Thread by @StefSimanowitz

1/. Missing from discussions around #operationmoonshot has been any mention of the govt’s proposal to change medicine regulations to make it possible to use unlicensed #COVID19 vaccines.

This would ensure manufacturers & suppliers couldn’t be held liable.
gov.uk/government/con…

2/. The new regulations would authorise of the supply of unlicensed vaccines, side-stepping EU legislation that - for safety reasons - requires biotechnological medicines to be authorised via the European Medicines Agency, & any product licensed by the European Medicines Agency.

3/. The consultation document makes clear that a “vaccine would only be authorised” if the licensing authority was satisfied of its “safety, quality & efficacy” & points out that ‘unlicensed’ does not mean ‘untested’. Ultimately the balance of risk & benefit needs to be assessed.

4/. The consultation paper also makes clear that an existing regulation could be used to override the requirements of the European Medicines Agency &
authorise distribution & supply of an unlicensed #COVID19 vaccine (or treatment) in the UK.

So why both with a new regulation?

5/. The answer lies in the fact that the
govt want to ensure manufacturers & suppliers are given complete immunity from civil liability.

“It is unfair to ask them to take responsibility for the consequences of the use of that medicine in the way that they normally would.”.

6/. Ultimately it’s a balance of risk & benefit.

“If there’s a compelling case for using a vaccine before it’s given a licence, the Joint Committee on Vaccination & Immunisation may take the unusual step of advising the govt to use a tested, unlicensed vaccine against #COVID19."

7/. In order for experts to offer their views on whether the benefits of using an unlicensed vaccine outweighs the risks, a consultation is open for responds using this link👇

The deadline is 18th September!
(next week) which doesn’t give much time. consultations.dhsc.gov.uk/5f43b8aca0980b…

8/. The clinical trials of the Oxford University-Astra Zeneca vaccine were suspended after one of the participants in India fell ill.

AstraZeneca's CEO says it’s a routine pause & the vaccine could be approved by December.

Here is @WHO’s @doctorsoumya👇

9. Nearly 180 #COVID19 vaccines are being tested around the world.

None has completed clinical trials successfully.

There are almost 30,000 people participating in the AstraZeneca-Oxford University vaccine trial in India, Brazil, South Africa, UK & US.

10/. It’s important to distinguish between two #COVID19 projects being led by Oxford University.

The VACCINE = an int'l clinical trial

TESTING = ”Operation Moonshot” - run by the Rapid Test Consortium (RTC) that aims to do "10 million tests per day".

This was the PM on Weds👇