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EMA begins rolling review of Sputnik V COVID-19 vaccine
The EU regulator has begun reviewing preclinical and early trial data for Sputnik V, the COVID-19 vaccine developed by Russia.
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Immunisation
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FDA approves the Janssen COVID-19 Vaccine for emergency use
The FDA has issued an Emergency Use Authorization for the single-dose Janssen COVID-19 Vaccine, making it the third COVID-19 vaccine available for use in the US.
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New variant-specific mRNA COVID-19 vaccine to enter clinical trials
Moderna has shipped the trial material for its mRNA-1273.351 vaccine candidate to the US National Institutes of Health for Phase I trials.
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FDA grants Priority Review to Pfizer’s tick-borne encephalitis vaccine TicoVac™
If approved, TicoVac would be the first vaccine in the US to help protect adults and children from tick-borne encephalitis.
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Sanofi and GSK start Phase II study of their COVID-19 vaccine candidate
The dose finding study will assess the safety, reactogenicity and immunogenicity of the companies’ investigational COVID-19 vaccine in 720 participants.
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Patient dosed with first Lassa fever vaccine to reach human trials
The first trial participant has been given INO-4500 in Ghana - INO-4500 is a DNA vaccine candidate being developed to protect against Lassa fever.
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FDA issues new guidance for developers of COVID-19 vaccines, diagnostics and therapeutics
The new recommendations address the evolving landscape of COVID-19 drug development, including the emergence of SARS-CoV-2 variants.
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Janssen submits for WHO Emergency Use Listing of COVID-19 vaccine
If granted Emergency Use Listing by the World Health Organization (WHO), up to 500 million doses of Janssen’s single-dose COVID-19 vaccine could be distributed under COVAX.
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BCG vaccine protects newborns against a variety of infectious diseases, finds study
According to researchers, ensuring that newborns in areas with high rates of infectious disease receive the BCG vaccine at birth, could have a major impact on infections and deaths.
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Pfizer-BioNTech COVID-19 vaccinee sera less able to neutralise South African variant
While the sera were able to neutralise SARS-CoV-2 viruses expressing the B.1.351-spike mutations in vitro, the neutralisation was almost two thirds weaker than for an early strain.
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First patient dosed with therapeutic prostate cancer vaccine
The trial will evaluate the safety, tolerability and immunogenicity of Ultimovacs’ prostate cancer-specific therapeutic TET-based vaccine.
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EMA receives conditional marketing authorisation application for Janssen’s COVID-19 vaccine
The European Medicines Agency will now review additional data on the efficacy, safety and quality of the COVID-19 Vaccine Janssen, deciding whether to approve the vaccine for use in the EU.
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AstraZeneca’s COVID-19 vaccines listed for emergency use by WHO
The Emergency Use Listing will allow doses of the COVID-19 vaccines to be distributed through COVAX, the WHO’s vaccine allocation facility.
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250mn Europeans to be vaccinated with COMIRNATY® by the end of 2021
Pfizer and BioNTech have agreed to supply the European Union with 200 million additional doses of COMIRNATY in 2021, making the total 500 million doses.
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Novel HIV vaccine approach shows promise in “landmark” first-in-human trial
The vaccine was able to target the desired immune cells and could become the first stage of a multi-step vaccine strategy to combat HIV and various other viral diseases.
