Partner Call: COVID-19 Vaccine Implementation

>> Hello everyone. My name is Michelle Putnam, and I would like to welcome you to today’s CDC Partner Update Call on COVID-19. This call serves as a way for CDC to share weekly updates on COVID-19 and our latest resources and guidance. Today’s call will focus solely around updates on the current status of the CDC 19 — excuse me — the COVID-19 vaccine.

First we will hear from Dr. Nancy Messonnier, the Director of the National Center for Immunization and Respiratory Diseases and lead for the CDC COVID-19 Vaccine Task Force, who will provide a vaccine update and a summary of recent developments and considerations moving forward. We will also hear from Dr. Sarah Mbaeyi, the Lead of the Vaccine Task Force Clinical Guidelines Team who will provide some clinical considerations to keep in mind as vaccine rollout and distribution begins. Afterwards, our speakers will stick around and answer some questions that we received over the last week via email. Since today’s call is devoted entirely to a vaccine update, we will be answering a lot of your questions throughout the presentations but will reserve some for the Q&A period as well.

I will note that if you experience technical difficulties or otherwise would like to review today’s call, you can find the recording on cdc.gov and YouTube in 8 to 10 days. All past partner calls can be found there, so please take time to review and share prior recordings. If this is your first webinar with us, welcome. These calls occur every Monday at 3pm Eastern, and you can please see the link on the slide to subscribe and receive future call invitations.

I will note that, due to the holidays, these calls will resume on January 11. Please note this call is not intended for media, although we do welcome any media who happened to be here with us today. Should media have questions, we invite you to reach out to media@cdc.gov. Before we begin today’s vaccine update, we would like to highlight some recent guidance and tools released by CDC.

The first is a travel planner, which allows you to receive information about various cities and states across the US that can help you in planning any trips. You can see the links to these resources in the chat box. The second are some tools for schools designed to help make in-person learning healthy and safe. We would also like to direct you to our Health Equity Team’s new COVID-19 Racial and Ethnic Health Disparities web resources.

And, again, all of these links are being put into the chat. And, finally, we would like to highlight the release of CDC’s Winter Holiday Guidance. Please see the links for more information. During this call, we will also have two short polls, one now and another at the end of the presentations to get feedback about the effectiveness of these calls.

Please answer the poll now as we get started and then again before we start the Q&A section. And with that, it is now my pleasure to hand you all over to Dr. Nancy Messonnier. >> Go back one slide for a minute. Thank you all for joining us today to talk about COVID-19 vaccination.

It’s been a really exciting week on the vaccine front, and I want to share our excitement with you but also try to measure that with the fact that, despite how exciting it is to now have these vaccines, we need to recognize that it’s going to take a little bit still longer to have enough vaccine and to be able to implement it across the entire country. I think it’s remarkable that less than a year after the identification of these virus — this virus, we now have not 1but two vaccines authorized by the FDA and recommended by CDC. And that is remarkable, but it didn’t just happen out of nowhere. It happened because it built on years of science, scientists who worked on the platforms and the ability to move so quickly with those vaccines.

And if it wasn’t for the work of those scientists over the years previously, we wouldn’t have those vaccines ready today. But also it’s true that vaccines don’t save lives. Vaccination saves lives. And so as important as it is to have those vaccines available, it’s certainly equally important to be able to use those vaccines well.

And that work also built on years of preparation at the state, local, territorial, tribal level as well as with CDC. Next slide. I hope you shared our excitement last week at the initiation of the COVID-19 Vaccine Program with the rollout of the Pfizer vaccine. This map sort of shows perhaps at a high level just what we knew about initiation of the vaccine as it reached all of the jurisdictions on Monday the 14th with every state and territory beginning vaccination at some point last week.

As of midday on the 20th, we were tracking something like 2.8 million doses of vaccine distributed and more than half a million doses of vaccine administered. Now, some caution about this data, which is now on COVID data tracker. There’s a few days’ delay in our administration data. Data is flowing from the provider level through the data lake.

So we do get access to it, but there are a few days’ delay. The point of that is that administration is probably at the low end of our estimate for how many people got vaccinated last week. Next slide. And on Friday the FDA authorized the Moderna vaccine as a second vaccine for use against COVID.

And over the weekend, ACIP voted to recommend the vaccine. And vaccines began arriving in jurisdictions yesterday. And hopefully today some folks will begin vaccinating. Our numbers are something like 1000 sites received the Moderna vaccine today, and more than 2000 will receive it tomorrow.

And, you know, we hope that the number of both vaccines received and doses administered starts to equally go up. So it’s been an incredibly exciting week for us. The MMWR was published yesterday, and Sarah will go over some of the clinical considerations that were also posted yesterday. Next slide.

I’m going to do this at a high level, but both the Moderna vaccine and the Pfizer vaccine are mRNA vaccines, which means they’re similar but not identical. One difference is the age. The Moderna vaccine is authorized down to age 18, and the Pfizer vaccine down to age 16. Both groups have started studies to hopefully move those age groups down to the teen and hopefully eventually through children.

Importantly, both vaccines are two-dose vaccines but, in a complicated way, they’re not interchangeable. That is, if you get your first vaccine with Moderna, you need to get the second vaccine also with Moderna and at 28 days later. That’s four weeks. In contrast, the Pfizer vaccine is a 1 and 21 day dose schedule.

And especially in these early days, it’s going to be really important to try to match those intervals as much as possible. And, finally, there are differences in the storage and handling of those vaccines. The Pfizer vaccine requires storage at this ultra-low cold temperature, minus 80 to minus 60. And it’s packaged in these pizza boxes at 975 vials, making it a little complicated to get to distant locations.

Moderna vaccine, frankly, is a little easier in this sense. It’s arriving in a thermal shipper between minus 25 and minus 15. And they come in smaller packages. And so it may be that the Moderna vaccine gives more flexibility to you.

But both vaccines are, frankly, equally exciting to have in our toolkit. Next slide. Nope. I think Sarah will go into this in more detail. But yesterday the CDC’s Advisory Committee on Immunization Practices did vote on the next stages of prioritization.

You know, our goal is to vaccinate every person in every corner of every community in the country. But at least in the early months, we have limited supplies of vaccines. And that means that, unfortunately, we need to make some prioritization decision. Our job at CDC is to provide a framework and the justification around these recommendations.

But it is at the local level where folks need to make actual decisions about who gets vaccinated and who doesn’t. And, frankly, I just want to say up front that I recognize how difficult this is going to be to try to make decisions about who gets access to this vaccine first. We hope that we will pass through this stage quickly. And then, as more vaccines become available in the early spring, we won’t have to make those decisions.

There was large consensus around the early Phase, that is, that healthcare workers who have been in the frontlines of this pandemic and long-term care facility residents who have borne the brunt, the word brutality from this pandemic be first. Yesterday, ACIP recommended and Dr. Redfield agreed today that the next Phase should be people over age 75, who have been also so hard hit, especially from hospitalizations and deaths, and frontline essential workers. And Sarah will go through this in more detail, but these are really the workers that in their day jobs have to have contact with the public and whose work is so essential to the functioning of our society. And then Phase 1c, which is persons over 65 to 74 and then 16 to 64 with high-risk medical conditions and the rest of the group of essential workers.

We are providing some gating criteria, but I hope that you’ll also see how these boxes overlap. What that’s meant to illustrate is that this is going to look different at different jurisdictions. In some jurisdictions, you may pass more quickly from one Phase to the next. But our goal every day should be that every dose of this vaccine is used, even if it means that you’re quickly going to some folks in a Phase that you haven’t completely got to yet.

You know, we don’t want there to be any wastage of a vaccine that really has shown to be so effective and could be such an important tool. Next slide. I wanted to just spend a couple minutes talking about vaccine safety, because I think this is something really important for you all to be clear about and also to be able to clearly discuss with your jurisdictions and your constituents. The size and scope of the studies which these vaccines were authorized is consistent with any vaccine that’s used today in the United States.

It is — the size is large, and the timeline is sufficient to identify adverse events that are generally found shortly after vaccination. But there’s still a huge difference between vaccinating in a clinical trial as big as it is of 40,000 people and rolling out the vaccine in the entire US population when our goal is to give everybody access to vaccine. So as big as that clinical trial is, a completely rare one in a million adverse event won’t be identified. And that’s why it’s so important in any case to be having robust safety systems in the United States.

The public sometimes doesn’t understand that we don’t stop evaluating the safety of the vaccine once it’s authorized or licensed. We forever monitor safety of every vaccine that’s given in the United States. But especially with these vaccines, because we are rightly moving so quickly, we wanted to make sure that our robust safety systems were on display and that we plugged any real or potential holes. So the moment that vaccines started last week, we stood up this series of safety systems.

The ones on the left are the systems that are really focused on these early days of vaccination to identify potential adverse events early and investigate them and report them. And then as we move to the right, as we move towards more widespread vaccination of the entire population, we have these large linked databases that are really monitoring for adverse events. In the early days of vaccination, we were concerned that we wanted to make sure that we didn’t miss anything. And so on top of our normal systems, we also added this system called v-safe, which is an active surveillance system.

So when people get vaccinated, they are given information and requested to enroll in v-safe where they get text messages. And the — their responses to the text message, if they say, for example, that they’ve been hospitalized, they’re going to get a call back from us to check on their status and get more information. We’ve been incredibly gratified with the number of people who have enrolled in the system. We really think it’s going to be an important additive factor to allow us — sorry — to allow us to monitor.

And so we do want to ask that you continue to advocate for that and make sure that folks are getting educated about it because it really is giving us an important early tool to monitor vaccine safety. Next slide. Now, as I said early on, in the early days of vaccination, our focus is going to be on these communities of 1a and then 1b. But we also recognize that to really control this pandemic, we’re going to need high coverage in all communities.

And we take lessons learned from that from our previous experiences, and one of the things that we reflect on is the outbreak of measles that occurred in 2018, 2019 in New York City in New York State. This came during a time of the global resurgence of measles where measles was imported into the United States. And in most cases high vaccine coverage kept it from spreading. There were pockets of under vaccination that were really driven by vaccine misinformation that led to these unprecedented measles outbreaks.

We really learned a lot about the importance of working both nationally but, very importantly, locally and that our messages need to be translated to the specific situation and the specific population but also that the messages are important but the messengers and the community engagement and who’s actually speaking those messages is perhaps even more important. So this — we’ve taken what we learned from this outbreak and really tried to infuse it into our planning forward for COVID vaccination. Next slide. Now, there’s been a lot of studies over the past six months, especially looking at the landscape of vaccine safety in the United States in preparation for COVID-19 vaccine.

And this is just data from one of those studies, but I think it’s useful to think about. At the time of this poll in October, 58% of the general public said they would have received the COVID-19 vaccine. And remember, in October, it was really before we knew how effective these vaccines were. Nor did we really have concrete data yet on the safety profile.

So this is sort of a general thinking from people, not data driven. But you can see that the factors that weigh people’s acceptance are not surprising and things that we would expect from what we know about other vaccines, concerned about side effects; concerns about whether the vaccine works or not; concerns about people’s individual risk, that is, if they’re really at risk for COVID, then they’d be more interested in taking the vaccine; and associated costs. And COVID-19 vaccines would be more acceptable if your healthcare provider said it was safe. You know, even in today’s era of social media and information so easily accessible, people still trust their own healthcare provider the most to help them make decisions about their own vaccination.

The vaccine is — one of the things that we need to make sure is really widely understood is that there is no cost to the individual either for the vaccine or the vaccination. The vaccine cost is being born by the government who’s purchased the vaccine. And provisions are in place to ensure that everybody can actually be administered the vaccine free of charge, even people who don’t have healthcare insurance. We expect that these vaccines will help us all get back to school and work.

In the short term, we need people to keep wearing their masks and socially distancing. But hopefully, as we learn more and as more and more of the population get vaccinated, we’ll be able to go back to little astringent provisions, not today but hopefully soon. And, finally, they could get it easily. And I think people miss — sometimes underestimate the importance of this.

For people who are a little hesitant to get vaccinated, making it easier to get to actually tilts the balance towards getting vaccinated. We should make it easy for people to make the right choice about getting the vaccine. I think this is going to come more into play again as we move towards this spring and we move to these smaller populations to really try and to fan out vaccination in every population. Next slide.

We’ve taken what we’ve learned about vaccines and how people accept them and turned it into this strategy. It’s called vaccination with — Vaccinate with Confidence. And it’s a national strategy to reinforce confidence in COVID-19 vaccines. I want to be clear what it’s not.

It’s not a campaign; it’s a strategy. And our ability to implement this strategy depends on a whole host of partners, state, local, tribal, territorial partners and also community partners and national partners and healthcare partners feel like this is a strategy that we want us all to be in together because it really is going to take all of us working together to get where we want to go. So the principles of this are reinforcing trust. We need to be regularly sharing clear and accurate COVID-19 vaccine information.

We need to take visible action to build trust in the vaccine, the vaccinator and the system. One of the things about this vaccine is, because of our desire to get the vaccine out there quickly, it has meant that the time between authorization and recommendations and the vaccine appearing on shelves is really short. Typically, that equation for normal vaccines, frankly, takes months; and we have lots of time to get messages out. And, of course, none of us wanted to wait and delay.

What that means is that we really need to escalate our attempts to make sure that everyone gets the information they need about this vaccine. We need to empower healthcare providers. We’ve been disturbed to hear some signs of vaccine hesitancy among healthcare providers. That’s, of course, bothersome because healthcare providers are really going to be the ones that people look to both about the decisions they make themselves and what they say to make decisions about vaccination.

So we really want to be promoting confidence among healthcare personnel and their decision to get vaccinated and to recommend vaccination to their patients. Finally, and really importantly, we need to be engaging communities in a sustainable, equitable and inclusive way, using two-way communication, to listen, increase collaboration and build trust in COVID-19 vaccines. And I think this third sector is going to become really the most important thing we do as we move forward into 2021 to really start now in engaging communities so that, when vaccine is available, they’re ready to accept it. Next slide.

This is my roll-up slide. If you want to take maybe just a few messages from this, here they are. It’s an exciting and historic time. Having this vaccine available is exciting to all of us.

And, frankly, I know that it cheered all of us at CDC and I hope that all of you, as well, to see that vaccine arriving in your jurisdictions. And we’ve been getting these lovely pictures of folks who are getting vaccinated. There will be unanticipated challenges, but our job at CDC is to work closely with you, our partners, to find solutions and overcome obstacles. This is not something that we’re going to solve from the federal level.

The action here is at the local level. We want to be your partner in seeing this through. Vaccines are an important tool to control the pandemic. But we need to continue to message the importance of masks, social distancing, and handwashing.

And I can tell you that the day after I get vaccinated, I know I’m going to want to tear my mask off and hug my neighbor. But we all need to be sure that we’re continuing to practice these social distancing conventions, at least for the time being. And, finally, community engagement is going to be so critical to the success of vaccine implementation. We need to engage now in conversations in every community, choose to get — to tell folks — that they can choose to get vaccinated when it’s their turn.

See it as a way to empower people and hopefully to be sharing CDC resources and toolkits. We are hosting an incredible amount of information on our website last weekend this week. And, you know, we recognize that there’s an incredible thirst out there for knowledge, and we really are doing everything we can to try to provide that information as quickly as possible. Next slide.

I thank you for your time. It is an exciting time. I think we’ve made an important step together. There are many more steps that we’re going to need to take in order to fully implement this vaccine, and there’s going to be bumps in the road.

Not everything is going to go perfectly. But I do believe that, working together, we can really use this vaccine is an important tool to end the pandemic. I’m going to turn this over now to Sarah, who’s going to take you through some much more informative information about these vaccines. Sarah, over to you.

>> Thank you so much, Dr. Messonnier. Next slide. So first let’s start with what is an mRNA vaccine. The mRNA is delivered through vac — the mRNA delivered through vaccination instructs the cell’s protein synthesis machinery to make the spike protein, which is then displayed on a cell surface.

In the lymph node, B cells and T cells interact with the spike protein and develop an adaptive immune response. This adaptive immune response includes production of antibodies and the development of T cell responses against the spike protein, resulting in immune memory. The mRNA is then degraded without interacting with or integrating into the DNA. In effect, this type of vaccine uses the cell’s own machinery to mimic the natural processes of viral production and immune response.

Next slide. As Dr. Messonnier mentioned, two mRNA COVID-19 vaccines are currently authorized under emergency use, the Pfizer-BioNTech and Moderna COVID-19 vaccines. Both vaccines demonstrate high vaccine efficacy across age groups, racial and ethnic groups and among persons with certain underlying conditions. Both vaccines also demonstrate an acceptable safety profile, though were fairly reactogenic, particularly after the second dose.

And we’ll get into some more details about this in later slides. Next slide. The Advisory Committee on Immunization Practices or ACIP has recently issued interim recommendations for the use of Pfizer-BioNTech and Moderna COVID-19 vaccines for the prevention of COVID-19 in the United States. While the goal is to offer vaccine to every person who wishes to receive it, ACIP provides recommendations for the Phased allocation of COVID-19 vaccines during the initial periods of limited vaccine supply.

Next slide. So this slide summarizes what Dr. Messonnier spoke about earlier in her presentation. So broadly speaking, the US adult population is divided into overlapping categories based on occupation as an essential worker as well as age and the presence of certain underlying medical conditions. In the first Phase of vaccine allocation or Phase 1a, which is shown in dark blue, healthcare personnel and long-term care facility residents are recommended to receive the vaccine.

These groups are followed by frontline essential workers and adults 75 years and older, which is shown in the medium blue color in Phase 1b. Next are the remaining essential workers, adults 65 to 74 years and adults 16 to 64 years with high-risk medical conditions. These are people being vaccinated in Phase 1c which is shown in light blue. And, finally, 16 to 64 year olds without high-risk medical conditions are included in Phase 2, which is shown in white.

Next slide. This slide summarizes a list of occupations that are considered frontline essential workers and, thus, those that are included in Phase 1b; and other essential workers, which are included in Phase 1c. Frontline workers are defined as those who are in sectors essential to the functioning of society and are at substantially higher risk of exposure to SARS-CoV-2. And as you can see here on the list, this includes people like first responders, those in the education sector, food and agriculture, manufacturing, corrections, Postal Service, public transportation and grocery store workers.

Next slide. Now we’ll go through some more information on CDC’s clinical considerations for use of mRNA COVID-19 vaccines starting with vaccine administration. Next slide. As Dr. Messonnier mentioned, Pfizer-BioNTech COVID-19 vaccine is authorized in persons aged 16 years or older, while the Moderna vaccine is authorized for those 18 years or older.

Both vaccines series consists of two doses administered intramuscularly, with the Pfizer-BioNTech vaccine series administered three weeks apart and the Moderna vaccine four weeks apart. Either vaccine series may be used. ACIP or CDC do not state a product preference. However, mRNA COVID-19 vaccines are not interchangeable with each other or with other COVID-19 vaccine products, so the same vaccine product must be used for both doses in the series.

MRNA vaccines should be administered alone with a minimum interval of 14 days before or after administration with any other vaccines. Next slide. Next, I’ll review considerations for vaccination of persons with prior SARS-CoV-2 infection or exposure. Next slide.

Data from clinical trials suggests that mRNA vaccines are safe in persons with evidence of a prior SARS-CoV-2 infection. Thus, vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection. And viral or serologic testing to assess for acute or prior infection, respectively, is not recommended for the purpose of vaccine decision-making. Next slide.

Vaccination of persons with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness if the person has symptoms and criteria have been met for them to discontinue isolation. While there’s otherwise no recommended minimum interval between infection and vaccination, current evidence suggests that reinfection is uncommon in the 90 days after initial infection. Thus, person’s with documented acute SARS-CoV-2 infection in the preceding 90 days may delay vaccination until the — near the end of this period if desired. Next slide.

Now I’ll review for persons with a known SARS-CoV-2 exposure. So persons in the community or outpatient setting who have had a known COVID-19 — known SARS-CoV-2 exposure should not seek vaccination until their quarantine period has ended to avoid potentially exposing healthcare personnel and other persons to SARS-CoV-2 during the vaccination visit. For persons residing in congregate healthcare settings, such as long-term care facilities where exposure and transmission of SARS-CoV-2 can occur repeatedly for long periods of time, residents with a known COVID-19 exposure may be vaccinated. In these settings, healthcare personnel are already in close contact with residents, for example, by entering patient rooms and for evaluation and treatment and should employ appropriate infection prevention and control procedures.

Thus, administering COVID-19 vaccines should not result in additional exposure. Residents of other congregate settings such as correctional facilities and homeless shelters with a known exposure may also be vaccinated in order to avoid delays and missed opportunities for vaccination given the increased risk for outbreaks in these settings. However, where feasible, precautions should be taken to limit mixing of these individuals with other residents or staff except those essential for the provision of vaccination services who should also employ appropriate infection and control procedures. Next slide.

Next I’ll review vaccination of special populations. Next slide. mRNA COVID-19 vaccines may be administered to persons with underlying medical conditions who have no other — who have no contraindications to vaccination. Clinical trials demonstrated similar safety and efficacy profiles in persons with certain underlying medical conditions, including those that placed them at increased risk for severe COVID-19 compared to persons without comorbidities.

Next slide. Persons with HIV infection, other immuno-compromising conditions or who take immunosuppressive medications or therapies might be at increased risk for severe COVID-19. Data are not currently available to establish vaccine safety and effectiveness in these groups. However, these individuals may still receive COVID-19 vaccination if they have no contraindications to vaccination but should be counseled about the unknown vaccine safety profile and effectiveness in immunocompromised populations as well as the potential for reduced immune responses and the need to continue to follow all current guidance to protect themselves against COVID-19.

Next slide. Observational data demonstrate that, while the absolute risk is low, pregnant women with COVID-19 have an increased risk of severe illness, including ICU admission, mechanical ventilation and death. Additionally, they might be at increased risk of adverse pregnancy outcomes such as preterm birth. There are currently few data on the safety of COVID-19 vaccines in pregnant women.

Limited animal developmental and reproductive toxicity data are available, and studies in humans are ongoing or planned. If a woman is part of a group such as healthcare personnel who is recommended to receive a COVID-19 vaccine and is pregnant, she may choose to be vaccinated. A discussion with her healthcare provider can help her make an informed decision. Next slide.

Pregnant women and healthcare providers should consider the level of COVID-19 community transmission, her personal risk of contracting COVID-19, the risks of COVID-19 to her and her — and potential risks to her unborn child, the efficacy of the vaccine, the side effects of the vaccine and the lack of data about the vaccine during pregnancy. Next slide. Next, I will review some considerations for patient vaccine counseling. Next slide.

Before vaccination, providers should counsel vaccine recipients about expected local and systemic post vaccination symptoms. Depending on the vaccine product, age group and vaccine dose, approximately 80 to 89% of vaccinated persons develop at least one local symptom such as pain or swelling at the injection site or localized lymphadenopathy or lymph node swelling on the same side as the vaccinated arm; and 55 to 83% report at least one systemic symptoms such as fever, fatigue, headache, chills or muscle aches following vaccination. Most systemic post-vaccination symptoms are mild to moderate in severity, occur within the first three days of vaccination and resolve within one to three days of onset. These symptoms are more frequent and severe following the second dose and among younger persons compared to those that are older.

Next slide. Both vaccines are highly efficacious with vaccine estimated at 95% for the Pfizer-BioNTech vaccine and 94% for Moderna. Efficacy after a single dose has not been systemically — systematically evaluated. Thus, patients should be counseled on the importance of completing the two-dose series in order to optimize their protection.

Next slide. However, protection from the vaccine is not immediate. The currently available vaccine is a two-dose series; and it will take one to two weeks following the second dose before a person is considered fully vaccinated. Additionally, as no vaccine is 100% effective, some vaccinated people may still get COVID-19.

Given the currently limited information on how well the vaccine works in the general population, how much it may reduce disease severity or transmission and how long protection lasts, vaccinated person should continue to follow all current guidance, including those listed below to protect themselves and others. This includes things like wearing a mask, social distancing, handwashing, following CDC’s travel guidance and following quarantine guidance after an exposure as well as any applicable workplace or school guidance. Next slide. Next, I’ll review contraindications and precautions to vaccination.

Next slide. For both of the currently authorized mRNA COVID-19 vaccines, severe allergic reactions such as anaphylaxis to any component of the vaccine is a contraindication to vaccination listed in the prescribing information. The prescribing information also stipulates that appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event that an acute anaphylaxis reaction occurs following administration of the vaccine. Next slide.

Although not reported during the clinical trials, multiple cases of anaphylaxis have been reported following vaccination with Pfizer-BioNTech COVID-19 vaccine. Two cases have been reported in the United Kingdom, and six cases to date have been reported in the United States among approximately 272,000 people — doses administered during a similar time period. As Dr. Messonnier mentioned earlier in her talk, we have more updated numbers on number of vaccine doses received; but this was as of a few days ago for this analysis. So this is a higher than expected rate of anaphylaxis.

In terms of the US cases, onset was rapid; and one person had had a prior history of anaphylaxis to rabies vaccine. Next slide. While these reports of anaphylaxis in persons who received the Pfizer-BioNTech COVID-19 vaccine are further investigated, CDC considers a history of severe allergic reaction such as anaphylaxis to any other vaccine or injectable therapy, those administered by the intramuscular, intravenous or subcutaneous route as a precautious but — precaution but not a contraindication to vaccination to both the Pfizer-BioNTech and Moderna COVID-19 vaccines, as these vaccines contain some ingredients in common. A risk assessment should be conducted in persons who report history of severe allergic reaction, such as whether they needed epinephrine or resulted in hospitalization.

These persons may still receive vaccination, but they should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefits of vaccination. Next slide. CDC recommends that vaccine providers observe all patients after vaccination. Those with a history of anaphylaxis due to any cause should be observed for 30 minutes.

All other persons should be observed for at least 15 minutes after vaccination to monitor for the occurrence of immediate adverse reactions. Next slide. In addition, CDC has developed tools that providers can use at the vaccination site to help identify persons with contraindications or precautions to vaccination, including a pre — a pre-vaccination form and further additional information in the form of fact sheets. We’ve also developed interim considerations for the potential management of anaphylaxis at COVID-19 vaccination sites.

Next slide. The key take-home messages from these considerations are the early recognition of anaphylaxis symptoms; prompt treatment with epinephrine, which is the medication of — frontline medication for treating anaphylaxis; and activation of emergency medical services so that the person can go to a level that they — a higher level of medical care and evaluation. Next slide. So, finally, I’ll review a few additional resources.

Next slide. So CDC’s website has a number of resources and vaccine tools. The links are included here below, both generally and for healthcare professionals. We also have some guidance developed around infection prevention and control recommendations for people who develop vaccine — symptoms following vaccination, specifically those healthcare personnel and long-term care facility residents.

Next slide. We also have some vaccine communication resources that, you know, kind of fall within that framework that Dr. Messonnier mentioned for vaccine confidence such as engaging in an effective COVID-19 vaccine conversation, as well as toolkits for medical centers, clinics and clinicians. And there are a number of other toolkits that are under development and will be out soon. Next slide.

And that’s all. Next slide. So just some pictures of people getting their vaccine. Thank you.

>> Thank you so much, Dr. Messonnier and Dr. Mbaeyi. And you can actually go back to the previous slide, and we’ll let Dr. Messonnier hop on at the end to give some final thoughts on that social media slide. I know we’ve covered a lot with these updates. So, again, thank you to the both of you.

You’ve got a lot of — we had a lot of questions submitted into our box, and we’ll go through as many as we can in the next few minutes that we have, in the next 15 minutes. But, as always, before we get started answering your questions, please take a moment and answer a couple of our questions by taking the poll on your screen. And I will note that we received many great questions in advance of this call, and I think the presentations did address a lot. So thank you for sending in those questions.

We appreciated them as we guided the thoughts around these presentations. And I will go ahead and kick us off with a question for you, Dr. Mbaeyi. This individual asks, Can vaccinated individuals spread the virus? Will the vaccine cause you to have a mild case of COVID-19 and then make you infectious? >> As for that question, so, no. The — you know, COVID-19 vaccines will — COVID-19 vaccines will not, you know, make you infectious or spread the virus.

And that’s because the COVID-19 vaccines, they’re not live viruses. They’re not attenuated live viruses. They are, as I mentioned, they — what they are is kind of provide instructions for your cells to make, you know, pieces of, you know, the spike protein that then the immune system can respond to. So, really, what you’re getting when you receive a vaccine is instructions that are then used by your cells and not actual virus itself.

And these — as I mentioned before, these kind of instructions, as you will, that are the mRNA, they degrade really quickly within in — within the body. So they don’t hang around. There’s not replication of the virus. So the answer is no.

Vaccinated individuals can’t spread the virus, and it won’t cause you to have a mild case of COVID-19 or make you infectious. >> Got it. Thank you so much, Dr. Mbaeyi. And I actually will piggyback on that one with another one for you that we got in around vaccine side effects.

So it kind of tags off of that one. But this individual asks, What are the vaccine side effects? And how long do they usually last? >> Sure. Great question. So as I mentioned before, you know, having a local or systemic side effect to the vaccine is relatively common in terms of, you know, things like getting a sore arm or some redness at the injection site or a headache, maybe some chills, muscle aches. Those types of symptoms happen fairly commonly in people who get the vaccine, so they are — they’re expected side effects.

So people shouldn’t be surprised if they do get those side effects. But the good thing is that they’re pretty short lived. They usually happen, you know, within a day or two of getting the vaccine, and in most people they resolve within one to two days. So they’re pretty mild, mild and short-lived side effects.

>> Wonderful. Thank you. That’s very helpful information for all of us to have as we have people in our lives who start getting vaccinated. Dr. Messonnier, I have a question for you.

An individual asks, Could the vaccine be mandated by employers, even though it’s under an EUA with FDA? That’s a — Am I unmuted now? I did a poor job of doing that. >> Yeah. We can hear you. >> Okay. I’m sorry. Technologically impaired.

That’s a really important question and, frankly, not so easy to answer. So there’s two parts of this. One part is that the FDA and CDC cannot mandate vaccines. That’s not within our scope.

In order to understand state and local jurisdictions, you actually need to know applicable state law. One thing that we do know is that I expect that nobody wants to even really have the conversation about mandating, and what we really want to do is educate people so that they’re able to make an informed choice. And we think in this situation, the informed choice should be to get vaccinated. So I’m hoping that we don’t have to walk that line around mandates and that we can really focus on education.

But the truth is that, in order to know about whether it’s even possible for someone to mandate the vaccine, you actually have to look at your applicable state law. >> That is very helpful. Dr. Messonnier. And while I have you, I’ll ask you another question from an individual about all of the vaccines that are in the works.

So they ask, There are a number of vaccines currently in the works, and do we anticipate that one will be better than the other or more effective or have fewer side effects and, of course, all the things that might follow, are safer, etc. So I’ll turn that one over to you. >> Yeah. It’s a great question. There are multiple vaccines in the works, including multiple vaccines globally. In the United States, in addition to these two vaccines, there are four more that are sort of closer on the pipeline and that Operation Warp Speed has been investing on.

And I certainly hope that one or more additional vaccines will be soon available because, frankly, it’ll make it easier for us to vaccinate. The two vaccines that Sarah told you about are both mRNA vaccines, and so they’re very similar. Therefore, we expect them to have similar effectiveness and similar adverse event profiles. The next vaccines are actually quite different.

And we really need to look to the data to understand the safety profile and the effectiveness profile of those vaccines and, importantly, whether there are any ways to look at what vaccines might work better in which populations. So the short answer is we don’t know yet. Stay tuned. Long answer is that, you know, this is going to be a process of us all together figuring out how best to use the vaccines that are available.

>> Thank you so much. That’s exactly what you alluded to in your remarks, that this is kind of ongoing work. And so we look forward to learning more as we learn more. Thank you, Dr. Messonnier.

The next individual — let’s see. I’ll ask this question to Dr. Mbaeyi and give Dr. Messonnier a break. This person asks, How long does the vaccine provide protection for? Is it forever? Or will we require annual boosters? >> So that’s a great question and one we don’t have the answer to yet. It’s going to take a little bit more time for us to see how long immunity lasts and if and when boosters will be needed.

So stay tuned for more on that. >> Wonderful. We will. Thank you for addressing that one. And, Dr. Messonnier, I’ll go back to you.

That wasn’t too long of a break. But I have another question that’s a very important one. This individual asks, Does CDC have a strategy to get the vaccine to minority populations? Is there a plan to promote the safety of the vaccine, especially with Latino and African-American communities who may have historically had a distrust for vaccines? >> I really appreciate getting this question. So I can start by saying this: The pandemic has clearly exacerbated the long-standing systemic health and social inequities.

There are many racial and ethnic minority groups that are at increased risk of getting sick and dying from COVID-19. We have to educate and engage and ensure that vaccines are going to be easily accessible to everybody in every corner of this country, no matter their age, race or ethnicity or socioeconomic status. And as you’re sort of alluding to, focus groups tell us that communities of color are wary of a vaccine that’s been developed so quickly and being first in line due to previous experience, and we need to be aware of that as we move forward. We have a number of strategies that we’re working on.

But one thing I want to talk about is the REACH Program. This is the Racial and Ethnic Approach to Community Health Program. We actually began working in that program, supporting organizations and community level actions to increase flu vaccine uptake because flu vaccine is another place where there are long-term inequities with lower flu coverage in adults of color than whites. And, therefore, we already had started working on that.

And we really plan to expand on that activity at a national level. I want to again emphasize how important I think it is that we engage now to begin building confidence. By spring, we believe that we will be funding hundreds of organizations, really focusing on partnerships with national organizations to address health disparities and hopefully working with all of you to start sharing best practices for how we can reach these communities in this — in this early time when we’re really building partnerships so that every community is ready to accept the vaccine when it’s available. So thank you again for that question.

>> Thank you, Dr. Messonnier. That was very, very helpful and a big question with a big answer. So thank you. Let’s see.

I’ll go over to Dr. Mbaeyi for this question. This person asks, If a vaccine requires two doses and due to deliveries or scheduling, you can’t get your second dose within the required timeframe, what should you do? Or what would that mean for you? >> Thanks for the question. So, you know, ideally, people should be getting their second dose as close to that recommended interval as possible. But, you know, there’s no maximum interval, you know, for these vaccines.

So if it doesn’t — if you’re not able to get that second dose, you know, either at three weeks or four weeks, depending on the vaccine, you should just get the second dose as soon as you’re able to. You don’t need to restart the vaccine series over again. >> Very helpful. Thank you.

Thank you. And, Dr. Messonnier, I’ll come back to you for this question. We’ve got a couple of questions around essential workers. But this person asks, Is there further clarity on the definition of essential workers outside the healthcare arena? And so that was one.

But I think one that kind of gets to both of these is, At what level of government will decisions about who falls within the essential worker category be made? And how will essential workers demonstrate that they fall within the categories? >> Great questions you’re asking us. I’m going to start with the second one, and then give Sarah notice and I’m going to pivot back to her and let her answer the first one, please. I think that it’s important to recognize what we think CDC’s role is. And our advisory committee gave us advice yesterday, and part of the role of the advisory committee is to discuss this in plain air, that is, that those meetings are projected and they’re recorded.

So you can go back and listen not only to what ACIP recommended but why they recommended certain kinds of essential workers, both on the front lines be included in Phase 1b, why they thought others could wait. So we do that framework. We make recommendations. And then we recognize that, in the end, it is the burden or the — I think of it as the burden, frankly, of the jurisdiction actually to have to make a decision about who’s in and who’s out.

So we can talk about frameworks. We can talk about data. We can set up the rationale for how to approach the issue. But, in the end, it is going to be the privilege and burden of the local jurisdiction and health departments to actually make a list of how you decide who’s in and out.

And, frankly, there are going to be local complexities; and we can’t pretend to understand all of them. All we can do is hopefully give you a way to approach it. The second question or the second piece of that question is, how do you do it? I think when it’s an age-based recommendation, it’s easier than it is when we’re talking about these essential workers. And what we’re going to try to do is come up with tools and approaches that jurisdictions can use.

For some essential workers, for example, it may make sense to do workplace vaccination as a way to ensure that you’re really getting those at high risk and making it easy for them to access vaccination. But we are going to be trying to come up with approaches that you can use, just like we did for long-term care facilities. And I’m going to be hoping that we have so much additional vaccines so soon that we can quickly pass through this stage of limited vaccines and the need to prioritize into more larger quantities of vaccine. Sarah, do you want to go through in more detail how the definition is of frontline essential workers? >> Sure, yes.

So I think there’s I think a few responses to that question. I mean, I think, in general, you know, essential workers, including frontline workers, those kinds of lists and definitions, there’s been attempts made at the federal government level to kind of establish those definitions because they have many more implications besides just, you know, vaccination, and so that everybody was kind of using the same kind of understanding of what those — those definitions are. So there’s a group — a unit within the Department of Homeland Security that has kind of established those definitions and kind of categorized them as frontline or other essential workers. And there’s many more details on their website as to the specific groups within it.

I think, you know, ACIP tried to look at, you know, what — you know, what — who are those people that, you know, I think we mentioned before, you know, things like whose job requires them to interface with the public and they can’t, you know, stay at home and do their job. And those types of people. Like I mentioned, front — first line — first responders, police, fire, etc., educators, etc., those are all part of the frontline list. And those lists have also been reviewed by the National Academies of Medicine when they were helping to build a framework for prioritization.

So I think — you know, I think ACIP really tried to take into account some of those factors when kind of presenting those groups of people, frontline and essential workers, other essential workers. >> Perfect. Thank you so much, Dr. Mbaeyi. That’s incredibly helpful and very thoughtful responses.

We did get a lot of questions. And I know we have the last four minutes and a lot of questions. I do want to give you both a chance to answer this question. Dr. Mbaeyi, I’ll turn to you first.

It usually takes years to develop a vaccine. And what, if any, assurance can you offer the public that this vaccine will not have any long-term effects, especially those with preexisting conditions? I know you iterated in your presentation that we are still looking at this. >> I think it’s a great question. And I think what I would like to emphasize is that, while the development process took, you know, we have a vaccine much earlier than we’ve had before, the same steps that are regularly used to evaluate and approve vaccines have been followed at every step.

So whether it’s, you know, the conducting clinical trials, Phase 1, Phase 2, Phase 3 clinical trials, I think where things have been accelerated is the manufacturing of these vaccines. So instead of waiting until the end of all the clinical trials to start manufacturing the vaccine, investments were made so that we could start producing vaccine to have it ready at, you know, Day 1 after these vaccines have been demonstrated to be safe and effective. And both — for both the FDA and the CDC, there are external advisory bodies made out of — made up of independent experts who reviewed the data very carefully and thoroughly and deliberate. And both of those independent bodies of experts agreed that these vaccines are safe, effective and have you gone through all the normal processes to assure the data that we have.

The other thing I’d like to say is, you know, now that vaccines are authorized in the United States, we will be following safety and effectiveness very closely. Dr. Messonnier described some of our safety systems that are in place that have — that rely on safety systems we’ve always — you know, for years had an existence, but also some additional effort’s being made to gather as much data as we can and evaluate everything very carefully and in as close to real-time as possible. But I’ll see if Dr. Messonnier has any other things. >> That was incredibly well said.

And the only thing I would add is, again, what we’re seeing is the end of a vaccine development pathway. But if you look underneath the hood, you’ll see that the science of these vaccines are based on has actually been science that researchers, especially including at NIH, have been working on in years — for years. And if that work hadn’t been done before, before they needed a COVID vaccine, these vaccines wouldn’t have been here so quickly. And so part of the reason that it’s faster is that.

And Sarah said part of the reason is things were done simultaneously. And part of the reason, frankly, is that these vaccines are actually faster to manufacture than some of the vaccines that we routinely use in the US. I have to say that I — it’s coming up on four o’clock. I have another call I need to get to, so I may sign off here and, if it’s okay, let’s Sarah sort of close out the meeting if that’s okay.

>> Yes. Thank you so much, Dr. Messonnier. We really appreciate your time today. We know you’re doing calls back to back to back. So thank you so much.

>> Thank you for the opportunity. We really want to make sure we take every opportunity to talk about these vaccines. So important to get the right information out there. So thank you.

>> Thank you again. And Dr. Mbaeyi, I’ll let you close us out. We only had two more questions. And it was, basically, kind of, What do we need community leaders to do? And when can we anticipate moving away from physical distancing and mask wearing? So I’ll kind of toss it over to you for some closing remarks maybe with those two in mind.

>> Oh, sure. Those are — those are great questions to end on. I think the important thing is leaders in the community and leaders, you know, within the family and the neighborhood and the church or, you know, religious organization, leaders at every level are needed to, you know, promote this vaccine and to talk about it with others in their community to let people know. And once, you know, you’re vaccinated, share with others.

Share with others your experience because that’s how we’re really going to boost confidence and get everybody vaccinated. And I apologize. I forgot the second question. >> Oh, no worries.

You actually — you did it. It was kind of keeping an eye on the prize of eventually getting to less mask wearing and social. >> Oh, yes, yes, >> We’re not there yet. >> Not there yet.

And we need everybody to kind of keep up — keep up their vigilance and keep — let’s get over this hump that we’re in currently and look to the future. But I think I’ll end it there. And thank you so much for this opportunity to talk to you all today. >> Thank you, Dr. Mbaeyi.

And thank you so much to Dr. Messenia as well. This concludes our time together, and I’ll leave you with some wonderful images there. And I want to thank you all for joining our call today and for sending some wonderful questions. A recording of this call will be posted online on CDC’s COVID-19 webpage and on YouTube in a few days.

And if we didn’t get to your question on today’s call, we will do our best to respond to you via email. So, again, thank you for sending those questions to us. And the subscription link to receive future updates and invitations we will put into the chat so you can come back for future calls. And the next one will be Monday, January 11, and the topic will be CDC COVID-19 Case Investigation and Contact Tracing Guidance and Tools.

So Happy Holidays to you all and be well. Thank you.

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Source: Centers for Disease Control and Prevention (CDC)