Moderna announced FDA authorization of Moderna COVID-19 vaccine in U.S.
On Dec. 18, 2020, Moderna announced that the U.S. Food and Drug Administration (FDA) had authorized the emergency…
XPhyto completed successful SARS-COV-2 RT-PCR diagnostic testk kit validation
On Dec. 17, 2020, XPhyto Therapeutics and 3a-diagnostics announced the successful validation of their point-of-care SARS-CoV-2 (COVID-19) RT-PCR…
Biotechnology | COVID-19 | FDA | Vaccine
Moderna received FDA Advisory Committee vote supporting EUA for vaccine against COVID-19 in the U.S.
On Dec. 17, 2020, Moderna confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological…
BioNTech and Fosun Pharma to supply China with mRNA-based COVID-19 vaccine
On Dec. 16, 2020, BioNTech and Shanghai Fosun Pharmaceutical announced an agreement to supply Mainland China with an…
CureVac commenced global pivotal phase 2b/3 trial for COVID-19 vaccine candidate, CVnCoV
On Dec. 14, 2020, CureVac announced that it had enrolled the first participant in the pivotal Phase 2b/3…
Moderna confirmed supply agreement to supply Singapore with mRNA vaccine against COVID-19
On Dec. 14, 2020, Moderna confirmed that the Company had concluded an agreement with the Ministry of Health…
U.S. Government exercised 1st option for additional 100 million doses of Moderna’s COVID-19 vaccine
On Dec. 11, 2020, Moderna announced that the U.S. government has exercised its option to purchase an additional…
Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
On Dec. 10, 2020, Roche announced a partnership with Moderna to utilise the Elecsys Anti-SARS-CoV-2 S antibody test…
Moderna announced first participants dosed in phase 2/3 study of COVID-19 vaccine candidate in adolescents
On Dec. 10, 2020, Moderna announced that the first adolescent participants had been dosed in the Phase 2/3…
Pfizer and BioNTech received FDA Advisory Committee vote supporting EUA for COVID-19 vaccine in the US
On Dec. 10, 2020, Pfizer and BioNTech announced that the FDA Vaccines and Related Biological Products Advisory Committee…
Roche partnered with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials
On Dec. 9, 2020, Roche announced a partnership with Moderna to utilise the Elecsys Anti-SARS-CoV-2 S antibody test…
Switzerland exercised increased option for 7.5 million doses of mRNA vaccine against COVID-19 (mRNA-1273)
On Dec. 8, 2020, Moderna announced the Swiss Federal Government had increased its confirmed order commitment from 4.5…
Canada exercised increased option for total of 40 million doses of mRNA vaccine candidate against COVID-19
On Dec. 7, 2020, Moderna announced that the Canadian Government had increased its confirmed order commitment by 20…
Moderna updated on clinical development and production of Its COVID-19 vaccine candidate
On Dec. 3, 2020, Moderna announced in a letter to the editor published in the New England Journal…
Pfizer and BioNTech achieved first authorization in the world for a vaccine to combat COVID-19
On Dec. 2, 2020, Pfizer and BioNTech announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in…
Pfizer and BioNTech submitted application for Conditional Marketing Authorization for COVID-19 vaccine
On Dec. 1, 2020, Pfizer and BioNTech announced they had submitted on Nov. 30, 2020, a formal Application…
Moderna announced primary efficacy analysis in phase 3 COVE study for COVID-19 vaccine candidate
On Nov. 30, 2020, Moderna announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273…
Moderna amended supply agreement with UK Government for 2 million doses of mRNA COVID-19 vaccine
On Nov. 29, 2020, Moderna announced a supply agreement with the United Kingdom (UK) government for an additional…
Moderna announced EC approval of purchase agreement for 80 million doses of mRNA COVID-19 vaccine
On Nov. 25, 2020, Moderna announced that the European Commission (EC) has approved an agreement to secure 80…
BioNTech and Fosun Pharma announced start of phase 2 clinical trial of mRNA COVID-19 vaccine in China
On Nov. 25, 2020, BioNTech and Shanghai Fosun Pharmaceutica jointly announced that their lead mRNA COVID-19 vaccine candidate…
Pfizer and BioNTech to submit Emergency Use Authorization Request to the FDA for COVID-19 vaccine
On Nov. 20, 2020, Pfizer and BioNTech announced they submitted a request to the Food and Drug Administration…
Pfizer and BioNTech announced phase 3 study of COVID-19 vaccine candidate met all efficacy endpoints
On Nov. 18, 2020, Pfizer and BioNTech announced that, after conducting the final efficacy analysis in their ongoing…
Moderna announced supply agreement with UK Government to supply mRNA vaccine against COVID-19
On Nov. 17, 2020, Moderna announced a supply agreement with the government of the United Kingdom (UK) to…
Moderna announced longer shelf life for its COVID-19 vaccine candidate at refrigerated temperatures
On Nov. 16, 2020, Moderna announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remained stable at…
BioNTech and Fosun Pharma approved to commence COVID-19 vaccine candidate BNT162b2 trial in China
On Nov. 16, 2020, BioNTech and Shanghai Fosun Pharmaceutica announced that the China National Medical Products Administration had…
European Medicines Agency began rolling review of Moderna’s mRNA vaccine candidate against COVID-19
On Nov. 16, 2020, Moderna announced that the European Medicines Agency (EMA) human medicines committee (CHMP) had started…
Moderna’s COVID-19 vaccine candidate met primary endpoint in first interim analysis of phase 3 COVE study
On Nov. 15, 2020, an independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of…
Swissmedic began rolling review of Moderna’s mRNA vaccine against COVID-19
On Nov. 13, 2020, Moderna announced that Swissmedic had started a rolling review of mRNA-1273, the Company’s vaccine…
CureVac’s COVID-19 vaccine candidate, CVnCoV, suitable for standard fridge temperature logistics
On Nov. 12, 2020, CureVac announced that its mRNA-based COVID-19 vaccine candidate, CVnCoV, remained stable and within defined…
Moderna completed case accrual for first planned interim analysis of mRNA vaccine against COVID-19
On Nov. 11, 2020, Moderna announced that it had completed case accrual for the first interim analysis of…