This week might feel like a repeat of last week with Pfizer’s vaccine. Moderna released the final results from their vaccine candidate. On Thursday, the FDA will review Moderna’s vaccine for the emergency use authorization and will be live-streamed. Then a vote. Then the CDC review. Then the final vote. And, then hopefully the roll-out.
𝐇𝐞𝐫𝐞’𝐬 𝐚 𝐫𝐞𝐯𝐢𝐞𝐰 𝐨𝐟 𝐭𝐡𝐞 𝐌𝐨𝐝𝐞𝐫𝐧𝐚 𝐝𝐚𝐭𝐚:
1. This uses the same biotechnology as Pfizer – mRNA.
2. Adults 18 years and older were included in the final group of 30,350 people. The follow-up period was two months. (Remember most adverse side-effects, 90%, show up within a few weeks after a dose – so, this follow-up period is really good and similar to Pfizer’s follow-up).
3. The efficacy data (so, how well this vaccine worked at protecting people from COVID-19) looks similar to Pfizer’s. -Overall, efficacy was 94% -80% effective after dose 1 (that’s really good) -Results were similar across sub-groups, including controlled chronic conditions like obesity, moderate/severe asthma, diabetes, liver disease, HIV -In the follow-up period, all severe cases were in the placebo group; none in the vaccine group. This is really good too!
4. Side effects – very similar to the Pfizer vaccine and other vaccines. Sore arm/injection site pain (91.6%), fatigue (69%), headache (63%), were the top symptoms. -Fever was reported after Dose 2 much more than Dose 1 – with a total of 15%. -Severe side effects were 1% in both groups – so, uncommon. The reported side effects looked similar to what is already seen in the general population. These looked similar to what we saw in Pfizer’s trial.
Have you heard of the DART studies? These are studies conducted in rats specifically geared towards looking at vaccine safety in pregnancy, female reproduction, development of the baby in utero, and postnatal development. Moderna included those results in the final report. No adverse events were observed on the pregnant/reproduction/fetal development listed above. I wrote about this a few days ago since I know many of you are seeing the myth-memes that mRNA affects women’s reproduction or can cause fertility issues. Look in the Myth Buster post (#5) below for more on that. This data dispels that myth more and more.
6. Conclusion The Moderna vaccine looks just as good as the Pfizer vaccine in terms of how well they (mRNA vaccines) work and how safe they are. This should not surprise anyone since the technology is the same. The other vaccines in the pipeline look a bit different, and we will talk about that when they are up for EUA approval.
Exciting vaccine developments all around! And, for all the women scientists reading this or my female students who want to be scientists or women in academics – I’m including the picture of Dr. Kizzmekia Corbett, a lead scientist at the National Institute of Health (Picture 2). who is heavily involved in developing the Moderna vaccine. Let’s hear it for the women – who should be called Dr. 👏 👏
-Friendly neighbor epidemiologist
Final Moderna report: https://www.fda.gov/media/144434/download
1. Herd immunity and vaccines: Vaccines 101 – https://tinyurl.com/y27txvro
2. Vaccine distribution info and how well do the current vaccines work? – https://tinyurl.com/y2vte5lz
3. Whoa, these were made quick, right? How can we make sure they are safe? https://tinyurl.com/y2awosyn
4. When will I get the vaccine? Who decides who gets a vaccine first? And, a note on solidarity versus individualistic thinking. – https://tinyurl.com/y39cbptv
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
6. Explaining the FDA review and talking about the final Pfizer study results. https://tinyurl.com/y22jd32f
7. Should we be worried about the side-effects seen in the UK? – https://tinyurl.com/yxvb36y4
8. Let’s talk about the FDA panel meeting- https://tinyurl.com/y6hzmcgt
9. Reflections on the EUA Pfizer FDA meeting – https://tinyurl.com/y4k2o6kc
10. Pfizer EUA approval, vaccine ingredients, and recommendations – https://tinyurl.com/yyvzeynx
11. Pfizer vaccine Q&A – https://tinyurl.com/y7e3jar8