answer text |
<p><del class="ministerial">On 21 February 2022, the Government accepted advice from
the Joint Committee on Vaccination and Immunisation (JCVI) on offering a further dose
to some individuals. The primary aim is to reduce the risk of severe disease across
the population. As protection against severe COVID-19 disease declines slowly, the
most vulnerable groups have been prioritised for vaccination.</del></p><p><del class="ministerial">A
dose will be offered to those over the age of 75 years old, residents in care homes
for older adults and people aged 12 years and over who are immunosuppressed. The JCVI
continues to consider the latest available data on the timing and value of further
doses.</del></p><p><ins class="ministerial"> <p><ins class="ministerial">The online
only guidance COVID-19 test approval: how to apply advises testing manufacturers on
the validation process for new devices. The guidance sets out the process from submitting
an application; the desktop review; how payment can be made; the outcome reporting
on tests which have passed; how to make a complaint; and where an application is unsuccessful,
how the manufacturer can request a review of the decision.</ins><ins class="ministerial"></ins></p></ins><ins
class="ministerial"><p><ins class="ministerial">For updates to products while an application
is being considered, applicants must inform the COVID-19 Test Device Validation Approval
processes (CTDA) administration team and provide the updated Instructions for Use.
For updates to approved products, manufacturers are encouraged to contact the CTDA
administration team. Guidance for such updates is currently being developed.</ins></p><p><ins
class="ministerial">The CTDA team aim to have the results of the application review
within 20 working days of submission, subject to the application being complete. This
process may take longer where there is a high volume of applications and if there
are additional queries on the data submitted.</ins></p></ins></p>
|
|