The FDA today approved a second Covid-19 vaccine, made by Moderna in a plant in Norwood. The vaccine, which can be stored in a regular freezer, should start rolling out to providers this weekend.
Why Norwood? Moderna explains.
Nowhere have I read about shelf life of the vaccine distributed and stored at Phase One safety net institutions like Boston City Hospital and shelters.along Methadone Mile. How long can the vaccine be preserved before it is given to people who want it? I'm in Phase Two. .
Pfizer will make its U.S. vaccine in Kalamazoo, Mich.
Pfizer also has a production site in Belgium
Moderna will manufacture its vaccine in New Hampshire, Pennsylvania and Indiana.
Moderna also plans to manufacture in Switzerland and Spain.
what does modernatx mean ?
similar to rx which means remedy, tx stands for treatment.
They couldn't just call it Pin 3?
Moderna Therapeutics, Inc. They dropped it from the formal name in 2018.
Pretty cool name, though the E is kinda cheating.
I'm rooting for the local guys.
Great news once again Massachusetts will lead the way.
I suspect most of us old pharts got it.
I GOT THE DAMN JOKE, JOHN. Sorry, didn't mean to yell.
Brian got it and he's what, 18 now?
I wish. I think you forgot you are as old as dirt now, but I guess that happens with aging.
I thought the joke was related to the Legal Seafood post directly below this one.
"If it isn't fresh, it isn't legal."
Yes, I got the joke, too.
Personally, I was considering "Contented cells give better antibodies", but whatever....
Let's not forget that big Genzyme building by the Allston turnpike ramps that contain giant tanks full of Chinese hamster ovary cells tweaked to churn out drugs for two rare diseases.
The FDA has authorized the use of the vaccine on an emergency basis. The FDA has NOT approved the vaccine.
Go ahead and use it, but I don't approve of it!
We're gonna sit here until you've finished this entire box of vaccines. Then we'll see how "cool" you feel!
Would you rather wait another four months without any vaccine?
The agency is granting emergency clearance based on two months of safety follow-up after trial participants received the last shot in a two-dose regimen. Full approval requires six months.
One of the reasons the stage 3 trials went so quick, is the number of people willing to enter the trial. Stage 4 trials would likely prove difficult as vaccines become more available and people drop out of trials if they think they’re getting a placebo.
To counter this, other U.S. programs will be tracking potential adverse effects in the public that weren’t seen in the clinical trials.
Phase 1: This phase typically consists of 50 to 100 healthy volunteers. During phase 1, researchers assess the drug’s safety, determine the side effects, and evaluate how the drug should be taken.
Phase 2: Typically, 100 to 300 patients with the condition for which the medicine, device, product, or treatment has been developed participate in this next phase. Researchers look to assess the short-term safety and effectiveness of the drug, find the dose at which it works best with the least side effects, and conduct a small-scale placebo comparison.
Phase 3: In phase 3, the pool of volunteers must be must larger. Typically, between several hundred and several thousand patients participate, so researchers can confirm the drug’s safety and effectiveness and compare the new drug to other compounds (e.g., a placebo or other therapies). There are no other vaccines for Covid so they tested it against placebo and tracked the number of people infected and the severity of illness. Over 43,000 were in the Pfzier trial. Over 30,000 were in the Moderna. Normally a phase 3 trial has 300 to 3,000 participants...
Following the completion of Phase 3, a drug is approved (or not approved) by the U.S. Food and Drug Administration (FDA) for use by specific patients. Phase 4 may only begin if the drug is approved.
Phase 4: Finally, after the drug is approved researchers look to study the effectiveness of the drug in a wide variety of patients as well as monitor the safety in a large group and enable the development of new uses for the compound. These studies often involve thousands of patients and can inform future research and development. It's goal is post marketing surveillance in the general public. Phase IV clinical trials happen after the FDA has approved medication. This phase involves thousands of participants and can last for many years.
Covid has not been around years.
To vaccinate their entire workforce?
It's dark, very dark.
Help keep Universal Hub going. If you like what we're up to and want to help out, please consider a (completely non-deductible) contribution.
Copyright 2021 by Adam Gaffin and by content posters.Advertise | About Universal Hub | Contact | Privacy