𝐓𝐇𝐄 𝐋𝐈𝐆𝐇𝐓 𝐀𝐓 𝐓𝐇𝐄 𝐄𝐍𝐃 𝐎𝐅 𝐓𝐇𝐄 𝐓𝐔𝐍𝐍𝐄𝐋 𝐈𝐒 𝐆𝐄𝐓𝐓𝐈𝐍𝐆 𝐖𝐈𝐃𝐄𝐑 – 𝐘𝐄𝐒𝐓𝐄𝐑𝐃𝐀𝐘 𝐖𝐀𝐒 𝐁𝐈𝐆. 𝐓𝐎𝐌𝐎𝐑𝐑𝐎𝐖 𝐖𝐈𝐋𝐋 𝐁𝐄 𝐄𝐕𝐄𝐍 ððˆð†ð†ð„𝐑.

Let’s talk about the Pfizer vaccine and the FDA review this week. I’m devoting this post specifically to Pfizer since that’s the first vaccine we have the full data on, the first one to apply for an EUA, and the first one to possibly roll-out. Let’s talk about it.

This week will be a huge week in the COVID-19 / vaccine world. Yesterday (Tuesday) Pfizer released their full report on the vaccine (93 pages) and the FDA released their report (53 pages). I read it all last night. Partly because it is great unbiased science. But, also because it is pointing towards relief for all of us. Tomorrow (Thursday), the FDA will provide a live stream (Youtube, FB, twitter, and webcast links below) of the panel of independent evaluators/scientists going over the Pfizer data – bit by bit and piece by piece. These panel discussions are not new and are part of the rigorous safety measures in place for vaccines in general. The new part is live-streaming it for all of us to see . And, that makes me excited because the FDA knows how important it is for all of us to understand how important this is (see Picture 4 on this post). Remember, these vaccines will go to their families too. Safety matters.

✅ Who are the independent scientists? I put a link at the end with the full roster – but, these are some widely trusted non-partisan, career scientists in the science/vaccine/equity space. These are also scientists that truly are independent and do not work for corporate think tanks or private for-profit organizations. In other words, the names I know on the panel (I don’t know them all) are consistent, calm, tough, very smart, and trusted veterans in science. They are who I want to evaluate the 93 pages of Pfizer’s data and the 53 report from the FDA. If something is “off”, this group will find it. If something doesn’t look safe, this group will find it.

✅ What will they talk about? I put a link to the agenda at the end of this post too. They will talk about a LOT of super exciting stuff – well, it will feel like Steve Kornacki’s excitement for data to us science-y people. All kidding aside though, they will go over every page of the Pfizer document. They will talk about the epidemiology (whoop!), safety, consideration for vaccine roll-out (if approved), and have a public hearing. Then a vote at the end. It will be a long day and I plan to watch it all. Maybe we should host a FNE watch party via zoom and we can all hang out that day? =) Ok, back to the Pfizer vaccine…

✅ What did the 93 page report say? There’s so much to unpack here – and even more good news! We heard from the preliminary press release that efficacy was really high. The final report says the same thing. Let me show you in pictures:

▪️ PICTURE 1 – This shows two lines. The red line shows COVID-19 infections among those who received the placebo and the blue shows COVID-19 infections who received the vaccine. Do you notice the split that happens around day 14? After vaccinations (in general), it takes your body about 2 weeks to make antibodies. So, this shows the same timeline for antibody production (a good sign). It also shows something else really important. This picture shows what happens after ONE dose – the efficacy is 52%. That’s a HUGE deal. After 2 doses, it jumps to above 90%. Whew, web-peeps – these findings should tell all of us relief is on the way. And, this is just one of the vaccines to be evaluated in the days/weeks to come.

▪️ PICTURE 2 – What about safety and side effects? I know this is a main question for many of you, understandably. This picture shows the monitoring of any adverse events (from small to large events) for vaccines in general. These are usually classified as immediate (like soreness in your arm or slight fever), intermediate, and long-term side effects.

***** I want to also point out that 90-95% of all types of vaccines (go to the Vaccine Series Post 1 to see the different types) show their long-term side effects (the bad ones) 30-45 days after the INITIAL dose. We are well past that time for the Pfizer vaccine. It doesn’t mean we won’t see any. BUT, none of the serious intermediate or long-term adverse events that typically show up by now in some vaccine trials, such as Guillain-Barre disease, have been seen at this point. This is a really good sign at this point in the monitoring timeline of this vaccine. *****

✅ What are the side effects? Injection site reactions (84%), fatigue (63%), headache (55%), muscle pain (38%), chills (32%), joint pain (24%), and fever (14%). Serious events were very low in the vaccine group (less than 0.5%). You can look at these in Table 23 in the FDA report below. There were 6 deaths (4 in placebo, 2 in vaccine group) but were not related to the vaccine or placebo. Remember, there were 38,000 people in the full trial too.

✅ The safety profile was generally “similar across age groups, genders, ethnic and racial groups, participants with or without medical comorbidities, and participants with or without evidence of prior SARS-CoV-2 infection at enrollment.” I’m sure there’s so much more to unpack in this report. I know many of you have questions about safety for other groups: immunocompromised individuals, COVID-19 long-haulers, pregnant/breastfeeding women, children under 16, asthma, hypertension, and others. I’m expecting we will hear more on this on Thursday and the days after. For lots of these groups, we just don’t know yet. I’ll definitely be listening on Thursday for answers to these questions, as will lots of others. After this meeting, recommendations are expected. Stay tuned.

✅ I know several of you participated in the trials. I want to say a big ole’ FNE thank you! This effort (and 2020) has been historic – and you helped pave the way out of the tunnel for us. The first person to receive the vaccine (in the UK) is the last picture in the post, Ms. Keenan. =) She is a 90 year-old former shop clerk who turns 91 next week. The 2nd was an 81 year-old man named William Shakespeare. =)

Ms. Keenan said with her Christmas/penguin sweater on, “It’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the New Year after being on my own for most of the year.” This is the light at the end of the tunnel getting lighter for our families.

-Friendly neighbor epidemiologist

SOURCES:

Full 93-page Pfizer report: https://www.fda.gov/media/144246/download

Full 53-page FDA report: https://www.fda.gov/media/144245/download?fbclid=IwAR0TTHLsCttK3Kei_vSAe4Wod0kwMT-EokpRlImsmK0FQw3x243HTFNAS7M

FDA press announcement about Pfizer’s advisory committee meeting: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccine

How to watch Thursday’s panel: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement

Members of the Thursday panel meeting: https://www.fda.gov/media/144232/download

Agenda of the Thursday panel meeting: https://www.fda.gov/media/144231/download

History of intermediate vaccine side effects: https://www.youtube.com/watch?v=ULCM5kYuF

Photo: https://www.nbcnewyork.com/news/coronavirus/uk-rolling-out-covid-19-vaccine-to-public-as-world-watches/2766821/

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