Moderna resizes its manufacturing footprint for a post-pandemic era

Moderna (NASDAQ:MRNA) is progressing on efforts to resume revenue growth in 2025 — even as COVID-19 vaccine sales decline now that the virus is endemic versus a pandemic.

During a presentation at the JP Morgan Healthcare Conference this week, Moderna CFO Jamey Mock noted that the company took a charge of $1.6 billion during the second half of 2023 as it resized its manufacturing footprint.

Meanwhile, the company is betting on a diverse pipeline that relies on its mRNA platform. The company enters 2024 with 45 therapeutic and vaccine programs, including nine in late-stage development. Key highlights include:

Respiratory syncytial virus (RSV) vaccine: Moderna expects regulatory approvals starting in the first half of this year for its vaccine to prevent RSV-associated lower respiratory tract disease and acute respiratory disease in adults 60 and up. The company says it will have the only pre-filled syringe product available at launch and has worked to genera…
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Pharma giants make progress in pivot to mRNA technology in race for next-gen influenza vaccines, but hurdles remain

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mRNA technology helped propel the development of some of the most successful drugs in pharma history — notably, the Comirnaty COVID-19 from Pfizer generated almost $56 billion in 2022 while Moderna’s Spikevax vaccine raked in $18.4 billion. But with demand for COVID-19 vaccines cooling, drug developers are aiming to extend the dominion of mRNA technology to flu vaccines. This month, Moderna and the CureVac/GSK alliance announced promising interim results for their respective flu vaccine candidates. Meanwhile, a year ago, in September 2022, Pfizer announced a phase 3 study for its mRNA-based influenza vaccine. NIH is also developing an mRNA vaccine that promises to provide protection against all known influenza subtypes. A phase 1 study of it is underway.

Sanofi has acknowledged the promise and perils of mRNA flu vaccines

Sanofi, a prominent flu vaccine maker, has acknowledge…

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Pfizer and Moderna win FDA nod for XBB.1.5 COVID-19 vaccine boosters, but projected sales pale in comparison to 2022’s

As Pfizer and Moderna receive the FDA nod for COVID-19 boosters, their 2023 global sales projections appear to be just a fraction of the previous year’s. In 2022, Pfizer and its partner BioNTech jointly sold $56 billion worth of their Comirnaty COVID-19 vaccine, marking the best-selling drug of the year. Moderna’s Spikevax COVID-19 vaccine wasn’t far behind, registering sales of $18.4 billion, signifying the fifth best-selling drug.

After the FDA nod for COVID-19 boosters, market projections remain subdued

Demand for COVID-19 vaccines, however, appears to be relatively weak, a reality reflected in revenue guidance from Pfizer and Moderna. The former announced in its Q2 2023 revenue guidance that it projects its COVID-19 vaccine sales of approximately $13.5 billion — a 64% slide from its respective 2022 global sales of $37.8 billion. Meanwhile, Moderna expects its 2023 COVID-19 vaccine sales in the range of $6 billion to $8 billion.

A simple li…

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Top 12 reported events for Moderna and Pfizer omicron-targeting COVID-19 boosters

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

With updated COVID-19 boosters set to launch in the near future and COVID-related hospitalizations on the rise again, scrutiny is on the rise of emerging variants and the benefit-safety profile of COVID-19 vaccines.

We performed a retrospective analysis of data from the Vaccine Adverse Event Reporting System (VAERS), focusing on the period covering the launch of the bivalent COVID-19 boosters in 2022 to August 25, 2023. The data captures 15,592 reported events for the Moderna vaccine and 21,553 for the vaccine from Pfizer and BioNTech.

COVID-19 reports: Correlation does not equal causation

Both Moderna and Pfizer vaccine boosters have associated reports of …

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Moderna and Pfizer ready updated COVID-19 boosters to combat BA.2.86 and other emerging variants

[Image courtesy of Production Perig/Adobe Stock]

Against the backdrop of a nearly 16% spike in COVID-19 hospitalizations in late August, according to CDC data, federal authorities are gearing up to greenlight updated boosters. Moderna announced that its latest COVID vaccine is effective against this new strain. Meanwhile, Pfizer revealed positive preclinical data for its vaccine, developed in collaboration with BioNTech.

In late August, Novavax also announced that its updated protein-based XBB COVID vaccine candidate retained neutralizing antibody responses to several emerging subvariants, including EG.5.1 and XBB.1.16.6. Unlike the mRNA-based boosters from Pfizer and Moderna, Novavax’s COVID vaccine would be the sole protein-based non-mRNA vaccine option available for the upcoming fall season.

The following visualization, based on CDC data, highlights the top SARS-CoV-2 variants for August and Sept…

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Pfizer and Moderna tout preliminary data in battle against Eris SARS-CoV-2 subvariant

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COVID-19 vaccine giants Pfizer and Moderna are gearing up for a battle against the Eris SARS-CoV-2 subvariant, which has rapidly emerged as the dominant strain in the U.S. Eris now is responsible for more than one in five COVID infections, based on CDC estimates from August 6 to 19.

Pfizer has noted that its most recent COVID-19 shot, which it is testing against emerging variants, demonstrated neutralizing activity against the “Eris”in a mouse study. The company said it is keeping a close watch on the variant and is ready to produce “variant-modified vaccine templates” if needed. Pfizer intends to launch its updated vaccine commercially by the end of August, pending regulatory approval.

Moderna has also announced positive preliminary testing of its latest vaccine shot against the Eris SARS-CoV-2 subvariant. The company indicates that preliminary clinical trial data demonstra…

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Moderna leans on RSV vaccine, AI and a diversified pipeline to regain competitive edge

Moderna surged to prominence thanks to its rapid development of a competitive COVID-19 vaccine. Since the early days of the pandemic, however, the company has struggled to maintain its momentum. Year-to-date, its stock is down close to 40%, trading around $110 per share.

Adapting to COVID-19 variants

The company hopes that its development of vaccines for the XBB.1.5 COVID-19 variant will help bolster financial performance. “We are now awaiting approval to start for our updated COVID-19 vaccine applications to regulators globally,” Moderna CEO Stéphane Bancel said.

Developing a robust pipeline

Moderna CEO Stéphane Bancel has stressed in the past that Moderna is more than a COVID-19 company. “Our commercial team is also preparing for the 2024 launch of our next respiratory commercial product,” Bancel said. This product in question, a vaccine for respiratory syncytial virus (RSV) could potentially compete against products from GSK and Pfizer, among others.

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How COVID vaccine options stack up for fall 2023

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The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is backing a significant shift in the current COVID-19 vaccine strategy: a move from multivalent to monovalent vaccines focusing on the XBB lineage strains. The advisory committee has set its sights on protecting against XBB.1.5 and has jettisoned is support for vaccines with a Wuhan component, which was included as a component of the bivalent vaccine boosters that debuted in fall 2022. “Continuing to include the original Wuhan strain was unnecessary since early strains are no longer in circulation,” said Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases.

While supporting monovalent vaccines, VRBPAC members acknowledged that the predominant SARS-CoV-2 sublineages could continue to evolve. “We may well find that XBB.1.16 or XBB.2.3 become more dominant than XBB.1…

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An overview of the RSV vaccine landscape: What comes after GSK’s approval of Arexvy?

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GSK (NYSE:GSK) has secured FDA approval for its respiratory syncytial virus (RSV) vaccine Arexvy, marking a significant milestone in the RSV vaccine landscape. RSV is common and usually results in mild infections, but can be dangerous in the immunocompromised as well as in younger and older populations.

The GSK vaccine targets adults aged 60 and older. In clinical studies, the single-dose vaccine demonstrated strong efficacy in preventing lower-respiratory tract infections and more severe diseases. In a phase 3 study published in NEJM with a median follow-up of 6.7 months, the vaccine efficacy against RT-PCR-confirmed RSV-related lower respiratory tract disease was 82.6%.

Efficacy against severe RSV-related lower respiratory tract disease was higher at 94.1% while efficacy against RSV-related acute respiratory infection was 71.7%. The most commonly reported side effects of Arexv…

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The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back

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The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19 vaccine. Although Comirnaty maintained its position as the best-selling pharmaceutical of 2022, it experienced a roughly 5% drop in sales compared to the previous year.

As the best-selling pharmaceuticals of 2022 demonstrate, signs are emerging that the reign of COVID-19 vaccines and  other therapies appears to be slipping.. The two companies — and Moderna — plan on hiking prices to address the weakening demand.

Humira: The second best-selling pharmaceutical of 2022 looking strong

Meanwhile, the heavyweight tumor necrosis factor (TNF) block…

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Moderna earnings miss in Q4 as COVID shot demand declines

Moderna (NASDAQ:MRNA) today reported fourth-quarter results that beat the Wall Street consensus on revenue but missed on earnings.

Demand for the company’s COVID-19 vaccines is down, and there is surplus production capacity.

Investors reacted by sending MRNA shares down more than 1% to $156.51 apiece in morning trading.

The Cambridge, Massachusetts–based creator of mRNA-based therapies and vaccines earned $1.5 billion, or $3.61 per share, off of $5.1 billion during the quarter that ended Dec. 31, 2022. Earnings were less than a third of what they were during Q4 2021. Revenue was down nearly 30%.

Wall Street analysts had expected an EPS of $4.68 and $5.02 billion in revenue.

“2022 was another impressive year for Moderna, with over $19 billion in revenue and significant clinical breakthroughs across our portfolio. We continue to provide our Omicron-targeting bivalent vaccines worldwide, with the latest real-world evidence highligh…

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Moderna’s RSV vaccine mRNA-1345 was more than 80% effective in a Phase 3 study 

mRNA vaccine company Moderna (Nasdaq:MRNA) plans on submitting for regulatory approval for its investigational RSV mRNA-1345 vaccine after it met primary efficacy endpoints in the Phase 3 ConquerRSV study (NCT05127434).

The RSV data are “a clear positive for MRNA” and represent a good omen for upcoming mRNA Phase 3 influenza data, noted UBS in a briefing note.

MRNA shares were up 5.70% in after-hours trading, hitting $201.55.

“Importantly, we think this is a milestone for MRNA’s pipeline beyond COVID in demonstrating the competitive efficacy of mRNA vaccines,” noted UBS Eliana Merle. “We think RSV could be a meaningful opportunity with no vaccine yet approved.

UBS sees an opportunity worth more than $5 billion in RSV.

The Moderna study, enrolling roughly 37,000 adults aged 60 or older in 22 countries, tested mRNA-1345 in older adults divided into two groups. One group had two or more symptoms of RSV…

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