Dr. Bishop discusses the the annoucnement made by BioNTech that the Pfizer COVID-19 vaccine appears to be effective in young people ages 12 to 15. Watch the full video below and reason on for a full recap.
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The major update today is the fact that Pfizer released an update on their vaccine today with some initial information about their follow-up trials that they did on kids between the ages of 12 and 15. So remember, Pfizer has an emergency authorization for ages 16 and up, Moderna and J and J are 18 and up. So Pfizer has been doing this study on 12 to 15 to extend the age ranges down on the pediatric population. And what they've said essentially is that they found that in a short trial, a few months, that the vaccine was both safe and effective for people ages 12 to 15.
So they didn't release detailed data, other than to say that it was essentially a hundred percent effective at preventing symptomatic illnesses within the trial and created good immune response, so antibody levels, that sort of thing. But we don't yet have the full data package. I'm sure that that will be forthcoming just like it was when the other data update from Pfizer came when they got their initial emergency authorization.
I'm sure we'll get another large 50 page data packet on the efficacy and the safety data on this group as well. Probably in the next couple of weeks. I think they did expect, they said they expected to submit this information shortly. And their goal is to have the emergency authorization extended for Pfizer, for the 12 to 15 year old population by the fall, by the start of next school year, essentially. So hopefully we'll get those data packets soon and we'll be able to see a little bit more about what's going on there with Pfizer.
I suspect Moderna will not be far behind in getting those same data sets out for younger people and then probably Johnson and Johnson, the same thing. So more to come on that, but more good news.
Again, the caveats with this are that it's a short trial, right, it's a few months. So I know people are going to have lots of questions. I have lots of questions about that in terms of the safety data in particular as we get into younger and younger populations. My concern is going to be long-term issues like with any vaccine or any new treatment that you approve for children especially, you do worry about whether it affects their physical or mental development in any way because of course they are going through the developmental phases in it. Their physiology is very different than adults as any pediatrician will tell you. So hopefully we'll get more information on that but we're going to need a lot more to come as well. So that's the big update today in terms of vaccines.
COVID numbers in general, there's been lots of data in the news here and there. Most places are, what I would consider to be roughly stable in terms of cases, hospitalizations and fatalities related to COVID.
The Virginia numbers are all still looking very good in particular, I check that pretty much every day and our numbers across the board have continued to decline pretty well. And that makes great sense, because again we've got good vaccine uptake in most places. I know in my home county in particular, Chesterfield, Virginia, we're about, we've reached about 50 some percent of our vaccine target for our population. So people are taking the vaccine, they are getting the vaccine.
It is still slow rollout in Virginia and other places but it is coming and people are taking advantage of the new vaccines as they come on board to, Johnson and Johnson, in particular I know a fair number of people who have gotten that. So that's been a welcome increase in vaccines supply for everybody. So that is good news as well. So those are my major updates today. What questions do you guys have? We're now over a year into this and into these updates, sadly. So here we are.
But, you know, I think that things are looking positive and looking up as we continue to roll out vaccines over the next couple of months here.
Andy says, do you share the CDC's director's concern that the nation's current mitigation levels put the U.S on track for a significant new wave of infection? As I'm sure you saw she expressed her fears strongly in her White House COVID taskforce presentation on Monday. I believe she is especially concerned for the majority are unvaccinated.
Yeah, I mean, the concern remains, right. I think we will continue to see waves of infection until the majority of the population is vaccinated. Given the number of vaccines that we do have out and given that we're going into the spring and summer, and I think this is probably going to be a seasonal respiratory virus to a large degree, I don't share an imminent fear that we're going to have a massive surge like we saw over the holidays.
We probably will see increases like we did in March and April last year, as it took its natural kind of curve. And then we'll probably see a downtrend May-June. Hopefully it will be blunted because we're doing all the vaccinations but I expect we will continue to see kind of, the curves will keep looking like this. And hopefully what will happen is each time the wave is smaller and smaller and smaller and then it just sort of peters out altogether as we get to that 70, 80% of the population vaccinated, hopefully in the next six months. But yeah, I mean, we're going to see waves over time.
Again, I don't share her fear that there's an imminent catastrophic disaster pending such that we're going to again, see rates, particularly hospitalization rates and death rates like we were seeing over the holidays, which was very concerning, but I don't think we're going to see that, again, because at this point we've, we have vaccinated many of the most vulnerable people. And those are the people who are contributing to hospitalizations and to fatality. So I'm hopeful that that's not going to happen but time will tell, but yeah, I think, yes, we'll see increases, but really what I care about is if we see increases in hospitalizations and death rates rather than cases.
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Andy says, do you think massages are appropriate post-vaccination if both participants remain unmasked? Unsure about the vaccine status of the masseuse.
Yeah, this is a good question. I think it's probably fine, especially if you're fully vaccinated, I think the risk to you is minimal at that point. And I think that the CDC keeps changing their guidance and language, which is a good thing as more data comes out to say, really the risk for the vaccinated person is minimal and the risk of transmission is minimal as well if you've been vaccinated. So I think that would be fine for you to do Andy. And definitely something that a lot of people should do with all the stress they've been under over the last year.
Sophia says, can you talk more about the Johnson and Johnson vaccine?
Yeah, so it is a slightly different type of vaccine compared to the Pfizer and the Moderna vaccines. It's based on what's called an adenovirus vector. So what that means is they've taken a common cold virus, which is adeno, an adenovirus is a type of cold virus.
The most common one you hear about is rhinovirus but adenovirus is a cold virus and they have tweaked it and they've put in a gene from the COVID virus into that adenovirus circle DNA. And that's what gets injected into you rather than an mRNA molecule which is what Pfizer and Moderna use.
Your body then translates that code briefly into the viral protein. That DNA code is broken down and destroyed. It doesn't stay permanently in your body. It doesn't integrate into your DNA. It doesn't do anything other than transmit that protein message to the immune system to tell the immune system to create a antibody response and then that message is destroyed. So it's a little bit different, but acts kind of in a similar way to Pfizer and Moderna. It's a one shot dose versus two shots, two doses for Pfizer and Moderna.
It's not quite as effective. It's about 72% effective in preventing illness compared to 90 some percent from a Moderna and Pfizer but it's still a very good vaccine.
Side-effects are similar, but not as bad actually as the second dose of Pfizer and Moderna. So overall I think it's a good vaccine for folks who want to just go through a one-shot series of something rather than having to go back for two doses. It's a good option for folks who were interested in that.
Debbie says, what percentage of people need to be vaccinated before we can say goodbye to masks?
Yeah, I think that's going to depend state by state, right. So each state is going to make their choice on that. I think that a little bit embedded in this is the question of the efficacy of masks, which I do continue to feel like the data does not really support significant efficacy of masks.
So, I mean, I think in most cases, if you've been vaccinated you probably don't need to wear a mask anymore. My guess is that most of the governors will not get rid of these mandates until we hit the 70, 80% vaccination targets. That being said, I do not fault any of the governors or the populations in some states that have decided to drop their mask mandates early. And we followed that data and most of these places have not seen significant changes in their case rates, hospital rates, et cetera. So I think that that is, I think either is a reasonable choice.
Each state is going to follow its own path on that. So we're just going to have to see. My guess is here in Virginia, Debbie, that we're not going to drop the mask mandate until we get to that 70% Mark or so, that's just my guess based on the way Governor Northam has approached everything.
Lindsay, I've seen real-world reports of efficacy for Pfizer and Moderna, when do you think we'll see this kind of data for J and J?
Probably soon. I think that it's, that, you know, I can, the data that they've released from their trials is good and positive and I think you can count that as real world data as well given the way the trials are constructed. So we'll see this in the coming months as well. It's going to take some time.
Even though the J and J vaccine is not quite as effective as the other two in terms of preventing all symptomatic illness, it's still very effective at preventing severe COVID, meaning being in the hospital, being in a ventilator, being in the ICU. So it's still a very good vaccine. So I think we're going to see similarly good outcomes and of course, sort of the real world that you're seeing with the Pfizer and Moderna vaccines too.
J and J is roughly equal to others with respect to preventing hospitalization and deaths - all three are close to a hundred. So J and J is still a good vaccine, really no concerns about it. And what it may mean essentially is if you got the J and J vaccine versus the other two you're more likely to have a mild version of COVID if you get exposed versus being very sick. So, but I think all things being equal it's not a serious concern, the main issue is keeping people out of the hospital, right.
So and all three vaccines do that at a pretty equal rate which just to say, very high. So I feel good about anybody who gets that vaccine too.
Any new insights on the length or strength of vaccinated immunity?
No, unfortunately, and I don't think we're going to know the answer to that for another year, at least that's my guess.
And how has our understanding of long COVID coming? I know both issues probably require a long-term study. Is there anything new?
No. The only thing new about long COVID is that I think we're going to have to, over the next few months you're going to probably start to see people create definitions and criteria around what is and isn't long COVID and trying to come up with a case definition for that because it's come to the point where so many potential symptoms are popping up from long COVID that I think we're going to have to gather all that data and then figure out what are the top five most common symptoms of long COVID and then create a case definition which is critical as you know, Andy, that's going to be a critical step for doing any kind of long-term research is coming up with a case definition, so we can start classifying people and figuring out how to study this population and treatments and modalities and things that are needed to help them out. So I think that's going to be the next phase of things.
It's coalescing around a common case definition. That's probably going to take some time but I know people are working on it. I know that VCU is creating a long COVID clinic and some others too. So they're going to start probably gathering this data, I suspect over the next year or so you're going to see conference reports, conference discussions around this amongst particularly the pulmonologists, ICU doctors and the cardiologists, since most of the symptoms are in those realms. And they're going to come to a case definition just like we do for a lot of other syndromes, like irritable bowel syndrome or reactive arthritis, or a lot of these other things that are a little bit mysterious at first. So probably a case definition will be what comes next.
Do most PartnerMD doctors agree with you about mask-efficacy?
I think everybody's got their opinion on it. And I think that's fine. That's healthy. The bottom line is that regardless of our individual opinions on it, we're following the local mandates and the local requirements in terms of vaccine, in terms of mask use. And I think that's fine. I don't think masks are dangerous in any way. So I wear them and that's fine. And most of the other, and all the other doctors do the same, but everybody's got their own way of interpreting the data sets that have come out.
I don't know that the other doctors have spent as much time looking at the data as I have, but I suspect they all do have their own opinions on it. You could probably ask your doctor what they think but that's my opinion on it based on what I've seen.
The data that has come out has not been strong. The most sort of evidence-based statement you could make about masks in the community setting at this point is that there remains a possibility that they may help prevent transmission. And that's really all you could say.
The healthcare setting, totally different. They clearly work in the healthcare setting for COVID and flu and other things too. So that's a different, that's a much more confined, closed environment versus out in the wider world though, quote, the real world outside of a healthcare setting and the data really is just not there. It doesn't mean they don't work. It just, there's no data to say definitively that they do.
Does the J and J vaccine have data on long-term effects from the clinical trials?
No one has long-term data yet, Pfizer, Moderna, J and J, AstraZeneca, nobody does have long-term data because the vaccines just haven't been around that long. That just takes time. So, you're not going to see long-term data for several years at this point. That's just because the nature of the beast we haven't had time to see that data yet.
For adverse effects, yeah, we just won't know. We just won't know long-term. I think the odds are that we're not going to have lots of long terms negative effects from the vaccines, just judging by their mechanism and in general.
I think most negative effects that you're going to see are going to happen in the short term, just like with other medications, but unpredictable things do happen. So there's no way to predict but I think the odds of there being a really negative long-term side effect that we don't see for five to 10 years are pretty small but it's not zero. And that's true for anything, right, it's not just the COVID vaccines that's for any drug that we use, antibiotics, vaccines, whatever, that could be anything.
Dr. Fauci and Masking
Deborah says, I certainly value your opinion, but listening to Dr. Fauci seems to indicate mask will continue to be important for a very long time.
Yeah. And that's Dr. Fauci's opinion and they have a lot of different things they're working on there. That's just not my read on the data. And I don't agree with Dr. Fauci on this and that's just all there is. That's the data that's been published. I've seen lots of reviews. I posted it, not too long ago in one of these chats, the systematic reviews that have been done on mask data. And the data's just not there. It's just not there. I wish it were much more clean cut and simple but it's just not.
Andy says, what will be the process for moving EUA to full FDA approval of the free vaccines?
So my guess is that probably at the year mark, two year mark they're going to have to submit more data on long-term side effects, long-term outcomes and following up on people for a long-term immunity from the vaccine. So I suspect we probably won't see full approval on these for a year or two from initiation, so, you know, probably what is it, 2020? So 2022, 2023, that would be my guess.
Most vaccines take several years to get through approval, a full approval. So I think that that's going to be awhile, but the next steps will be submitting more long-term data, outcomes data.
Debbie says my elderly parents are fully vaccinated, half of our family is vaccinated, those of us not due to the phase we fall in. Is it safe to visit them?
Yes. If you're visiting someone who's vaccinated I think it is safe to visit them.
Is there any reason a young woman wanting to get pregnant should be afraid of being vaccinated?
That's a bit of a loaded question. That's a hard question to answer. I think that's why everybody really needs to weigh the pros and cons very carefully for themselves and make their choices. I don't think there is any, based on the data we have we don't have much if any data at all about the safety or efficacy of the vaccines in pregnant women.
That being said, based on what I understand of the mechanism and everything else I don't think there's any cause for undue alarm in pregnant women, if a pregnant woman is high risk based on either, based on a comorbidity, right, or their profession, I think that that is a reasonable thing for them to get vaccinated either prior to or during pregnancy, if they're not high risk and they're worried about taking the vaccine, I think it's reasonable to wait until after pregnancy is done. And then take the vaccine afterward especially if they are young and otherwise healthy that sort of thing. That's the advice I've been giving people about pregnancy and the vaccine.
Again, it's individualized. If you're high risk for a bad outcome from COVID, please get vaccinated even if you're pregnant or going to become pregnant because we don't have anything saying that it's dangerous. And there's no reason to think in the mechanism that it would be. But if you're young and healthy, have no other problems, then it, I think it's also very reasonable to wait until after you've had the baby and all that sort of thing. So I think that's also very fine too. So that's been my advice for pregnancy.
That being said, I'm not an OBGYN so people should always talk to their OBGYN about these things.
What is your opinion on the COVID passports?
Yes. I have many thoughts on COVID passports. Andy and I have talked about this on Twitter a bit, I do not like them. I'll be quite honest, I do not like COVID passports for a number of reasons, there's a number of reasons, I don't like them. I much rather us give the vaccine program time to roll out and see how that works rather than jumping straight to this idea of COVID passports.
That being said, it depends on, the devil's always in the details, right, so if we're just talking about COVID passports for international travel or something like that I think that that's sort of okay. We can work through that.
If we're talking about a COVID passport that you have to have so you can go to the Kroger and buy groceries, I think we have a much bigger problem there. And I do not favor that at all. And I think that's dangerous. So I think it depends on what exactly we're talking about when we talk about COVID passports and what exactly they, they being the powers that be, decide the COVID passport mechanisms and limitations are. So, but in general, as a general idea I don't like them, but we'll see what happens.