FDA Pfizer vaccine meeting recap

So much happened yesterday in the all-day-event and I wanted to give a recap of the key take-aways. Here we go…

✅ 1. I was very impressed with how non-reality-TV this was. =) Let me explain. We heard from the public. We heard from Pfizer about the safety and efficacy data (allllll of it). Then we heard from the oversight committee (these are the independent scientists/MDs) who evaluated the data. Then we heard a discussion where the independent panel asked really hard questions – these were excellent questions that many of you have asked about safety, side effects, and where further studies are needed. This felt like my dissertation defense (times 1,000!) – the point of the discussion was to pick apart anything that looked “off” and propose what to do next. It was definitely NOT simply putting a stamp of approval on Pfizer’s data. The questions were much harsher than I expected – but, I was thankful for. This is where it felt non-reality-TV to me – it was just good science and very smart people asking important questions about vaccines for millions of us. I came away from this part of the day really encouraged with how rigorously the independent panel was evaluating the data. It’s one thing to read about it. It was another to see it in action.

✅ 2. We need to remember this will be a process. The recommendation on who should get the vaccine so far is based on the data we have so far. In other words, the recommendation is for people who were in the trials – that’s why recommendations for children will come later, as an example – those trials have just started. So, we need to remember that this will be a rolling process. First, recommendations will come out to the general population that looked like the people in the trial. Second, recommendations will come out to sub-groups that are now being evaluated more (persons with certain underlying conditions, children, etc). Third, all other sub-sub-sub groups will be evaluated. Step by step. But, we don’t have to wait on the third step before we vaccinate those who were included in the first step.

This is part of the process. This process will take some time. It will be important for us to remember that we are in the midst of a historic and devastating pandemic that needs a vaccine for quicker relief than relying on individual behavior (which we know relying on that is not working). We need that vaccine to be safe AND effective. Yesterday, I’m more convinced that is is safe AND effective. I’m also super impressed that sub-group trials of specific populations (children, pregnant/lactating women, groups with certain conditions, etc) are planned or have been started.

✅ 3. The safety profile looked really good. Be careful these next few days if you hear people saying the vaccine is not safe because it will do XYZ. But, XYZ was only seen in 4 out of the 38,000 people. An example is Bell’s palsy. Four of the participants who received the vaccine developed Bell’s palsy, a temporary health concern that all 4 have since recovered from. None of the participants in the placebo trial developed Bell’s palsy. So, something to watch and be aware of. But, not a reason to NOT get the vaccine for the general population- the oversight committee would have recommended if this was a concern. Also, 4 out of the 19,000ish people who received the vaccine is the same as the rate we see in the general population in everyday life. Again, we watch. But, this is normal for vaccine trials. The rest of the safety profile looked really good – sore arms, fatigue, etc. (If you’re wondering about the side effects from the UK in the 2 people with an allergic reaction, see my post from yesterday).

✅ 4. The efficacy numbers looked good too. We think an efficacy “win” in flu vaccinations is 50% or above. The efficacy “win” for the Pfizer vaccine was above 90%. In other words, it works really well.

✅ 5. The final vote included 17 ‘Yes’, 4 ‘No’, and 1 abstain. Of the ‘No’ group, the concerns were mainly due to recommendations going to 16 and 17 year olds – not due to safety concerns. Remember this committee is comprised of independent career scientists, not pharma execs or persons who receive compensation from pharma.

✅ 6. What are the next steps? The FDA will make a final decision on whether or not the EAU is authorized and what groups should or should not receive the vaccine. Then, the CDC Advisory Committee on Immunization Practices will meet this weekend and the CDC vote will happen probably on Sunday. Then. It’s go time. In summary – I felt hopeful reading through the 140 pages of the Pfizer and FDA report earlier this week. I feel really hopeful after yesterday’s meetings. Well done, science! I know you likely still have lots of questions on the details. I expect we will hear more on this in the days to come.

For now, relief is coming. I’ll post the link below if you want to watch the video from yesterday. And, the photo is a reminder of how well the vaccine works. =) https://www.nytimes.com/interactive/2020/health/pfizer-biontech-covid-19-vaccine.html

-Friendly neighbor epidemiologist

FDA announcements and video:

https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement

https://www.fda.gov/news-events/press-announcements/fda-statement-vaccines-and-related-biological-products-advisory-committee-meeting

Photo source: https://www.nytimes.com/interactive/2020/health/pfizer-biontech-covid-19-vaccine.html

✅ VACCINE SERIES (each of these posts have all-the-data at the end of each post):

𝐏𝐎𝐒𝐓 𝟏 – 𝐇𝐞𝐫𝐝 𝐢𝐦𝐦𝐮𝐧𝐢𝐭𝐲 𝐚𝐧𝐝 𝐯𝐚𝐜𝐜𝐢𝐧𝐞𝐬: 𝐕𝐚𝐜𝐜𝐢𝐧𝐞𝐬 𝟏𝟎𝟏 https://tinyurl.com/y27txvro

𝐏𝐎𝐒𝐓 𝟐 – 𝐖𝐡𝐚𝐭’𝐬 𝐭𝐡𝐞 𝐭𝐢𝐦𝐞𝐥𝐢𝐧𝐞 𝐟𝐨𝐫 𝐯𝐚𝐜𝐜𝐢𝐧𝐞 𝐝𝐢𝐬𝐭𝐫𝐢𝐛𝐮𝐭𝐢𝐨𝐧? 𝐇𝐨𝐰 𝐰𝐞𝐥𝐥 𝐝𝐨 𝐭𝐡𝐞 𝐜𝐮𝐫𝐫𝐞𝐧𝐭 𝐯𝐚𝐜𝐜𝐢𝐧𝐞𝐬 𝐰𝐨𝐫𝐤? https://tinyurl.com/y2vte5lz

𝐏𝐎𝐒𝐓 𝟑 – 𝐖𝐡𝐨𝐚, 𝐭𝐡𝐞𝐬𝐞 𝐰𝐞𝐫𝐞 𝐦𝐚𝐝𝐞 𝐪𝐮𝐢𝐜𝐤, 𝐫𝐢𝐠𝐡𝐭? 𝐇𝐨𝐰 𝐜𝐚𝐧 𝐰𝐞 𝐛𝐞 𝐬𝐮𝐫𝐞 𝐭𝐡𝐞𝐲 𝐚𝐫𝐞 𝐬𝐚𝐟𝐞? https://tinyurl.com/y2awosyn

𝐏𝐎𝐒𝐓 𝟒 – “𝐖𝐡𝐞𝐧 𝐰𝐢𝐥𝐥 𝐈 𝐛𝐞 𝐚𝐛𝐥𝐞 𝐭𝐨 𝐠𝐞𝐭 𝐨𝐧𝐞? 𝐀𝐧𝐝, 𝐰𝐡𝐨 𝐝𝐞𝐜𝐢𝐝𝐞𝐬 𝐰𝐡𝐨 𝐠𝐞𝐭𝐬 𝐚 𝐯𝐚𝐜𝐜𝐢𝐧𝐞 𝐟𝐢𝐫𝐬𝐭?” 𝐀𝐧𝐝, 𝐚 𝐧𝐨𝐭𝐞 𝐨𝐟 𝐬𝐨𝐥𝐢𝐝𝐚𝐫𝐢𝐭𝐲 𝐯𝐞𝐫𝐬𝐮𝐬 𝐢𝐧𝐝𝐢𝐯𝐢𝐝𝐮𝐚𝐥𝐢𝐬𝐭𝐢𝐜 𝐭𝐡𝐢𝐧𝐤𝐢𝐧𝐠. https://tinyurl.com/y39cbptv

POST 5 – Myth-busters for vaccines (we talk about fertility questions, 5G/micro-chips, fetal cells, and why the mRNA won’t change your DNA) https://tinyurl.com/y2woz462

POST 6 – Explaining the FDA review and talking about the final Pfizer study results. https://tinyurl.com/y22jd32f

POST 7 – Should we be worried about the side-effects seen in the UK? https://tinyurl.com/yxvb36y4

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