BIA Applauds UK Plan For Pre-Approval Use Of Coronavirus Vaccine
More Staff To Be Trained In Giving COVID-19 And Flu Vaccines
The UK can already OK the use of unapproved products, but the government wants more certainty around the conditions that will be attached to any decision to make COVID-19 vaccines available before they have been licensed. Moves are also under way to reassure pharmaceutical companies about liability issues.
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A consultation on plans for the early availability of coronavirus vaccines drew almost 192,000 responses, including a number of concerns to which the government has now responded.
Regulatory flexibilities combined with experience in cell and gene therapy and the wider use of technologies such as AI could help to keep the post-Brexit UK at the forefront of innovation in the life sciences. A UK regulatory conference will be discussing these and other key issues next week.
The UK government is proposing to take the "very unusual step" of making COVID-19 vaccines available before they are licensed. The international COVAX initiative is now supporting nine vaccines, and the EU and AstraZeneca have firmed up a vaccine purchase agreement.