4/4/2023 0 Comments Ema approved vaccinesMember States in the European Union have just started rolling out the booster vaccines and both the BA.1 and the BA.4/5 adapted vaccine will be available in due time for national roll-out. I would not consider the difference in approval time –approximately 10 days – of the bivalent original/BA.4/5 between EMA and FDA as having any significant impact on public health. Why did the EMA take longer than the US FDA to approve the BA.4/5 vaccine? Transcript: Vaccines Today interview with Dr Steffen Thirstrup If you have not had a Covid-19 vaccine, get it now if you have had your first course of vaccines, you may soon be offered a new booster dose.The SARS-CoV-2 virus is still changing – more adapted vaccines may be required in response to future variants.Adapted vaccines offer broad protection and offer reassurance should new variants emerge.European regulator has approved vaccines offering combined protection against the original Covid-19 virus and Omicron variants.Vaccines Today asked him to outline how the EMA approached the task of reviewing adapted vaccines, why protecting against the original strain is still worthwhile, and if we might expect the process for reviewing future adapted Covid vaccinesto mirror the regulatory approach taken to the annual flu vaccine. Now, as autumn arrives, European countries have new and approved vaccines to offer as part of booster programmes which, they hope, will make this winter brighter than than the last two.įor Dr Thistrup, a doctor, scientist and seasoned regulator, it has been a busy start at the EU watchdog. Vaccine developers were busy compiling data on adapted vaccines designed to protect against the original SARS-CoV-2 virus and Omicron BA.1 (which was first identified in South Africa in late 2021) while working on newer vaccines aiming to protect against the original virus and BA.4/5. Vaccines had helped to drive down hospitalisation and deaths, but cases were still high and new variants of the virus were emerging.Ī key driver of those early summer spikes in case numbers were the Omicron BA.4 and BA.5 variants which, although apparently milder than some of the viruses that had previously become dominant, were highly infectious and continued to cause serious illness in some patients. Dr Steffen Thirstrup took up the role of the European Medicines Agency’s Chief Medical Officer at a crucial moment in the brief history of the Covid-19 pandemic.
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