Wellness

[Mindy D]

"Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

Vaccine Candidate 72% Effective in the US and 66% Effective Overall at Preventing Moderate to Severe COVID-19, 28 Days after Vaccination

85% Effective Overall in Preventing Severe Disease and Demonstrated Complete Protection Against COVID-19 related Hospitalization and Death as of Day 28

Protection Against Severe Disease Across Geographies, Ages, and Multiple Virus Variants, including the SARS-CoV-2 Variant from the B.1.351 Lineage [1] Observed in South Africa

Single-shot compatible with standard vaccine distribution channels provides important tool in pandemic setting

[1] The B.1.351 lineage also known as 501Y.V2 variant and 20H/501Y.V2 (formerly 20C/501Y.V2) is a

variant of SARS-CoV-2, the virus that causes COVID-19"

Quoted directly from Johnson and Johnson

[Effie54]

I'll pass

[SilleeMee]

The single dose would be most beneficial for people located in the remote regions of the world where getting even one dose can be almost impossible to administer to begin with, let alone a second dose.

[Mindy D]

---

@SilleeMee wrote:

The single dose would be most beneficial for people located in the remote regions of the world where getting even one dose can be almost impossible to administer to begin with, let alone a second dose.

---

@SilleeMee  Very true. Plus it has been tested against the South African variant. I'll have to see the data on the variants once J&J publishes it in their request for approval from the FDA. 
Moreover, it does not require refrigeration at below zero temperatures. Every person's immunity affects every other person's chances of becoming ill. Getting help for those in remote regions will ultimately affect the continuing spread worldwide. 

@SilleeMee From J & J

"In addition, the Janssen vaccine candidate is compatible with standard vaccine distribution channels. If authorized, Janssen’s single-dose vaccine candidate is estimated to remain stable for two years at -20°C (-4°F), at least three months of which can be at temperatures of 2-8°C (36°F–46°F). The Company will ship the vaccine using the same cold chain technologies it uses today to transport other innovative medicines."

[itsmagic]

This past December when I had a doctor’s appointment, the nurse and I were talking about the two shot vaccines (Moderna and Pfizer) and she said to me - Do you know how hard it is for me to get people back for a second vaccine? (For example the shingles vaccine).   So I could see some people preferring the one shot J&J vaccine. (Personally I’m getting the two dose vaccine). 

[Mindy D]

"In the study, the definition of severe COVID-19 disease included laboratory-confirmed SARS-CoV-2 and one or more of the following: signs consistent with severe systemic illness, admission to an intensive care unit, respiratory failure, shock, organ failure or death, among other factors. Moderate COVID-19 disease was defined as laboratory-confirmed SARS-CoV-2 and one or more of the following: evidence of pneumonia, deep vein thrombosis, shortness of breath or abnormal blood oxygen saturation above 93%, abnormal respiratory rate (≥20); or two or more systemic symptoms suggestive of COVID-19.

Protection was generally consistent across race, age groups, including adults over 60 years of age (N= 13,610), and across all variants and regions studied, including South Africa where nearly all cases of COVID-19 (95%) were due to infection with a SARS-CoV-2 variant from the B.1.351 lineage [ii] ."

Johnson & Johnson complete press release and discussion

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwjG9Pq2tsHuAhWFZM0KHadRAscQ...

[Mindy D]

From J & J

"Phase 3 ENSEMBLE Study Demographics
The trial, conducted in eight countries across three continents, includes a diverse and broad population including 34% (N= 14,672) of participants over age 60.

The study enrolled 44% (N=19,302) of participants in the United States, 41% (N=17,905) in Central and South America (Argentina, Brazil, Chile, Colombia, Mexico, Peru) and 15% (N=6,576) in South Africa.

Forty-five percent of participants are female, 55% male.

Among participants globally, 59% are White/Caucasian; 45% are Hispanic and/or Latinx; 19% are Black/African American; 9% are Native American and 3% are Asian. In the United States, 74% are White/Caucasian; (15% are Hispanic) and/or Latinx; 13% are Black/African American; 6% are Asian and 1% are Native American.

Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19 (overall 41%, obesity (28.5%), type 2 diabetes (7.3%), hypertension (10.3%), HIV (2.8%); also other immunocompromised participants were in the study."

One comment I have is that they should have included more Asian participants. Another comment I have is that I would like to know the BMI ranges for obese participants. I'd like to see data on efficacy in those with higher BMIs. Until J & J release its data, I won't know if the vaccine has been tested in those persons that are heavier.

[noodleann]

Effective against S. African variant?

The NYT is reporting otherwise.

"The vaccine’s efficacy rate dropped from 72 percent in the United States to just 57 percent in South Africa, where a highly contagious variant is driving most cases."

I wouldn't call 57% "effective." Not when we've got standards set now for over 90% effectiveness. Even the 72% isn't enough. It means that more than one out of four people won't be adequately protected. I don't like those odds, and I was looking forward to this vaccine.

But it's better than nothing, and both the single dose and the less demanding storage requirements make this a good candidate for those countries that haven't had any vaccine at all.

[SchippyLuv]

Because I'm sensitive to Polyethylene Glycol, I don't have any other choice but Johnson & Johnson right now.

Color me disappointed...

[shoesnbags]

---

@itsmagic wrote:

This past December when I had a doctor’s appointment, the nurse and I were talking about the two shot vaccines (Moderna and Pfizer) and she said to me - Do you know how hard it is for me to get people back for a second vaccine? (For example the shingles vaccine).   So I could see some people preferring the one shot J&J vaccine. (Personally I’m getting the two dose vaccine). 

---

@itsmagic 

Actually, I don't think it's going to be a matter of choice.  The PTB will decide where the J&J single dose vaccine will be sent, and as has been mentioned, it will be most needed in less developed areas of the world.  Americans won't be just deciding which vaccine they want; they'll be taking whatever is available in their area.