Moderna Data
Okay, here we go again. Moderna’s data was made public this morning in preparation for Thursday’s external committee review board for FDA emergency approval. This is, again, the first time we have seen the data regarding efficacy and safety. I was a bit more excited to see this (compared to Pfizer) because this is Moderna’s first vaccine.
Here are your cliff notes...
In short, things are looking really good. And, not surprisingly, data are very similar to Pfizer’s data. This is because the Moderna vaccine is using the same biotechnology (mRNA) as Pfizer.
Number of Participants
-A total of 30,350 people had 2 months of follow-up data and were included in this report (15,184 in the vaccine group and 15,165 in the placebo group)
-Only adults aged 18 years and older were included (this is different than Pfizer)
Efficacy
- 94.1% overall. For those 65+ years, 86.4% efficacy
- After first dose, the vaccine is 80% effective- All severe cases of COVID19 (which was 30 people) were all in the placebo group
- Effectiveness did not differ by chronic conditions, including obesity
-The vaccine prevents asymptomatic infections after the first dose. This is a very important piece of new information
Safety
-The most common solicited adverse reactions (i.e side effects we were expecting) were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%); 0.2% to 9.7% were reported as severe, with severe solicited adverse reactions being more frequent after dose 2 than after dose 1
-Fever was reported after any dose by 14.8% of vaccine participant and 0.6% of placebo recipients. Fever was much more common after Dose 2
-There was a higher rate of hypersensitivity events among vaccine recipients than those who received placebo. There were no anaphylactic or severe hypersensitivity reactions related to the vaccine
-Serious adverse events, while uncommon (1% in both groups), represented medical events that occur in the general population at similar frequency as observed in the study. Of the 7 severe adverse events in the vaccine group, FDA considered 3 as related to the vaccine: nausea and vomiting (n=1) and facial swelling (n=2).
-Swollen lymph nodes (lymphadenopathy) was reported in 1.1% of vaccine recipients (173 people) compared to 0.63% of placebo recipients (95 people)
-There was a small imbalance in the number of participants reporting Bell’s palsy (3 people in the vaccine group compared to 1 person in the placebo group)
-Pregnant people were not eligible for the study. However, 13 people did get pregnant during the trial (6 vaccine, 7 placebo). One spontaneous abortion and one elected abortion occurred both in the placebo group.
-13 deaths were reported (6 vaccine, 7 placebo). Mostly heart issues again (which is the number one killer in the US, so this is no surprise)
-There are no specific safety concerns identified by age, race, ethnicity, medical comorbidities, or prior COVID19 infection
Pregnancy Sub-Study
-Moderna included results for their DART pregnancy study.
-Scientists gave rats 100 μg of the mRNA vaccine
-Rats did not have any adverse effects on female reproduction, fetal/embryonal development, or postnatal developmental. We are not surprised, but still good to know.
Conclusion: The Moderna vaccine should be approved this week for emergency use. With more and more vaccines coming out, you’ll start to have vaccine choices (maybe...depending on your emoloyer). There is essentially no difference between the Moderna and Pfizer vaccine. Now, when AstraZeneca and Johnson&Johnson comes out in a month or two, then there will be some decisions to be made. At this point, take what you can get.
Here is the Moderna document if you want to see the data yourself: https://www.fda.gov/media/144434/download
Moderna/FDA meeting is on Thursday! Live and open to everyone again.
Love, YLE