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India on Sunday granted emergency use approval for the COVID-19 vaccine co-developed by AstraZeneca (AZ) and Oxford University — formerly known as AZD1222 but now called COVID-19 Vaccine AstraZeneca — along with a separate vaccine, Covaxin, developed by Bharat Biotech. Read More
The commission is delaying the implementation of the EU’s landmark Medical Device Regulation until May 26, 2021, and said regulators may use their discretion in allowing some certificates to temporarily lapse during this time. Read More
On Wednesday, the UK authorized AstraZeneca’s (AZ) and Oxford University’s COVID-19 vaccine for emergency use, characterized as a rapid temporary regulatory approval, becoming the first country to do so as the nation contends with a new contagious strain of the virus leading to a spike in cases. Read More
The pricing of COVID-19 vaccines is expected to draw closer scrutiny in the new year — and even closer attention once the vaccines are no longer being issued for free by governments. Read More
With COVID-19 vaccines from Pfizer/BioNTech and Moderna receiving Emergency Use Authorization and others from AstraZeneca (AZ) and Johnson & Johnson (J&J) edging closer to regulatory approval, vaccine developers are now facing a new challenge: What to call their vaccines to make them more attractive — or at least less scary — for the general public? Read More
AstraZeneca’s (AZ) and Oxford University’s coronavirus vaccine may earn its first authorization this week if the UK or India moves to clear it as anticipated, but it’s unlikely to see emergency clearance in the EU until at least February, a European Medicines Agency (EMA) official said. Read More
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) appears ready to authorize AstraZeneca’s (AZ) and Oxford University’s COVID-19 vaccine as soon as this week, a move that could help lighten the load on Pfizer/BioNTech vaccinations as the country scrambles to deal with a new, mutated strain of coronavirus. Read More
Novavax has launched a phase 3 study in the U.S. and Mexico to evaluate its COVID-19 vaccine candidate, NVX-CoV2373, after deferring the trial for two months because of holdups in securing doses. Read More