Cohen discusses stopping shots of J&J vaccine

Monica McGee and Nicole fox are are american sign language

interpreters and Jackie and jasmine Batavia are spanish interpreters

So today out of an abundance of caution the center

for disease control and prevention and the food and drug

administration recommended a pause in the use of the Johnson

and Johnson COVID-19 vaccine

The recommendation follows six reported cases of a rare type

of blood clot in individuals after receiving the J&J vaccine

Now our primary concern is the health and safety of

all north Carolinians

Therefore we are following those recommendations of the F

D

A

And C

D

C

And have asked are vaccinating providers to pause the administration

of the J and J

Covid 19 vaccine until we learn more

The safety system in place is working as it should

These adverse events appear to be extremely rare

There have been six reported cases of this rare blood

clot which was also seen in combination with low levels

of blood platelets

This is a very different and rare type of blood

clot and needs to be treated differently

Usually an anti coagulant drug or a blood thinner called

heparin is used to treat blood clots

But in this case administration of heparin may be dangerous

An alternative treatments are needed

All six cases occurred among women between the ages of

18 and 48 and symptoms occurred in days 6-13 after

vaccination

None of the six reported cases were here in North

Carolina And as of last night North Carolina Providers had

administered 242,000 doses of the J&J vaccine and is important

to note that the vast vast majority of people who

received the johnson and johnson vaccine will only experience the

expected temporary reactions like soreness of an arm or feeling

a key or tired for a day or two

That's what I experienced when I got the johnson and

johnson shot mild headaches and flu like symptoms in the

first few days after a vaccination can be expected and

are not associated with this more severe concern

And while it is extremely rare that you could have

a severe adverse reaction people who have received the johnson

and johnson vaccine and who developed severe headache severe abdominal

pain leg pain or shortness of breath within three weeks

of their vaccination should contact their health care provider and

let them know that you've had the J and J

vaccine again

Today's actions are result of a vaccine safety system that

is working

Our safety monitors monitoring systems are highly sensitive which is

how the CDC could identify such a rare number of

events

This pause will allow them to look further at the

data and make sure that providers know how to treat

this rare blood clot

All vaccines are closely monitored and you can play a

part in that promoting their safety

Anyone experiencing possible side effects should report them to the

vaccine adverse event reporting system or bears

This national system collects data to look for adverse events

that are unexpected or appear to happen more often than

expected or have some sort of unusual pattern of occurrence

The CDC is convening a meeting of their advisory committee

on immunization practices to review these cases and the FDA

will review that analysis as it is also investigating these

cases and out of abundance of caution

We will pause the use of the johnson and johnson

vaccine until that process is complete and further recommendations are

provided

So if you have an appointment for Pfizer or Moderna

please go to your vaccine appointment as planned

If you have an appointment for johnson and johnson your

appointment will need to be rescheduled

We'll continue to provide everyone with timely and accurate information

as we learn more

COVID-19 vaccines remain the most effective way to end this

pandemic by preventing the spread of COVID-19 preventing hospitalizations and

death

Our goal is that everyone gets a safe vaccine

Everyone 16 and older is eligible right now to get

vaccinated

These vaccines are free and you don't need an I

D

Or insurance

You can learn more about vaccines at your spot your

shot dot n c dot gov

And with that we will open to your questions

A first question today is from brian Anderson the Associated

Press dr Colin brian Anderson here with the Associated Press

Thank you for the question

I know you just said that if you have a

J

And J

Appointment you'll need to have it were scheduled but we

know some clinics are saying that you could just come

in and get a different shot just to be clear

Is there enough supply of other vaccines in the state

to say anyone should come if they have a J

and J appointment and just get a different vaccine

Thank you

Thanks brian

So I have Amanda fuller more with me who heads

our covid vaccine operations

But let me start by saying that our providers are

making adjustments right now to how they are handling that

Many will need to be rescheduling their appointments some will

be able to shift over to the vaccine different vaccines

the Moderna or the fighter

Either way we want to make sure that our vaccine

providers are communicating with everyone clearly so that they know

what they're getting when they show up

Let me turn it over to Amanda full and more

Good afternoon

Thank you

So we do anticipate that at this point based on

our current state inventory we have about 85001st doses of

the Pfizer and Moderna vaccine available

We're also receiving additional first dose inventories today and tomorrow

We have a starter cohen said asked our providers to

reach out proactively to vaccine recipients who were scheduled for

a johnson and johnson vaccine to let them know what

their individual options are

If that is to reschedule if they choose to do

so or come in to receive another vaccine

But we do anticipate that we still have vaccine available

for anyone that wishes to receive it

Next question

We have a follow up from brian Anderson with a

P

Thank you

And we know that vaccine hesitantly has been a major

concern so far

We've heard from some experts who say if anything they

should give people more confidence that Moderna and Pfizer are

are safe and effective even more than they thought because

it's gone through more rigorous testing

I guess

What's your message to people who see this as a

sign that vaccines are unsafe and that they should just

Hold out and not get one

Well I think that today's announcement shows that we have

a robust safety system in place and that that system

is working to identify any concerns

This is a pause so that folks can look at

the data understand concerns and make further recommendations

We also want to make sure the provider community knows

how to treat these very rare events and these very

unique kinds of blood clots

Um as I said I think the system is working

as intended and we very much encourage those who have

their fighter or their Moderna appointment for this week to

keep those appointments to get vaccinated as soon as possible

We know these vaccines are safe

They are effective at preventing covid they are effective at

making sure you're not getting into the hospital um that

you are not dying from this uh this virus

Um so we want to make sure everyone gets vaccinated

as soon as possible

Our next question is from Maureen O Boyle the WbtV

in charlotte

Hi dr Cohen

Thanks for taking my question

Can you reiterate to those viewers who are concerned that

Gaza johnson and johnson vaccine as to who needs to

be concerned the people who just recently has

That's correct

Well thanks for that question

So if you have recently had the johnson and johnson

vaccine and you are feeling well You don't need to

do anything right now and you should not be concerned

What we are talking about today is an incredibly rare

event literally one in a million

We've seen six cases and in 600 more than Sorry

six million doses of Johnson and Johnson given across the

country

So again this is a very rare event

And if you've gotten johnson and johnson and you feel

well I have gotten johnson and johnson and feel well

nothing for you to be concerned about going forward

If you are someone who's had johnson and johnson within

the last three weeks and after day three of your

vaccine you develop a severe headache severe abdominal pain difficulty

breathing leg pain

Then you should be calling your doctor or other healthcare

provider and let them know you're having those symptoms and

to let them know that you've had the Johnson and

Johnson vaccine

Again we think most folks are really just going to

have the normal kinds of side effects that we're seeing

after Johnson and Johnson in the 1st 24 or 48

hours people feeling a little crummy tired um soreness of

their arm

Other than that if you are feeling well after you've

gotten your johnson and johnson vaccine the only thing you

could be doing is making sure that if something is

you are experiencing something you can report that to the

vaccine adverse reaction system the vares system and you can

report that through um through that if you're having any

other issues we have a follow up from Marino boil

WbtV Dr Cohen this announcement today almost seemed as a

way to also educate healthcare providers and making sure they

are treating this particular rare blood plot differently as you

mentioned

Would you agree Yes Thank you so much

We do agree that this is a way that we

want to make sure our providers have a high degree

of suspicion if they are seeing someone with a clot

and with low platelets that they should be asking about

vaccine history and making sure to put these pieces together

to say hey this blood clot is not like a

typical blood clot and probably needs to be treated differently

As I said in this case this is a kind

of blood clot that is associated with low platelets and

you don't want to be using an anticoagulant called heparin

In this case you need to be using other treatments

and so that is something we're making sure to communicate

to our providers

Mhm

Our next question is from Jonah Kaplan

It's A B

C L

A

Mhm

Good afternoon

Dr cohen

I wondered you know you've got the johnson and johnson

shot

I got the johnson and johnson shot

I know my answer to this question but if you

were to have an appointment tomorrow for johnson and johnson

knowing what you know today would you still be getting

the shot Well thanks for that Jonah

I did get the Johnson and Johnson shot in within

the 1st 24 hours

I really just felt a little bit achey and have

felt well since

Um and that's what the vast vast majority of folks

are experiencing which is just some temporary reaction

What we're talking about today is an incredibly incredibly rare

literally one in a million type of adverse reaction

But we do want folks to know about it

I think it's our vaccine safety system working

Um and so if you are having those severe reactions

of a severe headache after day three abdominal pain leg

pain shortness of breath please do get in touch with

your provider

As of right now vaccine administrations with johnson and johnson

are paused so we are not going to be vaccinating

Um and until we get further guidance from the federal

government

We have a follow up from Jonah Kaplan ACC 11

Thanks very much

How concerned are you about this happening now Especially when

we're finding out from some providers and some of the

counties they're starting to have more appointments opening up and

maybe a supply goes up

Demand is starting to plateau

Well again I think this is our vaccine safety system

working as intended and I think folks should feel really

good about the fact that Moderna and Pfizer have been

being used um here in north Carolina and around the

country and around the world Since december we continue to

monitor for any adverse reactions to that

But the good news is that we continue to see

temporary reactions to vaccines just in the 1st 24 to

48 hours soreness at your arm feeling a little crummy

Um so we encourage folks to get that safe and

effective vaccine as soon as it's available to you there

are appointments right now for Pfizer and Moderna

We encourage folks to get them as soon as possible

Our next question is from Samir Nazi with ABC 45

Yeah I thank you for taking my question

So I guess my question now uh really just looking

forward of course as we are starting to vaccinate more

north Carolinians and now we're taking away the johnson and

johnson vaccine

Is there any fear that this is gonna push the

state further behind when it comes to allocating the vaccines

and getting those doses out Well thanks for that

First I would say that you know every state in

our country is in the same boat Here we are

all pausing together um in terms of using the johnson

and johnson right now

Um and I would say the vast majority of the

vaccines we've been given out are the Pfizer and Moderna

vaccines and in fact continue to see even increases in

the manufacturing of that

So you know we've had a pretty robust supply now

for a number of weeks and we'll continue to see

that going forward into the future

Let me see if Amanda wanted to add more

She likes that answer

Okay thank you Samir

Yeah our next question is from Adam Wagner with the

News and Observer

Yeah

Secretary Cohen thank you for taking my question

Um I'm just wondering about when you had the first

indication that this might happen and then sort of what

the decision making process was like this morning was was

continuing to administer J

And J

Ever on the table

Well adam thanks for that question

And I'll turn over to demand a because we found

out through our communication channels with our federal partners very

early this morning around 7 30 in the morning

Um At that point when they are making a recommendation

to us again they are able to see data across

the country that were often not able to see just

here in north Carolina

We very much want to follow the guidance of the

F

D

A

And C

D

C

We've done that throughout this pandemic

Um and so it really wasn't a conversation about should

we pause We wanted to just communicate as quickly as

we could with our providers about what we know when

we know it

And so again 7 30 this morning

Got that information um quickly shared in uh some information

with our vaccine providers encouraging them to uh stop and

and and pause their their vaccinations with johnson and johnson

Do you want to thank you next question

We have a follow up from Adam Widner

Yeah

Thank you for taking this question as well

Um You mentioned that there were 85,000 doses of Pfizer

and Moderna in the state right now

Were those left over from last week And if so

is it concerning that there were that many doses of

those vaccines left over from the previous week First I

would say I want to thank our vaccinating providers for

getting shots into arms quickly and equitably

Um and I know that because of some of the

the changes in allocations as well as the easter holiday

we we are still administering vaccines but let me turn

it over to to I made a four more

So when we look back in our inventory those 85,000

doses are um much of them are from last week

There tends to be a little bit carried over each

week

Um we are working with our providers to do as

much as we can do to be able to make

that vaccine available in more places to make it more

accessible to work with our providers

To increase their there are two decrease their no show

rate to have folks come in for those appointments

So as secretary Cohen said we have also just come

out of a time period of the easter holiday many

people being out of town for spring break

So we will of course continue to follow that inventory

to ensure that we are able to move it as

quickly as possible including moving it amongst our providers to

help increase those vaccine outlets

Question is from Helen Chickering with Blue Ridge public radio

Thank you for taking my question

Um It seems the vaccine recipients who developed clots were

were on the younger younger age range saying for astrazeneca

could you help us understand the review process for the

johnson and johnson vaccine that will happen going forward And

do you think this perhaps the J

And J vaccine could come out with age restrictions on

the other end Thank you

Thanks for the question

So right now the six cases that were identified are

in women between the ages of 18 and 48

So you're right on the younger end

Um but I think we're just at the beginning of

understanding a full investigation that is what is happening right

now with these cases I know the C

D

C

And F

D

A working hand in hand

They'll be meeting with their advisory committee tomorrow to further

understand this um and to make sure that they are

making recommendations going forward

So I don't want to speculate yet about what could

come out of this again

An incredibly rare event literally one in a million

But I think this is our vaccine safety system working

to identify um something that may be associated with the

vaccine

Now

It's our time to do the investigation um and we'll

learn more over the next couple of days

Our next question is from Sharon van Zweden with Spectrum

News one

Hi Dr Cohen

Thank you for my question

Um what would be an acceptable number before the C

D

C

Or F

D

A

Halted uh the dissemination of the vaccine I mean six

cases would five have been okay and if it hadn't

grown that would have been all right

And how do these numbers compare to react severe reactions

from other kinds of vaccines like flu shots or MMR

or malaria or other things that people get Sharon

Thanks for that question

And I'd have to defer your question to the F

D

A

N

C

D

C

To understand their threshold for saying was it five cases

or six cases um in terms of making that decision

I think it's a combination of what they the case

itself the severity of this kind of of reaction

But it's also to make sure that as we were

mentioning earlier that our vaccine providers know that this is

not a typical clot

If you will it is a very rare form of

a clot that needs a different kind of treatment

So I think the pause at this moment was twofold

One is as I said to uh to investigate these

cases to understand them but it's also to make sure

that our medical community is understanding that these rare clots

do require a different kind of treatment

It's not typical anti coagulation but rather um other kinds

of immune related treatments that are needed to treat this

We have a follow up from Sharon dan Britain

The spectrum

Thank you

One follow up is that since the number of cases

or the incidence of cases seems to be more or

less limited to women between the age of 18 and

48 why do you think there's been a pause on

all of the vaccinations and not just that select group

Thanks Sharon

I think it's so that folks can identify additional cases

I think the cases we have seen have been and

women who tend to be younger

I think folks want to understand

Are there other cases in men in different age groups

before they make any other additional recommendations So this pause

gives them the time to do that investigation and to

communicate with the medical community about treatment

The next question is from Rose Hoban with north Carolina

health news

Uh Secretary Clinton thanks so much for taking my call

You know um you're talking about this

This is a pretty subtle message about how the vaccine

safety system is working

You folks have a plan for combating the um you

know there's just a formidable misinformation machine that's out there

and already you know they're already using this episode to

gin up more fears about potential problems with the vaccines

You know what's your plan for combating some of that

misinformation Well the first thing is being here today to

make sure folks understand what this is and what this

isn't

It is a pause folks are investigating further um and

what it tells you is that our vaccine safety system

is working

Um what it also says is that the Pfizer and

Moderna vaccine which we've been using for much longer than

the johnson and johnson vaccine

Um we continue to use we continue not to have

an issue with

And so if you do have a your appointment for

Moderna or Fighter this week we encourage you to keep

those

There are spots available

We want folks to get vaccinated as quickly as possible

as you know We've been doing a lot of work

to help folks understand the benefits of vaccine the facts

that they are safe and effective

Um the fact that they are now available everywhere and

folks are eligible for that if you are over the

age of 16 will continue to do education work P

S

A

S

Working with trusted partners

I think this is where partnership is really important um

to make sure we're combating any misinformation

We um will continue to share what we know when

we know it

Um and so that folks can trust that myself the

department is always giving you timely and accurate information

We have a follow up from Rose Hogan

Yeah

I did a quick look up on um the blood

clot rate for people taking the oral contraceptive pills

And it's about you know one in 1000 over the

course of a year

You know we're seeing this one in a million uh

here you know like can you uh and and it's

in in pretty much the same population

Can you sort of um you know why why taking

such an extreme move with this particular therapeutic when we

have other therapeutics in similar populations where you know blood

clots are more common

Well thanks rose I think two reasons why this pause

is being taken

One is to see if there are other cases associated

um with with um uh the vaccination and making sure

there were understanding and investigating the cases that are there

and understanding them better

I think the other part of this is this is

a very different and rare type of clot that needs

to be treated differently

So the clot you mentioned related to oral contraceptive is

a different kind of clot with a different kind of

treatment

Um this is more rare and actually requires as I

said not an anti coagulant but rather a different immune

mediated treatment

And it's really important for a medical community to understand

that as well as have a high suspicion of of

putting these pieces together

If you have someone who has severe headache has clot

has low platelets and in the context of having this

vaccine making sure your reporting that case

And we're understanding how all these pieces fit together

Thanks

We'll take our final question to vary from Michael Highland's

with CBS 17

Hi this is Michael Highland from CBS 17

I want to clarify something you had said earlier that

you all had reached out to the vaccine providers encouraging

them to pause on this

So to be clear do they have to stop administering

the J&J vaccine or do providers have any discretion whatsoever

to continue administering the vaccine right now Similar to the

guidance that came to the state from the federal government

It's not a mandate to stop vaccinating

It is a strong recommendation to pause

That is what we have recommended to our vaccine providers

Again this is a very rare event that we are

talking about and our vaccine providers do have the wiggle

room to decide that they want to keep vaccinating

Um we are asking folks to pause as we understand

this better um in the moment and we will learn

more over the over the next couple of days

But again there's no mandate to stop vaccinating

It is our strong recommendation to follow the guidance of

the FDA and the C

D

C

At this moment

As we learn more

And finally a follow up from Michael Highland's last question

I want to ask about was going forward with the

strategy

In terms of how you allocate the vaccines

You know one of the benefits potentially took johnson johnson

vaccines it's easier to get to some populations especially people

who have a difficult time scheduling the two doses and

ensuring to follow up happens

Is this going to do anything to affect your strategy

going forward especially if some people may be a little

more reluctant to get the johnson johnson vaccine

Well thanks Michael and I'll turn it over to Amanda

full and more to talk about what we're doing just

this week in this moment to make sure that folks

can continue to get access to vaccine

But I think you are right in saying that johnson

and johnson was very appealing because it both had a

different way of storage

So it did not need the deep freezer that some

of the other vaccines needed

Um it was able to be able to move it

around more easily

And certainly the one and done was very appealing um

for for populations particularly that we're moving around and maybe

leaving campus like our college students

So we want to very much um re look at

our strategy

But I think we'll also learn more over the next

couple of days

Again not sure yet how long the investigation will go

on from the C D C and F D

A

We're hopeful it will be a short period of time

So we'll understand how we're going to use the johnson

and johnson going forward

But let me turn to Amanda full or more just

to talk a bit about what we're asking our providers

to do in this moment

Thank you

So we are right now asking providers to make the

Pfizer and Moderna that they have available in as many

time slots and options as is possible

We will continue our allocations this week in a similar

fashion to what we used last week specifically for our

Moderna and our fighter

And we will also use some Moderna that we have

available to open up vaccination vaccine availability to as many

providers as we currently have enrolled and activated in our

system

Again we see this as a is a very clear

sign that our safety system is working

And so we are asking our providers with that in

mind to make every effort to continue vaccinating with the

fighter and the Moderna vaccine that they have available and

that's arriving today and tomorrow

Okay

I think that's the end of our time

I'll just close by reminding folks that we continue to

see viral spread across north Carolina

So take care of each other

Make sure you're still wearing your mask when you're out

in public

Um and to get your vaccine as soon as it's

available to you

Thank you