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.

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