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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…

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…

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…

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…

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…

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 …

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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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…

FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall

Photo from Pexels

The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

FDA followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.

In particular, the agency recommends that vaccine makers develop bivalent COVID-19 vaccines with an omicron BA.4/5 spike protein component combined with the current vaccine composition.

FDA expects the updated vaccines to be used as a booster in “early to mid-fall 2022,” but the current formulation of vaccines for use as a primary series will remain unchanged.

Moderna and Pfizer have already shared data from c…

Sanofi-GSK COVID-19 vaccine effective against omicron

GSK plc (LSE/NYSE:GSK) and Sanofi (NYSE:GSK) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study.

For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron.

The vaccine is based on the original D614 virus and the beta (B.1.351) strain.

Across variants, the vaccine was 64.7% efficacious against symptomatic infection in adults. For those previously infected with COVID-19, the vaccine was 75.1% efficacious overall.

GSK and Sanofi noted that the vaccine candidate appeared to be well-tolerated.

Moderna (Nasdaq:MRNA) is developing a bivalent omicron booster vaccine candidate known as mRNA-1273.214.

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) have released minimal data to date on their next-generation COVID-19 vaccine.

Sanofi’s and GSK’s Phase 3 COVID-19 clinical trial, dubbed VAT08, enrolled more …

Young children in U.S. now eligible for COVID-19 vaccination

Some 18 months after adults became eligible for COVID-19 vaccines, children between 6 months to 4 years old can now be vaccinated in the U.S.

FDA authorized the shots for young children on June 17, while CDC did so a day later.

“The United States is now the first country in the world to offer safe and effective COVID-19 vaccines for children as young as six months old,” said President Joe Biden in a press briefing. “And for the first time in our fight against this pandemic, nearly every American can now have access to life-saving vaccines.”

Biden noted that the U.S. government had ample supplies of vaccines for young children and had coordinated with states, local health centers, pharmacies and pediatricians to help administer the shots.

“My administration, with the help of the CDC, has been planning and preparing for this moment for a long time,” Biden said.

The federal government has also created a webs…

EMA begins rolling review of Moderna’s and Pfizer’s updated COVID-19 vaccines

European Medicines Agency (EMA) has begun a rolling review for updated versions of Moderna’s and Pfizer/BioNTech’s vaccines modified to optimize protection against newer variants of SARS-CoV-2.

Earlier this month, Moderna (Nasdaq:MRNA) announced that its Omicron-containing bivalent COVID-19 booster candidate, mRNA-1273.21, provided an antibody response that was statistically superior to the original version of the vaccine, mRNA-1273.

EMA has also begun a rolling review of an updated version of the COVID-19 vaccine from Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX).

EMA’s review will first focus on data from laboratory studies in addition to chemistry, manufacturing and controls (CMC) data associated with the manufacture of the vaccines.

The vaccine developers will ultimately provide EMA with more information as part of the rolling review process.

While mRNA-1273.21 is Moderna’s lead candidate for t…