Can BioNTech’s BNT165b1 malaria vaccine stand up to Oxford’s R21?

Malaria parasite connecting to a red blood cell [Image courtesy of NIAID]

The mRNA vaccine company BioNTech (Nasdaq:BNTX) has begun a Phase 1 study of BNT165b1, a multi-antigen malaria vaccine candidate that belongs to its BNT165 malaria program. 

Researchers at Oxford University are farther along with their R21/Matrix-M vaccine. A recently completed Phase 3 trial focused on R21. It could win licensure in 2023. 

In a Phase 2 study published in The Lancet, a booster of the R21 vaccine continued to offer strong protection against malaria one year after primary vaccination with three doses. In addition, the vaccine met the World Health Organization’s Malaria Vaccine Technology Roadmap standard of providing at least 75% efficacy.  

Oxford University is working with the Serum Institute of India to develop the R21 vaccine. 

Researchers at Oxford University were also instrumental in developing the …

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BioNTech to partner with Polish STING agonist firm Ryvu Therapeutics

The mRNA-focused biotech BioNTech (Nasdaq:BNTX) has partnered with Ryvu Therapeutics (Warsaw Stock Exchange:RVU), which specializes in novel small molecule therapies for emerging oncology targets.

In the deal, Mainz, Germany–based BioNTech will have an exclusive global license to commercialize Ryvu’s stimulator of interferon genes (STING) agonist portfolio. The companies will also partner to develop small molecule programs focused on immune modulation in oncology and potentially other disease areas. The STING agonist collaboration includes both potential monotherapy and therapeutic indications.

BioNTech will pay €40 million in the deal, which includes a €20 million upfront payment plus an equity investment of €20 million. The company will also provide additional research funding. The company could also potentially pay R&D and commercial milestone payments as well as low single-digit royalties.

BNTX shares were up 2% to $167.02. Ryvu’s shares surged 2…

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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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Developers of Pfizer/BioNTech COVID-19 vaccine to establish Asia-Pacific mRNA R&D center

mRNA Victoria announced today that the developers of the Pfizer/BioNTech COVID-19 vaccine will establish a clinical R&D center in the Asia-Pacific region.

The center enables Victorian and Australian researchers to advance the next generation of mRNA vaccines and therapies. The R&D center aims to facilitate partnerships on scientific mentoring, business development advice and drug design.

Once operational, the facility will manufacture next-generation mRNA treatments and vaccines for research and clinical trials. This includes potential infectious diseases, cancer medicines and personalized cancer treatments. It will form part of BioNTech’s global network to attract demand for Melbourne’s clinical trial expertise, according to a news release.

Establishing its first Asia-Pacific R&D center in Melbourne helps BioNTech provide state-of-the-art drug development and research capabilities to the local ecosystem, the company said. A partn…

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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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Pfizer and BioNTech get positive CHMP opinion for updated bivalent BA.4/BA.5-adapted COVID-19 vaccine booster 

Pfizer (NYSE: PFE) and its partner BioNTech (Nasdaq:BNTX) could potentially win authorization to market a 30-µg booster dose of their omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine after the Committee for Medicinal Products for Human Use (CHMP) backed the vaccine for individuals 12 and older.

The European Commission will likely make a final decision on the updated vaccine soon.

The updated vaccine has won emergency use authorization in the U.S. for use as a booster.

The new vaccine contains 15-µg of mRNA encoding the spike protein of the original form of SARS-CoV-2 and 15-µg of mRNA encoding the spike protein of the omicron BA.4/BA.5 sublineages.

Earlier this month, Pfizer and BioNatech announced they received a positive CHMP opinion for an omicron BA.1-adapted bivalent COVID-19 vaccine booster.

“Due to our multifaceted approach helping to address emerging variants and subvariants of concern, public health authorities in the EU will ha…

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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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Pfizer and BioNTech seek U.S. authorization for omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

[Image courtesy of Wikimedia Commons]

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have filed paperwork with the FDA requesting Emergency Use Authorization (EUA) for an updated COVID-19 vaccine booster.

Specifically, the request relates to an omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.

In late June, FDA recommended including an omicron BA.4/5 component for COVID-19 vaccine boosters.

Last week, the UK approved Moderna’s bivalent COVID-19 vaccine based on the original omicron lineage BA.1.

Pfizer and BioNTech are seeking authorization for a booster vaccine targeting the more recent sublineages omicron BA.4/BA.5.

If granted, the booster would be available for individuals at least 12 years old.

Pfizer and BioNTech note that the vaccine, if authorized, is available for immediate shipment.

The companies note that they plan on beginning a clinical trial focused o…

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Next-gen Pfizer-BioNTech vaccine candidates fare well in Phase 2/3 study

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have released positive data regarding two omicron-specific COVID-19 vaccine candidates.

One is monovalent, and the other is bivalent, combining the companies’ original BNT162b5 COVID-19 vaccine with mRNA based on the BA.1 omicron variant.

A Phase 2/3 study found that a booster dose of the next-gen Pfizer-BioNTech vaccine candidates led to a significantly higher immune response against omicron BA.1 than the companies’ original vaccine.

Booster doses of 30 µg and 60 µg generated a robust immune response in the Phase 2/3 study.

In the U.S., the BA.1 variant is responsible for a single-digit percentage of COVID-19 infections.

The company plans on sharing the data with the scientific community and health authorities to accelerate the potential introduction of an omicron-adapted booster “as soon as possible if authorized by regulators,” said Pfizer CEO Dr. Albert Bourla.

“Omicron has ne…

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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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Pfizer and BioNTech complete European submission for omicron-adapted COVID vaccine

Pfizer and BioNTech today announced they submitted to the European Medicines Agency (EMA) for an omicron-adapted bivalent COVID-19 vaccine candidate based on the BA.1 sub-lineage.

The application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to develop an omicron-adapted bivalent vaccine candidate to address the spread of SARS-CoV-2.

Pfizer recently announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the omicron-adapted bivalent vaccine candidate had a superior immune response against omicron BA.1 as compared to its current COVID-19 vaccine. The bivalent vaccine candidate was well-tolerated with a favorable safety profile.

Pfizer and BioNTech previously shared the data with the FDA to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency.

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Pfizer and BioNTech seek EMA authorization for COVID-19 vaccination in young children

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) have filed paperwork with the European Medicines Agency (EMA) requesting permission to use the Comirnaty COVID-19 vaccine in children aged 6 months to 5 years old.

As in the U.S., the companies are attempting to win authorization for a 3-µg dose vaccine administered as a three-dose series.

On June 17, FDA authorized the use of the Pfizer-BioNTech and Moderna vaccines in children as young as six months in the U.S. Before that, an FDA advisory committee unanimously supported the authorization of the Pfizer and Moderna vaccines in young children.

The EMA request included data from a Phase 2/3 randomized, controlled study based on data from 4,526 children 6 months to less than 5 years of age.

The study found that three doses of the vaccine resulted in a robust immune response with a safety profile similar to a placebo. In addition, the companies noted that adverse events were less common in young c…

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