Thread by @BigBiteNow

(1/10)
Those wishing to take a serious look at likely roll out dates for the Oxford/AZ Covid vaccine, if indeed successful, I would suggest watching the following ;

#AVCT #GDR



Professor Madhi is leading the S.A. phase 2 trial, which began this week.

(2/10)
According to Prof. Madhi, Oxford vaccine is the most advanced in terms of clinical development.

When will it be available to the public?

"best guess right now is probably around about Sept/Oct of next year, provided that we actually show that the vaccine works this year"

(3/10)
"longer that we delay being able to show that the vaccine actually works, the further it pushes out the timeline."

S.A. "scientific data will also be used by the WHO in terms of its recommendations as to whether this vaccine should be used, in low middle income countries"

(4/9)
So the S.A. trial has to be completed in order for this vaccine to be recommended for use in Africa and other closely related low to middle income countries.

Current actual roll out, so the commencement of the process, which itself will take time, is c. Sept/Oct 2021.

(5/9)
"study that is currently under way in UK has already enrolled more than 4,000 participants" in that particular phase 2 study & over the next 1 or 2 months plan to go into a phase 3 study, which is a sort of pivotal study which determines if the vaccine is actually working"

(6/10)
"That study in the UK will enroll about 10, 000 people"

"The same vaccine is also planned to go into clinical trials in the US, where they are planning to enroll as many as 30,000 individuals."

The headline from Astra Zenica is first deliveries in Sept.

(7/10)
How do they achieve that through a phase 3 trial that only gets into full swing in August?

Given the data has to be collected, analysed, passed to manufacturers, tested, then authorised for use by regulatory bodies.

(8/10)
All of which must take place in a Europe that is seeing far fewer cases, which undermines the infection rates for the trial.

S.A. with a far greater infection rate, is saying that the process will take until Q3 2021 and they have already begun their trial this week.

(9/10)
And all of this assumes that it actually works and protects a sufficient number of people.

We all have loved ones affected by Covid and we have all had enough of it in our lives, so a working vaccine is most welcome but we have to realistic about timelines.

(10/10)
Astra Zenica claim first deliveries in Sept and that statement must be respected but the lead professor in the African study, in S.A. says that its the wrong Sept.

If so then really good tests such as those from #GDR and #AVCT, are going to be needed for a long time.

(10A)
For those haven't seen it, here is the Guardians interview with Prof. Pollard of Oxford Uni, who is leading up the team on the Astra Zenica licensed vaccine trials.

#AVCT #GDR

https://twitter.com/UniofOxford/status/1275858485809479685?s=20

(10B)
"Most vaccines that have been developed over the years don't work so well in adults over the age of 70"

due to "the ageing of the immune system because it just doesn't get charged up properly, when people are vaccinated in that age group."

(10C)
"This is a real concern for all vaccine developers that we may not be able to get very good protection in oldest adults. Certainly with 1 dose and we may need 2 or more doses to do that and so a lot of work needs to go into studying that age group to optimise protection"

(10D)
"In think one of the most important things about the concept of herd immunity, is that within a population there are some people who cannot be protected because their immune systems doesn't work, which could of course in this case be the very elderly,

(10E)
"or people who are on chemotherapy for example and they may not get protection from being vaccinated."

"if we can stop the virus transmitting because every time it tries to transmit it meets someone who's immune and it cant do anything,"

(10E)
"then that'd be a really good scenario because those of us who are immune, could protect those that can't be vaccinated."

Whatever happens, other protective measures will not be fully removed, until herd immunity is sufficient enough and proven to be the case.

(10F)
My view.

There will still be a need for 'easy' cost effective testing, until min. such time authorities are clear, that any vaccine, employed world wide, is doing its job properly and then even then, a % of the most vulnerable part of the population will remain at risk.

(10G)
Logic says testing, be it at a smaller scale, will remain in place for years to come or for as long as Covid wishes to stick arounf.

A continuous revenue stream for a off the shelf self-test, of high quality, will for me be a reality.

(11A)
Here's an article from Fierce Pharma, who are well worth keeping close tabs on if you're invested in this space.

It covers the latest advice from the FDA on vaccine approvals, which ties in with previous thread above.

#AVCT #GDR

fiercepharma.com/vaccines/fda-t…

(11B)
"To win approval, any vaccine must be at least 50% effective in preventing the disease."

Key takeaway ;

"It sets a bar about on par with a flu shot's performance in a good year—but it falls short of some expert recommendations for arresting the virus' spread.

(11C)
Breathe that statement in for a moment.

Furthermore ;

"An efficacy figure of 50% would compare somewhat favorably to flu vaccine efficacy in the last decade, which has ranged from 19% to 60% since 2010"

(11D)
Herd immunity and the ability to counter the Covid pandemic, not remove Covid from society, is deemed to be c. 70%.

A successful vaccine is not the only answer required.

"The WHO has set its own success benchmarks for COVID-19 vaccines"

(11E)
"The higher benchmark calls for 70% efficacy and a duration of protection for one year, while the lower threshold calls for 50% efficacy for 6 months."

The current Oxford/AZ trial in S.A. (see above) is designed to test the vaccine for that WHO approval.

(11F)
"The full approval would require about 30,000 participants to enroll in a phase 3 trial"

"An emergency authorization, meanwhile, would be a quicker process than a full approval, but it’d still require the developer to show proof of efficacy."

Much food for thought when

(11G)
tied into the previous notes above but any vaccine being brought to the table, has to better than the best flu jab of the last decade and even then, might still fall short of the herd immunity goal.

The Oxford vaccine is the very 1st attempt.