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

[Peter Hansen/Adobe Stock]

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

[sizsus/Adobe Stock]

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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FDA clears Moderna and Pfizer-BioNTech bivalent COVID-19 boosters in children

The FDA has amended emergency use authorizations (EUAs) for the bivalent COVID-19 vaccine boosters from Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE) to allow their use in children at least five years old.

FDA authorized a single dose of either bivalent vaccine in younger age groups at least two months after completion of primary or booster vaccination.

MRNA shares were up 8.28% to $130.72. PFE shares were mainly flat, holding steady at $42.03. BioNTech, which worked with Pfizer in developing the original and updated mRNA vaccine, saw its stock increase 5.53% to $136.65.

The bivalent vaccines from Moderna and Pfizer-BioNTech include an mRNA component shared between the omicron variant BA.4 and BA.5 lineages.

FDA’s decision to authorize the bivalent Pfizer-BioNTech COVID-19 vaccine booster overrides its prior authorization of the companies’ monovalent booster in children aged five to 11.

The revised Moderna authorization will make its 25 μg bi…

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Pfizer and Moderna seek FDA nod for omicron-adapted COVID boosters in children

[Image courtesy of Pixabay.]

Pfizer/BioNTech (NYSE:/PFE, Nasdaq BNTX) and Moderna (Nasdaq:MRNA) have both won emergency use authorizations in the U.S. for bivalent vaccine boosters based on BA.4/BA.5.

Pfizer is aiming to win authorization to use its updated COVID-19 vaccine in children aged 5 through 11 years. Moderna has requested that FDA greenlight the use of its omicron booster in individuals 6 to 17.

Pfizer’s shot is currently authorized for individuals at least 12 years old, while Moderna’s is authorized for individuals 18 and up.

Pfizer noted in a news release that it had submitted safety and immunogenicity data for the bivalent BA.1-adapted vaccine to FDA. The company also included preclinical and manufacturing data related to the bivalent omicron BA.4/BA.5-adapted vaccine.

Moderna’s updated booster for adults includes a 50-µg dose of mRNA, while the Pfizer-BioNT…

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FDA greenlights bivalent COVID-19 boosters from Pfizer and Moderna

FDA has authorized bivalent COVID-19 boosters from Moderna (Nasdaq:MRNA) and Pfizer/BioNTech (NYSE:PFE/Nasdaq:BNTX).

The FDA has authorized the updated Moderna vaccine as a single booster dose in individuals at least 18 years old. In addition, the agency authorized the Pfizer/BioNTech vaccine for those at least 12 years old.

Individuals in those age groups who have waited at least two months after receiving a second or third dose of a monovalent COVID-19 vaccine are eligible for the bivalent COVID-19 boosters.

The updated Moderna mRNA-1273.222 and Pfizer/BioNTech BNT162b5 vaccines could be available at U.S. vaccination sites in the coming days.

The updated COVID-19 vaccines encode the spike protein from the original SARS-CoV-2 strain and the BA.4 and BA.5 lineages of the omicron variant.

According to data from Walgreens, the omicron variant is responsible for nearly 100% of COVID-19 infections in the U.S.

Clinical trial data suggeste…

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Moderna says Pfizer-BioNTech COVID vaccine infringed its patents

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer and its COVID-19 vaccine partner BioNTech over patent infringement in U.S. and German courts.

Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany.

The suits could pit three of the most significant COVID-19 vaccine makers against each other in an IP battle with billions of dollars potentially at stake. COVID-19 vaccine revenue boosted Pfizer to the top of the list among the Pharma 50 largest pharmaceutical companies on Drug Discovery & Development. Moderna and BioNTech also joined the Pharma 50 for the first time in the most recent edition.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” Moderna CEO…

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Moderna inks deal with US for up to 300M omicron boosters

The U.S. government will pay $1.74 billion to buy 66 million doses of Moderna’s COVID-19 vaccine made with the new omicron-adapted formula, the drugmaker said today.

The government has the option to acquire up to 300 million total doses of the omicron boosters under the agreement.

The U.S. last month agreed to buy 105 million doses of Pfizer and BioNTech’s updated vaccine for $3.2 billion. That deal similarly includes an option for up to 300 million doses.

Moderna is developing the bivalent vaccine candidate mRNA-1273.222 based on feedback from the FDA. The vaccine incorporates mRNA from the omicron BA.4/5 strain.

“Moderna’s mRNA platform is enabling us to rapidly create mRNA-1273.222, a bivalent vaccine that specifically targets omicron subvariants BA.4 and BA.5, the most prevalent variants of concern in the U.S. today,” Moderna CEO Stéphane Bancel said in a news release.

Scientists are uncertain whether BA.4/BA.5–based v…

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Fall 2022 COVID-19 vaccine candidate tracker

[Photo from Pexels]

Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine. 

But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus. 

A variety of companies are developing next-generation COVID-19 vaccines that could potentially optimize the strength and durability of immune protection compared to the first crop of vaccines. 

Here, we round up notable COVID-19 vaccine candidates that, at least, could help pave the way for the fall 2022 booster drive.

BNT162b5

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) are developing a bivalent COVID-19 vaccine candidate known as BNT162b5 based on the ancestral strain and a BA.1 Omicron variant. The vaccine has a modified spike protein design to optimize the immune response …

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White House holds next-gen COVID-19 vaccine summit

Image courtesy of Wikipedia

The federal government continues to work closely with notable COVID-19 manufacturers, including Moderna and Pfizer, hosting a summit today focused on the future COVID-19 vaccines.

“We need a vaccine that can stand up to multiple variants,” said White House Covid-19 Response Coordinator Ashish Jha.

While White House officials called for developing inexpensive novel vaccines that could be delivered nasally or via a skin patch, they did not specify where the funding for such efforts would come from.

As the omicron BA.5 lineage has gained momentum, some pundits have called for the government to spur the development of novel vaccines.

The Biden administration hopes to stymie future SARS-CoV-2 variants, curb infection and transmission of the virus and ensure that future vaccines offer longer-lasting protection.

Moderna and Pfizer are both developing bivalent …

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July 2022 Issue: Pulsed-field ablation, DeviceTalks Boston and the Pharma 50

 

What is pulsed-field ablation? Here’s what you need to know

Dexcom CEO expects ‘science boom’ with CGM, automated insulin delivery

Tips for vetting contract manufacturers

They said it at DeviceTalks Boston

FDA can’t explain drop in device recalls, but experts point to COVID disruption

2022 Pharma 50: The 50 largest pharmaceutical companies

Innovators shake up the Pharma 50

As a father raising a toddler and an infant, I was relieved by the latest milestone in the COVID-19 pandemic: the authorization of vaccines for children between 6 months and 5 years.

The good news came as Pharma Editor Brian Buntz and the rest of our team were putting the final touches on this edition’s Pharma 50 project. It’s our annual ranking of the biggest pharmaceutical companies by global revenue, featured on our affiliated Drug Discovery & Development site. (Our Big 100 report on largest medic…

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