Long Thread (sorry) on the vaccine to answer some common questions:
I'm not a leading expert but have worked in Market Access consulting for a decade.
1. Why is this vaccine available so quickly?
Obviously, there is unprecedented demand.
I'm not a leading expert but have worked in Market Access consulting for a decade.
1. Why is this vaccine available so quickly?
Obviously, there is unprecedented demand.
Pharma often get a bad rap and often for good reason, however in this case they have invested BILLIONS of dollars into development at rapid pace and scale.
Most pricing information I have been privy shows the vax from all major parties are being delivered at cost or near cost.
Most pricing information I have been privy shows the vax from all major parties are being delivered at cost or near cost.
It's not bad for company advocacy ratings either. Also, these people are educated and in my experience good people. They want to invest in healthcare.
Pharma's common condition is that they are not as liable for Adverse Events (commonly known as side effects). Generally this is fair. The world needs a vaccine. They are incredible scientific organisations and have done a great job.
People cannot have their cake and eat it.
People cannot have their cake and eat it.
People are rightyly reviwing Pfizer's history of adverser events/fiunes etc. Yes there are some. Most big Pharema have them. Were they deliberate? No. Werer they a big deal? Yes. But this will have more scrutiony than any drug ever. To suggest they haver faked results is wrong.
Life sciences technologies have never been more agile. Both in clinical terms but also in supporting technology. Clinical trial systems for example have sped up trials, facilitated better protocol design etc.
Another major factor is the disease itself. Coronaviruses come in many forms and are numerous. They are well studied and we'll known.
The low mortality and high infection rate also led to a huge pool of clinic trialists. Cultural acceptance of trialing for this is also high.
The low mortality and high infection rate also led to a huge pool of clinic trialists. Cultural acceptance of trialing for this is also high.
After trials come approval &pricing negotiation (reimbursement).
The latter is a non issue for obvious reasons.
Approval is often given based on impact of not only safety but Vs current standard of care and economic benefit.
You do the maths but only safety really matters here
The latter is a non issue for obvious reasons.
Approval is often given based on impact of not only safety but Vs current standard of care and economic benefit.
You do the maths but only safety really matters here
2. Why the UK first?
Under EU law all countries with established approval bodies have the right to approve in advance of the EMA in emergency situations.
To be clear, it has nothing to so with Brexit. Although I do think they've sped this up for political point scoring.
Under EU law all countries with established approval bodies have the right to approve in advance of the EMA in emergency situations.
To be clear, it has nothing to so with Brexit. Although I do think they've sped this up for political point scoring.
The UK has a long history of leading human data science, being a first reviewer. In fact the UK is often first to undertake an HTA because the rigour means other countries refer to the UK. Same with reimbursement reviews.
3. Is it safe?
MHRA/EMA/FDA will not compromise standards and rigour. I would be confident they have gone through all standard processes. Dr. June Rain said so today.
Ideally for something that will touch so many lives you'd have Post Approval Real World studies (PASS) but...
MHRA/EMA/FDA will not compromise standards and rigour. I would be confident they have gone through all standard processes. Dr. June Rain said so today.
Ideally for something that will touch so many lives you'd have Post Approval Real World studies (PASS) but...
I would trust the MHRA here.
4. What's next?
Refrigeration and roll out are the main challenges, and then supply.
If it's managed by the imbeciles in the current government I'd expect some hiccups but ultimately this is good news (unless you're an anti-vax loon)
4. What's next?
Refrigeration and roll out are the main challenges, and then supply.
If it's managed by the imbeciles in the current government I'd expect some hiccups but ultimately this is good news (unless you're an anti-vax loon)