COVID-19 vaccine NOW in phase 1 trials

Submitted by Alligator Ed on Mon, 03/16/2020 - 6:42pm

Still early but...the FDA and CDC realizing that their reputations are at stake are flying through an accelerated vaccine production program.

Phase 1 are the initial safety trials for any drug, including biologicals such as vaccines and antiviral drugs. Too soon to tell. Based on political implications, my impression is that Trump will relentlessly push the FDA to authorize approval, possibly ahead of the 18 month time frame declared by Dr. Fauci. I gave great respect for DR. Fauci. He was among the first to realize that AIDS was viral and what the offending virus was. He wasn't the first but his was amongst the strongest voices pushing this, an idea at first rejected by stodgy medical types.

First patient dosed in Phase 1 study of mRNA-based vaccine against COVID-19

The US National Institutes of Health (NIH) said Monday that the first participant has been dosed in a Phase I study of the experimental COVID-19 vaccine mRNA-1273. The study is being conducted at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, with funding from the National Institute of Allergy and Infectious Diseases (NIAID).

The trial aims to enrol 45 healthy adults ages 18 to 55 years over approximately six weeks, with each subject receiving two doses of the vaccine via intramuscular injection in the upper arm approximately 28 days apart. Each participant will be assigned to receive either a 25 mcg, 100 mcg or 250 mcg dose at both vaccinations, with 15 people in each dose cohort.

NIH news release

Scientists at NIAID’s Vaccine Research Center (VRC) and Moderna were able to quickly develop mRNA-1273 because of prior studies of related coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Coronaviruses are spherical and have spikes protruding from their surface, giving the particles a crown-like appearance. The spike binds to human cells, allowing the virus to gain entry. VRC and Moderna scientists already were working on an investigational MERS vaccine targeting the spike, which provided a head start for developing a vaccine candidate to protect against COVID-19. Once the genetic information of SARS-CoV-2 became available, the scientists quickly selected a sequence to express the stabilized spike protein of the virus in the existing mRNA platform.

The Phase 1 trial is led by Lisa A. Jackson, M.D., senior investigator at KPWHRI. Study participants will receive two doses of the vaccine via intramuscular injection in the upper arm approximately 28 days apart. Each participant will be assigned to receive a 25 microgram (mcg), 100 mcg or 250 mcg dose at both vaccinations, with 15 people in each dose cohort. The first four participants will receive one injection with the low dose, and the next four participants will receive the 100 mcg dose. Investigators will review safety data before vaccinating the remaining participants in the 25 and 100 mcg dose groups and before participants receive their second vaccinations. Another safety review will be done before participants are enrolled in the 250 mcg cohort.

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Submitted by Alligator Ed on Mon, 03/16/2020 - 6:44pm

An opportunity for Washington state residents

Adults in the Seattle area who are interested in joining this study should visit https://corona.kpwashingtonresearch.org. For more information about the study, visit ClinicalTrials.gov and search identifier NCT04283461.

Submitted by Pricknick on Mon, 03/16/2020 - 7:30pm

Therein is the problem.

Trump will relentlessly push the FDA to authorize approval, possibly ahead of the 18 month time frame declared by Dr. Fauci.

No medication and I mean

no

medication, should be authorized, approved or tested on the pressure from a single individual.
This country is beyond stupid to follow through on anything medically necessary unless those who are at the front of the research say it should happen. Even then it should be a cautious approach.
When you rush to save lives, you usually kill more.

—

Regardless of the path in life I chose, I realize it's always forward, never straight.

Submitted by CB on Mon, 03/16/2020 - 7:34pm

Too little, too late. Is it time for pitch forks and torches?

Coronavirus calls US’ ‘world's richest country’ bluff: Will it cling to busted myths or evolve under pressure?

The coronavirus containment measures the US has (belatedly, reluctantly) taken are revealing enormous fissures in its first-world facade, from legions of hungry schoolchildren to their broke parents left to fend for themselves.
...
The federal government has been accused of dragging its feet in responding to the epidemic, and not without reason. While other nations rushed into action, President Donald Trump held back from making public statements about the coronavirus out of fear of “spooking the markets.” The Centers for Disease Control didn’t just refuse to use the WHO-developed test for Covid-19 – it actively intervened to stop infectious disease experts in Washington state from testing patients for the disease until the last week of February. Trump waited until last week to declare a public health emergency. Many Americans wondered what was taking their government so long, and some suspected ulterior motives.
...
States and cities that filled the void left by federal inaction with their own containment measures have often started by closing schools, only to be confronted with just how many American children rely on these educational institutions to feed not their minds, but their bellies. More than 22 million American children – over two thirds of students who eat lunch at their public schools – receive free or reduced-price lunches, a figure that is as shocking as it is ubiquitous. The 14.6 million who eat breakfast at school – and 1.3 million who eat dinner there – are proof these institutions have become de-facto daycare facilities for parents forced to work ever-longer hours or multiple jobs just to keep a roof over their families’ heads.
...
The lights have come up on the myths of rugged individualism, and the vision is grim. Rather than promise its citizens a financial rescue package, like the bill, proposed earlier this month by Hawaii congresswoman Tulsi Gabbard, to adopt a form of Universal Basic Income to tide Americans through the coronavirus emergency, the Trump administration has focused its energies on bailing out the financial sector. The Fed dumped a breathtaking $1.5 trillion onto the cratering markets in a single day last week, and traders could barely catch their breath before the red arrows reappeared. It’s clear where Washington’s priorities lie, but the average struggling American no longer has any reason to believe they’re alone in failing economically in an otherwise-functional society. A people deprived of their myths will not remain complacent forever.

Submitted by Roy Blakeley on Mon, 03/16/2020 - 7:43pm

Phase 1 clinical trials

Phase 1 clinical trials are just a safety test and it is unlikely (although not impossible) that there will be significant adverse reactions. Efficacy is another story, although they should be able to test for production of the spike protein even after phase 1.

Submitted by Alligator Ed on Mon, 03/16/2020 - 8:06pm

definitions of phases in FDA testing

@Roy Blakeley
phase 1: safety trial, which includes dosing

phase 2: efficacy trial, which also includes dosing

phase 3: clinical utility trial, typically with large numbers, sometimes with double-blinded studies

phase 4: post-marketing experience.

Submitted by boriscleto on Mon, 03/16/2020 - 10:42pm

They never did find a vaccine for SARS

It failed in animal trials..."vaccine-induced enhancement"...

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" In the beginning, the universe was created. This has made a lot of people very angry, and is generally considered to have been a bad move. -- Douglas Adams, The Hitch Hiker's Guide to the Galaxy "