Do COVID-19 Vaccines Cause Infertility?

One question that has come up regarding COVID-19 vaccines, especially among young women of childbearing age, is, 

Is it possible that this vaccine or these vaccines could affect fertility, could affect my ability to get pregnant?

The answer in short is, NO..! 

And let me explain why and where this whole false notion came from. This false notion was born of the letter that was actually written to the European Medicines Agency, which is like the European equivalent of the  Food and Drug Administration, claiming that there was similarity between the SARS-CoV-2 spike protein, which is what you're making an antibody  response to when you get these vaccines, and a  protein that sits on the surface of placental cells called syncytin-1. 

So the thinking was, if you're making an antibody response to that spike protein of coronavirus, you're also inadvertently making an antibody response to this syncytin-1 protein on the surface of placental  cells, which would then affect fertility.

First of all, that wasn't true. Those two proteins  are very different. It's like saying you and I both have the same social security number because they both contain the number five. So that was wrong to begin with. 

Plus, you can argue there's two strong pieces of evidence that argue against it. One is that there was two prospective  placebo-controlled trials done before submission for emergency use authorization from both Pfizer and Moderna. During those two trials, 36 women, roughly, became pregnant. Now, if it was true that  this vaccine or these vaccines affected fertility, then there should have been more pregnancies in the placebo group than in the vaccine group, but that wasn't true. There were really 18  instances of pregnancy in the vaccine group and 18 instances of pregnancy in the placebo group. 

So,  therefore, the vaccine didn't enhance fertility and it didn't negatively affect fertility. Also, if you're arguing that antibodies directed against the SARS-CoV-2 spike protein would affect placental cells, remember that about a 100 million people have been infected with this virus over  the past year and a half. During that time, they have been making antibodies to the SARS-CoV-2  spike protein. 

So, if it's true that that would affect fertility, then the question is, 

what's  happened to the fertility rate or the birth rate right in this country, say between 2019  and 2020? 

If it was affecting fertility, if natural infection was affecting fertility, then  birth rates should have gone down, but that's not what happened. Birth rates have actually gone up  slightly. So, those are two pieces of evidence that argue against this vaccine or natural infection in any sense affecting fertility.

Should Pregnant and Breastfeeding Women Get Vaccinated?

Pregnant women are at about three times increased risk of ending up in the hospital in an ICU, and about twice as high chances of being on a ventilator when they get COVID, compared to non-pregnant women.So, it's serious. 

The other thing that can happen with COVID during pregnancy is the illness itself can induce preterm delivery and then you'd have a premature baby, which could have complications. So we think it's very important for pregnant women to be protected against COVID. 

So in the clinical studies, the large Phase 3 studies that were performed prior to the data being submitted to the FDA for the Emergency Use Authorization, all the manufacturers did these studies and they tried to exclude women who were pregnant or breastfeeding just because there wasn't any data on that. And there was little known and everybody's scared of things that could happen during pregnancy or during breastfeeding. 

However, during those studies, some women, either the screening missed them and they were enrolled in the studies or they became pregnant during the study. So there are a handful of women that did become pregnant and some who were breastfeeding during those vaccine studies, and what all the manufacturers found is; no signal that there was any danger to the fetus, nothing unusual between the vaccine group and the placebo groups in terms of the pregnancies and the pregnancy outcomes. In addition to that, the manufacturers have done studies in animals who were pregnant or getting pregnant. And again, giving even twice the equivalent dose, the human equivalent dose, to animals did not result in any dangers that occurred during pregnancy.

So theoretically, these vaccines are very similar to inactivated vaccines that women already get. So we know that they're novel technology with the messenger RNA (mRNA) and the adenovirus DNA vector, but the end result is just a protein-based vaccine, which is very similar to what women already receive during pregnancy, Tdap vaccine (Tetanus, Diphtheria, Pertusis) and influenza vaccine, which are recommended. They protect the mother and they protect the newborn too. So we can say that the CDC, who is very conservative and has recommendations that are considered permissive, that women who have the vaccine available to them, who are pregnant or breastfeeding, may choose to be vaccinated.

It's important, not only for those women to be studied to make sure that it's safe and effective, but on balance, that since COVID can be more serious in women who are pregnant, it is recommended that they should be vaccinated. And that's what one should counsel women, is to strongly consider getting vaccinated. So, researchers don't think that any of the current vaccines will be transmitted through the placenta to the baby. So the baby won't have an immune response. And they don't think that it's going to be dangerous to the baby either. But the mother, of course, we hope that she forms antibodies, and in response to being vaccinated, and those antibodies are transmitted across the placenta and they may protect the baby.

It is not necessary that vaccinated women would have the vaccine itself, any part of the vaccine, be transferred via breast milk to the breastfeeding infant. However, if this does occur, presumably it would be totally degraded in the child's stomach, with the acid and digestive enzymes. So the child wouldn't get exposed to it in a meaningful way. It can be assumed that the child would benefit either from being exposed to a mother who's breastfeeding and been vaccinated, so they won't get any of that vaccine dose.

Is Sinovac (and Other Covid Vaccines) Effective Enough?

 Is Sinovac (and Other Covid Vaccines) Effective Enough? & Do We Need Booster Shots FOR DELTA VARIANTS?

We know that the first covid19 vaccines 

were a welcome development during the pandemic because they were the ones that offered hope to an end for this pandemic. But, what we know is that these vaccines would keep us safe and protected against severe disease but there's a lingering question among us as to how long will the production last would variants make these vaccines available to us less effective? 

Another question would be, Would everyone need a booster shot in six months or in a year or in two years so could some people get away without that boost? or it is advisable for all these are actually the same questions that headlined the meeting of the Centers for Disease Control and Prevention Advisory Committee on immunization practices. 

What we know of as of now that the group isn't making recommendations around covid-19 vaccine boosters, but the discussion shows how leading health experts are thinking through these issues. So, let's go through them one by one. 

Here's what we know so far that the vaccines authorized by the World Health Organization (WHO) based on clinical studies work extremely well at protecting the majority of people from coronavirus infection. We know that the protection seems to last a while but, we're not sure quite how long. What we know so far that protection lasts longer than flu vaccination of which we give flu vaccination to our patients with diabetes every year. 

So far, data at present also shows that the shots still work against coronavirus variants even the fast moving delta variant. However, there are special groups of people where the vaccines don't work as much as we want them to work and these include people who are immunocompromised, particularly, people who had organ transplants. These people often don't produce antibodies after regular doses of covid19 vaccines and thereby neuro research have shown that third booster of covid19 vaccine could give more protection to these groups of immunocompromised people. That's the group that CDC seems to think could be the first to get a booster because we have clear signals that it could help these groups of people to protect against covid-19. Then after we learn more about how long the protection lasts for everyone else or if new variants emerge experts could hammer out details about boosters for the rest of us. 

In short at present, there's really no data to support recommendations for booster doses except for the caveat in severely immunocompromised hosts who are not able to mount a strong immune response. For other patients especially the general population, what we know for now is that the data will come later and that ongoing studies are tracking the durability of covid-19 vaccine protection and the CDC is watching to see if any variants evade the vaccine at present. 

Ongoing studies are tracking the durability of covid-19 vaccine production. For example, the CDC is watching to see if any variants invade vaccines and second several studies are present are ongoing  to check if people should get a third dose of the covid19 vaccine that already exists or a new shot with an updated form of the vaccine that targets specific variants. Most experts do agree however that if we start to see an uptick of infections or re-infections for people or new infections in people who have been vaccinated, that's a clue that we need to move quickly. 

Covid-19 vaccines are likely to be rolled out in UK in the fall to avoid another winter surge. Seven different vaccines are being tested in volunteers in England in the world's first booster study. So we have to await the data of booster shots. What we also know is that more transmissible variants including the Beta strain that emerge in South Africa require higher antibody titers to prevent infection. Prompting vaccine makers including Pfizer and Moderna to test whether tweaked versions of their existing shots will provide broader immunity. 

We also have data that one dose of the Novovax variant directed vaccine may provide sufficient protection against these strains in individuals previously immunized with against covid-19. So the modified shot has also the potential to provide broad protection against various strains if used as a primary vaccine regimen and this is one exciting new vaccines that soon will hopefully be rolled out across the world which is Novavax.   

As for SINOVAC, it is the primary vaccine that we're given that has been given to most of the general population. We now know that based on a second phase clinical trial produced by synovac company the third dose of Sinovac's inactivated vaccine can increase antibody response tenfold in a week. The study showed that the volunteers who had received two doses of Sinovac covid-19 vaccine and then received a third shot after three to six months, the antibody response inside the body's soared tenfold in a week and 20 fold in 15 days. It has been shown that after completing the two shots clearly, our body is producing very robust immune memory. 

Sinovac vaccine and the company will however conduct more thorough and longer periods of research to determine the best time to receive the booster for the general public based on the analysis of early vaccinated groups to combat the threat of mutant strains. Data from people vaccinated six months ago is now being analyzed and preliminary results show that antibody levels and about half of them are still good within that specific period. But the general concern at present is not whether to give booster shots or not. 

The CDC is pretty worried about the troubling rates of vaccination in the world. Only 17.7 percent of the world is vaccinated. In fact, if you look closely at the data clearly we have a long way to go in terms of vaccination but there are certain areas in the world like Israel where in majority of the patient population have already been vaccinated. We still have a long way to go to get the population protection. 

We know that unvaccinated people don't need the boosters because they really need their first shots and we need to convince this unvaccinated people to help protect the community by getting their shots having more people vaccinated will definitely slow the spread of the virus and prevent new variants. It will protect people who are immunocompromised too, when everyone around them is far less likely to have covis-19. Therefore, they are at far lower risk of catching it. Figuring out boosters definitely is important but getting unvaccinated people their shots right now is a very critical way to protect everyone prior to going around giving vaccines or giving everyone boosters we really need your help in convincing your friends and your relatives that hopefully they can get their vaccines and we can in general improve the overall vaccination rate.

Delta Variant and Vaccines

At least in the United States, the delta variant has popped up and that's what we're going to talk about. But even more importantly, let's talk about variants in general. So if you've got a coronavirus and specifically the SARS-CoV-2 virus and it  goes to infect an individual, the issue is as we've talked about before the virus is going to hijack  your cells to produce many more copies of itself. 

In fact, in some studies it's been shown that the  virus will make up to a billion copies of itself in just one individual, but here's the problem: the  way that it does it is not very accurate and so there will be some slight mistakes, and you might  see a variant being produced in these infections.  

Now, variants are produced all the time; in fact, the  truth is is that most of these variants are just duds. They don't infect anything or they might  not affect as well, but every now and then you might get a mutation that allows the virus to bind  better to the next individual, and that would be a variant of concern which are not very common. We  have some examples we have the UK variant, for instance, or the South African variant. And more  recently, we have the delta variant, which we're going to talk about now. This was first discovered  in India; this should not be very surprising, as you may recall at one point in India they were  getting as many as 400,000 cases on a daily basis.  

Now imagine those 400,000 cases each producing  over a billion copies, 

and you can see there that  it's only a matter of time before you get  a mutation that is fortuitous for the virus,  and you can see here very easily that a mutation that allows the virus to infect better and be more contagious is going to be a virus that is  certainly going to take over the world. In terms of the different types of variants, so while there  may be many different variants at once if there is a variant that is able to infect better. And  that's really all that matters to the virus, is to spread its genetic material as far and  wide as it possibly can. That is the virus variant that is going to win in terms  of the prevalence in the population, and again this mutation that causes increased  fitness can be manifested as better binding or evading the immune system. There's a  number of different ways that this can happen, so as it turns out, this delta variant has  some characteristics of it and it's known as B.1.617.2. It seems that it is more  contagious than the original virus to give you an example. 

Some experts have said that if you look at the original virus,the number of people that one person would  have infected otherwise, known as the R-naught (R0), it was originally around 2.5. This delta variant has been estimated anywhere between 3.5 and 4.0. Okay, so it seems to be more contagious, but  

where does it seem to be found the most?

Well, there was another paper that was  published. This paper was known as the "REACT-1  

round 12 report," and while it has not been  published or peer-reviewed as yet, there are some interesting findings. This was put out by the  Imperial College in London in the United Kingdom, and what they found is that the prevalence of the  delta variant in those aged 5 to 49, in other words, those people less than 50 years of age, was two and  a half times higher compared to those that were age 50 years and above. And so while it is possible  that people over the age of 50 are more likely to be vaccinated, there could also be a connection  between this virus and younger aged individuals. All right, what about hospitalization? Well,  there was a correspondence that was published in the Lancet regarding the delta variant, and they  were able to look at PCR, and what they found was surprising. What they found, essentially using  a Cox regression analysis, which is a way of adjusting for age, sex, and economic status, temporal  trend comorbidities, was that the delta variant had a 1.85 times higher risk of getting the person  infected in the hospital with severe COVID-19. So if you look at the SARS-CoV-2 infection since  April in the United States, you'll see here that the British variant, or the UK variant, the B.117, has  been up to this point the most dominant infection. But as of recently, there is one that is taking  over very quickly, and that is the delta variant. And as you can see, the delta variant has made some  inroads very quickly here in the last two to three months. And the reason for that is because it is  the most infectious variant that is currently there in the UK, where greater than ninety percent  of the cases are the delta variant. It is what is fueling the latest surge.

 At least 60 percent of  the population is vaccinated with two doses, which is actually very good, and despite the fact that  the cases have gone up in England and in Wales, Scotland and Northern Ireland, the good news is  that the corresponding deaths have not come along with that surge as yet. In Israel, where they've  done a tremendous job of vaccinating, primarily with the very effective Pfizer-BioNTech vaccine,  there has been only a small recurrence of cases, at this date, most of them from the delta variant.  So where we stand here in the United States is that there has definitely been a resurgence and a  doubling of the number of cases, which is an early sign that there's something potentially coming,  and we are seeing here on the daily deaths chart that for the first time, daily deaths have stopped  going down and are now starting to creep up.

In California, and specifically in Southern  California, where I practice, there has been a 

recent resurgence of cases of SARS-CoV-2. Daily  deaths have not yet picked up, but I can tell you anecdotally, in the hospitals that I work at and  in the friends that I have, some of them in LA County, there has been an increase in the number of  admitted cases. For instance, one hospital where I work at had not seen COVID-19 patients in months,  literally, are now admitting patients with COVID-19 and some of them are requiring high levels of  oxygen. So given that, what are the tools that we have? How well equipped are we with the different  vaccines that are available against this delta variant? Let's review the data up to this point.

Now we know that there are several different types of vaccines in the world. We're going to  talk about these four mainly, because we have recent data that shows the efficacy of these  vaccines against the delta variant: that is the Pfizer-BioNTech vaccine, the Moderna vaccine, the  Oxford-Astrazeneca vaccine and the Johnson & Johnson vaccine, and they are different. The Pfizer-BioNTech  and Moderna, of course, are messenger RNA vaccines, and the Oxford-AstraZeneca and the Johnson and  Johnson are DNA that use adenovirus as the vector. And if you have more questions about that,  look at our previous MedCram videos on those particular vaccines for more information  about how they work. Now, as you know, these three first vaccines are first and second shot, and  the Johnson & Johnson vaccine is a one-time shot. Now, there's two different categories that I want to  refer you to, and the first category that we're going to talk about is infection. So infection,  what I mean by that is: does the vaccine prevent the individual from being infected, and therefore  prevent them from spreading it onto somebody else? That has great epidemiological importance in terms  of stopping that R-naught (R0) number and preventing the infection from spreading epidemiologically,  And, of course, who wants to get sick? Nobody does. But there's another important endpoint as well, and  that's hospitalization. Does the vaccine prevent the most serious complications of getting SARS-CoV-2, which is of course COVID-19, hospitalization?  

High flow oxygen and ventilation, ARDS, things  of that nature, and so those are going to be 

two different numbers. So let's talk first  of all about the Pfizer-BioNTech vaccine. Now, I'm going to be referencing a number of  articles. Some of them have not been peer-reviewed, but it is recent data. I will give a link to  all of these studies in the description below. So there was a UK study that showed after the  first dose -- so we're talking about usually two weeks after the first dose -- the Pfizer-BioNTech  vaccine, regarding the delta variant, I'm talking about the delta variant now, specifically was 33  percent effective after the first dose and 88 percent effective after the second dose at preventing  symptomatic infection, and that was the UK study.  

Now there was a Canadian study that  came up with slightly different numbers 

that was 56 percent after the first dose and 87 percent  after the second dose. There was an Israeli study that showed after the second dose, they got 64 percent, and there was a Scottish study that showed 79 percent. Now all of these are above 50 percent and would have been  approved if this were the original virus, so I think these are all very good numbers. And again,  we're talking about infection. Now, remember that the primary way that your body prevents infection  is antibodies, and we know that the mutation that has caused this variant may be slightly off  enough that some people's antibody responses may not be good enough at preventing infection, but  remember that one of the things that helps you prevent getting worse is T cell activation. When T  cells are replicated in the human body, they also are replicated in a way that is not perfect, so it  allows for variance in the T cells, and so if you have variants in the virus and variants in the  T cells, that will sometimes allow for a bit of change. The T cells can be effective at reducing  hospitalizations and taking care of cells that are already infected, and therefore what we  typically find is that the hospitalization numbers are usually much better. So that same UK  study found that after the second dose, there was a 96 percent prevention of hospitalization and death if you  got the Pfizer-BioNTech vaccine after the second dose. And when I say prevent here, I'm talking  about efficacy. So, in other words, if there's a 90 percent plus efficacy, that would be in comparison  to a control, or where there's no vaccine, which would have a zero percent efficacy. There was a  Canadian study that looked after the first dose, there was a 78 percent reduction in hospitalization  after the Pfizer-BioNTech vaccination, and that was the Canadian study. You might be wondering why we  don't have data after the second dose. There wasn't enough data points to make that available in  the study so far. 

There was also an Israeli study that showed in terms of preventing hospitalization  after the second dose that it was 93 percent effective at preventing hospitalization and death  in Israel. So the bottom line here for the Pfizer- BioNTech vaccine is that, despite the fact that  delta is more infectious and causes potentially more hospitalization, Pfizer is exceptionally good  at preventing hospitalization and death from the  delta variant. What about Moderna? Well, there was  a Canadian study that showed that after the first dose, there was a 72 percent reduction, and that  was the Canadian study. In that same study, after the first dose, the Moderna vaccine was 96 percent effective  at preventing hospitalization and death. 

Now the Oxford-AstraZeneca vaccine, which has been given  authorization in the UK. After the first dose, they found it to be 33 percent effective at preventing  infection. And after the second dose, 60 percent effective. That was the UK study. In Canada, where  it's approved, they found that after the first dose, it was 67 percent effective at preventing infection,  and that in Scotland, after the second dose, it was again 60 percent effective at preventing infection.  Now what about hospitalization? 

Well in that UK study, they found that it was 93 percent effective after  the second dose, preventing hospitalization. In the Canadian study that they looked at, it was 88 percent effective at preventing hospitalization and death, if you took the Oxford-AstraZeneca vaccination. So  again, very good numbers at preventing the worst outcomes. Now what about the Johnson & Johnson  vaccine? That's a one-time shot. What they found is we don't have studies, currently, that look at  the efficacy, but we do have some surrogates that could be very informative. Now, the Johnson & Johnson  vaccine was tested against the most strenuous variant, or the worst variant at the time, back  about six months ago, and that was the South  African variant, and when they tested the antibody  response of the delta variant in comparison to the South African variant, what it showed was that  there was a higher level of antibody response to the delta variant than there was even to  the South African variant. In other words, a very  good antibody response to the delta variant.  

You may recall the South African variant with respect to the Johnson & Johnson vaccine, there  were no people who were hospitalized or died of the South African variant 49 days after  they received the Johnson & Johnson vaccine. In fact, Johnson & Johnson put out a statement  saying that as time went on, the immunity got better up to even eight months after the Johnson & Johnson vaccination. So because these vaccinations are so good at preventing hospitalization and  death and also reasonable at preventing infection, your risk from the delta variant is going to be  predicated on a couple of things: number one, it's going to be predicated on whether or not you're  vaccinated. So it's also going to be predicated on the amount of people in your area that  are vaccinated. If there's a high frequency of vaccination in the population around you,  then you're going to be more protected and, of course, the question also is how prevalent  is the delta variant in your community as well? 

I highly recommend going to the CDC covid data tracker, which gives you up-to-date  information in your county and also your state. There are a number of  factors that could be in play: there is  a change in humidity; there is the change in daylight hours; vitamin d production; being  indoors versus outdoors. All of these may play a role in the resurgence of a potential delta  wave.

 I'd like for all of you out there to remain safe, get plenty of sleep, boost your immune system.