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BioNTech and Matinas BioPharma forge mRNA-based research alliance

BioNTech SE (Nasdaq:BNTX) will partner with Matinas BioPharma (NYSE AMER:MTNB) to develop mRNA formats that use Matinas’ proprietary lipid nanocrystal (LNC) platform technology that could enable oral delivery.

The two companies will partner on formulation, optimization and in vitro testing.

BioNTech CEO Dr. Ugur Sahin said that the partnership could lead to the development of mRNA-based vaccines that facilitate intracellular delivery and the potential for oral delivery.

“This collaboration with BioNTech is an important validation from a leading global biotech company with demonstrated expertise in the design, formulation and delivery of mRNA,” said Matinas CEO Jerome D. Jabbour.

BioNTech will pay Matinas an upfront exclusive access fee and provide additional research funding.

BioNTech 2021 revenue surges 39x year over year

The mRNA vaccine pioneer (Nasdaq:BNTX) announced fourth-quarter revenue of €5.5 billion and €19.0 billion in revenue for 2021.

Sales of the BNT162b2 COVID-19 vaccine, developed jointly with Pfizer, fueled the revenue growth.

In 2020, BioNTech’s revenues were €482.3 million.

“Looking back, 2021 was an exceptional year during which BioNTech had a momentous impact on human health and the global economy with our first approved vaccine based on our mRNA technology,” said Dr. Ugur Sahin, BioNTech CEO, in a news release.

The company plans on using the recent cash infusion to boost R&D spending by roughly 50%. In all, the company plans on spending between €1.4 billion to €1.5 billion in R&D in 2022.

It seeks to advance various programs, including the development of mRNA-based immunotherapies, cell therapies and bi-specific antibodies. The company will also invest in regenerative medicine and autoimmune diseases.

BioNTech also plans t…

FDA advisory panel to convene to consider second booster dose

[Photo by Daniel Schludi on Unsplash]The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to discuss the potential use of COVID-19 vaccine booster does.

Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) are seeking to amend the emergency use authorization of their respective vaccines to allow for an additional booster.

Pfizer and its partner BioNTech SE (Nasdaq:BNTX) are seeking authorization for a second booster in adults 65 and older, while Moderna is hoping FDA will authorize a second booster in adults 18 and older.

Get the full story from our sister site, Pharmaceutical Processing World.

Pfizer and BioNTech seeking FDA authorization of fourth COVID-19 vaccine dose for older adults

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older.

The two companies submitted two real-world data sets from Israel while the omicron variant was widespread.

Pfizer notes that an additional dose of the BNT162b2 vaccine enhanced protection against infections and severe illness.

Get the full story on our sister site Drug Discovery & Development.

Pfizer and BioNTech seeking FDA authorization of fourth COVID-19 vaccine dose for older adults

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older.

The two companies submitted two real-world data sets from Israel while the omicron variant was widespread.

Pfizer notes that an additional dose of the BNT162b2 vaccine enhanced protection against infections and severe illness.

One dataset involved patient records from the Israeli Ministry of Health involving more than 1.1 million adults at least 60 years old with no known prior COVID-19 infection eligible for a fourth dose booster. That data suggested that individuals receiving an additional dose were half as likely to be infected and had one-fourth the risk of contracting severe illness than those who had received a single booster.

The companies also submitted data from an ongoing, open-label, non-randomized study focused on healthcare w…

Pfizer-BioNTech vaccine moderately effective against omicron in children

The Pfizer-BioNTech COVID-19 vaccine lowered the incidence of omicron-based SARS-CoV-2 infection by 31% in children aged 5 to 15 in a recent study.

The vaccine was more effective in children between the ages of 12 and 15, lowering the risk of omicron infection by 59%, according to the study from CDC and Abt Associates.

Participants in the study received two doses of the vaccine.

The Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study incorporated real-world data and also gauged vaccine effectiveness against the delta variant.

Studying weekly nasal swab and survey data from 1,346 children in Arizona, Florida, Texas and Utah, researchers were able to capture mild infections.

“Other pediatric vaccine effectiveness studies relied on lab testing data or health records and generally captured only cases where a child had symptoms and received health care,” said Lauren Olsho, the PROTECT study’s principal investi…

NIH to study allergic reactions to COVID-19 mRNA vaccine

Image courtesy of Pexels

Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines.

The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants who experienced a mild or moderate systemic allergic reaction to either the Pfizer/BioNTech or Moderna COVID-19 vaccines.

Get the full story at our sister site, Drug Discovery & Development.

NIH to study allergic reactions to COVID-19 mRNA vaccine

Photo from Pexels

Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines.

The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants who experienced a mild or moderate systemic allergic reaction to either the Pfizer/BioNTech or Moderna COVID-19 vaccines.

People who developed a severe allergic reaction to a first dose of a COVID-19 mRNA vaccine are not eligible to enroll.

According to a news release, participants will receive a second dose of the vaccine as inpatients under carefully controlled conditions at the National Institutes of Health’s Clinical Center in Bethesda, Maryland. NIAID’s Laboratory of Allergic Diseases’ Dr. Pamela A. Guerrerio…

Pfizer plans to share data on fourth dose of COVID-19 vaccine with FDA

COVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg.

The company and its partner BioNTech (Nasdaq:BNTX) are also developing an omicron-specific version of the vaccine.

Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose of its original COVID-19 vaccine and a new formulation intended to protect against multiple SARS-CoV-2 variants.

Get the full story from our sister site, Drug Discovery & Development.

Pfizer plans to share data on fourth dose of COVID-19 vaccine with FDA

COVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg.

The company and its partner BioNTech (Nasdaq: BNTX) are also developing an omicron-specific version of the vaccine.

Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose of its original COVID-19 vaccine and a new formulation intended to protect against multiple SARS-CoV-2 variants.

Data related to the omicron-specific version are not yet available.

Pfizer also said that clinical trial data involving children under 5 who received three doses of its COVID-19 vaccine would be available in April.

A small Israeli study summarized in Nature last month indicated that a fourth vaccine dose provides a modest increase in antibodies.

Pfizer-BioNTech omicron-based vaccine may be delayed

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have launched a clinical trial to test an omicron-specific version of their COVID-19 vaccine.

The two companies initially vowed to launch the updated vaccine by the end of March, but that goal may shift depending on the volume of clinical data regulators demand, according to BioNTech.

In the meantime, a number of countries have begun administering a fourth COVID-19 vaccine dose to immunocompromised individuals. In addition, Israel and Denmark have started offering a fourth dose to the public.

The European Medicines Agency (EMA) has stated it wants to see data showing that updated vaccines lead to higher neutralizing antibody levels than first-generation vaccines while potentially bolstering the protection against emerging variants.

Moderna is also working on an omicron-specific vaccine, but it won’t likely be available until August.

FDA hits pause on COVID-19 vaccine for children under 5

FDA may wait several months before deciding to authorize a COVID-19 vaccine for children between the ages of 6 months to 4 years.

The agency had planned on adjourning a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the potential use of the vaccine in younger children.

But FDA decided to postpone the meeting until further notice after Pfizer (NYSE:PFE) shared new data related to its emergency use authorization (EUA) request for an ongoing clinical trial testing the Pfizer-BioNTech vaccine in young children.

FDA indicated in a statement that it wants to review data related to a third dose of the vaccine to foster “a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines.”

The agency noted that evaluating initial data from the clinical trial was “useful,” but “at this time, we believe additional information regarding the ongoing evaluatio…