Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies' COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older.

The fast spread of the highly infectious Delta variant underscores the need for faster identification of COVID-19 mutations. Uniting governments and medical communities in this challenge, the University of Oxford and Oracle's Global Pathogen Analysis System (GPAS) is now being used by organizations on nearly every continent.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) with data supporting a booster (third) dose of COMIRNATY® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the government of India has issued a registration certificate and a permission to import the COVID-19 Vaccine Moderna for restricted use in an emergency situation.

BioNTech SE (NASDAQ: BNTX, "BioNTech" or "the Company"), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The study is evaluating the Company's therapeutic cancer vaccine candidate BNT111 in combination with Libtayo® (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma.

CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced results of the second interim analysis of its international pivotal Phase 2b/3 study in approximatively 40,000 subjects (the HERALD study) of CureVac's first-generation COVID-19 vaccine candidate, CVnCoV.