Pharma

Indian scientists divided over restricted use approval for Covaxin — Science Chronicle

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While some scientists have raised concerns about granting restricted use approval to Covaxin even in the absence of efficacy data, four-dozen scientists have in a statement slammed them saying “reprehensible utterances are causing huge credibility crisis for the Indian scientific community”. Apparently, questioning the approval process by the Indian regulator is seen as being anti-Indian […]

Indian scientists divided over restricted use approval for Covaxin — Science Chronicle

India’s drug regulator approved two COVID-19 vaccines on 3 January, a decision Prime Minister Narendra Modi hailed on Twitter as “a decisive turning point to strengthen a spirited fight!” against the pandemic and a testament to the Indian scientific community’s self reliance. But some scientists and patient advocates are sharply critical of the move—in particular, the decision to greenlight Covaxin, a vaccine developed in India by Bharat Biotech, without awaiting the results of a phase III trial to determine efficacy and safety…

Efficacy data from a challenge study in rhesus macaques and immune responses in a human phase II trial suggested the vaccine was likely to be very effective.

The approval of a vaccine without phase III data is “unconscionable,” says Vineeta Bal, an immunologist at India’s National Institute of Immunology.

Scientists criticize ‘rushed’ approval of Indian COVID-19 vaccine without efficacy data — https://www.sciencemag.org/news/2021/01/scientists-criticize-rushed-approval-indian-covid-19-vaccine-without-efficacy-data

It worked in monkeys so let’s just skip the Phase III trial.

See my earlier post I would not take Covaxin without efficacy data: Gagandeep Kang — Science Chronicle

Utter Chaos? No Just Your Normal Vaccine Rollout in a Pandemic

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With the vaccine rollout left mostly up to states and counties, they have had to rapidly devise their own methods for distributing shots to their residents. Every state has its own priority system and way of scheduling appointments, which sometimes change week to week. The complicated logistics paired with inconsistent communication to the public has resulted in mass confusion. The result: People are spending hours seeking information and searching for coveted appointment slots.

‘Just utter chaos’: A Twitter thread offers a window into the frustrating search for Covid-19 shots — https://www.statnews.com/2021/01/28/just-utter-chaos-twitter-thread-offers-window-into-frustrating-search-for-covid19-shots/?utm_campaign=rss

Here in Oklahoma we’re in Phase 2 of the rollout and the process to get a Covid vaccination appointment in this state can best be described as incredibly difficult. We don’t have a huge number of residents here in flyover country and to be honest, that’s a good thing. I can’t imagine how difficult this process is in the more heavily populated areas of the country.

BTW I’m getting jabbed tomorrow.

Vinay Prasad MD MPH is a Very Smart Person

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For most people, once you get 14 days out of your second dose of vaccine, I believe you can ease up on masking or another restriction, such as visiting a loved one for lunch or having more than one person visit a nursing home at the same time, or a small gathering of vaccinated people for dinner without masks.

Op-Ed: Throw Away Your Mask After COVID Vaccination? — Op-Ed: Throw Away Your Mask After COVID Vaccination?

Dr. Prasad’s Op-Ed article is worth reading. Or if you’re a watch, listen and learn type check out the video.

BUT if you have an hour to spare the following podcast is downright entertaining.

Update on Severe Allergic or Anaphylactic Reactions to Initial Dose of Pfizer COVID-19 Vaccine — The Skeptical Cardiologist

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A report from two CDC scientists was published online today in JAMA Insights which describes in detail 21 cases of anaphylaxis that were reported to the US Vaccine Adverse Events Reporting System between December 14-23, 2020. This corresponds to a very low rate of 11.1 cases of anaphylaxis per million doses administered. 17 of these…

I continue to urge all my patients to get vaccinated as soon as possible. Benefits far outweigh the risk.

Update on Severe Allergic or Anaphylactic Reactions to Initial Dose of Pfizer COVID-19 Vaccine — The Skeptical Cardiologist

ACE2-interacting domain of SARS-CoV-2

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In a study published in the Journal of Neuroimmune Pharmacology, mouse models with COVID-19 showed positive results when a small peptide was introduced nasally. The peptide proved effective in reducing fever, protecting the lungs, improving heart function and reversing cytokine storm — a condition in which an infection triggers the immune system to flood the bloodstream with inflammatory proteins. The researchers also report success in preventing the disease from progression.

Rush University Medical Center. “Potential COVID-19 drug is successful in lab study: Peptide reduced COVID-19 symptoms in mice.” ScienceDaily. http://www.sciencedaily.com/releases/2021/01/210119194322.htm (accessed January 20, 2021).

Journal Reference – Ramesh K. Paidi, Malabendu Jana, Rama K. Mishra, Debashis Dutta, Sumita Raha, Kalipada Pahan. ACE-2-interacting Domain of SARS-CoV-2 (AIDS) Peptide Suppresses Inflammation to Reduce Fever and Protect Lungs and Heart in Mice: Implications for COVID-19 Therapy. Journal of Neuroimmune Pharmacology, 2021; DOI: 10.1007/s11481-020-09979-8

Our neighbor Dr. Arlan Richardson at https://nathanshockcenters.org/oklahoma part of the University of Oklahoma Health Sciences Center knows a lot about mice. I’ll have to ask him what he thinks of the potential of this peptide for human use.

J&J Covid-19 Vaccine Appears to be Safe

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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

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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

CDC reports more allergic reactions to Covid-19 vaccines, but cases remain few

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The Centers for Disease Control and Prevention said at present it looks like anaphylaxis cases are occurring at a rate of about 5.5 per 1 million vaccine doses given, though the agency cautioned that figure may change as the vaccination effort continues.

The allergic reactions do not change CDC’s recommendations on who can be vaccinated against Covid-19, with senior officials stressing that the risk of severe illness and death from the disease still outweighs the risk of developing anaphylaxis after vaccination.

CDC reports more allergic reactions to Covid-19 vaccines, but cases remain few — https://www.statnews.com/2021/01/06/cdc-reports-more-allergic-reactions-to-covid-19-vaccines-but-cases-remain-few/?utm_campaign=rss

Get jabbed.

The Pandemic Will Not End Soon – a Case Study in Finger Pointing and Blame Games

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Some vaccine experts, though, said they are not surprised by the speed of vaccine distribution so far. “It had to go this way,” Paul Offit, a professor of pediatrics at Children’s Hospital of Philadelphia, told STAT. “We had to trip and fall and stumble and figure this out.”

Claire Hannan, executive director of the Association of Immunization Managers, said some of the gap between doses administered and delivered is likely due to a program run by CVS and Walgreens to vaccinate those in nursing homes. States participating in the program have to set aside 50% of their doses, which Hannan said could account for a share of the difference between doses shipped and doses administered nationally.

“I don’t think it’s bad,” she said of the pace of distribution so far. “I think it was always going to be like this. And I think that this is actually the easy part.”

Frustration over vaccine rollout builds, as new variant reported in U.S. for first time — https://www.statnews.com/2020/12/29/public-health-experts-grow-frustrated-with-pace-of-covid-19-vaccine-rollout/?utm_campaign=rss

We are definitely so screwed.

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

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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.