Vaccines and Therapeutics 2.0 & 3.0 Merge

[Jersey Girl]

I thought this was important enough to post in it's entirety.

Covid-19 vaccine no 'walk in the park,' CDC committee told

By Maggie Fox, CNN

Updated 9:30 PM ET, Mon November 23, 2020

(CNN)Americans need to be prepared for the possibility that they may feel a little unwell after they get a coronavirus vaccine, if one is authorized, members of a US Centers for Disease Control and Prevention advisory committee said Monday.

The CDC's Advisory Committee on Immunization Practices met to discuss whether to recommend use of any Covid-19 vaccine that the US Food and Drug Administration might authorize.

Volunteers in vaccine trials have reported they frequently feel flu-like effects after getting vaccinated, and members of the ACIP -- as well as liaison representatives who take part in the discussion -- said that could affect people's willingness to get vaccinated in the first place, or to get the second dose of the two-vaccine regimen.

"As a practicing physician, I have got to be sure my patients will come back for the second dose. We really have got to make patients aware that this is not going to be a walk in the park," Dr. Sandra Fryhofer of the Emory University School of Medicine, representing the American Medical Association, told the meeting.

"They are going to know they got a vaccine. They are not going to feel wonderful."

The whole point of vaccination is to cause an immune response in the body and that can sometimes cause flu-like symptoms such as body aches, or even fever and a headache.

Patricia Stinchfield of Children's Hospitals and Clinics of Minnesota, representing the National Association of Pediatric Nurse Practitioners, said providers must be ready to explain this to people getting any vaccine.

"These are immune responses, so if you feel something after vaccination, you should expect to feel that. And when you do, it's normal that you have some arm soreness or some fatigue or some body aches or even some fever," Stinchfield told the meeting. Some people may feel bad enough to need to stay home from work for a day, she said.

Dr. Paul Hunter of the city of Milwaukee health department and a voting member of the committee, said it will be important for the first people to get vaccinated to describe these experiences to others.

Boosting confidence in a vaccine

"The people who highly value getting the vaccine soon and fast, early, are going to be really helpful to everyone else. And I think we really are going to need to honor them, because they are going to let us know how it feels," he said. "And I think these people are likely to be health care workers who are likely to be up for that kind of task."

Public willingness to get a coronavirus vaccine has been steadily dropping since the spring, but it might improve when people start to hear more about the safety and efficacy of the various vaccines in the works, the CDC's Dr. Sara Oliver told the committee during the five-hour-long meeting.
Oliver said the CDC has been looking at various surveys on attitudes and noted that anywhere between 40% and 80% of those surveyed said they'd be willing to get vaccinated.

"Many adults reported intentions to receive Covid vaccine. But concerns were raised around side-effects, unknown efficacy and the speed of the (authorization) process," Oliver told the meeting.

Vaccine acceptance was highest among Asian-Americans and lowest among African-Americans, Oliver said. That's of concern because ACIP wants to make sure any vaccine that is approved gets to the groups most affected by the pandemic, and Blacks are among the hardest hit by Covid-19.
Nurses were also a concern. One survey showed that while nurses agreed vaccines were likely to be safe and effective, only 34% would voluntarily get vaccinated, Oliver said.

Members of ACIP said they thought these fears could be addressed with education campaigns and as people learned about data showing that, for example, the Pfizer and Moderna vaccines were about 95% effective in preventing symptomatic disease with no significant safety concerns.

Allocating the vaccine

Any plan for distributing coronavirus vaccine should take into account fair and equitable access to everyone—especially groups that are disproportionately affected by the pandemic.

Fair access is at the top of the list, ACIP committee members said in a document published at the start of the meeting.

"How do characteristics of the vaccine and logistical considerations affect fair access for all persons?" they asked in the document, released in the CDC's MMWR report.

"Does allocation planning include input from groups who are disproportionately affected by Covid-19 or face health inequities resulting from social determinants of health, such as income and health care access?"

The CDC, the National Academies of Science, Engineering and Medicine and other advisers have proposed four groups that should get vaccinated first: health care personnel, other essential workers, adults with high risk medical conditions and other adults 65 and older.

That's a lot of people. The CDC estimates there are 21 million healthcare personnel, 87 million essential workers, 100 million adults with high risk medical conditions and 53 million others are 65 and older. The federal government has said 40 million coronavirus vaccine doses could be available by the end of December.

There's little disagreement that frontline healthcare workers should be in the first group -- designated as 1a. At issue is whether residents of long term care facilities should be in this group, also.

There's no question it's a highly vulnerable population. "Long term care facility residents and staff accounted for 6% of cases and 39% of deaths in the US, despite the fact that long term care facility residents account for less than 1% of the US population," the CDC's Dr. Kathleen Dooling told the meeting.

Plus, it's a group that would be easier to reach if the staff caring for them are already being immunized in the first phase of any vaccine that might get emergency authorization from the FDA.

But ACIP member Dr. Helen Keipp Talbot worried that this frail group might do poorly in general and damage faith in the vaccine.

"There is such a high mortality rate in long term care facilities," Talbot told the meeting. "There will be a number of patients who receive immunizations for Covid and will pass away. And it will be regardless of the vaccine and most likely will be regardless of the vaccine," Talbot said.

"But early on as we're building confidence and we will not be able to show any data to say that it was not due to the vaccine because there's not been a randomized, controlled trial. And I think we're going to have a very striking backlash of 'my grandmother got the vaccine and she passed away,' and they're not likely to be related, but that will become remembered and break some of the confidence in the vaccine."

But others did not think that putting these residents further back in line would help.

Hunter said it would be inefficient to vaccinate healthcare workers in the facilities but skip residents. "Why not vaccinate people that, you know, you, you've got it all set up and ready to go?" he asked. "It's an efficiency to vaccinate a bunch of people who could benefit from it."

The ACIP will not make a decision Monday. The group will meet after the FDA's Vaccine and Related Biological Products Advisory Committee (VRPBAC) meets Dec. 10 to discuss an application by vaccine maker Pfizer and its German partner BioNTech for an emergency use authorization.

https://www.cnn.com/2020/11/23/health/c ... index.html

[Gunnar]

Good information, Jersey Girl! Thanks!

[Jersey Girl]

Good information, Jersey Girl! Thanks!

I thought so too, Gunnar. Particularly the strategies under consideration for distribution. I think the side effects pale in comparison to what I had with the pneumonia shot. I hope to hear more about side effects if there is any more to hear. Based on what I've read so far, you can just toss me the Tylenol and shoot me up.

[Chap]

Based on what I've read so far, you can just toss me the Tylenol and shoot me up.

I am glad to hear you say that. Maybe I am over-reacting, but when I saw that the CNN report included the phrase:

Volunteers in vaccine trials have reported they frequently feel flu-like effects after getting vaccinated ...

I thought to myself "Frequently? Really??". That might give readers the impression that it is quite likely, or even more likely than not that they will feel such symptoms, which is not so far as I know the case. Temporary soreness at the site of injection, yup, that's frequent, certainly. But frequent flu-like symptoms (headache, fever, limb pain ...)? I don't think I have seen that in reports of trials, and it certainly does not chime with my own experience of having a wide variety of vaccinations for travel over many years, during which I have only once felt somewhat feverish for 24 hours.

I do wish they had said "in some cases you may experience mild flu-like symptoms', which would have considerably lessened the chance of this 'information virus' mutating into "They say the COVID shot can make you ill like you have flu. I don't want to take the risk of that - sounds worse than the virus". But maybe I am too pessimistic ...

[Some Schmo]

All this talk about bad reactions to shots seemed overblown to me all my life... until just recently, in fact.

I've had countless shots in my life, but never reacted negatively to them until last month when I had the first of two shots for shingles vaccination. Holy crap, that was brutal. I couldn't lift my arm for a whole day, and I had the chills like never before. I wouldn't describe the experience as similar to having the flu, but I was not well for a good two or three days.

Still, I've heard shingles is even worse. I'll take the second shot.

[Res Ipsa]

It might be difference in language usage, Chap, but "flu-like symptoms" is a common description here of the mild side effects of flu shots. So, when I read that sentence, my first thought was "OK, just like the flu shot."

[honorentheos]

It seemed the concern is with people skipping the required second dose because they felt crappy after. That whole, "The flu shot gave me the flu when I got it, do I don't get the shot," argument.

I thought the article was good.

"As a practicing physician, I have got to be sure my patients will come back for the second dose. We really have got to make patients aware that this is not going to be a walk in the park," Dr. Sandra Fryhofer of the Emory University School of Medicine, representing the American Medical Association, told the meeting.

"They are going to know they got a vaccine. They are not going to feel wonderful."

The whole point of vaccination is to cause an immune response in the body and that can sometimes cause flu-like symptoms such as body aches, or even fever and a headache.

Patricia Stinchfield of Children's Hospitals and Clinics of Minnesota, representing the National Association of Pediatric Nurse Practitioners, said providers must be ready to explain this to people getting any vaccine.

"These are immune responses, so if you feel something after vaccination, you should expect to feel that. And when you do, it's normal that you have some arm soreness or some fatigue or some body aches or even some fever," Stinchfield told the meeting. Some people may feel bad enough to need to stay home from work for a day, she said.

[Some Schmo]

"As a practicing physician, I have got to be sure my patients will come back for the second dose. We really have got to make patients aware that this is not going to be a walk in the park," Dr. Sandra Fryhofer of the Emory University School of Medicine, representing the American Medical Association, told the meeting.

"They are going to know they got a vaccine. They are not going to feel wonderful."

Holy crap, yes. I mentioned to my wife that I was retroactively shocked the nurse didn't warn me about the shot's side-effects (especially given this new healthcare facility we started using - I've never been to a doctor's office that was so "preventative-medicine" oriented. They're awesome, and part of the awesome is how much they communicate everything).

Perhaps she thought (because of my age) I would have already had this experience, but I hadn't, and I was not prepared for those few days of recovery. I plan to let them know.

[Jersey Girl]

Based on what I've read so far, you can just toss me the Tylenol and shoot me up.

I am glad to hear you say that. Maybe I am over-reacting, but when I saw that the CNN report included the phrase:

Volunteers in vaccine trials have reported they frequently feel flu-like effects after getting vaccinated ...

I thought to myself "Frequently? Really??". That might give readers the impression that it is quite likely, or even more likely than not that they will feel such symptoms, which is not so far as I know the case. Temporary soreness at the site of injection, yup, that's frequent, certainly. But frequent flu-like symptoms (headache, fever, limb pain ...)? I don't think I have seen that in reports of trials, and it certainly does not chime with my own experience of having a wide variety of vaccinations for travel over many years, during which I have only once felt somewhat feverish for 24 hours.

I do wish they had said "in some cases you may experience mild flu-like symptoms', which would have considerably lessened the chance of this 'information virus' mutating into "They say the COVID shot can make you ill like you have flu. I don't want to take the risk of that - sounds worse than the virus". But maybe I am too pessimistic ...

Of course I will get vaccinated against COVID. What am I stupid? No, I'm a trooper. Tylenol is the only pain reliever/fever reducer I'm allowed to take so yes, I'll just dose myself up around the clock and do whatever I have to do. It's only for a day or so. Beats ending up on a vent.

As for the article, I really thought it was informative. I am not at all discouraged by the wording "flu-like symptoms" but I am sure there are folks who would feel put off by that. The only thing that puts me off is burying one of my family members. Compared to that, the vaccine is cake.

[Jersey Girl]

All this talk about bad reactions to shots seemed overblown to me all my life... until just recently, in fact.

I've had countless shots in my life, but never reacted negatively to them until last month when I had the first of two shots for shingles vaccination. Holy crap, that was brutal. I couldn't lift my arm for a whole day, and I had the chills like never before. I wouldn't describe the experience as similar to having the flu, but I was not well for a good two or three days.

Still, I've heard shingles is even worse. I'll take the second shot.

When I read your comments I had to pull out my planner and see which shot it was that I reacted to in the way that you describe. Here I've been misremembering it as the pneumonia shot but sure enough it was the shingles vaccine. I have to get the second shot in December. I got them both at the same time in different arms. I just told the pharmacist to "go for it". The pneumonia shot when administered really hurt a lot. The shingles didn't hurt at all.

Until the next day. I couldn't lift my right arm (dominant) for a good 4-5 days. I had chills and felt generally messed up--slept during the day. My arm was swollen to at least twice it's normal size. And then (just like magic) it went away. But of course I'll get the second shot. Only I'll have it in my non-dominant arm.

About 3-4 weeks ago now I bashed my rib cage. It still hurts but I'm okay living with pain including after-pain from shots.

With regard to shingles, Schmo, let me tell you something. Years ago my mother got the shingles. We lived across country and we called back and forth every Saturday or Sunday. When she had shingles, Schmo, that was the first time in my life that I really feared my mother would harm herself. She always soldiered her way through anything and my prime example of how to push, pull, drag oneself through challenge/crisis. But when she got shingles she wasn't herself. She was in such all-encompassing misery. She cried and told me it felt like razor blades on her skin. I was scared to death for her because she lived alone.

So when the shingles vaccine came out, I ran for it like I was running for my life and that was years ago and long before I ever left my job. I managed to talk the base into inoculating me early age-wise for both shingles and pneumonia on account of my work and the population I worked with.

Yeah, don't mess with shingles. Everyone here who is due to get the shingles shot--get off your duff and go get it.