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Moderna applies for regulatory authorisation for COVID-19 vaccine
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
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Vaccines
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Regulatory response to the COVID-19 pandemic
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
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MHRA approves Pfizer and BioNTech COVID-19 vaccine
The UK's MHRA has given temporary emergency authorisation to Pfizer and BioNTech's COVID-19 vaccine, making it the first in the world to receive approval.
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Survey finds 64 percent of UK adults would receive COVID-19 vaccine
A survey of 1,500 adults in the UK showed that most would be happy to receive a COVID-19 vaccine, while nine percent said they would be unlikely to get the vaccine.
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Pfizer and BioNTech submit for EU marketing authorisation for COVID-19 vaccine
If the Conditional Marketing Authorization application is approved, the COVID-19 vaccine BNT162b2 could be used in the EU by the end of 2020.
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UK secures total of 357 million doses of various COVID-19 vaccines
After purchasing an additional two million doses of Moderna's COVID-19 vaccine, the UK will now receive a total of 357 million doses of vaccines from seven developers.
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WHO report suggests African countries are not ready for COVID-19 vaccines
The WHO Regional Director for Africa urges governments to “ramp up readiness” as report suggests the region is not prepared for a COVID-19 vaccine roll-out.
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EU secures 80 million doses of Moderna COVID-19 vaccine
The European Commission and Moderna have agreed that the company will supply at least 80 million doses of mRNA-1273, the company's COVID-19 vaccine candidate.
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COVAXX commits to deliver 140 million COVID-19 vaccine doses to emerging markets
The company suggests their experimental COVID-19 vaccine, UB-612, has the features and potential to disrupt the traditional vaccine distribution and supply status quo.
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EDQM releases updated pharmacopoeial quality standards for vaccines
To aid COVID-19 vaccine developers, the EDQM has released an updated European Pharmacopoeia that can be accessed for free.
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Case study: Upgrade of an existing sterile production room of freeze-dried vaccines to comply with the requirements of the new GMP annex 1
Challenges in day to day operations. The battle of performance in production.
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One of the oldest vaccines could help combat COVID-19
Researchers have shown that recipients of the Bacillus Calmette-Guérin (BCG) vaccine are less likely to contract COVID-19 in a new study.
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New microneedle vaccine shows promise in pre-clinical trials
A single-use, self-administered microneedle vaccine has been developed to provide immunisation against infectious diseases.
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EC approves new meningitis vaccine
MenQuadfi® has been approved for use in individuals 12 months of age and older, based on its safety and immunogenicity in 6,300 trial subjects.
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Sputnik V COVID-19 vaccine over 90 percent effective, interim data shows
Phase III trial interim data has shown that Russia's COVID-19 vaccine candidate, Sputnik V, is 91.4 percent effective.
