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BioNTech

FDA concludes Pfizer-BioNTech vaccine likely safe and effective in kids under 5

June 13, 2022 By Brian Buntz

In the U.S., COVID-19 vaccines are widely available to all age groups apart from children under the age of five. However, that could change this month now that FDA has signaled that three doses of the Pfizer-BioNTech (NYSE:PFE/Nasdaq BNTX) COVID-19 vaccine are likely effective against COVID-19 in an analysis ahead of a June 15 Vaccines […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: BioNTech, COVID-19 vaccine, Moderna, Pfizer

Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children

May 23, 2022 By Sean Whooley

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data support a three-dose primary series of their COVID-19 vaccine in young children Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong immune response and […]

Filed Under: Business/Financial News, Clinical Trials, Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, coronavirus, COVID-19, Pfizer

FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11

May 17, 2022 By Brian Buntz

The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine. The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said […]

Filed Under: Blog, Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, COVID-19 boosters, COVID-19 vaccine, Pfizer

FDA signals careful approach in authorizing COVID-19 vaccines in young children

May 2, 2022 By Brian Buntz

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June. In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months […]

Filed Under: Featured, Pharmaceutical Tagged With: BioNTech, COVID-19 vaccines, FDA, Moderna, Novavax, NVX‑CoV2373, Pfizer, Vaccines and Related Biological Products Advisory Committee, VRBPAC

Pfizer and BioNTech file for EUA for COVID-19 vaccine booster in kids 5 to 11 

April 27, 2022 By Brian Buntz

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11. The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: BioNTech, COVID-19 vaccine booster, Pfizer

Pfizer-BioNTech COVID-19 vaccine booster spurs strong immune response in kids 5–11

April 14, 2022 By Brian Buntz

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have shared positive data from a Phase 2/3 clinical study testing a third 10-µg dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children aged 5 through 11. The most recent data show that a booster dose of the BNT162b2 vaccine led to increased neutralizing titers for the omicron variant […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: BioNTech, booster, COVID-19 vaccine, Pfizer

FDA advisory panel to convene to consider second booster dose

March 21, 2022 By Brian Buntz

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) […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: BioNTech, COVID-19, COVID-19 boosters, FDA, Pfizer, Vaccines and Related Biological Products Advisory Committee, VRBPAC

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

March 16, 2022 By Brian Buntz

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 announced yesterday that they have submitted two real-world data sets from Israel while the omicron variant was widespread. Pfizer […]

Filed Under: Featured, Food & Drug Administration (FDA), News Well, Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccines, Pfizer

NIH to study allergic reactions to COVID-19 mRNA vaccine

March 9, 2022 By Sean Whooley

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 […]

Filed Under: Clinical Trials, Featured, Pharmaceutical Tagged With: BioNTech, coronavirus, COVID-19, Moderna, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Pfizer

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

March 9, 2022 By Brian Buntz

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 […]

Filed Under: Featured, Pharmaceutical Tagged With: BioNTech, COVID-19, Omicron, Pfizer

7 potential applications of mRNA-based therapeutics

January 10, 2022 By Brian Buntz

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: BioNTech, cardiovascular disease, infectious disease, mRNA, Pfizer

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