Jan. 27, 2021 -- The U.S. is nearly 6 weeks into its historic campaign to vaccinate Americans against the virus that causes COVID-19, and so far, the two vaccines in use look remarkably low-risk, according to new data presented today at a meeting of vaccine experts that advise the CDC.

With 23.5 million doses of the Pfizer and Moderna vaccines now given, there have been very few serious side effects. In addition, deaths reported after people got the vaccine do not seem to be related to it.

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Is It Safe for People With Allergies to Get the COVID-19 Vaccine?WebMD's Chief Medical Officer, John Whyte, MD, explains the safety of getting the COVID-19 vaccine for people with allergies.95

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JOHN WHYTE: Can I still get

the COVID vaccine if I have

allergies?



There have been a few--

very few-- instances

of a severe allergic reaction

to the current vaccines.

These have occurred in people

who have a history

of severe allergic reactions

and carry EpiPens.

If you have ever had

a severe allergic reaction

to any ingredient in a COVID-19

vaccine, the CDC recommends

that you should not get

that specific vaccine.

You can check out the vaccine's

ingredients online.



If you've ever had

a severe allergic reaction

to other vaccines

or injectable therapies,

you should ask your doctor

if you should get a COVID-19

vaccine.

Your doctor will help you decide

if it's safe for you

to get vaccinated.

If you have a history

of severe allergic reactions not

related to vaccines

or injectable medications,

such as allergies to food, pets,

venom, or latex, you can still

get vaccinated.

People with a history

of allergies

to oral medications,

a family history

of severe allergic reactions,

or who might have a mild allergy

to vaccines with no anaphylaxis,

you may also still get

vaccinated.



If, for some reason,

you have

a severe allergic reaction

after getting the first shot,

you should not get

the second shot.



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John Whyte, MD, MPH, Chief Medical Officer, WebMD/delivery/aws/f2/cb/f2cb74db-6544-3450-8f44-c51ae2ad817f/Vaccines_Allergies_Final_v5_,4500k,2500k,1000k,750k,400k,.mp401/22/2021 12:00:0018001200Vaccines_Allergies_v5_thumb_1800_1200/webmd/consumer_assets/site_images/article_thumbnails/video/covid19-images/Vaccines_Allergies_v5_thumb_1800_1200.jpg091e9c5e820e9eae

The most common symptoms reported after vaccination were pain where people got the shot, fatigue, headache, and muscle soreness. These were more common after the second dose. In addition, about 1 in 4 people reported fever and chills after the second shot.

“On the whole, I thought it was very reassuring,” said William Schaffner, MD, an infectious disease expert with Vanderbilt University School of Medicine in Nashville who listened to the presentations.

The CDC is collecting safety information through multiple channels. These include a new smartphone-based app called V-Safe, which collects daily information from people who’ve been vaccinated; the federal Vaccine Adverse Event Reporting System, or VAERS, which accepts reports from anyone; and the Vaccine Safety Datalink, which is a collaboration between the CDC and nine major hospital systems. There’s also CISA, the Clinical Immunization Safety Assessment Project, a collaboration between the CDC and vaccine safety experts.

After surveying these systems, experts heading the safety committee for the CDC’s Advisory Committee on Immunization Practices say there have been few serious side effects reported.

Very rarely, severe allergic reactions -- called anaphylaxis -- have occurred after vaccination. There have been 50 of these cases reported after the Pfizer vaccine and 21 cases reported after the Moderna vaccine to date. Nearly all of them -- 94% of the anaphylaxis cases after Pfizer vaccines and 100% of those after Moderna’s vaccine -- have been in women, though it’s not clear why.

That translates to a rate of about five cases of anaphylaxis for every million doses of the Pfizer vaccine and about three for every million doses of the Moderna vaccine. Most of these occur within 15 minutes after getting a vaccine dose, with one reported as long as 20 hours after the shot.

The CDC suspects these may be related to an ingredient called polyethylene glycol, or PEG. PEG is a part of the particles that slip the vaccines’ mRNA into cells with instructions to make the spike protein of the virus. Cells then express these spikes on their surfaces so the immune system can learn to recognize them and make defenses against them. PEG is a common ingredient in many drugs and occasionally triggers anaphylaxis.

Reported Deaths Seem Unrelated to Vaccines

Through Jan. 18, 196 people have died after getting a vaccine.

Most of these deaths -- 129 -- were in patients in long term care facilities. . These deaths are still being investigated, but when they were compared with the number of deaths that might be expected over the same period due to natural causes, they seemed to be coincidental and not caused by the vaccine, said Tom Shimabukuro, MD, deputy director of the Immunization Safety Office at the CDC, who studied the data.

Promoting Confidence in COVID-19 VaccinesWebMD's Chief Medical Officer, John Whyte, MD, speaks with William E. Fox, MD, Chair, Board of Governors, American College of Physicians (ACP), about promoting confidence in COVID-19 vaccines. 914

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JOHN WHYTE: Welcome, everyone.

You're watching "Coronavirus

in Context."

I'm Dr. John Whyte,

chief medical officer at WebMD.

Today I want to spend

a little time talking

about the impact of COVID

on health care professionals.

We've talked about the impact

of PTSD, but I also want to talk

about the role,

in terms of vaccine confidence

as well as what might be

on the horizon.



And to help provide

some insight, I've asked Dr.

William Fox.

He is chair of the Board

of Governors of the American

College of Physicians.

Dr. Fox, thanks for joining me.



WILLIAM FOX: John, it's

great to be with you today.



JOHN WHYTE: Well, everyone's

talking about the vaccine

and vaccine confidence.

But I want to ask you--

something that we haven't talked

enough about is--

we're talking about patients

having concerns about the safety

and efficacy of vaccines,

but we also know some

of our clinical colleagues

are expressing

some reservations.

So how do we help

inspire confidence

in the vaccine?



WILLIAM FOX: Well, first of all,

I think we should just pause

for a minute

and just acknowledge the moment

that we are in.

I think it was last January 10,

where the genomic sequence

of the SARS-CoV-2 virus

was first published.

And now it's 11 months later,

and we are delivering a vaccine

into the arms of patients.

And I think

that's

an extraordinary achievement

for science.



So this provides us with a lot

of hope

as we move

into this dark winter.

But I think physicians,

to answer your question

specifically,

are a lot like patients.

They run the gamut in terms

of their fears and concerns.

The last I saw, I think, when I

read a media report,

was that about 70%

of individuals across the board

have an interest in getting

that vaccine.

But that means that 30% still

have concerns, and physicians

are among them.



JOHN WHYTE: And it varies

by race as well.

We do know, in some categories,

there is higher mistrust

of the health care industry,

as you know.



WILLIAM FOX: Yes.

I think fortunately, John,

patients still trust

their physicians to provide

trustworthy advice to them.

And so I think physicians play

a very big role not only

in convincing their patients

or working with their patients

to instill that confidence,

but also to work

with their colleagues

to encourage them to get

the vaccine so

that the public can see

that physicians are, first

and foremost,

supportive of this process.



JOHN WHYTE: So we have to be

out there,

showing that we have confidence

in the vaccine.

What is the college,

the American College

of Physicians doing,

organized medicine, to help

inspire confidence?

What tools and resources?

Let's be honest, Dr. Fox,

we know in vaccines that require

multiple doses--

hep-B, chicken pox-- we have

challenges in getting people

to come back for fully

licensed vaccines.

So what strategies can ACP help

practicing internal medicine

physicians utilize?



WILLIAM FOX: Well, I'm really

proud of what the American

College of Physicians

has done with regard

to this vaccine process.

The American College

of Physicians

has representatives

to the American College

of Immunization Practices.

That's the group of the CDC

that helps determine which group

should be vaccinated and also

in what order.



And we were very involved

in that process

and very supportive

of that process.

We recently put out a statement

in full support of the FDA

and CDC recommendations

regarding this vaccine.

We're also encouraging

our members to support efforts

to get this vaccine

on social media.



I've already seen many

of my colleagues

post their shots

with the hashtag

#COVIDVaccine or #IAmVaccinated.

And I've even seen some use

the hashtag #TanBadgeOfCourage,

referring to the Band-Aid

that you normally get

after the shot.

So I think we are out there,

we are fully

supportive of this process,

and encouraging all

of our members to move forward

with this vaccine

and share their experiences,

in a way,

to help others and move them

along in this process.



JOHN WHYTE: I do want to talk

about some misinformation

out there that has made

a lot of our clinical colleagues

angry.

And that's been that

there's been the accusation that

physicians are coding diseases

relating to other health

conditions-- heart disease,

diabetes, cancer--

as COVID, when they're not.

Tell us what's going on there.

And has that made you angry,

Dr. Fox?



WILLIAM FOX: Well, I trust

in the integrity of physicians.

And I've heard these kinds

of things out there,

that physicians are miscoding

patients as COVID.

But, for the life of me,

I'm not sure where the evidence

for this is.

Certainly, in our outpatient

practice, I can't imagine

that ever being done.



There was some talk earlier

in the year that physicians are

profiting off of this.

Nothing could be farther

from the truth.

In fact, a lot of health care

systems, and especially

independent, small practices

like mine, are really hurting

financially as a consequence

of this pandemic,

which seems somewhat ironic,

but that certainly is the case.

And to a large degree, that's

based on the way physicians are

paid.

But I think to accuse physicians

of profiting off

of the COVID pandemic is really

ill-advised and wrong.



JOHN WHYTE: Absolutely.

I mean, our clinical colleagues

are on the front line, day in,

day out, putting themselves

at risk.

We know that PPE has been

an issue.

Has that gotten better?

The college has worked to help

make PPE available.

But where are we on that?

Are we still having instances

where there's not enough?

Or have we resolved that

to some degree?



WILLIAM FOX: I don't think it's

fully resolved, John.

Certainly we are much better off

than we were

at the very beginning

of the pandemic.

We all saw photographs

of physicians using garbage bags

as part of their PPE protection.

Those were really dark days

at the beginning.

There is an organization called

the Primary Care Collaborative,

and they work in conjunction

with the Larry Green Center.



I don't know if you've ever

heard about it.

But they are doing a series

of surveys.

I think they do one

every other week

or every month on the condition

of, especially, outpatient

physicians like me.

And in the last survey,

I think they recorded that 38%

of physician practices--

it was in the 30s percent,

something like that,

were still having issues

obtaining PPE.



It's certainly better,

but we haven't solved that issue

yet.

The American College

of Physicians

has worked

with a nonprofit agency called

Project N95 in an effort to get

PPE at cost

to physician practices.

I know many states,

like the state of Virginia,

have also worked to get PPE

to practices.

So it's better.

We haven't solved it completely

yet.

In my office, we probably reuse

PPE a little bit more than we

would like.



JOHN WHYTE: And let's talk

about burnout.

It's not just for the physician

community.

It's nurses, it's pharmacists,

it's EMT, it's

the administrative staff that

are in the emergency room,

in other areas of the health

care system.

Burnout was a problem pre-COVID.

What are we doing now to address

issues of burnout,

and what resources are

available for our clinical

colleagues?



WILLIAM FOX: Yeah, so burnout

remains a big issue.

And just to put something

like that in perspective,

physicians die by suicide

at a rate that is twice

as

great as the general population.

We all remember a local story

here in Charlottesville, Dr.

Lorna Breen, her story

got national attention.

She was an emergency department

physician in New York,

and she has family here where I

live in Charlottesville.



And she succumbed to suicide.

And that just kind of

encapsulates a lot of the issues

that physicians are going

through.

Physicians, and the staff as you

mentioned, they are strained

to the limits with the number

of patients that they're taking

care of.

And it's relentless.

It is nonstop.

They are seeing a lot of trauma

in terms of the number

of patients that they are caring

for who are dying,

many under very difficult

circumstances, many dying alone

because they can't have family

members with them in the rooms.



We need to do a better job

with physician burnout.

The ACP and the AMA

and other medical organizations

are working really hard on this,

providing a lot

of great resources.

On the ACP website,

there are a lot of resources.

But we need to kind of drill

down and get to some

of the systemic issues that

create burnout

in the first place.



And that means working

with health institutions

all over the country.

We also need to remove

the stigma surrounding getting

help, getting mental health

help,

in the setting of this pandemic

and even afterwards.

We don't want physicians

or other health care workers

to be stigmatized or punished

in any way for trying to reach

out for help.



JOHN WHYTE: How do you think

things are going to change

with a new administration?

In terms, it'll

be new leadership at FDA, CDC,

the Department in general,

as well as CMS,

and many of those issues impact

practicing clinicians.

What do you see

as the potential biggest area

of change,

and what are you, and organized

medicine and the college,

planning to do about it?



WILLIAM FOX: Well,

one potential silver lining,

John, of the entire pandemic

was that it moved forward

in 20 days what we worked 20

years to try to--

to try to get,

which is real telemedicine,

the ability to interact

with our patients

via live audio-video,

real-time communication.

So during the pandemic,

the current administration

realized that this was really

important.

And it was a lifesaver

for physicians as well.



And our patients love it.

They find

that for the right circumstance,

it is much more convenient

and highly effective.

So we hope

that after the pandemic,

we can incorporate telemedicine

into our practices

without some of the restrictions

that have been in place.

Obviously, there will be a lot

of other changes.

Our organization is really--

I think we can say

that this pandemic has put

into stark relief

the issues of uninsured

and underinsured

in this country.



And if the American College

of Physicians

stands for anything,

one of the things it has stood

for the most is the idea that we

need to get universal access

to health care in this country.

So we do hope to work

with the incoming administration

to try to expand access

to health care and access

to insurance

through either a regulated

private insurance company,

private insurance rather,

or a public option.



JOHN WHYTE: So what's

the message that you have

to our clinical colleagues

that you want to leave them

with, as we close out what

everyone will admit

is an extremely difficult year,

recognizing

that the first few months

of 2021

are going to be very

similar, as they are right now?

What's your message?



WILLIAM FOX: Well, we all

recognize this has been one

of the most extraordinary years

in 100 years.

And we know that the physicians

and other health

care workers on the front lines

are working harder than they

have ever worked.

But we also recognize they are

rising to the challenge.

They are overcoming all kinds

of obstacles.



I know that I and other members

of the American College

of Physicians, we are really

proud of the work

that they are doing.

They are leaning in,

they are solving the issues that

need to be solved.

So we are incredibly

appreciative.

They are heroes, in my mind.

And we do know that we are going

to get through this.

It may be a tough winter.

It will be a tough winter.

But there is hope--

there is hope in the form

of a vaccine.

And we just need to hold

on a little bit

longer, follow the advice

of public health officials,

roll up our sleeves,

get to work,

roll up our sleeves,

get the vaccine.



JOHN WHYTE: Well Dr. Fox, I want

to thank you for taking the time

today to provide your insights

as well as the work

that you're doing to keep

our clinical colleagues dealing

with the issues

that they have

on a day-to-day basis

on the front line

as well as helping make

sure patients get quality

care during this pandemic

and beyond.



WILLIAM FOX: John, thank you so

much for giving me

the opportunity today.



JOHN WHYTE: And I want to thank

you all for watching.

If you have questions

about COVID-19 send them

our way.

You can email it

to [email protected] as well

as post it on our social

properties--

Instagram, Facebook Pinterest

and Twitter.



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John Whyte, MD, MPH, Chief Medical Officer, WebMD.<br>William E. Fox, MD, Chair, Board of Governors, American College of Physicians (ACP)./delivery/aws/7e/46/7e461e8a-ff80-354b-bcc6-09bc4cd02c57/Fox_121720_v5_,4500k,2500k,1000k,750k,400k,.mp401/07/2021 12:00:0018001200Fox_121720_v2_1800x1200/webmd/consumer_assets/site_images/article_thumbnails/video/covid19-images/Fox_121720_v2_1800x1200.jpg091e9c5e820cd3bf

In fact, death rates were lower among vaccinated nursing home residents, compared to those who had not been vaccinated.

“These findings suggest that short-term mortality rates appear unrelated to vaccination for COVID-19,” Shimabukuro said.

This also appeared to be true for younger adults who died after their shots.

There were 28 people under age 65 who died after being vaccinated. Most of these deaths were heart-related, according to autopsy reports. When investigators compared the number of sudden cardiac deaths expected to occur in this population naturally, they found people who were vaccinated had a lower rate than would have been expected without vaccination. This suggests that these deaths were also unrelated to the vaccine.

More Vaccines on the Horizon

The panel also heard an update from drug company AstraZeneca on its vaccine. It’s being used in 18 countries but has not yet been authorized in the U.S.

That vaccine is currently in phase III of its U.S. clinical trials, and more than 26,000 people who have volunteered to get the shot had received their second dose as of Jan. 21, the company said.

The FDA requires at least 2 months of follow-up before it will evaluate a vaccine for an emergency use authorization, which means the company would be ready to submit by the end of March, with a possible approval by April.

The AstraZeneca vaccine uses a different method to create immunity than the mRNA vaccines. Instead of using nanonparticles, it uses a different virus, called an adenovirus, to ferry genetic material into our cells. This material contains instructions that help cells build the spike proteins of the virus. The spike proteins are then expressed on the outer surface of our cells. When the immune system sees the spike protein, it generates protective defenses against it.

The two-dose vaccine can be stored in a regular refrigerator for up to 6 months, which makes it easier to handle than the mRNA vaccines, which require much colder storage. Another advantage appears to be that it’s less likely to trigger severe allergic reactions. So far, there have been no cases of anaphylaxis reported after this shot.

In total, four serious side effects have been reported with the AstraZeneca vaccine, including two cases of transverse myelitis, a serious condition that causes swelling of the spinal cord, leading to pain, muscle weakness, and paralysis. One of these was in the group that got the placebo. The reports paused the trial, but it was allowed to continue after a safety review.

This vaccine also appears to be less effective than the mRNA shots. Data presented to the panel show it appears to cut the risk of developing a COVID infection that has symptoms by 62%. That’s over the 50% threshold the FDA set for approval but less than seen with the mRNA vaccines, which are more than 90% effective at preventing infections.

“Is the average person going to want to take the AstraZeneca shot? What role is this going to play in our vaccination program?” Schaffner said.

Johnson & Johnson will have enough data from its clinical trials to submit it to the FDA within the next week, the company said in a call with shareholders on Tuesday. So far, its one-dose shots looks to be about as effective as both the Pfizer and Moderna vaccines.

“It could be that we wind up with four vaccines: Three that can run very fast, and one that’s not so fast,” Schaffner said.

WebMD Health News

Sources

William Schaffner, MD, professor of preventive medicine, Department of Health Policy, Vanderbilt University School of Medicine, Nashville.

CDC: Advisory Committee on Immunization Practices meeting, Jan. 27, 2021.

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