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Monica Gandhi MD, MPH

29 Jan, 10 tweets, 3 min read

Wonderful news about the Johnson&Johnson vaccine! Let me explain (and also let me tell you I was just on an interview with Dr. Paul Offit, who believes - like me- that control is nigh). J&J vaccine press release here:
jnj.com/johnson-johnso…

J&J vaccine is a modified cold virus adenovirus (this vector doesn't replicate or cause illness in humans) with double stranded DNA coding the spike protein of SARS-CoV-2 inside. Nice explanation of NYT of how it works. The adenovirus "vector" (carrier)
nytimes.com/interactive/20…

gets the DNA inside host cell nucleus where it is "transcribed" into mRNA and then you make the spike protein of the virus % raise immune response against it. Initial phase I/II data from NEJM showed high immunogenicity of 1st dose that went up over time.
nejm.org/doi/10.1056/NE…

Phase 3 trial (ENSEMBLE) enrolled 43,783 participants U.S./Latin America/S. Africa- outcomes: total 468 symptomatic cases of COVID-19 (some in placebo; some in vaccine) and let's breakdown 3 endpoints. 1st outcome of hospitalization/death- vaccine was 100% effective in preventing

100% effective against scariest thing- hospitalization/death. 2nd outcome. 2nd outcome of severe disease - vaccine was 85% effective against all regions. That is exactly what we don't want - severe disease. Also, immunogenicity phase I/II data showed increase in antibodies over

time with just 1 dose and trial looked at 14 days; 28 days after 1 dose so efficacy data likely to go up over time as your immune response escalates. Moderate disease outcome varied by region: Protection 72% in U.S., 66% in Latin America & 57% in South Africa at 28 days

Bottom line? 100% effective against the worst thing (hospitalization/death); 85% effective against severe disease; varying efficacy across regions against moderate disease. highest (72%) U.S. 1 dose; can be in fridge (regular fridge) for LONG time; 2-dose trial going. GREAT NEWS!

Want to clarify outcomes in the J&J vaccine trial: severe COVID-19 (lab confirmed) and >=1 of signs consistent with severe systemic illness, admission to ICU, shock, organ failure or death, among others. So kind of vague but hospitalization/death is a SUBSET of that so 100%

prevented that subset. Moderate- evidence of pneumonia, deep vein thrombosis (clot), shortness of breath (oxygen saturation>93%), respiratory rate ≥20; or >=2 systemic symptoms suggestive of COVID-19. So, as you can see severe would include O2 sat drop<93% (and could be once)

Also, please remember outcomes in phase 3 trial measured 14-28 days after 1st dose. Immunogenicity data (phase I/II trial) in NEJM shows increasing antibodies/immunity after 14-28d so 1 dose likely will work better after time (and 2-dose trial continuing):
nejm.org/doi/full/10.10…

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More from @MonicaGandhi9

Monica Gandhi MD, MPH

@MonicaGandhi9

30 Jan

And then wanted to explain why you should be beaming ear-to-ear about vaccine data. Why would an infection trigger all of this testing, masking, life halting? Because severe illness/hospitalizations/deaths occur. All vaccines to date prevented hospitalizations/deaths completely.

Severe illness prevented completely in Moderna/Pfizer/AztraZeneca trials; 85% across regions (even in South Africa - South Africa variant there) in J&J trials and immune response from 1 dose may keep on giving (remember, outcomes evaluated 14-28 days out due to expediency)

But as I wrote yesterday, immunogenicity from 1 dose of J&J likely extends beyond 14-28 days - keeps on going so likely more protection over time - see graphs in this paper. Two-dose trial still going. Finally, S. Africa variant is one with less protection
nejm.org/doi/full/10.10…

Read 6 tweets

Monica Gandhi MD, MPH

@MonicaGandhi9

30 Jan

Know very tempting to feel nervous about variants. Please don't: 1) RNA viruses do mutate and those more fit spread more readily; 2) SARS-CoV-2 has much lower mutational rate than influenza A - we are seeing more because transmission high, want to tamp down (& now sequencing);

3) Vaccines do not generate just antibody response, but T cell responses (measured in all 3 trials published) and B cell responses). So if neutralizing antibodies slightly lower in vaccinated blood to a variant (and not yet lower in clinically significant way), remember T cells.

4) So far, all of these vaccines involve genetic material that code for the spike protein/RBD- mRNA in mRNA vaccines and double-stranded DNA in adenovector vaccines. Sequences of genetic material can be "tweaked" to respond to variants as needed; 5) As tweeted before, efficacy

Read 4 tweets

Monica Gandhi MD, MPH

@MonicaGandhi9

29 Jan

At risk of upsetting people, I need to address why I think teachers should feel very safe going to in-person learning after vaccination. Let's start with why COVID-19 was a bad virus and how vaccines defang this virus and then let me address transmission one more time. As said

many times, Moderna and Pfizer phase 3 trials were meant to assess the risk of COVID-19 infection with symptoms as they were designed for expediency. So, 1st outcome was 1) do you have any symptoms suggestive of COVID-19, we will swab and see if you have COVID-19? 2nd outcome was

did you get severe disease from COVID-19?. In terms of 1st outcome to look at, 95% of COVID-19 cases with symptoms occurred in people who got placebo, not vaccine. Vaccine massively reduced chance of getting COVID-19 with symptoms. In 2nd outcome, all of the severe COVID-19

Read 16 tweets

Monica Gandhi MD, MPH

@MonicaGandhi9

28 Jan

Please don't panic too much about these new variants of SARS-CoV-2. Taking a step back, RNA viruses (viruses that use RNA as their genetic material rather than DNA; SARS-CoV is an RNA virus) have higher mutation rates than DNA viruses (like chickenpox).
jvi.asm.org/content/92/14/…

Their RNA-dependent RNA polymerases (which replicate the genetic material) do not "proofread" assiduously like DNA polymerases so random mutations occur and those that confer a "fitness advantage" (helps them replicate more efficiently) take off. See this:
biorxiv.org/content/10.110…

Mutations that lead to an enhancement of the ability of the spike protein to bind to the host's receptor (the ACE receptor) may be advantageous to the virus. Of 295,507 full-length genome sequences of SARS-CoV-2 worldwide, authors looked at mutations affecting that interface and

Read 5 tweets

Monica Gandhi MD, MPH

@MonicaGandhi9

18 Jan

What about COVID-19 vaccines in pregnancy? A question asked often. I think safe but wanted to discuss. I have worked in women & HIV for long time & drugs/vaccines/etc. not studied in pregnant & breastfeeding women despite FDA saying they should
fda.gov/media/90160/do…

Similarly, pregnant & breastfeeding women included in Pfizer/Moderna trials (at start) so can't specifically comment on this group. However, these are not "live" vaccines (weakened live virus) which we don't use in pregnant women. mRNA in these vaccines is inert and

degrades very quickly after being "translated" (made) into the spike protein and doesn't stick around. Therefore, this genetic material does NOT stay in your body and should not harm fetus in any way. The spike protein and the immune response you make against it should not harm

Read 4 tweets

Monica Gandhi MD, MPH

@MonicaGandhi9

17 Jan

Oh dear. I didn't read the post that had incited such confusion on here from a fellow scientist because I think polemics against fellow scientists is unmerited but I am beginning to get a hint that she slandered me (which happened before on a hypothesis our group had that reduced

viral #inoculum reduces severity of disease). I will take a small break from Twitter now as I have so much work. But please remember this. Scientists usually write academically and their "fame" is very circumscribed within academic circles & they usually don't get listened to

by anyone else! So, it is tempting and exciting to become "famous" in a pandemic and be listened to by so many. And any scientist right now is as lonely and miserable as anyone else during COVID-19 because we are all human and connection is a part of human existence. So, that

Read 6 tweets

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