Month: September 2020
-
AstraZeneca Covid-19 vaccine and serious neurological symptoms
The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.…
-
MHRA – pharmacovigilance updates
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements for submission of pharmacovigilance data at the end of the Brexit Transition period, as well as guidance on the qualified person responsible for pharmacovigilance (QPPV) and pharmacovigilance system master files (PSMF). Summary of updates: MHRA will retain…
-
University of Oxford Covid-19 vaccine study put on hold due to suspected adverse reaction
A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford has been voluntarily paused due to a suspected serious adverse reaction in a participant in the United Kingdom. A spokesperson for AstraZeneca, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of…
-
Sputnik-V trials results
The Lancet said the early-stage trials suggested the Sputnik-V vaccine produced a response in a component of the immune system known as T cells. Scientists have been scrutinising the role played by T cells in battling coronavirus infection, with recent findings showing these cells may provide longer-term protection than antibodies. [L1N2EH0X8] The Sputnik-V vaccine is…