FDA Blocks Publication of Vaccine Safety Studies
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Should l Buy MRNA?
Officials at the Food and Drug Administration have blocked publication of several studies supporting the safety of widely used vaccines against Covid-19 and shingles in recent months, according to The New York Times' Christina Jewett, who reports this was confirmed by a spokesman for the Department of Health and Human Services. Publicly traded companies that make vaccines and drugs include Moderna (MRNA), Pfizer (PFE), BioNTech (BNTX), Novavax (NVAX), AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Roche (RHHBY), and Sanofi (SNY).
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy MRNA?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on MRNA
Wall Street analysts forecast MRNA stock price to fall
20 Analyst Rating
1 Buy
16 Hold
3 Sell
Hold
Current: 48.790
Low
17.00
Averages
32.47
High
63.00
Current: 48.790
Low
17.00
Averages
32.47
High
63.00
About MRNA
Moderna, Inc. is a biotechnology company advancing a new class of medicines made of messenger ribonucleic acid (mRNA). It is engaged in developing medicines across infectious disease vaccines, oncology therapeutics and rare disease therapeutics. Its platform incorporates advances across three components, mRNA, delivery, and the manufacturing process, to advance its medicines. Its products are Spikevax and mNEXSPIKE (its COVID vaccines), and mRESVIA (its vaccine against respiratory syncytial virus (RSV)). It also has a diverse development pipeline that consists of 35 therapeutic and vaccine programs, six of which are in late-stage development. It has regulatory filings under review for its seasonal flu+COVID vaccine (mRNA-1083) in Europe and Canada and for its seasonal flu vaccine (mRNA-1010) in the United States, Europe, Canada and Australia. Its rare disease programs are Propionic acidemia (mRNA-3927); Methylmalonic acidemia (mRNA-3705), and Cystic Fibrosis (mRNA-3692/VX-522).
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.
Novavax Q1 Revenue Exceeds Expectations with Strong Vaccine Data
- Revenue Beat: Novavax reported Q1 revenue of $139.5 million, surpassing analysts' expectations of $78.3 million, primarily driven by licensing agreements and vaccine supply partnerships, indicating a strategic shift away from reliance on direct COVID vaccine sales.
- Increased Vaccine Preference: Data revealed that patients receiving Nuvaxovid were twice as likely to choose the same vaccine again next year compared to those who received Moderna's vaccine, providing Novavax with a significant competitive edge in the crowded vaccine market.
- 2026 Revenue Outlook: The company maintained its adjusted revenue forecast for 2026 at $230 million to $270 million, with expectations that existing cash and partner reimbursements will fund operations through 2028, even without additional milestone or royalty revenue.
- Optimistic Market Sentiment: Retail sentiment for NVAX on Stocktwits is deemed 'extremely bullish', with a 430% surge in message volume over 24 hours, reflecting strong investor confidence in the company's growth potential, despite a 4% downside from current price targets.
See More
Moderna Reports Strong Q1 2026 Earnings Driven by International Sales
- Significant Revenue Growth: Moderna reported $400 million in revenue for Q1 2026, reflecting a year-over-year increase primarily driven by its long-term strategic partnership with the U.K. government, with expectations of up to 10% growth in 2026 indicating strong international execution.
- New Product Approvals: The company secured approvals for mCOMBRIAX and mNEXSPIKE in the EU, which are expected to be key growth drivers in 2027, further solidifying Moderna's position in the $1.8 billion annual European respiratory vaccines market.
- Rising Cost Expectations: Due to litigation and settlement costs, Moderna has raised its sales cost projection from $900 million to $1.8 billion, which includes a $900 million litigation settlement charge, potentially impacting future profitability.
- Flu Vaccine Progress: Management expressed optimism regarding the regulatory status of its U.S. flu vaccine, with a PDUFA date of August 5 for mRNA-1010, marking a strategic shift from previous disappointment to clearer expectations for future market entry.
See More
Atlassian and Others See Significant Stock Gains
- Atlassian's Optimistic Guidance: Atlassian shares surged 23% after projecting a 24% revenue growth for the year, exceeding its previous 22% forecast and the FactSet consensus of 22.2%, indicating strong market performance and growth potential.
- nVent Electric's Strong Earnings: nVent's stock jumped 11% as first-quarter EPS and revenue surpassed Wall Street's highest estimates, with full-year revenue growth forecasted at 26% to 28%, significantly above the consensus of 18%, reflecting robust demand in data centers and energy storage.
- Cboe Global Markets Layoffs: Cboe shares rose 9% following the announcement of a 20% workforce reduction, with first-quarter adjusted EPS at $3.70 and revenue of $728.9 million, both exceeding market expectations, demonstrating the company's commitment to operational optimization.
- Roku's Revenue Beat: Roku's stock increased by 4% after reporting first-quarter revenue of $1.25 billion, surpassing the expected $1.20 billion, with adjusted EBITDA also exceeding estimates, showcasing the company's ongoing growth potential in the streaming market.
See More
Moderna Executive States Company is Seeking FDA Guidance on Resuming US Filing for Flu-COVID Combination Vaccine
Moderna's Next Steps: Moderna executives are awaiting guidance from the FDA regarding the next steps for resuming the filing process for their flu-COVID combination vaccine.
Focus on Combination Vaccine: The company is particularly focused on advancing its flu-COVID combination vaccine, which aims to address both illnesses in a single shot.
See More
Moderna Targets 10% Revenue Growth for FY 2026
- Revenue Growth Target: Moderna is targeting a 10% increase in revenue for FY 2026 compared to 2025, with an expected 50% sales split between U.S. and international markets.
- Q1 Performance Exceeds Expectations: In Q1 of FY 2026, Moderna reported net product sales of $389 million, significantly surpassing the Street's estimate of $235.5 million, indicating a strong rebound in COVID vaccine demand.
- Vaccine Review Progress: The U.S. FDA reversed its initial rejection and agreed to review Moderna's mRNA flu vaccine in February, a shift that may reflect changes in regulatory policies and impact the company's future market strategies.
- Market Reaction: Despite retail investor sentiment shifting from 'extremely bearish' to 'bearish', Moderna's shares rose nearly 6% in pre-market trading on Friday, reflecting a positive market response to its Q1 earnings report.
See More
Atlassian Shares Surge 25% on AI-Driven Revenue Growth
- Revenue Surge: Atlassian's third-quarter revenue rose 32% year-over-year, leading to a 25% jump in pre-market trading, and despite restructuring costs impacting profitability, non-GAAP earnings per share soared by 80%, reflecting strong demand for AI services.
- Cloud Transition: CFO James Chuong cautioned that the shift of customers to cloud services would result in a more muted level of data center expansion, with expectations for moderated revenue growth in Q4, which could impact future market performance.
- Product Advantage: Analyst Meilin Quinn noted that while workflows may be taken over by agents, there remains a need for trusted company knowledge and systems, providing Atlassian with a stronger foothold in engineering processes and enhancing its competitive edge.
- Market Reaction: Major stock indexes hit new highs amid continued growth in AI spending, with the S&P 500 closing above 7,200 points for the first time, reflecting strong market confidence in tech stocks and further boosting Atlassian's stock performance.
See More
Novavax Q1 Revenue Exceeds Expectations with Strong Vaccine Data
- Revenue Beat: Novavax reported Q1 revenue of $139.5 million, surpassing analysts' expectations of $78.3 million, primarily driven by licensing agreements and vaccine supply partnerships, indicating a strategic shift away from reliance on direct COVID vaccine sales.
- Increased Vaccine Preference: Data revealed that patients receiving Nuvaxovid were twice as likely to choose the same vaccine again next year compared to those who received Moderna's vaccine, providing Novavax with a significant competitive edge in the crowded vaccine market.
- 2026 Revenue Outlook: The company maintained its adjusted revenue forecast for 2026 at $230 million to $270 million, with expectations that existing cash and partner reimbursements will fund operations through 2028, even without additional milestone or royalty revenue.
- Optimistic Market Sentiment: Retail sentiment for NVAX on Stocktwits is deemed 'extremely bullish', with a 430% surge in message volume over 24 hours, reflecting strong investor confidence in the company's growth potential, despite a 4% downside from current price targets.
See More
Moderna Reports Strong Q1 2026 Earnings Driven by International Sales
- Significant Revenue Growth: Moderna reported $400 million in revenue for Q1 2026, reflecting a year-over-year increase primarily driven by its long-term strategic partnership with the U.K. government, with expectations of up to 10% growth in 2026 indicating strong international execution.
- New Product Approvals: The company secured approvals for mCOMBRIAX and mNEXSPIKE in the EU, which are expected to be key growth drivers in 2027, further solidifying Moderna's position in the $1.8 billion annual European respiratory vaccines market.
- Rising Cost Expectations: Due to litigation and settlement costs, Moderna has raised its sales cost projection from $900 million to $1.8 billion, which includes a $900 million litigation settlement charge, potentially impacting future profitability.
- Flu Vaccine Progress: Management expressed optimism regarding the regulatory status of its U.S. flu vaccine, with a PDUFA date of August 5 for mRNA-1010, marking a strategic shift from previous disappointment to clearer expectations for future market entry.
See More
Atlassian and Others See Significant Stock Gains
- Atlassian's Optimistic Guidance: Atlassian shares surged 23% after projecting a 24% revenue growth for the year, exceeding its previous 22% forecast and the FactSet consensus of 22.2%, indicating strong market performance and growth potential.
- nVent Electric's Strong Earnings: nVent's stock jumped 11% as first-quarter EPS and revenue surpassed Wall Street's highest estimates, with full-year revenue growth forecasted at 26% to 28%, significantly above the consensus of 18%, reflecting robust demand in data centers and energy storage.
- Cboe Global Markets Layoffs: Cboe shares rose 9% following the announcement of a 20% workforce reduction, with first-quarter adjusted EPS at $3.70 and revenue of $728.9 million, both exceeding market expectations, demonstrating the company's commitment to operational optimization.
- Roku's Revenue Beat: Roku's stock increased by 4% after reporting first-quarter revenue of $1.25 billion, surpassing the expected $1.20 billion, with adjusted EBITDA also exceeding estimates, showcasing the company's ongoing growth potential in the streaming market.
See More
Moderna Executive States Company is Seeking FDA Guidance on Resuming US Filing for Flu-COVID Combination Vaccine
Moderna's Next Steps: Moderna executives are awaiting guidance from the FDA regarding the next steps for resuming the filing process for their flu-COVID combination vaccine.
Focus on Combination Vaccine: The company is particularly focused on advancing its flu-COVID combination vaccine, which aims to address both illnesses in a single shot.
See More
Moderna Targets 10% Revenue Growth for FY 2026
- Revenue Growth Target: Moderna is targeting a 10% increase in revenue for FY 2026 compared to 2025, with an expected 50% sales split between U.S. and international markets.
- Q1 Performance Exceeds Expectations: In Q1 of FY 2026, Moderna reported net product sales of $389 million, significantly surpassing the Street's estimate of $235.5 million, indicating a strong rebound in COVID vaccine demand.
- Vaccine Review Progress: The U.S. FDA reversed its initial rejection and agreed to review Moderna's mRNA flu vaccine in February, a shift that may reflect changes in regulatory policies and impact the company's future market strategies.
- Market Reaction: Despite retail investor sentiment shifting from 'extremely bearish' to 'bearish', Moderna's shares rose nearly 6% in pre-market trading on Friday, reflecting a positive market response to its Q1 earnings report.
See More
Atlassian Shares Surge 25% on AI-Driven Revenue Growth
- Revenue Surge: Atlassian's third-quarter revenue rose 32% year-over-year, leading to a 25% jump in pre-market trading, and despite restructuring costs impacting profitability, non-GAAP earnings per share soared by 80%, reflecting strong demand for AI services.
- Cloud Transition: CFO James Chuong cautioned that the shift of customers to cloud services would result in a more muted level of data center expansion, with expectations for moderated revenue growth in Q4, which could impact future market performance.
- Product Advantage: Analyst Meilin Quinn noted that while workflows may be taken over by agents, there remains a need for trusted company knowledge and systems, providing Atlassian with a stronger foothold in engineering processes and enhancing its competitive edge.
- Market Reaction: Major stock indexes hit new highs amid continued growth in AI spending, with the S&P 500 closing above 7,200 points for the first time, reflecting strong market confidence in tech stocks and further boosting Atlassian's stock performance.
See More
