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kaitak
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Some questions about Covid 19 and a vaccine

Mon Aug 03, 2020 1:03 pm

The whole Covid 19 situation is obviously causing the world - and particularly the aviation sector, a lot of stress.

I have a few questions and these are asked from the perspective of someone with very limited medical knowledge, so please be understanding if the questions appear a bit stupid.

1) I'm hearing various stories about the stages of development of a vaccine. Dr. Fauci, who is obviously an expert, seems to be optimistic that a vaccine might be available next year; there is a group of Oxford based scientists who also seem to have made huge progress. On the other hand, there is still (apparently) no vaccine for SARS, which was around over a decade ago. Which is closer to the truth? I am guessing that due to the massive economic hit from Covid, that it is being prioritized all over the world

2) Once it is proven that whatever vaccine is successful and does the job, what are the procedures; presumably, much like a plane has to be approved by various different airworthiness authorities, its the same with medicines, BUT might that not get wound up in politics? Would the FDA and the European/UK/Australian etc authorities recognise each others' certification. Given (for example) the UK/EU Brexit talks at the moment, could a vaccine become a pawn in that dispute? Are there international treaties/agreements which prevent medicines becoming pawns in trade talks, particularly in situations such as this?

3) Cost: the organisations and companies investing in this will have thrown billions at it and no doubt got financial support from governments. It's one thing for it to be exported to/licensed in wealthy countries, but what about (say) sub-Saharan Africa or other poorer regions? Not getting the vaccine at the same time as others will almost certainly cause huge problems for them?

4) What if the vaccine itself works as far as Covid is concerned, but creates other problems, e.g. birth defects - which, given the speed at which it is being introduced - might not be noticeable until it's too late? Pharma companies could find themselves facing billions in lawsuits. However, given that national govts are probably putting massive pressure on Pharma companies and research teams, might they be protected/indemnified from this?

5) Scale: basically, you will need about 4-5bn people inoculated, which is going to be a massive logistical challenge. That's not going to happen quickly. Also, is there going to be an agreed system of recognising other countries' inuculations - e.g. will people get a passport stamp or some other fraud-proof certificate to show that they have received the vaccine and can therefore travel?

It seems to me that much though we might wish that the vaccine would be available very quickly, there is a lot that has to happen, even when a vaccine is developed, that can delay it and therefore, it might well be well into the second half of next year before it can actually be available to everyone who needs it.

I'd love to know a bit more, especially from people with some knowledge of medicines and the approval process, which I understand it (necessarily) quite complex.
 
frmrCapCadet
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Re: Some questions about Covid 19 and a vaccine

Mon Aug 03, 2020 1:22 pm

Your summary is fairly complete and accurate. Here is one link which provides some information

https://www.fda.gov/media/139638/download
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DocLightning
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Re: Some questions about Covid 19 and a vaccine

Mon Aug 10, 2020 4:28 am

kaitak wrote:
1) I'm hearing various stories about the stages of development of a vaccine. Dr. Fauci, who is obviously an expert, seems to be optimistic that a vaccine might be available next year; there is a group of Oxford based scientists who also seem to have made huge progress. On the other hand, there is still (apparently) no vaccine for SARS, which was around over a decade ago. Which is closer to the truth? I am guessing that due to the massive economic hit from Covid, that it is being prioritized all over the world


There is no vaccine for SARS because SARS went away. SARS was much easier to control with public health measures because all patients were symptomatic and they all were symptomatic when they were contagious. That's not the case for SARS-CoV-2 (the current virus). So once SARS went away, a lot of the funding got pulled and also, there would be no way to prove efficacy. But the research didn't just stop. There has been research on vaccines against MERS-CoV and SARS-CoV.

2) Once it is proven that whatever vaccine is successful and does the job, what are the procedures; presumably, much like a plane has to be approved by various different airworthiness authorities, its the same with medicines, BUT might that not get wound up in politics? Would the FDA and the European/UK/Australian etc authorities recognise each others' certification. Given (for example) the UK/EU Brexit talks at the moment, could a vaccine become a pawn in that dispute? Are there international treaties/agreements which prevent medicines becoming pawns in trade talks, particularly in situations such as this?


The FDA has requirements. The vaccine must be tested on certain populations, it must meet certain standards of efficacy, and it can't have serious side-effects not found in placebo.
[/quote]

3) Cost: the organisations and companies investing in this will have thrown billions at it and no doubt got financial support from governments. It's one thing for it to be exported to/licensed in wealthy countries, but what about (say) sub-Saharan Africa or other poorer regions? Not getting the vaccine at the same time as others will almost certainly cause huge problems for them?


Out of my wheelhouse, I'm afraid
4) What if the vaccine itself works as far as Covid is concerned, but creates other problems, e.g. birth defects - which, given the speed at which it is being introduced - might not be noticeable until it's too late? Pharma companies could find themselves facing billions in lawsuits. However, given that national govts are probably putting massive pressure on Pharma companies and research teams, might they be protected/indemnified from this?


Vaccines are generally safe because of the way that they stimulate the immune system. There has never been a case to my knowledge of a licensed vaccine causing birth defects. Generally, any serious side-effects of the vaccine will be seen within about 6-8 weeks after injection. They don't just pop up years or decades later.

The real risk that a vaccine could trigger the wrong kind of immune response (say, Th2, which is antiparasitic vs Th1, which is antiviral) and thus make someone sicker with COVID-19 than if they'd not gotten the vaccine. So far, all the vaccines that have been tested produce a robust Th1 response, which is what they're supposed to be doing. Another risk is for something called "antibody-dependent enhancement, (ADE)" which is seen in dengue, in which antibodies that bind to the virus particle but do not neutralize it can serve as portals for the virus to infect more cells. We have not seen any evidence of ADE with SARS-CoV-2.

5) Scale: basically, you will need about 4-5bn people inoculated, which is going to be a massive logistical challenge. That's not going to happen quickly. Also, is there going to be an agreed system of recognising other countries' inuculations - e.g. will people get a passport stamp or some other fraud-proof certificate to show that they have received the vaccine and can therefore travel?


Again, above my pay grade, but we already have nations that require proof of vaccination against certain diseases to enter. I'd support requiring proof of vaccination to get a passport, a visa, or even a plane ticket.

It seems to me that much though we might wish that the vaccine would be available very quickly, there is a lot that has to happen, even when a vaccine is developed, that can delay it and therefore, it might well be well into the second half of next year before it can actually be available to everyone who needs it.

I'd love to know a bit more, especially from people with some knowledge of medicines and the approval process, which I understand it (necessarily) quite complex.


I'm a physician and a former virologist. Ask me anything.
-Doc Lightning-

"The sky calls to us. If we do not destroy ourselves, we will one day venture to the stars."
-Carl Sagan
 
olle
Posts: 2233
Joined: Tue Feb 06, 2007 3:38 am

Re: Some questions about Covid 19 and a vaccine

Mon Aug 10, 2020 9:52 am

in this subject I must admit I do not know anything ;-)

what is the chance that we get a vaccine in enough quantities to handle risk groups within 6 month that with 80-90% gives let say a 6-12 month protection?

if the chance is low what can be done and how long tim can we expect it to take until it cab be spread around the globe? 1 year, 3 years never?
 
bhill
Posts: 1827
Joined: Thu Sep 13, 2001 8:28 am

Re: Some questions about Covid 19 and a vaccine

Mon Aug 10, 2020 7:30 pm

Good Day Doc...what about antibody persistence with CV-19? I am hearing differing reports of boosters being needed, and is this virus mutating enough that we would need "seasonal" immunizations such as influenza?
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