Port Reopenings After Vaccine?

[Roberto256]

5 minutes ago, npcl said:

No they will not.  Because in addition to safety, you need the trials to prove that they work.

 

You apparently missed the sarcasm intended in my post.

 

It all depends on whether the country follows a reasonable, scientific approach to testing vaccines,

or follows politicians.

Edited June 6, 2020 by Roberto256

[npcl]

4 hours ago, donaldsc said:

 

Remember thalidomide.  .  It was a well tested perfectly safe drug used to control morning sickness in pregnancy by many many women - until we found out the hard way that that wasn't.

 

DON

thalidomide was not approved in the US for that use. Though there were approximately 20,000 patients in the US as part of an unregulated clinical trial. The impact was mostly in Europe where it had been approved.

 

IN 1998 it did get limited approval for to treat inflammation associated with leprosy and also acts as a chemotherapeutic agent for patients with cancer of the plasma cells in bone marrow (multiple myeloma).

 

The impact of Thalidomide resulted in drastic change in the drug approval process, resulting in the much stricture process used today.  Pre-Clinical - IND - Ph 1,2,3 clinical trials - NDA - post market phase 4 trials in some cases - Adverse Event Reporting Systems.

 

Due to thalidomide's effects on fetuses, both nationally and abroad, the US Congress passed the 1962 Kefauver-Harris Amendments to the 1938 Food, Drug, and Cosmetic Act. These amendments imposed guidelines for the process of drug approval in the US and required that a drug be safe as well as effective before it could be approved and marketed. Thalidomide also influenced the FDA's creation of pregnancy categories; a ranking of drugs based on their effects on reproduction and pregnancy. 

Edited June 6, 2020 by npcl

[portiemom]

14 hours ago, Steelers36 said:

In regards to a vaccine, if effective, is it not just going to keep me from "catching" COVID?  Could I not still be a carrier like present asymptomatic people?  Could I "catch" the virus and disperse it into the air to potentially infect others, while I remain immune to falling ill?

 

People who are asymptomatic are infected and shedding virus but they are not showing symptoms of illness. The premise behind a vaccine is to prevent someone from being infected, because they already have antibodies that disable the virus, therefore they can't spread it.

[AnyMajorCruiseDude]

Glad that many of you are medical experts.   I will wait to see what happens.

[HappyInVan]

Resuming will resume before there is a vaccine. Ponant is preparing a contingency where cruises depart French ports, on a France-only itinerary. Avoiding the complications of cross-border restrictions.

 

In addition, cruising can resume even before the WHO downgrades the pandemic. Insurance would be provided by the EU's universal health coverage for European pax.

 

That said, Ponant may require distancing and masks. As well as covid tests prior to disembarkation.

 

 

There seems to be a great deal of optimism about a vaccine.

 

https://ca.news.yahoo.com/coronavirus-99-chance-covid-19-vaccine-says-chinese-133900363.html

 

https://www.msn.com/en-ca/news/world/chinese-covid-19-vaccine-expected-to-begin-mass-output-this-year/ar-BB14NC9t?li=AAggFp4

 

As others have noted, the vaccines will not be effective in all cases. So risks remain.  As also noted, the vaccines may require an annual update if covid19 is as shifty as the seasonal flu.

 

IMO, a return to 'normal' has to wait until enough states have squashed the disease. Only then, will we see multinational itineraries and long ocean voyages.

 

Good sailing.

 

 

 

[portiemom]

2 hours ago, AnyMajorCruiseDude said:

Glad that many of you are medical experts.   I will wait to see what happens.

My specialty is clinical microbiology and infectious diseases. I spent a good portion of my career in virology, and I'm waiting to see what happens also.

[npcl]

5 hours ago, AnyMajorCruiseDude said:

Glad that many of you are medical experts.   I will wait to see what happens.

10+ Years with FDA,  10+ years after that in the pharmaceutical Industry on the drug development side.

[npcl]

4 hours ago, HappyInVan said:

Resuming will resume before there is a vaccine. Ponant is preparing a contingency where cruises depart French ports, on a France-only itinerary. Avoiding the complications of cross-border restrictions.

 

In addition, cruising can resume even before the WHO downgrades the pandemic. Insurance would be provided by the EU's universal health coverage for European pax.

 

That said, Ponant may require distancing and masks. As well as covid tests prior to disembarkation.

 

 

There seems to be a great deal of optimism about a vaccine.

 

https://ca.news.yahoo.com/coronavirus-99-chance-covid-19-vaccine-says-chinese-133900363.html

 

https://www.msn.com/en-ca/news/world/chinese-covid-19-vaccine-expected-to-begin-mass-output-this-year/ar-BB14NC9t?li=AAggFp4

 

As others have noted, the vaccines will not be effective in all cases. So risks remain.  As also noted, the vaccines may require an annual update if covid19 is as shifty as the seasonal flu.

 

IMO, a return to 'normal' has to wait until enough states have squashed the disease. Only then, will we see multinational itineraries and long ocean voyages.

 

Good sailing.

 

 

 

I expect that it will be an annual shot, even if it does not mutate.  Do not expect  the immunity from either the  infection or the vaccine to last much more than a year, if even that much.  But we will see.

[donaldsc]

13 hours ago, npcl said:

The most of the things you listed get tested as part of the clinical trial process.  The biggest gap will be long term impacts (usually not an issue with vaccines) and if there are any issues with infections after the vaccine wears off (Dengue fever example).  

 

The following document goes over the requirements for clinical trials for vaccines.  While this is a document from the European Medicines Agency (EMA) , the FDA requirements are similar. There is a group (International Conference on Harmonization, ICH) which is made up of the Regulatory Authorities (FDA, EMA, Japanese MHW), Pharmaceutical Industry Groups (PHRMA, JPMA, EFPIA) with WHO and Canadian HPB participating as observers.  This group has been abd still is actively working to harmonize drug approval requirements in the 3 regions.  I have represented the FDA and PHRMA to one of the ICH working groups for a total of 8 years.

 

 If you go down to the safety section you can see a list of special populations that are required as part of the process for any vaccine that will apply to them.

 

Guideline on clinical evaluation of vaccines

https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-evaluation-vaccines-revision-1_en.pdf

 

 

 

Sounds like you know what you are talking about.  In your professional opinion, do you think that there is any chance at all that a functional and safe vaccine can be developed, tested, produced and distributed in the time that all the politicians are saying it will be done by?

 

DON

[caribill]

56 minutes ago, donaldsc said:

 

Do you think that there is any chance at all that a functional and safe vaccine can be developed, tested, produced and distributed in the time that all the politicians are saying it will be done by?

 

 

 

What worries me is that the FDA might allow vaccines to be released without going through the full FDA approval procedures.

 

This is what they did with new N95 mask manufacturers, Covid-19 tests, and Covid-19 antibody tests. Many of the unapproved items proved to not meet standards and/or produce a high number of inaccurate results, all after much $$$ (some at inflated pricing) was paid to purchase the ineffective items.

[RocketMan275]

On 6/5/2020 at 5:04 PM, Hlitner said:

Whenever I see a post like this I cannot help but ask a simple question, What if there is never a safe/effective vaccine?  My skepticism comes from working in the government health insurance industry and seeing many promised vaccines simply melt away once they get into Stage 2 and 3 testing.  I know we are all hearing a lot of optimism about a vaccine and I pray that scientists are successful.  But many of these same folks were telling us (over thirty years ago) about an AIDS vaccine.  And there is also the minor fact that science has never been able to develop any vaccine that works against a Coronovirus.

 

Hank

Did they ever develop a vaccine for the Spanish Flu?

Do we still live in fear of the Spanish Flu?

[Earthworm Jim]

1 hour ago, RocketMan275 said:

Did they ever develop a vaccine for the Spanish Flu?

Do we still live in fear of the Spanish Flu?

 

Coronaviruses and the flu are two different things. I'm not sure whether Spanish flu mutated to something less deadly, or enough people were infected to develop herd immunity. Either of those things could happen with coronavirus, but there are no guarantees. It may not mutate as quickly as influenza does (which is why we need new flu vaccines every year). And if we have to wait for herd immunity, there'd be a huge death toll ahead before we could get there. They say we'd need around 60% of the people to have had it to reach herd immunity, and even in hard hit areas such as NYC under 20% of people have antibodies.

 

So yeah, it could go away on it's own. But that's a dangerous path to commit to.

[PrincessLuver]

1 hour ago, Earthworm Jim said:

 

Coronaviruses and the flu are two different things. I'm not sure whether Spanish flu mutated to something less deadly, or enough people were infected to develop herd immunity. Either of those things could happen with coronavirus, but there are no guarantees. It may not mutate as quickly as influenza does (which is why we need new flu vaccines every year). And if we have to wait for herd immunity, there'd be a huge death toll ahead before we could get there. They say we'd need around 60% of the people to have had it to reach herd immunity, and even in hard hit areas such as NYC under 20% of people have antibodies.

 

So yeah, it could go away on it's own. But that's a dangerous path to commit to.

 

People suggested the Spanish flu died out over 15 months ( 1918-1919) after 1/3 of the world population  (500,000,000) were infected and supposedly 50,000,000 people died.  That was in the days of no air travel and also there were no antibiotics to treat secondary conditions of the infection.  Both were new virus and not seen before.  I agree.....a lot of us would have to become infected and die to reach herd immunity.

 

 

Edited June 7, 2020 by PrincessLuver

[npcl]

10 hours ago, donaldsc said:

 

Sounds like you know what you are talking about.  In your professional opinion, do you think that there is any chance at all that a functional and safe vaccine can be developed, tested, produced and distributed in the time that all the politicians are saying it will be done by?

 

DON

I am still looking at the original 15-18 months as a good timeline.  That would make it sometime between March and July of 2021 for wide spread public access.  I do expect a fully approved vaccine to be safe. That said I would not be surprised if there are some groups that might be recommended not to take the vaccine when it first comes out, pending additional testing.  

 

Things are moving at record pace, but testing will take time.  One of the reasons to not believe everything in the news about some of the time lines, is that while some of the organizations that are announcing the shortest timelines have never taken a vaccine fully through the approval process.  They have interesting technology, but no experience in the full process.

 

On the other hand other companies that have successfully taken vaccines fully through the process, such as Merck, who is extremely successful in vaccine development, are forecasting times in mid-2021.

 

One thing that will save time is that several companies are manufacturing product at their own risk, in order to make sure that if their vaccine is approved that it can be distributed quickly.  I also expect some of the phase III trials will include medical professionals, and other at risk groups, so in some ways part of the phase III trials will provide some early access.

 

I pay attention to what  Dr. Scott Gottlieb says on the subject.  He is a former director of the FDA and is both very knowledgeable and well connected on the subject.

[RocketMan275]

3 hours ago, Earthworm Jim said:

 

Coronaviruses and the flu are two different things. I'm not sure whether Spanish flu mutated to something less deadly, or enough people were infected to develop herd immunity. Either of those things could happen with coronavirus, but there are no guarantees. It may not mutate as quickly as influenza does (which is why we need new flu vaccines every year). And if we have to wait for herd immunity, there'd be a huge death toll ahead before we could get there. They say we'd need around 60% of the people to have had it to reach herd immunity, and even in hard hit areas such as NYC under 20% of people have antibodies.

 

So yeah, it could go away on it's own. But that's a dangerous path to commit to.

There are already reports from Italy that the Wuhanflu is mutating to something far less lethal.  Then there are reports that the Wuhanflu was not as lethal as originally reported.  

 

The path will be choosen for us.

[Daniel A]

43 minutes ago, RocketMan275 said:

There are already reports from Italy that the Wuhanflu is mutating to something far less lethal.  Then there are reports that the Wuhanflu was not as lethal as originally reported.  

 

The path will be choosen for us.

I've seen that too where hospitals are reporting milder symptoms now.  Theory is the virus doesn't 'want' to kill the host, just infect it so it can continue replication.

[caribill]

7 hours ago, RocketMan275 said:

Did they ever develop a vaccine for the Spanish Flu?

Do we still live in fear of the Spanish Flu?

 

The Spanish Flu was an H1N1 flu. The yearly flu vaccines have inbcluded this variety when it was predicted to occur.

[Earthworm Jim]

1 hour ago, RocketMan275 said:

There are already reports from Italy that the Wuhanflu is mutating to something far less lethal.  Then there are reports that the Wuhanflu was not as lethal as originally reported.  

 

The path will be choosen for us.

 

Yeah, but other experts dispute that. Who knows for sure which is right? Time will tell I guess.

[RocketMan275]

41 minutes ago, caribill said:

 

The Spanish Flu was an H1N1 flu. The yearly flu vaccines have inbcluded this variety when it was predicted to occur.

True but we didn't have vaccines for H1N1 until decades after the Spanish Flu pandemic.  Yet, we survived without lockdowns, masks, etc.  Even now, only a small portion of the population gets the vaccine.

Edited June 7, 2020 by RocketMan275

[Roberto256]

2 hours ago, npcl said:

I pay attention to what  Dr. Scott Gottlieb says on the subject.  He is a former director of the FDA and is both very knowledgeable and well connected on the subject.

 

Thank you for your very well-reasoned post.

[Daniel A]

11 minutes ago, RocketMan275 said:

True but we didn't have vaccines for H1N1 until decades after the Spanish Flu pandemic.  Yet, we survived without lockdowns, masks, etc.  Even now, only a small portion of the population gets the vaccine.

According to the British Medical Journal : "St Louis did much better than Philadelphia in the 1918 pandemic—long before effective drugs and vaccines were available. St Louis had its first cases on 5 October 1918, and on 7 October it took a range of measures, such as closing schools, theatres, and dance and pool halls and banning public gatherings, including funerals. In contrast, Philadelphia had its first cases on 17 September but didn't act until 3 October, and on 28 September a city-wide parade was held. St Louis experienced fewer cases and a much slower increase in the number of cases. "

[RocketMan275]

15 minutes ago, Daniel A said:

According to the British Medical Journal : "St Louis did much better than Philadelphia in the 1918 pandemic—long before effective drugs and vaccines were available. St Louis had its first cases on 5 October 1918, and on 7 October it took a range of measures, such as closing schools, theatres, and dance and pool halls and banning public gatherings, including funerals. In contrast, Philadelphia had its first cases on 17 September but didn't act until 3 October, and on 28 September a city-wide parade was held. St Louis experienced fewer cases and a much slower increase in the number of cases. "

You might want to read "The Great Influenza" by John M. Barry or "The Pale Rider" by Laura Spinney.  

My point was this, the Spanish Flu was by all measures over with by 1921.  I doubt we will be taking these countermeasures until there is a vaccine.  That scenario isn't born out by the experience with the Spanish Flu.  

FWIW, I'm well aware of the effects of this past pandemic since my father told me his mother died from the Spanish Flu in early 1920.  I never met her since I wasn't born until more than twenty years later.

[donaldsc]

4 hours ago, npcl said:

I am still looking at the original 15-18 months as a good timeline.  That would make it sometime between March and July of 2021 for wide spread public access.  I do expect a fully approved vaccine to be safe. That said I would not be surprised if there are some groups that might be recommended not to take the vaccine when it first comes out, pending additional testing.  

 

Things are moving at record pace, but testing will take time.  One of the reasons to not believe everything in the news about some of the time lines, is that while some of the organizations that are announcing the shortest timelines have never taken a vaccine fully through the approval process.  They have interesting technology, but no experience in the full process.

 

On the other hand other companies that have successfully taken vaccines fully through the process, such as Merck, who is extremely successful in vaccine development, are forecasting times in mid-2021.

 

One thing that will save time is that several companies are manufacturing product at their own risk, in order to make sure that if their vaccine is approved that it can be distributed quickly.  I also expect some of the phase III trials will include medical professionals, and other at risk groups, so in some ways part of the phase III trials will provide some early access.

 

I pay attention to what  Dr. Scott Gottlieb says on the subject.  He is a former director of the FDA and is both very knowledgeable and well connected on the subject.

 

Thanks for the answer.  Do you think that there will be a lot of political pressure to shortcut the approval process and what do you think is the probability that the regulators will cave?

 

DON

[dan4182]

I think ports and cruising will start-up long before there is a vaccine in place...

There may never be a vaccine, SARS occurred first years ago and no vaccine to date. There is still not a 100% effective flu vaccine and the flu kills tens of thousands every year.

Take whatever precautions are reasonable for you and get on with life!


Sent from my iPad using Forums

[npcl]

1 hour ago, donaldsc said:

 

Thanks for the answer.  Do you think that there will be a lot of political pressure to shortcut the approval process and what do you think is the probability that the regulators will cave?

 

DON

As I learned working for a government agency, there is political pressure in every thing that is done. However, keep in mind that when it comes to pharmaceuticals and vaccines every thing is a trade of risk vs benefit.  There is no such thing as a total safe drug.  When I worked there we always said that If aspirin was going through the NDA (new drug application) today, it would probably not get approved due to the number of side effects compared to benefits. 

 

What will have to be determine with the vaccine are the exact details on that risk vs benefit.  The number of severely ill, the number of deaths, the economic impact are going to impact the process (political or not) because those kinds of calculations are part of the process. So they might be willing to accept some additional risk because of how enormous the impacts are.

That risk might include things like approval but not recommended for some patients, approval with additional studies required, maybe willingness to accept a few more side effects.

 

The approval process will involve public expert panels.  That review and comment in a public forum their opinions about approval or not.  

 

While I expect the potential benefits mean being willing to accept a little more risk, I do not think that you will see political pressure  impact the process in any major way.  The number of deaths, and effects of the illness are generating their own pressure for speeding the process along.

 

One major reason why I do not think that they will circumvent the process is that for the vaccine to do any good there must be public confidence that it is safe and effective in order for people to take it. Skip steps in the process and you lose that confidence and then the vaccine is useless.

Edited June 7, 2020 by npcl