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Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design

Pfizer

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

The clinical trial remains ongoing with other sites not operated by the third party, and Pfizer continues to enroll new participants at those sites. The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S.

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Biopharma Leaders Unite To Stand With Science

The Pharma Data

The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson.

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Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine

The Pharma Data

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Pneumococcal Disease.

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Biopharma Leaders Unite To Stand With Science

The Pharma Data

United States Food and Drug Administration. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. www.sec.gov. www.sec.gov. About AstraZeneca. AstraZeneca. March 31, 2020. which is available on the SEC’s website at.

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Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 6 Months to less than 5 Years in the European Union

Pfizer

Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the original Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series in this age group in June 2022. Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus.

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Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age

Pfizer

1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted 5-adapted bivalent vaccine, and preclinical data from the companies’ Omicron BA.4/BA.5-adapted