Pfizer and BioNTech announced collaboration with Brazil’s Eurofarma to manufacture COVID-19 vaccine doses
On Aug. 26, 2021, Pfizer and BioNTech announced the signing of a letter of intent with Eurofarma Laboratorios,…
Pfizer and BioNTech initiated rolling submission of SBLA to U.S. FDA for booster dose of COMIRNATY in individuals 16 and Older
On Aug. 25, 2021, Pfizer and BioNTech announced the initiation of a supplemental Biologics License Application (sBLA) to…
Pfizer-BioNTech COVID-19 vaccine COMIRNATY received full U.S. FDA approval for individuals 16 years and older
On Aug. 23, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) approved the…
Amyris achieved promising in-vivo results for intranasal delivery of RNA/NLC vaccine
On Aug. 20, 2021, Amyris announced promising in-vivo results in a study of its licensed RNA vaccine through…
NIH scientists developed faster COVID-19 test
On Aug. 16, 2021, scientists at the National Institutes of Health (NIH) announced they had developed a new…
Moderna announced FDA authorization of third dose of COVID-19 vaccine for immunocompromised individuals
On Aug. 13, 2021, Moderna announced that the Food and Drug Administration (FDA) had approved an update to…
NIH launched study of third COVID-19 vaccine dose in kidney transplant recipients
On Aug. 10, 2021, the National Institutes of Health (NIH) announced that a pilot study had begun to…
Moderna and Canada announced collaboration to bring mRNA manufacturing to Canada
On Aug. 10, 2021, Moderna announced a Memorandum of Understanding (MoU) with the government of Canada to build…
Twist Bioscience began shipping synthetic RNA positive controls for Delta (B.1.617.2) SARS-CoV-2 variant
On Jul. 22, 2021, Twist Bioscience announced that it had started shipping its synthetic RNA reference controls for…
Biotechnology | COVID-19 | FDA
U.S. FDA granted Priority Review for Biologics License Application for Pfizer-BioNTech COVID-19 vaccine
On Jul. 16, 2021, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) had granted…
Moderna announced supply agreement with Argentina for 20 million doses of its COVID-19 vaccine
On Jul. 12, 2021, Moderna announced a supply agreement with the government of Argentina for 20 million doses…
10 million doses of mRNA-based COVID-19 vaccine supplied to Taiwan Region
On Jul. 12, 2021, BioNTech announced that Fosun Industrial Co. had reached advance procurement agreements for the mRNA-based…
HDT Bio received notice to proceed from FDA for U.S. phase 1 clinical trial of RNA COVID-19 vaccine
On Jul. 1, 2021, HDT Bio announced the U.S. Food and Drug Administration had reviewed the companyﾒs Investigational…
WHO supported South African consortium to establish first COVID mRNA vaccine technology transfer hub
On Oct. 6, 2021, the World Health Organization and its COVAX partners are working with a South African…
Twist Bioscience began shipping of synthetic RNA controls for Kappa (B.1.617.1) SARS-CoV-2 variants
On Jun. 8, 2021, Twist Bioscience announced that it had started shipping its synthetic RNA reference controls for…
NIH researchers identified potential new antiviral drug for COVID-19
On Jun. 3, 2021, the National Institutes of Health announced that the experimental drug TEMPOL may be a…
Moderna announced rolling submission of Biologics License Application with FDA for COVID-19 vaccine
On Jun. 1, 2021, Moderna announced that it had initiated the rolling submission process with the U.S. Food…
Pfizer and BioNTech received first authorization in European Union for COVID-19 vaccine in adolescents
On May 28, 2021, Pfizer and BioNTech announced that the Conditional Marketing Authorization for COMIRNATY in the European…
Moderna announced TeenCOVE study of COVID-19 vaccine in adolescents met primary endpoint
On May 25, 2021, Moderna announced that the Phase 2/3 study of its COVID-19 vaccine (mRNA-1273) in adolescents…
Moderna and Aldevron announced expanded partnership for mRNA vaccine and therapeutic pipeline
On May 24, 2021, Moderna and Aldevron announced their expanded collaboration in support of the Moderna COVID-19 Vaccine…
Moderna and Samsung Biologics announced agreement for manufacturing of Moderna’s COVID-19 vaccine
On May 22, 2021, Moderna and Samsung Biologics announced a Manufacturing Services and Supply Agreement in which Samsung…
Japan’s Ministry of Health, Labour and Welfare approved Moderna’s COVID-19 vaccine
On May 21, 2021, Moderna announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan granted…
Ministry of Food and Drug Safety of South Korea authorized Moderna’s COVID-19 vaccine
On May 21, 2021, Moderna announced that the Ministry of Food and Drug Safety of South Korea (MFDS)…
Pfizer and BioNTech announced supplying EU with up to 1.8 billion additional doses of COMIRNATY
On May 20, 2021, Pfizer and BioNTech announced a new agreement with the European Commission (EC) to supply…
Second-generation COVID-19 vaccine candidate, CV2CoV, demonstrated high immunogenicity in preclinical study
On May 13, 2021, CureVac announced together with its collaboration partner GSK, first preclinical data in a rat…
Moderna announced new supply agreement with Australia for 25 million doses of its COVID-19 vaccine
On May 12, 2021, Moderna announced a new supply agreement with the government of Australia for 25 million…
Pfizer and BioNTech initiated rolling submission of Biologics License Application for FDA approval of COVID-19 vaccine
On May 7, 2021, Pfizer and BioNTech announced the initiation of a Biologics License Application (BLA) with the…
Moderna announced positive initial booster data against SARS-CoV-2 variants
On May 5, 2021, Moderna announced initial data from its Phase 2 study showing that a single 50…
HDT Bio, Gennova Biopharma announced volunteers dosed in phase I/II trials of COVID-19 RNA vaccine in India
On May 4, 2021, HDT Bio announced that its development partner in India, Gennova Biopharmaceuticals, had begun dosing…
Gavi signed agreement with Moderna to secure doses on behalf of COVAX Facility
On May 3, 2021, Gavi, the Vaccine Alliance, that it had signed an advance purchase agreement with Moderna…