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FDA failed to authorised it, MHRA did, MHRA does not always follow FDA. Your stated "trust me" 25 years experience of everyone following the FDA is factually and demonstrably wrong, get over it
Twatcher we're in a pandemic. Pfizer's mRNA vaccine is new technology but was fast to produce and got over the line first. AZs viral vector technology is well understood. Both underwent all required clinical trails. You can make your own assessment on why FDA/US don't want / need a British developed Vaccine (we'd struggle to supply US any case) based on well understood science and instead have plumbed for a US based vaccine that is new to science. Both appear to work.
"Looking after there own I'd say. Plentiful supply from J&J / Pfizer. We could take a leaf instead of depending on chinese shzz!"
Nice attempt at dodging the facts which is that the FDA does not lead the way in all things (e.g. the AZ vaccine) contrary to your "experienced" determination.
Looking after there own I'd say. Plentiful supply from J&J / Pfizer. We could take a leaf instead of depending on chinese shzz!
Also,
from the BMJ
Sheila Bird, former programme leader at the MRC Biostatistics Unit, University of Cambridge, said, “The MHRA may need some time to tackle fully the plethora of study design, regulatory, and transparency problems raised by the FDA. Needing some time may explain why the MHRA accorded the Department of Health and Social Care an interim two month extension and has yet to make public the basis for its interim judgement.”
She said that the MHRA’s transparency failures, including that it has not provided details on how the recent review was carried out or its findings, must be immediately redressed.
"I have 25yrs working in pharma and medical device industries and trust me when I say If you think other regulators inc. MHRA ignore FDA advice you are completely wrong. FDA lead the way."
FDA has refused to authorise the use of the AZ vaccine. MHRA has authorised it over 6 months ago in the UK and 10Ms doses have been administered.
What's your 25 years of experience say about that ?
All I would say about that is that there is a lot of arse covering going on. MHRA did approve emergency use after all FDA did not. The need for LFTs in expected to run into yrs and yet only a 2 month extension? really? All about brushing it under the carpet and quietly moving to the UK suppliers IMO. each to there own though
I recently read that regarding the Innova tests, "the UK Medicines and Healthcare products Regulatory Agency (MHRA) yesterday concluded they are safe.
The Government has spent £2.8billion on the Innova kits, distributed by NHS Test and Trace. The MHRA said their licence, due to end next week, had been extended after a ‘satisfactory outcome of the review undertaken as a result of recent action in the USA’.
This must be worrying.
LTH
We have a gold standard LFT currently going through FDA approval for home use. The same FDA that have advised to chuck the Innova test in the bin. I have 25yrs working in pharma and medical device industries and trust me when I say If you think other regulators inc. MHRA ignore FDA advice you are completely wrong. FDA lead the way.