J&J Covid-19 Vaccine Appears to be Safe

A total of 800 adults aged 18 to 55 or aged 65 and up were randomized to various combinations of low-dose or high-dose vaccines or placebo, given 56 days apart.

Adverse events were common, with fatigue, headache, myalgia, and injection-site pain reported most often. At day 29 after the first dose, the seroconversion rate was 99% or more in the younger cohort across dosing groups. Older vaccine recipients had a 96% seroconversion rate. At 57 days after the first dose, antibody titers had increased further.

COVID-19: Single Dose of J&J Vaccine / Plasma / New Testing Requirement — https://www.jwatch.org/fw117413/2021/01/13/covid-19-single-dose-j-j-vaccine-plasma-new-testing

The J&J vaccine is in a multi-center, placebo-controlled, phase 1–2a trial. Here’s the link to the NEJM article https://www.nejm.org/doi/full/10.1056/NEJMoa2034201

From Stat Phase 3 results are coming soon.

There are two Phase 3 studies running. A 40,000-volunteer study of the one-dose vaccine, conducted in the U.S., is set to read out in the next two weeks. A second, equally big study is being conducted using the same vaccine given as two doses, each administered 57 days apart, in case the vaccine does not prove effective in a one-dose regimen or there are other advantages, such as the durability of the vaccine, to giving a second dose.

https://www.statnews.com/2021/01/13/data-fuel-debate-over-whether-jjs-one-dose-covid-vaccine-will-measure-up/ — Data fuel debate over whether J&J’s one-dose Covid vaccine will measure up

And from the Medscape article.

Unlike the Pfizer/BioNTech and Moderna messenger RNA vaccines, the Johnson & Johnson product is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike (S) protein.

The Next Likely COVID-19 Vaccine Has Its Advantages — https://www.medscape.com/viewarticle/944151?src=rss

I would not take Covaxin without efficacy data: Gagandeep Kang — Science Chronicle

Serum’s Covishield and Bharat Biotech’s Covaxin are examples of atmanirbhar (self-reliance) but have an element of non-Indian science — and at least to me that is fine, says Dr. Gagandeep Kang. Though Covaxin uses inactivated virus, neutralising antibodies against the spike protein are critical for reinfection. So if Covaxin is based on an old viral […]

I would not take Covaxin without efficacy data: Gagandeep Kang — Science Chronicle

The Pandemic Will Not End Soon — Over half of U.S. adults ‘unlikely’ to get COVID vaccine under emergency use authorization

The coronavirus vaccine is finally a real thing and millions of people have already received it. While the rollout has the world cheering, researchers from Virginia Commonwealth University finds many Americans aren’t exactly chomping at the bit to be the first in line for the vaccine under an emergency use authorization. Their survey reveals 53.1 percent are definitely, likely, or somewhat unwilling to get the shot under emergency use conditions.

Over half of U.S. adults ‘unlikely’ to get COVID vaccine under emergency use authorization — https://www.studyfinds.org/half-adults-unlikely-to-get-covid-vaccine/

Journal Reference

Willingness to get the COVID-19 vaccine with and without emergency use authorization

Published:November 19, 2020 DOI:https://doi.org/10.1016/j.ajic.2020.11.018

We are so screwed.

Phase 3 trial of Novavax investigational COVID-19 vaccine opens

In animal tests, NVX-CoV2373 vaccination produced antibodies that blocked the coronavirus spike protein from binding to the cell surface receptors targeted by the virus, preventing viral infection. In results(link is external) of a Phase 1 clinical trial published in the New England Journal of Medicine, NVX-CoV2373 was generally well-tolerated and elicited higher levels of antibodies than those seen in blood samples drawn from people who had recovered from clinically significant COVID-19. NVX-CoV2373 also is being evaluated in a Phase 2b trial in South Africa, now fully enrolled with 4,422 volunteers, and data from a Phase 1/2 continuation trial in the United States and Australia is expected as early as first quarter 2021. Novavax also recently completed enrollment of more than 15,000 volunteers in a Phase 3 trial of the candidate vaccine in the United Kingdom, which is also testing two injections of 5 mcg of protein and 50 mcg of Matrix-M adjuvant administered 21 days apart.

Phase 3 trial of Novavax investigational COVID-19 vaccine opens — https://www.nih.gov/news-events/news-releases/phase-3-trial-novavax-investigational-covid-19-vaccine-opens

Vaccine Distribution SNAFU – Blame it on the Algorithm or “It Looked Good on Paper”

Residents are the lowest-ranking doctors in a hospital. Stanford Medicine has about 1,300 across all disciplines. Only seven made the priority vaccination list, despite the fact that this week, residents were asked to volunteer for ICU coverage in anticipation of a surge in COVID-19 cases.

“Residents are patient-facing, we’re the ones who have been asked to intubate, yet some attendings who have been face-timing us from home are being vaccinated before us,” said Dr. Sarah Johnson, a third-year OB-GYN resident who has delivered babies from COVID-positive patients during the pandemic. “This is the final straw to say, ‘We don’t actually care about you.’”

Only Seven of Stanford’s First 5,000 Vaccines Were Designated for Medical Residents – https://www.propublica.org/article/only-seven-of-stanfords-first-5-000-vaccines-were-designated-for-medical-residents

Stanford Medicine demonstrates how much they care about their residents.

Here’s an interesting breakdown of lessons learned.

In its earliest attempts at explaining the problem, Stanford’s administrators laid blame with the algorithm. Despite best intentions, they explained, the algorithm had made a mistake that the humans had to answer for.

This is a bit like blaming the hammer for missing the nail.

3 lessons from Stanford’s Covid-19 vaccine algorithm debacle — https://www.statnews.com/2020/12/21/stanford-covid19-vaccine-algorithm/

Operation Warp Speed also experienced some hiccups.

“It looked very good on paper,” Perna said. “Paper plans are very good. Execution is where we learn, and we adapted accordingly.”

‘I failed’: Operation Warp Speed leader takes responsibility for Covid-19 vaccine distribution confusion — https://www.statnews.com/2020/12/19/operation-warp-speed-leader-takes-sole-responsibility-for-covid-19-vaccine-distribution-confusion/?utm_campaign=rss

Remember “Everybody has a plan until they get punched in the mouth”

ATTENTION Non-Anti-Vaxxers – A side-by-side comparison of the Pfizer/BioNTech and Moderna vaccines

The most common side effects are injection site pain, fatigue, headache, muscle pain, and joint pain. Some people in the clinical trials have reported fever. Side effects are more common after the second dose; younger adults, who have more robust immune systems, reported more side effects than older adults.

To be clear: These side effects are a sign of an immune system kicking into gear. They do not signal that the vaccine is unsafe. To date there are no serious, long-term side effects associated with receipt of these vaccines, which will be closely monitored as their use expands.

A side-by-side comparison of the Pfizer/BioNTech and Moderna vaccines — https://www.statnews.com/2020/12/19/a-side-by-side-comparison-of-the-pfizer-biontech-and-moderna-vaccines/?utm_campaign=rss

Post and link for informational purposes only. I will not waste my time trying to convince people that a virus doesn’t care about your gender, age, sexuality, religion, skin color, politics, net worth, personal freedoms, dietary preferences, or anything else.

A virus merely wants a host organism to infect.

Severe Allergic or Anaphylactic Food Reactions and the COVID-19 Vaccine — The Skeptical Cardiologist

As one who has suffered the severest of allergic reactions, anaphylaxis, on several occasions after nut ingestion, I was quite worried when I heard that the British FDA-equivalent had announced that “any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine.” The UK began vaccinating…

Severe Allergic or Anaphylactic Food Reactions and the COVID-19 Vaccine — The Skeptical Cardiologist

Thank you Dr. Pearson.

Meanwhile in Oklahoma – 12.04.20

Meanwhile at the CDC…

We don’t have enough vaccine yet for all health care workers. We will eventually, but we don’t yet.

Helen Keipp Talbot — who is known by her middle name — raised serious concerns during the meeting of the Advisory Committee on Immunization Practices about using the vaccines in the frail elderly, noting there are no data yet to suggest the vaccines work in this population.

CDC advisory panel’s lone dissenter on why long-term care residents shouldn’t receive Covid-19 vaccine first — https://www.statnews.com/2020/12/03/cdc-advisory-panels-lone-dissenter-on-why-long-term-care-residents-shouldnt-receive-covid-19-vaccine-first/

Talbot is an associate professor of infectious diseases at Vanderbilt University. Despite the fact no one seems to be listening to her opinions, she makes some excellent observations.

Meanwhile back in Oklahoma

I’m confused as to why people are confused.

Oxford vaccine shows 90% efficacy in Phase-3 trial — Science Chronicle

Interim data analysis of Phase-3 trial of Oxford/AstraZeneca COVID-19 candidate vaccine (ChAdOx1 nCoV-2019) showed different efficacies in preventing COVID-19 disease. In the case of the regimen where a halved dose was used as a prime (first dose) followed by a standard dose of booster, the efficacy was 90%. However, when full doses (standard doses) were […]

Oxford vaccine shows 90% efficacy in Phase-3 trial — Science Chronicle