Are vaccines the light at the end of the tunnel?

[Baron Barracuda]

1 hour ago, deadzone1003 said:

Then, what good is a vaccine if it doesn't work very well?  It is their choice.  They have limited funds to throw around.

Even when J&J is approved how long will it take for production to ramp up and supply to reach SA?  They are sitting with a million doses of Astra Zeneca vaccine in inventory.  Absent evidence of severe side affects why not use them?  

[eas2225]

On 2/6/2021 at 10:30 AM, TeeRick said:

Even though I am 63, I qualify (for medical reasons) right now.  I go to that PA web site every day as well as my county site, the pharmacy sites, etc.  No appointments available.  I am on a few waiting lists.  Our state is just not doing what it needs to do.  I should at least be able to get an appointment even if months away.

 

My husband is 69 and has an underlying condition.  I did the same as you, as far as trying to get an appointment for him on the PA site, county site, etc.  

 

But he sees Doctors from 3 different hospital systems, and he has a portal for each system.  

 

I went to each portal and was able to sign him up, and last week the Temple Health System emailed with me a schedule for appointments.  I got the email last Tuesday and made his appt. for two days later.  

 

If any of your doctors belong to a health system like Main Line Health, Grand View,  etc. try it.

 

I work at Temple and just got my second dose last Thursday.  Injection site was more sore, had a mild case of fatigue, and that was about it.

[zanderblue]

Novavax phase 3 trial here in Scotland is being modified. They are now changing to what they are calling “crossover” phase. Basically, they are offering Novavax vaccine to all those in the trial who were originally given the placebo. The vaccine will be given in 2 doses, 3 weeks apart assuming it is approved by the regulator (probably late March)

I only found out about this when I talked to trial team earlier this morning to discuss being unblinded since I have been called to get my first NHS vaccine shot. 
 

[TeeRick]

1 hour ago, eas2225 said:

 

My husband is 69 and has an underlying condition.  I did the same as you, as far as trying to get an appointment for him on the PA site, county site, etc.  

 

But he sees Doctors from 3 different hospital systems, and he has a portal for each system.  

 

I went to each portal and was able to sign him up, and last week the Temple Health System emailed with me a schedule for appointments.  I got the email last Tuesday and made his appt. for two days later.  

 

If any of your doctors belong to a health system like Main Line Health, Grand View,  etc. try it.

 

I work at Temple and just got my second dose last Thursday.  Injection site was more sore, had a mild case of fatigue, and that was about it.

Thank you much appreciated!

[markeb]

1 hour ago, Baron Barracuda said:

Even when J&J is approved how long will it take for production to ramp up and supply to reach SA?  They are sitting with a million doses of Astra Zeneca vaccine in inventory.  Absent evidence of severe side affects why not use them?  

I can’t speak to South Africa, but there’s been at least an unofficial philosophy you hear from people who work a lot with the FDA that if you can’t demonstrate a benefit, then a product is inherently unsafe. Especially for something like a vaccine that’s given to a healthy person. And safety and effectiveness are the two basic criteria for approving a drug or biological. That’s the safety philosophy that would get to why not use them. Even one or two serious adverse events if you can’t show benefit would be too many. 
 

If AZ had recruited a study population that allowed some estimation of reducing serious disease, there’d be no discussion about continuing to collect data that might show benefit against that endpoint. They had an incredibly complicated trial with multiple endpoints in the US. If, and it’s only an if that I expect to be seriously discussed, they hit a stop here, it feels self-inflicted. Some of those choices could have been imposed by the regulators, of course. The other candidates show great protection against serious disease, and have been reported effective against this variant in particular. That makes things complicated.

[TeeRick]

12 minutes ago, markeb said:

I can’t speak to South Africa, but there’s been at least an unofficial philosophy you hear from people who work a lot with the FDA that if you can’t demonstrate a benefit, then a product is inherently unsafe. Especially for something like a vaccine that’s given to a healthy person. And safety and effectiveness are the two basic criteria for approving a drug or biological. That’s the safety philosophy that would get to why not use them. Even one or two serious adverse events if you can’t show benefit would be too many. 
 

If AZ had recruited a study population that allowed some estimation of reducing serious disease, there’d be no discussion about continuing to collect data that might show benefit against that endpoint. They had an incredibly complicated trial with multiple endpoints in the US. If, and it’s only an if that I expect to be seriously discussed, they hit a stop here, it feels self-inflicted. Some of those choices could have been imposed by the regulators, of course. The other candidates show great protection against serious disease, and have been reported effective against this variant in particular. That makes things complicated.

The most confusing thing to me is that all of these vaccines present the exact same antigen to the host immune system.  The mRNA vaccines and the vectored vaccines do this the same way using host cell expression after injection.  The J&J vaccine is human adeno and the AZ vaccine is chimp adeno.  So yes possibly a species/vector effect.  But we are talking here about the same antigen (original) in all current vaccines.  So why should the expression method make a lot of difference against variants with slightly different SPIKE sequences?

[bigbenboys]

As I'm 62 and healthy. I know I dont qualify. If I lied and said I live with my parents a mile away I could qualify. My father gets his 2nd shot this month and my mother gets her 1st shot this month.

Interesting article about reinfections.

https://www.huffpost.com/entry/new-variants-raise-worry-about-covid-19-virus-reinfections_n_602193e6c5b689330e31dcc4

[UnorigionalName]

50 minutes ago, TeeRick said:

The most confusing thing to me is that all of these vaccines present the exact same antigen to the host immune system.  The mRNA vaccines and the vectored vaccines do this the same way using host cell expression after injection.  The J&J vaccine is human adeno and the AZ vaccine is chimp adeno.  So yes possibly a species/vector effect.  But we are talking here about the same antigen (original) in all current vaccines.  So why should the expression method make a lot of difference against variants with slightly different SPIKE sequences?

 

I'm not an expert in immunology/vaccines, but from my understanding:

 

viral vectors have had a lot of issues.  They've been in development for many years without too much success.  There's lots of potential reasons:

 

1) Immunity to vector.  Many people have pre-existing antibodies to many of the human adenovirus vectors.  While the non-human (chimp) vectors shouldn't have this issue, they seem to have lower efficiency in general.

 

2) Side effect profile limits your maximum dose.  They produce a pretty brisk immune response, and generally in the past, acceptable side effects from vaccine was very low because you are giving it to healthy people.  The mRNA vaccines are really on the high side for side effects, but I think FDA is willing to put up with the fevers due to the nature of the disease.

 

3) It's mixed in with all sorts of other junk.  You have the viral proteins all intact since they need to invade into the cell.  So your system can respond to the vector proteins.  The virus still has most of its dna intact, and who knows what the dendritic cells chose to make and present on its surface.  I'm not sure exactly how they produce it, I am sure there is some method to try to get the cells to make the spike protein, but apparently it's not as effective as the mRNA vaccines.

[Host Jazzbeau]

I am happy to report that in at least one case [serious scientific anecdotal evidence here 😉] my son got the mRNA vaccine and for the first time in his life did NOT have a reaction.  He is very glad he didn't have to get the more normal type vaccine.

[markeb]

2 hours ago, TeeRick said:

The most confusing thing to me is that all of these vaccines present the exact same antigen to the host immune system.  The mRNA vaccines and the vectored vaccines do this the same way using host cell expression after injection.  The J&J vaccine is human adeno and the AZ vaccine is chimp adeno.  So yes possibly a species/vector effect.  But we are talking here about the same antigen (original) in all current vaccines.  So why should the expression method make a lot of difference against variants with slightly different SPIKE sequences?

 

Interesting question, honestly. Almost certainly the sequences are slightly different between the candidates, and almost certainly not to a point you'd expect any differences. I'm sure they've done every possible 21st century measurement of protein structure and conformation, and everything predicted a good to great conformation match between the fragment to the wild type protein. Maybe the segment folds differently in the body than in the lab? Maybe the virus actually undergoes a conformation change as it binds to the cell, and the others got lucky in a better match? Maybe the mRNA vaccines and the human adeno vector express a more appropriate (more or less?) amount of antigen? Or maybe Oxford snipped in exactly the wrong place for this variant that they couldn't have predicted?

 

Great time to be a molecular virologist/immunologist because this will give you something to study for awhile, and there might even be grants to fund it! Maybe not so great if you're actually trying to make a vaccine...

[CRUISEFAN0001]

Both of us got  COVID vaccine...NO SIDE EFFECTS - glad to now be vaccinated.

 

If they decide a booster is needed in the future for other "mutant" strains...no worries here.

 

 

[Ken the cruiser]

We waited over 5 hours in line today at a mass vaccination site here in Montgomery, but we now have the Pfizer vaccine flowing through our veins, with an appointment for 3 weeks later at the same site for the second one. Yay!!!  One big suggestion if you are lucky enough to attend one of these types of clinics in your area. Go one hour earlier than you were planning to. We got there about 2 hours before they were scheduled to start giving shots and we were numbers 853/854 in line. Also, if you go with someone, bring a deck of cards to pass the time. ☺

Edited February 8, 2021 by Ken the cruiser

[hcat]

Received a reminder call today for shot #2 ( Moderna)  for later this week. Nervous but want to get it over with..friend got " Covid arm " with her 1st shot..never heard of that til it happened.  Hope in the future the boosters /annual shots are easier to book and process less stressful! Learning curve.

 

Hearing from  all the smart folks on here gives great confidence we will prevail!

[cangelmd]

2 hours ago, Ken the cruiser said:

We waited over 5 hours in line today at a mass vaccination site here in Montgomery, but we now have the Pfizer vaccine flowing through our veins, with an appointment for 3 weeks later at the same site for the second one. Yay!!!  One big suggestion if you are lucky enough to attend one of these types of clinics in your area. Go one hour earlier than you were planning to. We got there about 2 hours before they were scheduled to start giving shots and we were numbers 853/854 in line. Also, if you go with someone, bring a deck of cards to pass the time. ☺

Happy to read today that Vaughan Med Center in Selma had a great response to their mass vaccination clinic in their 70% African-American community. Those stories will get vaccines flowing in those reluctant (understandably) groups.

Word of mouth successes will be important.

[Caymus88]

Received my second dose of Moderna Feb 4.

I had every side effect but one and am still not well yet.

5 other people got the second dose as well. They are fine.

Better than getting Covid though.

[hcat]

14 minutes ago, Caymus88 said:

Received my second dose of Moderna Feb 4.

I had every side effect but one and am still not well yet.

5 other people got the second dose as well. They are fine.

Better than getting Covid though.

Hope you feel better soon!

Did you tolerate the 1st shot okay..?

Our friend with Covid arm  registered for a tracking study so she was able to report her issue.  Doing better now!

 

Can anyone simply go over how reactions are being tracked and how this might help refinements.? At a certain level we are all the guinea pigs/ lab rats

[Arizona Wildcat]

23 minutes ago, hcat said:

Hope you feel better soon!

Did you tolerate the 1st shot okay..?

Our friend with Covid arm  registered for a tracking study so she was able to report her issue.  Doing better now!

 

Can anyone simply go over how reactions are being tracked and how this might help refinements.? At a certain level we are all the guinea pigs/ lab rats

DW and I were given a sheet with phone numbers to notify both the medical group that injected us and the CDC about any " moderate to severe" reactions.  

[D C]

1 hour ago, Caymus88 said:

Received my second dose of Moderna Feb 4.

I had every side effect but one and am still not well yet.

5 other people got the second dose as well. They are fine.

Better than getting Covid though.

Hopefully it passes soon. DW got her 2nd Moderna on Fri.  Temp in the 99s and felt drained all day. Her co-workers generally faired worse but were feeling mostly better by today. 

[markeb]

DW got her first dose of Pfizer on Saturday through her school district. In and out in twenty minutes, including observation. They took their time to trickle the appointments out, but they were efficient once she got there! Soreness yesterday, but she hasn't reported any other issues.

 

Now I'm trying to navigate the 16-64 underlying health condition group. Virginia collapsed 1b and 1c together, but my health care is through the military facilities, and they're still on over 75. Supposedly CVS, Walgreens, etc., will be offering vaccinations in the area probably next week.

[Lady Chew]

Virginia may have collapsed 1b&c together, but they're still on over 75.  We've filled out some online forms with the county, hospital system, & physicians office, but still cant get appointments.  (We're both 1c)

 

On the other hand, my daughter lives in a residential care facility in Pennsylvania, and she just received her second shot of Pfizer this morning.  I've been told she had no side effects with either shot.

 

We are anxious to get our own vaccs so we can finally get so see her.  It's been over a year.

[markeb]

12 minutes ago, Lady Chew said:

Virginia may have collapsed 1b&c together, but they're still on over 75.  We've filled out some online forms with the county, hospital system, & physicians office, but still cant get appointments.  (We're both 1c)

 

On the other hand, my daughter lives in a residential care facility in Pennsylvania, and she just received her second shot of Pfizer this morning.  I've been told she had no side effects with either shot.

 

We are anxious to get our own vaccs so we can finally get so see her.  It's been over a year.

 

Yeah. Signed up on the waitlist for PWC today. TRICARE has broken links. Surprise. Officially, according to their global information, I can schedule appointments today, but Belvoir has a 8 February update that apparently requires a 1995 version of Flash to actually load...

 

I would like the element of protection the vaccine should offer me, with underlying conditions that may make me respond less effectively. But I really want it so my wife isn't scared to teach for fear she'll infect me...

[cangelmd]

11 hours ago, Caymus88 said:

Received my second dose of Moderna Feb 4.

I had every side effect but one and am still not well yet.

5 other people got the second dose as well. They are fine.

Better than getting Covid though.

Did they recommend any pre-medication or post-medication? I'm curious because when I got my second shot in early January, pre and post meds were being recommended, but now the CDC is very cagey about this issue, because of concerns with the meds somehow lessening the immune response to the vaccine. There's no data, so CDC is acting out of caution. They recommend (at least last week) taking meds if and when you become symptomatic. I was glad to have some reaction, I felt reassured that I developed some immunity.

[wrk2cruise]

I was interested to see Covid Arm mentioned here.  When I looked it up I figured out that's what DW had about a week after getting Moderna first dose.  It was a round redness around the injection site a bit larger than a quarter and she said it itched but wasn't sore.  Resembled a spider bite and was gone after a couple of days.  Nice to know it was a real thing.

[TeeRick]

21 hours ago, deadzone1003 said:

Then, what good is a vaccine if it doesn't work very well?  It is their choice.  They have limited funds to throw around.

Here is a summary of where the COVID vaccine effort is in South Africa.  The country has bought some vaccine (AZ/Oxford) and has a contractual agreement with J&J.  Much of the vaccination effort for African countries are funded by the African Union and WHO (through COVAX).  My guess/opinion is that going forward this year, companies making variant-matched vaccines (mRNA and Adeno-vector vaccines) will be in a rush to do large efficacy studies in S. Africa.  This will help the country in many ways.

https://www.bbc.com/news/world-africa-55675806

[TeeRick]

1 hour ago, cangelmd said:

Did they recommend any pre-medication or post-medication? I'm curious because when I got my second shot in early January, pre and post meds were being recommended, but now the CDC is very cagey about this issue, because of concerns with the meds somehow lessening the immune response to the vaccine. There's no data, so CDC is acting out of caution. They recommend (at least last week) taking meds if and when you become symptomatic. I was glad to have some reaction, I felt reassured that I developed some immunity.

I agree.  I don't see how taking ibuprofen before the shot will matter much.  Post-injection it takes several days to ramp up antigen expression and present it to the immune system.  And pre-treatment by taking an OTC anti-inflammatory drug will not down-regulate the immune response for days after.  The timing does not make any sense.  And for those with natural viral and bacterial infections of most types don't they recommend aspirin, Tylenol or ibuprofen to treat fever, aches and pains while your immune system is fighting these infections?