Are vaccines the light at the end of the tunnel?

[K.T.B.]

6 hours ago, npcl said:

Not necessarily. Considering that the current agreement only delivers 100 million doses by December , and the option to buy up to 500 million, but no time frame on the additional purchases probably not.  Especially since Pfizer is partnered with a German company so their production will certainly be split. With some going to other countries in addition to the US. The initial 100 million is probably earmarked for priority targets (military, first responders, teachers, those with chronic condition, etc)

 

It depends on which vaccine you're talking about though.  AstraZeneca is well ahead of where they need to be.  They'll be able to deliver its full order to both the US and UK by December, which is 400 million doses (60 million for the UK).  No idea about Pfizer.

[npcl]

12 minutes ago, K.T.B. said:

 

It depends on which vaccine you're talking about though.  AstraZeneca is well ahead of where they need to be.  They'll be able to deliver its full order to both the US and UK by December, which is 400 million doses (60 million for the UK).  No idea about Pfizer.

If they are approved by December.  The AZ trail is not scheduled fully recruited until the end of September.  Would not expect any results until late November and a filing maybe in late December

[Doris&Nereus]

1 hour ago, npcl said:

If it was really all that promising they would not have a funding issue.  There would be a number of Pharma companies offering to partner on the product or buy the company.  Centivax has no track record.  Lilly has multiple trials running for their product including both as treatment, and as a preventive therapy.

Dr. Glanville is young and an idealist. He states that he does not want to partner with big Pharma, as he wants to keep the cost affordable for all. As I posted before, his Mabs went through phase II trials with the Army medical lab as well as Stanford University, and one other major university.  I believe that big pharma should not be our only way forward. I know everyone is looking at their stocks, but what good is money if people are dying.  

[Ken the cruiser]

24 minutes ago, npcl said:

If they are approved by December.  The AZ trail is not scheduled fully recruited until the end of September.  Would not expect any results until late November and a filing maybe in late December

Just curious, didn't Oxford/AZ start conducting their initial stage 3 trials in Brazil and South Africa back in late June or doesn't that count when it comes to applying for an EUA with the FDA and/or the appropriate British approval agency?

Edited August 21, 2020 by Ken the cruiser

[npcl]

29 minutes ago, Doris&Nereus said:

Dr. Glanville is young and an idealist. He states that he does not want to partner with big Pharma, as he wants to keep the cost affordable for all. As I posted before, his Mabs went through phase II trials with the Army medical lab as well as Stanford University, and one other major university.  I believe that big pharma should not be our only way forward. I know everyone is looking at their stocks, but what good is money if people are dying.  

What good is having a good idea if no one funds the development when people are dying.  

 

Funny thing is that his companies web site  list 40 partners for other products including big Pharma.  DistributedBio, the parent company, is basically a company built around a discovery platform.  Funny that they partner with big pharma on everything else.

 

The other issues is that his company has none of the personnel in clinical and regulatory affairs necessary to set up and execute the clinical trials and drug development activities.  For that matter he does not have any of the staff that is necessary to actually development and execute even exploratory drug manufacturing.  His entire team is listed on his web site all of the way down to interns.

 

If his results with the Army were as good as he claims how come they have not funded it.  The government is funding other developers.

 

Keep drinking the cool aid.  I assume you sent in a check for their crowd funding.

Edited August 21, 2020 by npcl

[npcl]

1 minute ago, Ken the cruiser said:

Just curious, didn't Oxford/AZ start conducting their initial stage 3 trials in Brazil and South Africa back in late June or doesn't that count when it comes to applying for a EUA with the FDA and/or the appropriate British approval agency?

It counts the issue is when they get enough data to submit.  Their major tials were not expected to finish accruing until the end of September, kind of neck and neck with Moderna.

[npcl]

15 minutes ago, Ken the cruiser said:

Just curious, didn't Oxford/AZ start conducting their initial stage 3 trials in Brazil and South Africa back in late June or doesn't that count when it comes to applying for an EUA with the FDA and/or the appropriate British approval agency?

You can get the planned dates here

 

https://clinicaltrials.gov/ct2/show/NCT04516746?term=vaccine&recrs=abdf&cond=COVID-19&phase=0123&sort=nwst&draw=2

 

Primary Completion date Dec 2, 2020

Study Completion date October 5, 2022

 

In the case of Oxford the doses are given 4 weeks apart compared to the 2 weeks in the Moderna trial.

 

So you can see that the primary completion date is scheduled for early December.

[Ken the cruiser]

22 minutes ago, npcl said:

You can get the planned dates here

 

https://clinicaltrials.gov/ct2/show/NCT04516746?term=vaccine&recrs=abdf&cond=COVID-19&phase=0123&sort=nwst&draw=2

 

Primary Completion date Dec 2, 2020

Study Completion date October 5, 2022

 

In the case of Oxford the doses are given 4 weeks apart compared to the 2 weeks in the Moderna trial.

 

So you can see that the primary completion date is scheduled for early December.

Thanks! Am I correct in thinking, though, that October should be an interesting month with regards to seeing who will be submitting approval requests to the FDA for EUAs?

[npcl]

24 minutes ago, Ken the cruiser said:

Thanks! Am I correct in thinking, though, that October should be an interesting month with regards to seeing who will be submitting approval requests to the FDA for EUAs?

That is when Pfizer said that they would have info.

[TeeRick]

18 hours ago, mayleeman said:

@TeeRick & @markeb :

 

So, if there are several potential vaccines being developed that work somewhat differently, and if each is not highly effective, would researchers start looking at combining some into a "cocktail" to get a cumulative inoculation effect?  Or would triggering the immune system in several different ways run the risk of triggering an overloaded response?

Very good question but a very complicated answer.  The responses from @markeb are very good so I will not comment much here.  All of the COVID vaccines being developed are using many different technologies.  If some of them work and they produce effective and protective responses after one or two doses that will be all that is needed.  IF that is not the case, and the clinical trial results show variances in the types of immune responses, then future vaccine trials might use different combinations in prime-boost as @markeb suggests.  But not likely that different vaccines of different technologies will be formulated in a cocktail in a single shot.  As an example, if an adenovector vaccine (like AZ/Oxford) gives a good T-Cell response but relatively poor antibodies, then a trial could be designed with a priming dose of the adenovector and a boosting dose of the subunit vaccine (better for antibodies).  Hopefully none of this is needed as it will take years.

[TeeRick]

14 hours ago, Doris&Nereus said:

I believe that monoclonal antibodies can be a good bridge to a vaccine, and we should be able to cruise as soon as these come out because the correct ones can eliminate the virus. Also, the phase III studies can move very fast BK as soon as they are given to enough people who are sick with the virus and agree to an emergency use of the Mab, we will know if they work. However, I only know of three companies who are ready to be or now are in phase III: Eli Lilly, Regeneron and Centivax. Furthermore, I believe the small Co Centivax is on hold for lack of funding.  It's CEO, Jacob Glanville has some promising results, and we need to make sure his Mab cocktail is funded now to ensure that we have at least one that works. I don't understand why we only focus on vaccines when Mabs can get us out of this mess so much faster.

Monoclonal antibodies are therapeutic. And they have been proven for a number of diseases.  But they are not a substitute for a prophylactic vaccine or even a bridge to one.  There is certainly a place for a good monoclonal AB therapeutic approach in COVID-19 hospitalized patients, but it is likely to be very expensive ($thousands per dose), probably iv drip, and limited in the overall number of doses that could be produced on a worldwide scale.  A vaccine is typically manufactured in millions of doses and is very inexpensive as compared to a monoclonal AB.  It would be nice to have both.  Outside of biologic therapies like monoclonal AB's, if one of the traditional (chemical) oral anti-viral drugs being developed in tablet form at low cost per dose is effective, that would be a great game changer.

[UnorigionalName]

3 hours ago, TeeRick said:

Monoclonal antibodies are therapeutic. And they have been proven for a number of diseases.  But they are not a substitute for a prophylactic vaccine or even a bridge to one.  There is certainly a place for a good monoclonal AB therapeutic approach in COVID-19 hospitalized patients, but it is likely to be very expensive ($thousands per dose), probably iv drip, and limited in the overall number of doses that could be produced on a worldwide scale.  A vaccine is typically manufactured in millions of doses and is very inexpensive as compared to a monoclonal AB.  It would be nice to have both.  Outside of biologic therapies like monoclonal AB's, if one of the traditional (chemical) oral anti-viral drugs being developed in tablet form at low cost per dose is effective, that would be a great game changer.

 

There is currently some groups doing research for intramuscular injections of large amounts of anti-COVID antibodies.  Since it has a relatively longish half life, proponents are pushing for it to be used prophylactically.  They I believe has some early limited evidence that it may be prophylactic and may help.

 

There are many issues though, one being that so far they are all convalescent plasma, and if it works, it will be a victim of its own success.  As cases go down, less convalescent plasma able to be used. Also the difficulty in producing.  Even if it were miraculously approved today, it would only be available to very few. 

 

There are a lot of barriers to finding, cloning, and producing a monoclonal antibody.  Or a reproducible oligoclonal mixture.  One being just time.  One being the feared antibody dependent enhancement.  There is increasing evidence there is at least some amount of ADE and it will take to find out what target constitutes a protective antibody or not.

[npcl]

2 hours ago, UnorigionalName said:

 

There is currently some groups doing research for intramuscular injections of large amounts of anti-COVID antibodies.  Since it has a relatively longish half life, proponents are pushing for it to be used prophylactically.  They I believe has some early limited evidence that it may be prophylactic and may help.

 

There are many issues though, one being that so far they are all convalescent plasma, and if it works, it will be a victim of its own success.  As cases go down, less convalescent plasma able to be used. Also the difficulty in producing.  Even if it were miraculously approved today, it would only be available to very few. 

 

There are a lot of barriers to finding, cloning, and producing a monoclonal antibody.  Or a reproducible oligoclonal mixture.  One being just time.  One being the feared antibody dependent enhancement.  There is increasing evidence there is at least some amount of ADE and it will take to find out what target constitutes a protective antibody or not.

Lilly is doing a trial in nursing homes using their antibody treatment as preventative. They are also doing a clinical trial as a treatment for those with serious illness.

[excitedofharpenden]

The WHO I have found to be somewhat pessimistic in their outlook so this is encouraging. To be honest, I can deal with two years. I would not have said that at the start, but the seriousness of the situation, any news like this is good!

 

https://www.bbc.co.uk/news/world-53870798

 

Phil 

[npcl]

Pfizer took two vaccines into their phase 1/2 trials (same technology).  Based upon the data from that trial both generated antibodies.  However, they moved their second candidate into first and took it into their phase 2/3 trials due to a better safety profile.  Candidate A had 50% of the patients have some adverse effects (minor), with Candidate B they got the same antibody response but only 18% had any adverse events.  Candidate B is what they moved forward into the large Phase 2/3 trial.

 

 

Edited August 22, 2020 by npcl

[TeeRick]

19 hours ago, UnorigionalName said:

 

There is currently some groups doing research for intramuscular injections of large amounts of anti-COVID antibodies.  Since it has a relatively longish half life, proponents are pushing for it to be used prophylactically.  They I believe has some early limited evidence that it may be prophylactic and may help.

 

There are many issues though, one being that so far they are all convalescent plasma, and if it works, it will be a victim of its own success.  As cases go down, less convalescent plasma able to be used. Also the difficulty in producing.  Even if it were miraculously approved today, it would only be available to very few. 

 

There are a lot of barriers to finding, cloning, and producing a monoclonal antibody.  Or a reproducible oligoclonal mixture.  One being just time.  One being the feared antibody dependent enhancement.  There is increasing evidence there is at least some amount of ADE and it will take to find out what target constitutes a protective antibody or not.

IMO there might be some very limited utility to these mAB and/or mixed AB approaches.  But they are not by any means a long term or an inexpensive solution.  But I guess we can see the data and perhaps learn something.

[TeeRick]

15 hours ago, excitedofharpenden said:

The WHO I have found to be somewhat pessimistic in their outlook so this is encouraging. To be honest, I can deal with two years. I would not have said that at the start, but the seriousness of the situation, any news like this is good!

 

https://www.bbc.co.uk/news/world-53870798

 

Phil 

Phil, so the head of the WHO says he hopes the COVID pandemic could be over in two years.  Not any specific reasons except that we have medical advances over what we had to battle the 1918 influenza pandemic.  I personally do not see that as particularly encouraging or even newsworthy. But if it gives you hope that is always a good thing. 

[K.T.B.]

5 hours ago, TeeRick said:

Phil, so the head of the WHO says he hopes the COVID pandemic could be over in two years.  Not any specific reasons except that we have medical advances over what we had to battle the 1918 influenza pandemic.  I personally do not see that as particularly encouraging or even newsworthy. But if it gives you hope that is always a good thing. 

 

"And like magic, it will disappear."

[norn iron]

Professor Chris Witty, Chief Medical Officer for England and the UK Government's Chief Medical Adviser, has been quoted today saying it was unlikely there would be a vaccine in 2020 but there was a "reasonable chance" of a successful vaccine being ready for the following winter in 2021-22. 

 

[Ken the cruiser]

12 minutes ago, norn iron said:

Professor Chris Witty, Chief Medical Officer for England and the UK Government's Chief Medical Adviser, has been quoted today saying it was unlikely there would be a vaccine in 2020 but there was a "reasonable chance" of a successful vaccine being ready for the following winter in 2021-22. 

 

Wow! And here I thought Oxford University/AstraZeneca as well as Pfizer and Moderna were doing so well. Do you by chance have a link to where this key UK person was mentioned saying this?

[Fouremco]

5 minutes ago, Ken the cruiser said:

Wow! And here I thought Oxford University/AstraZeneca as well as Pfizer and Moderna were doing so well. Do you by chance have a link to where this key UK person was mentioned saying this?

https://www.theguardian.com/world/2020/aug/22/whitty-says-it-would-be-foolish-to-count-on-having-covid-jab-by-winter

[npcl]

27 minutes ago, norn iron said:

Professor Chris Witty, Chief Medical Officer for England and the UK Government's Chief Medical Adviser, has been quoted today saying it was unlikely there would be a vaccine in 2020 but there was a "reasonable chance" of a successful vaccine being ready for the following winter in 2021-22. 

 

Nothing new in what he is saying.  Same as most of the other experts.  

 

The key is this phrase

 

"but I’d be quite surprised if we had a highly effective vaccine ready for mass use in a large percentage of the population before the end of winter, certainly before this side of Christmas."

 

It is not a negative comment about the existing vaccines.  It is more about the reality of the clinical trial process, and the logistics of manufacture and distribution to get it to a large percentage of the population.

 

Like many other comments it is a sitting of expectations to make sure that people continue to social distance and do their part.

Edited August 23, 2020 by npcl

[markeb]

8 minutes ago, Ken the cruiser said:

Wow! And here I thought Oxford University/AstraZeneca as well as Pfizer and Moderna were doing so well. Do you by chance have a link to where this key UK person was mentioned saying this?

 

They are doing historically well. In general, this is a slow, tedious, calculated process. It's going amazingly fast and well...

 

His statement actually has many of the same caveats a number of us have had. "Whitty added: “I would obviously be delighted if it came earlier, but I’d be quite surprised if we had a highly effective vaccine ready for mass use in a large percentage of the population before the end of winter, certainly before this side of Christmas...."

 

Available for use in limited populations late this year or early next year, expanding as the various vaccines come online and there's data to support which ones perform best in which populations. 

[Ken the cruiser]

10 minutes ago, Fouremco said:

https://www.theguardian.com/world/2020/aug/22/whitty-says-it-would-be-foolish-to-count-on-having-covid-jab-by-winter

Thanks! It's always nice to read the entire article to put it all into context.

Edited August 23, 2020 by Ken the cruiser

[TeeRick]

IMO.  It does not matter much what all of these experts say.  Or what their title is.  Or what country they are from.  They are waiting for the vaccine data from phase 3 trials just like the rest of us.  Perhaps then their quotes about timelines to vaccinate people will be more meaningful.