decisions during his tenure, highlighting the turbulence within the FDA's leadership.
- Regulatory Challenges: Prasad's tenure included managing the fallout from several deaths linked to the gene therapy Elevidys developed by Sarepta and Bayer, raising significant public and industry scrutiny, suggesting that Szarama's leadership may steer the FDA towards a more cautious regulatory approach.
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- Partnership Impact: The PROGRESS-AD trial was a key component of Alector's collaboration with GSK, and its discontinuation highlights the challenges faced by Alector following last year's Phase 3 trial failure for another form of dementia, raising concerns about the viability of their pipeline.
- Commitment to Future Development: Despite the trial's halt, CEO Arnon Rosenthal emphasized Alector's commitment to advancing its broader pipeline targeting neurodegenerative diseases, including multiple wholly owned candidates enabled by their ABC platform, showcasing confidence in future research endeavors.
- Market Reaction Analysis: Alector's stock price increase following the trial discontinuation reflects investor trust in the company's other research projects, indicating that despite setbacks, the market remains optimistic about its potential in the neuroscience field.
See More
Halozyme and GSK Reach Drug Delivery Technology Licensing Agreement
- Agreement Reached: Halozyme Therapeutics (HALO) has entered into a global collaboration and licensing agreement with GSK (GSK) to advance subcutaneously delivered cancer drugs, marking a strategic partnership in cancer treatment.
- Clinical Trial Initiation: Under the agreement, the companies plan to initiate their first clinical trial this year, focusing on developing injectable versions of antibody-drug conjugates, which is expected to accelerate the market introduction of new therapies.
- Future Development Options: Halozyme will provide GSK with an option to develop Enhanze-based therapies targeting other drug targets in the future, indicating the potential for long-term collaboration in innovative drug development.
- Financial Terms Undisclosed: While the agreement includes undisclosed upfront payments and royalties on net sales of Enhanze-based products, specific financial terms remain confidential, which may affect market expectations regarding the collaboration.
See More
HALOZYME AND GSK ENTER INTO GLOBAL PARTNERSHIP AND LICENSE DEAL TO ADVANCE SUBCUTANEOUS FORMULATIONS FOR SEVERAL PROMISING CANCER TARGETS
Global Collaboration Announcement: Haloyzime has announced a global collaboration and licensing agreement with GSK.
Focus on Oncology: The partnership aims to develop subcutaneous formulations targeting multiple promising oncology therapies.
See More
FDA Blocks Publication of Vaccine Safety Studies Amid Controversy
- Vaccine Study Publication Blocked: The FDA confirmed it has blocked the publication of several studies supporting the safety of Covid and shingles vaccines, reflecting the Trump administration's ongoing skepticism towards vaccines, which may hinder patient access to these shots.
- Vaccine Recommendation Policy Shift: Under Secretary of Health and Human Services Robert F. Kennedy Jr., federal health agencies have reduced recommendations for Covid shots, indicating a weakening support for vaccine development research that could impact public trust in vaccinations.
- Withdrawal of Studies Explained: FDA scientists analyzed millions of patient records and found rare side effects of the vaccines; however, they were directed to withdraw two accepted Covid vaccine studies, highlighting the agency's commitment to maintaining the integrity of its scientific process.
- Shingles Vaccine Research Concerns: An HHS spokesperson stated that the design of the shingles vaccine study fell outside the FDA's purview, further emphasizing the strict standards and policies governing vaccine research oversight.
See More
GSK Completes $950 Million Acquisition of 35Pharma to Enhance Pipeline
- Acquisition Completed: On April 15, 2026, GSK plc announced the completion of its $950 million acquisition of Canadian clinical-stage biopharmaceutical firm 35Pharma Inc., granting GSK full control over 35Pharma and its pipeline, strategically enhancing its market position in pulmonary hypertension treatment.
- New Drug Development: The acquired 35Pharma is developing HS235, which aims for improved selectivity that may reduce bleeding risks and other side effects associated with existing pulmonary arterial hypertension treatments; early clinical trials indicate metabolic advantages such as fat-selective weight reduction and enhanced insulin sensitivity, suggesting significant future market potential.
- Cancer Treatment Breakthrough: GSK's prototype targeted cancer drug Mo-rez shows breakthrough potential, with preliminary data indicating that 62% of patients with platinum-resistant ovarian cancer and 67% with endometrial cancer achieved at least a 30% reduction in tumor size, laying a foundation for GSK's further development in cancer treatment.
- Investment Outlook: While GSK is viewed as a low-risk investment, analysts note that certain AI stocks may offer greater upside potential, indicating that GSK's competitiveness in the biopharmaceutical sector requires ongoing market attention to maintain its investment appeal.
See More
FDA Appoints New Acting Director for Biologics Center
- New Appointment: The FDA has appointed Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research (CBER), responsible for regulating vaccines and biologic drugs, indicating the agency's ongoing commitment to the biologics sector.
- Career Background: Szarama joined the FDA in December 2022, previously serving as the deputy director of CBER and having worked at the U.S. Centers for Medicare and Medicaid Services from 2016 to 2019, providing her with a robust foundation for her new role.
- Leadership Transition: Her appointment follows the departure of Vinay Prasad in April 2023, who faced criticism for several controversial decisions during his tenure, highlighting the turbulence within the FDA's leadership.
- Regulatory Challenges: Prasad's tenure included managing the fallout from several deaths linked to the gene therapy Elevidys developed by Sarepta and Bayer, raising significant public and industry scrutiny, suggesting that Szarama's leadership may steer the FDA towards a more cautious regulatory approach.
See More
Alector Discontinues Mid-Stage Alzheimer’s Trial for Latozinemab
- Trial Discontinuation: Alector announced the discontinuation of its mid-stage trial for latozinemab after recommendations from its independent data monitoring committee, indicating that the 76-week global study was unlikely to meet its primary endpoint of slowing disease progression, resulting in a ~5% rise in stock price.
- Partnership Impact: The PROGRESS-AD trial was a key component of Alector's collaboration with GSK, and its discontinuation highlights the challenges faced by Alector following last year's Phase 3 trial failure for another form of dementia, raising concerns about the viability of their pipeline.
- Commitment to Future Development: Despite the trial's halt, CEO Arnon Rosenthal emphasized Alector's commitment to advancing its broader pipeline targeting neurodegenerative diseases, including multiple wholly owned candidates enabled by their ABC platform, showcasing confidence in future research endeavors.
- Market Reaction Analysis: Alector's stock price increase following the trial discontinuation reflects investor trust in the company's other research projects, indicating that despite setbacks, the market remains optimistic about its potential in the neuroscience field.
See More
