The U.S. Food and Drug Administration (FDA) issued the first emergency use authorization (EUA) for a vaccine for the prevention of COVID-19) in individuals 16 years of age and older.
This EUA enables the experimental Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) to be distributed effectively in the USA.
USA Authorizes First COVID-19 Vaccine
Protein-Based COVID-19 Vaccine Candidate Delays Advanced Research
Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults.
This decision was published on December 11, 2020, and was based on the Phase 1/2 study interim results which showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years.
But, a low immune response in older adults, likely due to an insufficient concentration of the antigen, stated the companies.
New Polio Vaccines Display Good Immune Response Against Mutated Strain
Clinical studies indicate the new poliovirus vaccine may have the potential to overcome outbreaks caused by a mutated polio strain linked to the oral vaccine.
According to studies published by The Lancet on December 9, 2020, scientists have developed the first poliovirus vaccine against a mutated form of the disease that is causing disease outbreaks across Africa and Asia.
Australian COVID-19 Vaccine Candidate Cancels Clinical Trial
The University of Queensland announced that following consultation with the Australian Government, CSL will not progress the UQ-CSL v451 COVID-19 vaccine candidate to Phase 2/3 clinical trials.
Oxford and AstraZeneca To Test Sputnik V Vaccine’s Components
The Russian Direct Investment Fund (RDIF) and the N.F. Gamaleya Research Center announced AstraZeneca has accepted the RDIF proposal and will begin clinical trials of its vaccine in combination with the Sputnik V adenoviral vector of the 26th serotype, by the end of 2020.
Pennsylvania Developed COVID-19 Vaccine Candidate Expands Study in China
A biotechnology company announced the successful dosing of its first subject in its Phase 2 clinical trial for COVID-19 DNA vaccine candidate, INO-4800, in China.
The Phase 2 clinical trial being conducted in China will enroll approximately 640 participants who are 18 years or older.
INOVIO and Advaccine Biopharmaceuticals Suzhou Co., Ltd. announced in a press release on December 10, 2020, the dosing regimen involves two vaccinations at 0 and 28 days, with either 1.0 mg or 2.0 mg dosing levels and is similar to the Phase 2 segment of Phase 2/3 clinical trial in the USA.
Ulcerative Colitis Treatment Prepares for Phase 3 Study
A clinical-stage biotechnology company announced the progression of its development program for its lead drug candidate, ABX464, into phase 3 preparation for the treatment of moderate-to-severe ulcerative colitis (UC).
Live-Attenuated Virus Vaccine Development ‘is the Right Approach'
A vaccine biotech firm based in Massachusetts points to the proven science of live-attenuated viruses in vaccine development as key to the company's commitment to the development platform.
A live-attenuated virus is a weakened (attenuated) virus that is able to multiply within the host to a limited extent and engineered to be unable to cause any disease.
Live-Attenuated Virus Vaccine Development 'is the Right Approach'
A vaccine biotech firm based in Massachusetts points to the proven science of live-attenuated viruses in vaccine development as key to the company's commitment to the development platform.
A live-attenuated virus is a weakened (attenuated) virus that is able to multiply within the host to a limited extent and engineered to be unable to cause any disease.
Russia’s COVID-19 Vaccine Development Plans Are Extensive
In addition to the two coronavirus vaccines that have already been registered by the Russian Federation, another twenty-four COVID-19 vaccine candidates were reported by Interfax to be in various stages of development.
Inna Kulikova, the director of the Russian Health Ministry's Department of Emergency Medical Care and Health Risk Management, stated at the Medicine and Quality 2020 conference held on December 8, 2020, "The Health Ministry of the Russian Federation registered the Gam-Covid-Vac (Sputnik V) vaccine on August 11, 2020, and the EpiVacCorona vaccine two months later.”