Welcome to another MedCram COVID-19 update. Daily new cases in the United States are at an
all-time high, and if we look at the daily new deaths in the United States, the rate
seems to be consistently increasing at least at this point. So as this is being recorded, we have
the advisory group at the FDA giving the green light. The FDA giving the green light, and now
finally the CDC green lighting the decision to recommend the Pfizer vaccine for use,
so as it stands there really isn't any further regulatory decisions that have to be made.
The vaccines have already been shipped, and they are arriving at facilities for distribution,
there were a number of questions from some of you about this vaccine in terms of practical things,
like who gets it, who shouldn't get it, for instance, pregnancy, what happens if you've had COVID-19 in
the past, what happens if you've had plasma, for instance, in the past. What are some of the issues
that are raised with that? And the purpose of this video is to go over those questions and see if
we can answer those. So the source of a lot of the answers to these questions that I've been getting
is from a clinical considerations slide set from the CDC, and we'll put a link to that slide set in
the description below. But before we answer those questions, I wanted to make you aware
of an interesting website here on the New York Times. So as many of you know, the vaccine is going
to first go to health care providers, and those that are at risk, for instance, nursing homes, etc.,
and if you want to know how long it's going to be before you have the opportunity to get this type
of vaccine, you can simply go to this website, and read a little bit of an article about it
you can put in your age what county you live in, and if you're one of these professions, like
I've done here or whether or not you have these COVID-related health risks and simply submit it,
and what they'll do is they'll tell you a little bit of information based on the information you've
given it, and they'll show you here at the front of the line who gets the first vaccine,
and then where you might be in line based on the answers that you've submitted, but the final say
is actually with the state governments. There is some variability, and this New York Times
article actually takes that into consideration when you plug in which county you live in, and
of course, we'll put a link in the description below. So this is a two injection vaccination,
after the first shot is given, you have 17 to 21 days to get the second shot. If you happen to go
past 21 days, you need to get the second injection as soon as possible. In that situation, you do not
need to repeat the first dose, you just get the second shot, and remember that we really don't
know how effective this vaccine is with just one shot, so you really do need to get the second shot.
Now, in case you were thinking of maybe getting a different vaccine for your second shot, it's not
interchangeable with other COVID-19 vaccinations, so you need to complete the second shot with the
same product, in this case it's the Pfizer BioNTech vaccine. Now, currently, the authorities are saying
if somebody were to get a second shot, that was a different vaccine, then there's no recommendation
at this point to get a second of one of those vaccinations. It would not be the ideal situation,
but at this time they're saying that you would not need to get a third vaccination.
Okay, what about if somebody has a previous infection with COVID-19?
So what currently they're saying is regardless of whether or not you've had a previous
infection, whether or not you had severe COVID or even asymptomatic COVID, but you found out later
that you were positive, they're still recommending that you get the vaccination. You do not need to
get a COVID-19 test, either a PCR or an antigen test, and you do not need to get antibody tests
to see whether or not you can get the vaccine. Okay, well what happens if you have a current infection?
If you have a current infection with COVID-19, you should not get the vaccination. You should wait at
least 14 days after the infection and you're done with isolation before considering getting
the vaccination. Now as a caveat, current evidence is suggesting that reinfection,
while it can happen, is not common within 90 days after the initial infection, so if you wanted to
defer vaccination until the end of the 90-day period after your first infection, you could do
that if you so desired. Okay, well what happens if you got previous antibody or plasma therapy from
a previous infection? Well, we actually don't know. We don't have any data on this vaccine in people
who have received antibody, monoclonal antibody, or plasma treatment for COVID-19 in the past, and so
it's potentially advisable to wait, again, 90 days after you received any kind of plasma or antibody
therapy to make sure that those antibodies are out of the system before getting the vaccination.
Okay, what happens if you have underlying medical conditions? So long as you don't have any contra-
indications to the vaccination, like allergies, etc., there seems to be similar safety and efficacy
in the phase two and three trials in the Pfizer-BioNTech vaccine for people with
underlying medical conditions, so that's a go. And, by the way, these medical conditions also include
immunocompromised patients. Those are patients with HIV or other immunocompromised medical conditions,
but also remember that patients with those kind of conditions, with HIV or immunocompromised
conditions, should be counseled that there's no real available data to establish the safety or
efficacy of the vaccine in these groups, but they're not excluding them at this point.
All right what about pregnancy? A couple things that you need to know: first of all we have no
data on safety or efficacy in pregnancy, but you should know that studies are ongoing.
It looks as though we will have some data, because there were some people in the vaccine arm of the
trial that did get pregnant, so that data should be forthcoming shortly. You should know that, generally
speaking, we don't like to give live vaccines in pregnancy, and the good news is is that this Pfizer-
BioNTech vaccine is not a live virus. Messenger RNA vaccines are broken down quickly in the cells,
and they do not enter the nucleus of the cell. They do not change your DNA. On the flip side, you should
know that we are finding out that patients who are pregnant seem to have a worse course of COVID, and
there has been noted in research increased risk of adverse pregnancy outcomes like pre-term birth.
Currently what they're recommending is that if a woman who is pregnant
is part of a group that is recommended to be vaccinated as the timeline goes on that
it is okay if a pregnant woman is part of that group. She can be vaccinated if she so chooses.
What they're recommending is that there be a discussion with the pregnant woman in terms of
recommendation to make an informed decision of the risk of contracting COVID-19 during pregnancy
versus efficacy and side effects of the vaccine. If a pregnant woman decides to
take the COVID-19 vaccine and she develops a post-injection fever, the recommendation
is to take acetaminophen due to fever being associated with adverse pregnancy outcomes,
and currently they're recommending against routine testing for pregnancy in child-bearing age women
before giving a COVID-19 vaccine. What about if you're breastfeeding? There is no safety data with
COVID-19 vaccine or effect of mRNA vaccines on the breast-fed infant or on milk production. Again
mRNA vaccine and not thought to be a risk factor for the breastfeeding infant, and what
they're currently recommending is if a lactating woman is part of a group, like a healthcare worker
that has been recommended to receive the COVID-19 vaccine, she may be vaccinated if she so chooses.
So if you do get the vaccine and it's a week after your second shot, do you still wear masks and do
social distancing and wash your hands? Hopefully you're still washing your hands. The answer is yes,
you still need to do that until we reach herd immunity, or until we have data that shows
that this Pfizer-BioNTech vaccine actually can stop transmission. My understanding is that
they're going to be looking at blood samples in the study, and we should have some data next
month or in February about whether or not this vaccine is able to stop transmission.
Currently at this point, all we know is that this vaccine is very effective at preventing
COVID-19 disease, and it's about 95 percent able to do that. There's no vaccine that's 100 percent effective.
Remember that something that's very common is post-vaccine side effects that are expected, so
that would be like pain at the injection site or you might have within the next 24 hours fevers or
chills or muscle aches. That's to be expected, because it is stimulating your immune system
to have an immune response against the vaccine. So another term for this is "reactogenicity." It's
basically telling you that your body is doing what it needs to do. It's creating an immune response,
and if you get that on the first shot, expect to get that on the second shot as well. It may even be
more intense on the second shot. You should also know that medications for reducing fever
or for analgesia is okay to take in these post-vaccination symptoms, medications like Tylenol
or NSAIDs. What they're saying is you can use that if you have issues with fever or
pain, but that routine prophylaxis with antipyretic or analgesic medication is not recommended due
to a lack of information on the impact of use on vaccine-induced antibody responses.
So only use if needed now. What about the flu shot? Obviously we're during the flu season
and so what are the recommendations in terms of giving the COVID-19 vaccine with the flu shot? And
what they're saying is that the COVID-19 vaccine should be administered with a minimum interval of
14 days either before or after administration with any other vaccine, and that includes the flu shot.
So you really shouldn't have it so that either the first shot or the second shot of the Pfizer-
BioNTech COVID-19 vaccine within 14 days of the flu shot, and as we said, the second shot should be
given between 17 and 21 days after the first shot. If it's more than three weeks, it's okay.
It's not ideal, it will still be considered a complete vaccination schedule. What about tests?
Suppose that you want to get on a plane, you want to fly, let's say, to Hawaii, and you want
to make sure that you don't get tested positive for SARS-CoV-2 because you got a vaccination.
The good news is the Pfizer-BioNTech COVID-19 vaccine will not affect the results of a SARS-CoV-2
nucleic acid amplification test, otherwise known as a PCR test or antigen test, so that's good news.
If you want to check antibodies, however, and of course this vaccine induces both a humeral,
which is antibody response, and also a T cell response, remember that the Pfizer-BioNTech vaccine
mRNA codes for the spike protein, and so if the antibody that you're testing for is against
the spike protein and it's positive after the vaccination, you won't be able to tell whether
or not that positive antibody was a result of vaccination or a previous infection with
COVID-19. Now, because the mRNA vaccine codes for the spike protein, that's the vaccination,
that if you make an antibody against the nucleocapsid protein since the Pfizer-BioNTech
vaccine, mRNA does not code for the nucleocapsid protein, which is another portion of the virus,
and if you are positive for that, then you can say it's not from the vaccination, but you actually
had an infection with COVID-19 virus SARS-CoV-2. So in other words, after you get the vaccination,
it's going to be important to let people know that you have been vaccinated, and that if they
want to check to see whether or not you've actually been infected with the virus itself,
they should be checking the nucleocapsid protein antibody. Now if you receive the Pfizer-BioNTech
vaccine and there's an adverse event, make sure you tell the administering organization that there has
been an adverse event, and they will report it to the vaccine adverse event reporting system,
so that pfizer will know that something has happened, and they can investigate that answers.
A lot of the questions that I have been receiving regarding this Pfizer vaccine that is coming out,
we will put the references to these questions in the description belowI O want to thank everybody
for the wonderful feedback from the vitamin D video that we published a couple of days ago.
If you haven't seen it, please watch it. Be safe, and thanks for joining us.