Podcast Transcript:

Rachel Boyd: Hello and welcome to another episode of OviaAsks. My name is Rachel Boyd, VP of Enterprise Marketing here at Ovia and today I’m pleased to say we have a special episode and guest to talk about the recent news of COVID-19 vaccine approval for children ages 5-11, a topic that, if you’re a parent, I’m sure is top of mind this week.

I’ve got a few kids at home myself, 2 of them in that age range, and can say that my reaction to the news is wow - hope is on the horizon. It’s a turning point that so many families have been waiting for — after 2 years of unpredictable quarantines, saying no to playdates, the movies, and generally having work life balance turned upside down.

I know I'm not alone in that reaction, and am thrilled to have Jessica Malaty Rivera, the Science Communication Lead for the COVID tracking project, and an accessible voice that families have depended on to follow COVID and vaccine developments throughout the pandemic. She’s also a mother of 2 herself. Welcome Jessica!

Jessica Malaty Rivera: Thanks for having me! 

Rachel Boyd: Today, Jessica is going to tell us more about the changes to vaccine availability, explain what parents need to know as the vaccine becomes available for their children, and discuss ways organizations can step up, and help parents make informed healthcare decisions. Jessica, so nice to have you on the show today. Tell us a little about your background, and your work with the COVID Project.

Jessica Malaty Rivera:  Yes, so I have a background in emerging infectious diseases, specifically on tracking pandemics, so this is kind of my Superbowl for lack of a better term. I got my masters in emerging infectious disease from Georgetown about 10 years ago, and while I was there I worked on a project that basically helped track indicators and warnings of emerging threats. And since the pandemic I've been working with a few organizations, including the COVID Tracking Project, to basically make sense of the data and explain what's going on with regard to transmission and vaccines and everything in between. 

The COVID Tracking Project actually is no longer collecting data. One of my jobs right now is actually working with Boston Children's Hospital on a lot of code research and data. I'm also doing some work with independent prevention institute at the Rockefeller Foundation, where we're trying to track the new phase of data, which includes breakthrough infections and variants. 

But, the COVID Tracking Project was a really unique experience in my career. It started in by a couple of journalists at The Atlantic and a spreadsheet they were using, trying to get a sense of testing data in the US and really couldn't find a place where it was standardized. So it started as a simple project and then turned into a volunteer network, I think by the end we had almost 800 volunteers, as part of the community, who filled in the gap to provide daily testing, cases, hospitalizations, and death data for all 50 states and varying jurisdictions. And we were doing that in the absence of federal data standards, so we kind of functioned like the CDC through the pandemic to be completely honest. It was the most rewarding work I've ever done in my entire career. 

Rachel Boyd: Yeah, oh my gosh, that dedication and hearing kind of the grassroots way The COVID Project started. Just a group of very motivated, caring individuals trying to piece together information and get it out to families. What a remarkable journey. And, you know, as someone who is a parent yourself, and has been following this pandemic more closely than others, I'm sure you're excited about the news. 
 
As you know, we're here to talk about the announcement that happened earlier last week. The CDC just announced approval for children ages 5-11 to receive the COVID-19 vaccine, which I’m sure is a relief to most parents. Can you tell us a bit more about the change and what it means?

Jessica Malaty Rivera: Yeah, so this is a very very exciting milestone in our road to end the pandemic. As of Tuesday evening, ACIP, which is the Advisory Committee for Immunization Practices, unanimously voted to extend the Pfizer Emergency Use Authorization (EUA) to include ages 5-11 years old. They approved the smaller dose, at 10mcg compared to the adult 30mcg dose. And then, that night, and this was the final step, the CDC Director, Dr. Walensky affirmed that decisions and vaccines are now available to all children 5+ in the US.

I just I mean I couldn't believe it! I couldn't believe just the tremendous amount of work and collaboration to get to this point I'm just so moved. My daughter actually turned 5 last week and I got emotional as I booked her appointment for next week.

Rachel Boyd: Me too! I actually just booked my daughters’ appointments last night and took them aside to explain. But, I know some parents may still have some questions about the ruling that just came out. Even As we learn about the details of the vaccine communication, we hear terms like What’s the difference between approved for temporary emergency use - and full CDC approval? And what do next steps in the process look like?

Jessica Malaty Rivera: The next step will be the FDA reviewing an even larger data package (larger than 82 pages that is, which I read top to bottom). In order for the full approval to be granted for this vaccine in the same way as adults, you kind of have to think of this vaccine as entirely separate — it’s a different dose, smaller needle, different packaging and thankfully a longer shelf life due to a different buffer, and so it will have an opportunity to be fully reviewed. That could happen in early 2022, as far as the data submission and then the review will happen.

In early next year, I do think it’s important to note, that the that EUA is intended for use in emergencies, which we are very much still in. This pandemic is a public health emergency. But. the thresholds for safety and efficacy are no different from a full approval. The only difference is the volume of data. When it comes to what they are expecting as far as safety and tolerability and its effectiveness and people, those standards are the same. So we have this as a kind of protection to expedite the process of getting these tools in our toolkit, but by note means is it a reduced threshold of integrity.

I know there are questions about timing and if it being rushed, but if anything, this is kind of like the Government doing something fast, for the first time, because all hands were on deck. 

Rachel Boyd: Great point. That’s helpful framing around the integrity of the process, that there’s no difference in thresholds for safety and efficacy from full approval. So given the age range we’re talking about, understandably, parents may be putting a lot into digesting. Now that they’ve lowered the age threshold, what would you say to parents who are considering the decision?

Jessica Malaty Rivera: So the first thing I'd recommend to any parent is to talk to your pediatrician. Now, I am aware of this not always resulting in the same answers across the board, but your provider does know you/your child best. I would then say, if you're feeling like you're hearing a view that is contrary to the consensus  from FDA and CDC, to consider the totality of evidence, as presented by these regulatory bodies. There are a multitude of reasons to vaccinate your child, and I can go through a couple of things that motivated me:

• Since the beginning of the pandemic there have been nearly 2 million pediatric cases of COVID — which is likely an undercount because pediatric cases aren’t always detected or reported. I know that when we sent to the COVID Tracking Project, so many of us are parents and wished there were richer data on kids, but there just isn't.
• Next, we simply don’t know which cases will be severe or which kids are going to have mild infections.  
• Kids can transmit it to other kids and adults. We know that kids get COVID, we know they transmit COVID and do it in various contexts like at home and at schools and on playgrounds.
• And we also know that kids can suffer some really preventable complications from this infection, like like myocarditis, MIS-C, and long-covid which can have years long impact on their organs and development.
• Kids are a part of our communities, and we need everyone in our community to help slow down the transmission of this virus.

We can't reduce the fact that low risk does not mean no risk. No parent would sign up for a risk of death in any circumstance, right? There's no amount of hospitalization or death for kids that would be acceptable, especially now that we have this tool to prevent exactly that. 

Rachel Boyd: Of course, of course — there is not risk that you’d want to take for your children but you’re right, it’s a situation of weighing risks — and there is this great opportunity to prevent COVID-19 in this age group - including potentially some severe cases. Now I know you’ve had to make this decision personally as well — how did you go about it?

Jessica Malaty Rivera: My plan is to vaccinate my children. My 5yo is going next week and my 3.5 year old will have to wait until we see that data reviewed by FDA and ACIP, likely in Q1 2022.

You know, we were privileged to be able to keep our kids home, and they have been home this whole time. Because my personal risk tolerance is very low, and we all have different risk tolerances. And I recognize that some people have different circumstances that require them to have kids at in childcare or kids in daycare or even in school. But for us, the priority was to be able to see high risk people in our family and so because of that we've kept them home. But, our hope is that my oldest can start school in the new year now fully vaccinated and that is something I really can't even believe that that could be a reality so soon.

Rachel Boyd: It's incredible you must be so excited to have your kids back in school and that's just just a new a new phase of life that they're analytics people to take on. As parents digest their level of risk tolerance and what they're comfortable with, what should they know? What are the risks for kids who get the vaccine, vs who get COVID? How do the outcomes compare?

Jessica Malaty Rivera: Yeah, so as I mentioned before, I've spent a lot of the time in the data, and one of the things that I find to be most compelling, was some of the projections on the benefits of vaccinating this population. So one of the projections was that for every 1 million doses of the COVID-19 vaccine will prevent 56K infections, 200 hospitalizations, hundreds of MIS-C cases, and 70 ICU admissions. 

It's clear that the benefits outweigh the risks of getting infection, and also any possible risks of the vaccine. Which, based on the data from the 5 - 11 cohort, was just exceptionally well tolerated without any major complications. I will say, specifically in this cohort there were no reports of anaphylaxis no reports of myocarditis pericarditis appendicitis bell's palsy, all the kind of big things that would signal some safety concerns.

And one of the most amazing things about that too is that the small dose the 10 milligram dose kind of allowed kids to mount as good of a response as the older kids 12 and older who got the full adult dose that tells us that we are going to be protecting our kids well enough for it to be beneficial for this Community.  I also think that you know when we think about how this process has gone down, this is truly the most intensive safety monitoring we’ve seen for a vaccine in HISTORY.  It's of the utmost priority for these groups to think about safety, especially in this young population. 

I think it's important, that you know we want parents to feel empowered to make this choice we want them to get all the information that they need from their health care providers from the medical experts, like the American Academy of Pediatrics. But, I also recognize too that risk is a very difficult thing to align on, and we have to kind of remember the fact that our experiences, our trauma, our fears, all of that stuff influences our level of comfort. 

That's why I just have an abundance of patience and empathy for parents who are still navigating this, because this is a lot I recognize that my bias allows me to be very comfortable in this deluge of data and information because it's my job to go through it. But, I also recognize too that when it comes to something as acute as this pandemic also happening right when flu season is upon us and the holidays are upon us, it would be very, very risky to withhold something that we know, based on this data can prevent preventable suffering.

Rachel Boyd: Absolutely — I love what you said there. That sense of empathy for diverse life circumstances — and that need for that to be included in the messaging. But the stats you’ve just mentioned speaks volumes about the benefits outweighing risks — every 1 million doses preventing 56k cases and 200 hospitalizations, what an enormous prevention opportunity for communities. And a timely development for families to feel more comfortable and confident going into the holidays, with more considering traveling and potentially seeing families.

So we’ve also started to hear about Booster shots as something the CDC is recommending, although there has been some confusion over who should get one. What can you tell us about those, and how should parents be considering these?

Jessica Malaty Rivera: yeah, so I'll start by saying that right now, the definition of fully vaccinated has not changed. I don't want people to be concerned they'll have to keep getting boosters to be considered fully vaccinated. The definition for fully vaccinated for people who received either the Pfizer or Moderna vaccine has remained two doses. And even for Johnson and Johnson, just the one.

That said, the recommendations are that those who are immunocompromised, those who are 65+, those who work in high risk settings (like health care workers, essential works, and those who are pregnant) should get the mRNA booster if it’s been at least 6 months since their last dose. If you got J&J, anyone over 18 is recommended to get a second dose if it’s been at least 2 months since your vaccination.

Rachel Boyd: That’s helpful — so you mentioned that expecting mothers are part of that high risk category. As I’m sure has been an ongoing topic in your work, vaccine hesitancy is still ongoing among pregnant women. We’ve also following attitudes toward the vaccine in a monthly survey of about 4,500 members in our Pregnancy program, and while vaccine uptake is steadily climbing to about 71%, and about half of members sharing that providers are having conversations with them to help them weigh pros and cons for an informed decision — hesitancy and fears over impacts on mom and baby have also lingered. And we are carefully monitoring that and preparing parents with decision support tools within our experience to help them have clear direction and the most up to date information in a readily accessible way.

So as child vaccines become widely available, we recognize that confidence in adoption will still evolve over time. What are your thoughts on the lingering hesitancy?

Jessica Malaty Rivera: Yeah, so vaccine hesitancy is an absolutely valid sentiment. It's also not one thing and the community that experiences hesitation is not a monolith. We need to acknowledge that people have very real and different experiences. They have real medical trauma, abuse, the homes and biases people are surrounded by, and hold space for the fact that navigating a public health emergency is very disorienting and scary.

And we need to adapt messaging that is culturally competent and emotionally intelligent so that wide, diverse audiences can hear that information and it be personally meaningful to them and digestible and judgment free and shame free. 

Fertility and reproductive health are both very sensitive topics, and when there are accusations and claims flying all over the Internet, about things that are already very sensitive already. It's not surprising that people would feel fear and concern and hesitation and doubt. Now, I will say that claims of infertility is kind of a common anti-vaccine talking point that gets attached to vaccines in general. It's most known for its attachment to the HPV vaccine which is pretty ironic, because the HPV vaccine is an incredibly safe and effective vaccine intended to preserve fertility by preventing cervical cancer. 

Now, that said, I do think that when we talk about fertility, we need to recognize that people have very, very different journeys in their road to becoming parents, if that's something they choose, and we need to be speaking with sensitivity and kind language so that people aren't dismissed about this fear. 

I will say though, based on the data, there is no scientific validity to the claims that the vaccines impair fertility or reproductive health. In fact, we know that during the trials unplanned pregnancies were reported in the vaccine arm and thousands of people have reported pregnancies post vaccination. So that said, you know I think we should recognize the fact that this kind of stems from reports of people having irregular periods. That's something. It's important to identify that 

1. Irregular cycles can happen for a number of reasons. Stress being one of them, illness being another.
2. We know that the vaccine can trigger an immune response. One that is even included in the endometrium, which is very much a part of our immune system. 
3. So having having a reaction in the form of spotting bleeding or temporarily irregular periods is not unexpected, but I just want to be very, very clear that the evidence is abundantly clear that there are no long term effects on fertility and reproductive health.

Rachel Boyd: Thank you, you’re absolutely right. It is so important to recognize the nuances that go into each person’s fear, and a sense of grace that pregnancy is an incredibly sensitive time where we’re wary of literally everything that goes in our bodies. And you’re right that there’s power in messaging in an emotionally intelligent, judgment free way to help women leverage evidence in a digestible way.

But with that in mind, can you expand on the driving factors and urgency for vaccination now rather than waiting?

Jessica Malaty Rivera: Yeah, I think urgency is the right word honestly, because there is a sense of we should do this as soon as possible for a few reasons right, we are well into November, now we are in the throes of flu season. And flu season was really, really mild last year for a lot of reasons, in part because we had such strict code and mitigation efforts with masking and people weren't traveling as much and kids were not in school, and so many people got the flu vaccine.

This year, we're not on track in the same way, we are last year, and our mitigation efforts look very different so because of that there is a risk of what we're calling a twin-demic of really bad flu and a surge due to the winter months, you know indoors activities and holidays and all that stuff. We can't afford another surge COVID. We really can't afford that. Our health care system cannot afford that, I mean some of the places that you never thought you would see at 200 300% capacity, like Los Angeles California that happened last year and we cannot risk that again, because then everybody suffers even people who have regular emergencies, or even pregnant people who are trying to have a baby, right? So I think that there is a sense of urgency here, knowing that should be protecting our children as soon as possible, because our communities rely on our children to be protected, too.

I'd like for the December holidays, to look a little different I think we have the opportunity to make you know Christmas, Hanukkah, Kwanzaa, New Year's look very, very, very different than they did last year.

Rachel Boyd: That’s so good to know, thank you for sharing your expertise there. I think debunking a lot of the myths that surround these things, and getting reliable, factual information is what people want, but can be hard to find. So hearing it from you is incredible.

You know, today we’ve talked a lot about individuals, and what they should know and be thinking about, but we don’t live in a vacuum. I know a lot of organizations want to help, because they want to support working parents and their families, and help get everyone one step closer to a healthier, safer society. But, many organizations don’t know where to start, or how to help without overstepping boundaries.

What should organizations consider doing or providing to support their workforce in vaccine decisions for their families?

Jessica Malaty Rivera: Yes, so I think companies, you know in their adaptation to you know, being in the pandemic should provide resources to this stuff. If they're noticing any kind of hesitation or reluctance to follow vaccine policies or mass policies or any kind of health policies that are being enacted. That can be done in the form of seminars, or one on one support as needed I have actually led a lot of those conversations with groups of smell as nonprofits to big corporations to kind of help people understand their risk as individuals, as well as the risk that the company is willing to adopt for their employees, and even customers, if that's the kind of business they're working in. 

When it comes to creating policies to standardize things like vaccination I'm actually very much in favor of that because I think that there's too many factors and people's different kind of exposures that make it so that we would constantly just be going back and forth and back and forth if we didn't decide to standardize that. 

Also, I think that companies need to be providing the kind of support to make vaccinations actually happen. That's things like paid time off. We need better paid time off for families in general, which is a very relevant topic right now as for some reason we're still debating whether or not parental leave should be provided by employers or the US Government. But, it should accommodate everything from pregnancy, pregnancy loss, children’s health, vaccine visits for adults and children, and time to recover from vaccines and/or illness.

I mean it's really astounding that this is still being debated, but I think it's part of the ways in which companies can tell their employees, "hey, we're trying to support you making healthy choices for yourself." Because, healthy choices for yourself keep everyone in the office, and the company safer and more productive. 

Rachel Boyd: Yeah, and prioritizing that leave and making sure it's normalized. I'm also astounded that we're still having some of these conversations in 2021. But, it's such a part of the human experience to support families, especially during these early life stages. And it's an incredible opportunity for employers to be thoughtful about those holistic policies to really help families. To help them be able to take action on their health, and provide resources on things like feeling confident and supported in vaccine decision making. 

As we think about the evolution, and extending the vaccine to children and even ages younger than five, what does that look like from here? 

Jessica Malaty Rivera: Yeah, so I am very sensitive to the fact that there are many parents of children who are younger than five who feel left out, and feel like they're the ones waiting the longest and I'm in that boat too. As I mentioned before I've got a three and a half year old he's not eligible yet to be vaccinated. So we have to wait. We have to wait for that data, and I say this, a lot, but time and data will tell, and I can't predict any type of certainty when the data will be available because again, we're not rushing This, I think, if anything, we're kind of proving to the public that this is not a rush we're not just trying to get data to prove decisions. We have to wait for the data to become available to us, and so the science, the regulatory process, the analysis is something that requires a ton of work.

And we're still working to that end, and so I feel like if we were to provide estimates, we could be seeing something like what we're seeing right now with the review of the data between a sub and FDA probably happening between January and March of 2022.

Rachel Boyd: Which is soon!

Jessica Malaty Rivera: Yes it is!

Rachel Boyd:  Incredibly exciting and I also have a little one myself so she'll be the only one that not immunized in my family. So, that'll be something I follow closely, as I know so many families will. And so, as we you know take time to get as informed as we can, as all these age ranges become available, where do you Where would you direct parents to find some more trusted information along the way in these next few months?

Jessica Malaty Rivera: So, again, I always think that people should be talking to the providers, especially their pediatricians about this decision.
But, there are so many wonderful resources, like that CDC website and FDA website or the American Academy of Pediatrics.

There's also just a ton of wonderful science communicators board certified pediatricians epidemiologists like myself. Other data scientists, many of whom are parents, myself included, who are following this data very closely and share it publicly, whether on Facebook or instagram or Twitter, or  through listers and newsletters etc. 

I think that the the abundance of good information is is really wonderful one of the best silver linings of this pandemic and I think that if you're still looking for information i'm happy to help you know direct any of the followers here to good sources.

Rachel Boyd: That’s a great reminder that there is an abundance of good information out there. We’ll be sure to post your information so folks know how to follow you after this. It’s very reassuring to know there’s people like you and your team bringing thoughtful messaging into communities and translating. As we leave our talk today, are there thoughts you’d like to leave parents and organizations with?

Jessica Malaty Rivera: Yeah I mean, I want to recognize the fact that this is it's been a long road right, we are going on our second holiday season with things not feeling like they're back to normal and that's a really hard thing to accept.

But I also want to re-emphasize, and I said this many times that the sacrifices that we're making are not in vain, that every vaccination gets us closer to the finish line. Every time we say no to something awesome or something fun, every time we delay celebrations where do we meet for the sake of everybody around us, is costly, but worth it.

This is just an amazing opportunity for us to model to our kids that at the basis of public health is community. We're all in this together, and our kids can actually be part of the solution and that's really exciting to me, I mean my kids are really little and they already understand that we wear masks to protect other people, and even to protect ourselves and it's just another opportunity to show our kids how we can do something super altruistic like getting vaccinated.

I also want to say to you that if you're feeling overwhelmed by the pandemic itself or by this info-demic, which is kind of this overwhelming amount of information to parse through, know that I hear you and I will continue to be a resource to those who need translation of all these headlines and make it as judgment free as possible.

You know I don't think that I'll be done with this work for quite a while, because I know that there's always angles and experiences that require much more nuanced and a lot of grace that is, you know, we're all still learning as we go and so we'll get there we'll get there for sure, but you shouldn't feel rushed either, and your comfort levels and trying to understand these things there's there's patients to be had for sure.

Rachel Boyd: We’ll get there for sure, our kids are seeing this moment in history and this great appreciation for what they can do for public health - we had similar moments at home too in explaining the significance and they essentially said “ yay science!”.

That sense of community is a great way to leave off - that despite the “info-demic”, reliable information is out there and so many in the science community, including us at Ovia are here to help for evidence driven information delivered in an unbiased and non judgemental way. Thank you for reminding us that these decisions aren’t monolithic, and that with this information, organizations and families can feel empowered for informed decisions.

On behalf of the Ovia team, thank you so much for sharing your in depth perspective and a sense for what to expect in child vaccinations. We thank you for your work in the community at large and immense value you bring in your dedication to reaching families with data and evidence delivered in a relatable way. For those of you listening, thank you for tuning in - we’ll be sure to post the resources below to follow Jessica and Ovia’s COVID resources, and make sure to lookout for the next episode of Ovia Asks.