SCIENCE SAYS SUNDAY – What does the Pfizer/BioNTech EUA mean?

So much vaccine talk leads to much confusion!

In the US, the FDA has issued emergency use authorization (EUA) for a single vaccine so far: The Pfizer/BioNTech COVID-19 vaccine. You can learn more about what an EUA means here. You may have heard about the FDA meeting that happened live via YouTube this week, as well as the vote that happened Saturday (12/12/2020). All the information about these meetings, including details about the vote for approve the EUA can be found here.

You may have also heard about the Moderna vaccine, but as of today (12/13/2020) we do not yet have emergency use authorization for that vaccine, however, we anticipate that it is forthcoming SOON! Meetings about that EUA are expected this coming week.

In the meantime, here’s what you need to know. States are coordinating with the federal government to roll out vaccination programs for certain individuals. Based on the Pfizer data, FDA EUA, and CDC recommendations, the EUA for the Pfizer/BioNTech vaccine is currently only recommended for the following individuals, if supply is in short demand (which for this specific vaccine and the number of doses that were purchased by the US, yes, it is in short demand):

  • Healthcare personnel
  • Workers in essential and critical industries
  • People at high risk for severe COVID-19 illness due to underlying medical conditions
  • People 65 years and older

There’s a super comprehensive Atlantic article that lays down the hammer on what we should REALLY be expecting in 2021. An excerpt from that article is quite telling:

“Because the first shipments of vaccines will not cover all 24 million people in these two groups, the CDC has recommended sub-prioritizations too. Hospital workers who are in contact with patients are first on the list—including janitorial and support staff. The CDC also asks hospitals to consider that people who have recovered from COVID-19 likely have some immunity, so they do not need to be vaccinated first, though they won’t be prevented from getting vaccinated when doses are available later. For long-term care facilities, the CDC recommends putting skilled-nursing facilities, which have the sickest patients, before assisted-living facilities.”

Sarah Zhang, December 11, 2020, The Atlantic

24 million out of 328.2 million means these first doses will only reach 7.3%, when we actually need between 196-230 million people vaccinated. That means we have a ways to go logistically, but again, SUCH great news that we have this vaccine available to get started!

If there is significant supply (like sometime in the summer/fall), the Pfizer/BioNTech vaccine will be recommended for:

“persons 16 years of age and older in the U.S. population under the FDA’s Emergency Use Authorization.”

There are some exceptions. For example, we do not currently have data for the following populations:

  • Individuals aged less than 16 years of age
  • Immunocompromised individuals
  • Individuals who have severe allergic reactions to one of the ingredients in the vaccine
  • Women who are pregnant/lactating

There is a trial ongoing in 12-18 year olds, and results from that trial should be available some time in 2021. For women who are pregnant or lactating, there also isn’t a lot of data at this time, however, early animal studies are promising. The ACIP for example says the following about women who are pregnant or lactating:

At this time, we know that two trial endpoints were met:

  1. Individuals in the trial who got the vaccine did not develop symptoms consistent with COVID-19
  2. Individuals in the trial who got the vaccine did not develop severe COVID-19, such that they required hospitalization, for example.

We don’t yet know – though data is coming to tell us – whether the vaccine prevents people from becoming infected with sars-cov-2 (the virus that causes COVID-19), and/or if it prevents people from transmitting sars-cov-2 to others, even if they themselves don’t become super sick. We will know more about these two specific questions/endpoints in the coming weeks/months, but AT THIS TIME, we do not know the answers to these questions.

Therefore, it’s important to know that when you have access to the Pfizer/BioNTech vaccine (lucky you!), until we know otherwise, you will still need to wear your mask, watch your distance, and wash your hands. However, it does mean you will be less likely to have symptoms and/or severe disease, which is so amazing since we still don’t fully understand why some people become so sick and why some die.

Also keep in mind that if you are lucky enough to get a vaccine in the first or second round, it is not uncommon for you to experience some symptoms including fever, aches, or headache for example. That means the vaccine is working! Most people reported symptoms for no longer than 12 hours, most often the second day, and felt fine after.

For more information, feel free to read last week’s #sciencesayssunday post, which cites tons of literature about how the vaccine was developed and how it works.

Science Says Sunday – A short primer about COVID-19 vaccines

Just as expected, this winter is turning out to be as dark as many forecasted this spring and summer. We know that coronaviruses generally have some seasonality aspect to them, but more so, we knew that as people moved indoors, the virus would spread far more easily than it had in the summer months. Why? Because in addition to droplet transmission that many of us knew about and tried to protect ourselves against, aerosol transmission is also possible with sars-cov-2. What does that mean? That means that in places that aren’t well-ventilated (eg our homes), the saliva and mucus that comes out of our nose and mouth (especially those super small droplets) tend to hang in the air and get breathed in by others who are around us. Read more about that here and here.

In the meantime, many of us continue to practice the things we know to work to prevent transmission of SARS-CoV-2:

  • Washing our hands
  • Wearing our masks
  • Watching our distance
  • Avoiding indoor spaces
  • Not gathering with non-household members

Because it takes a great deal of effort, in some cases, to be able to do all of those things, many of us have been super excited about the two new vaccines from Pfizer and Moderna. Announcements that these would be available for some members of the public resulted in a great deal of questions from the general public, but also a TON of misinformation. As per usual, we’re having to combat the #infodemic once again. Above I debunk a few of the myths that are circulating, but thought it would also be useful to give some background about how the vaccines were created.

I created the following Instagram posts to summarize in laymen’s terms how the two vaccines work:

It’s important to note that this is a very basic explanation of the way these vaccines work, but additional, detailed information can be found in a number of articles I will list below. In the meantime, I am 1) super excited that science has made this possible and 2) can’t wait to be able to get the vaccine myself.

For additional information, read the following articles (which I had to read just to put three Instagram slides together!):

An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

Nanomedicine and the COVID-19 vaccines

mRNA vaccines — a new era in vaccinology

JAMA Network – Coronavirus Vaccines – An Introduction

The story of mRNA: How a once-dismissed idea became a leading technology in the Covid vaccine race

Developing mRNA-vaccine technologies (published in 2012!! I’m telling you, this technology is NOT NEW)

How Pfizer’s Vaccine Works

Bad News Wrapped in Protein: Inside the Coronavirus Genome

How mRNA vaccines from Pfizer and Moderna work, why they’re a breakthrough and why they need to be kept so cold

Understanding and Explaining mRNA COVID-19 Vaccines

SARS-CoV-2 vaccines in development

Science Says Sunday – COVID-19, Vaccines, and Why You Should Mentally Prepare to Keep Wearing Your Mask

We’re on the eve of 🦃 week today. More than 1 million people passed through US airports Friday, with more anticipated in the upcoming days. Some may be traveling because they couldn’t cancel their plans in time or afford to cancel at all. Others, may be excited about news of a vaccine, with some news sources citing availability as early as late December.

While it is true that we have very encouraging news about the Pfizer and Moderna 💉s (95% effective against SARS-CoV-2!!), the fact is that it will be months (no earlier than spring at min) before you and I may be able to get access to any doses (and we will each need 2 doses), unless we happen to be among those for who emergency use will the authorized in the coming months.

So, what does that mean? While we definitely see the finish line and the cavalry is on it’s way, several things have to remain in place in order to get the majority of people in the US safe. This means, through 2021, but especially this and next month.

1. We have to continue to distance, wash our 🧤, wear our 😷 s, and avoid indoor spaces.
2. Our ICU’s are filling up and our health care workers are falling ill (and in isolation) or are out due to close contact (in quarantine), so that means there are not only fewer 🛏️s, but also fewer staff to take care of people who need those 🛏️s.
3. Thus, we must, must, prioritize sticking to our household members only for the foreseeable future. That includes 🦃 and most likely 🎅 + New Years. I’m sorry. I know we’ve had a focus on 🦃 only, but the reality is, we’re in deep trouble for weeks to come.
4. Once a 💉 is available for the majority of the population, we will still need everyone to get it so that all can be protected.

To get people vaccinated, we need to address the 🐘 in the room. There is a lot of uncertainty about the 💉, the biggest being mistrust. People don’t feel safe taking a vaccine that was created so quickly. I get it. The unknown is scary. In this case, one of the reasons these 2 💉s were able to be created so quickly is bc the template for the key component needed to make these 💉s work had been started yrs earlier when scientists worked on designing a 💉 for MERS. The groundwork had been laid years prior. It’s phenomenal that scientific work done previously led to success now! I’m linking articles to help explain further, and will continue to post information about the vaccines in the coming days, but for now, please, please keep 1-4 above in mind and practice 1 and 3 as much as possible.

Two articles I found super useful in explaining what happened to help make the two vaccines so successful are:

  1. The tiny tweak behind COVID-19 vaccines: https://cen.acs.org/pharmaceuticals/vaccines/tiny-tweak-behind-COVID-19/98/i38
  2. Politics, Science and the Remarkable Race for a Coronavirus Vaccine: https://www.nytimes.com/2020/11/21/us/politics/coronavirus-vaccine.html?referringSource=articleShare

There are great Instagrammers that have clear information about vaccines too.

  1. Jessica Malta Rivera: https://www.instagram.com/jessicamalatyrivera/
  2. Science Says Sam: https://www.instagram.com/science.sam/
  3. Laurel Bristow: https://www.instagram.com/kinggutterbaby/
  4. Kizzmekia Corbett (Virologist who helped work on Moderna vaccine!): https://www.instagram.com/kizzyphd/

All three are phenomenal science communicators, which means they are communicating accurate science that is easy to take in and to understand. Highly recommend all three!

Thank you all for your continued vigilance, for your sacrifices, and most of all, for helping us all work together to make sure that we get through this winter and are able to be with our loved ones once these vaccines are available for us all.