Moderna says its COVID-19 vaccine may prevent asymptomatic infection - FDA panel endorses emergency use - December 17, 2020

[Gert van der Hoek]

NEW YORK (Reuters) - Moderna Inc said data from the late stage trial of its COVID-19 vaccine suggests that it could prevent some asymptomatic infections as soon as the first dose of the shot is given.

The vaccine maker said in briefing documents it submitted to the U.S. Food and Drug Administration released on Tuesday that it had not yet completed its full analysis on the efficacy against asymptomatic infection.

Still, it said that 38 trial participants in the placebo arm of its trial tested positive for COVID-19 without exhibiting symptoms at the time of their second dose. That was nearly triple the number in the vaccine arm of the trial, where there were 14 positive tests from asymptomatic people.

[sharon sanders]

F.D.A. Panel Endorses Moderna’s Covid-19 Vaccine


By Denise Grady, Abby Goodnough, Carl Zimmer and Katherine J. Wu

• Dec. 17, 2020Updated 5:50 p.m. ET

The coronavirus vaccine made by Moderna moved closer to authorization on Thursday, a significant step that would expand the reach of the nation’s vaccination campaign to rural areas and many more hospitals.

As the nation buckled from uncontrolled spread of the disease, with 3,611 deaths on Wednesday setting yet another horrific record, a panel of independent experts recommended by a vote of 20 in favor and one abstention,that the Food and Drug Administration authorize the Moderna vaccine for emergency use. The formal decision, expected on Friday, would clear the way for some 5.9 million doses to be shipped around the country starting this weekend.

more...

https://www.nytimes.com/2020/12/17/h...mid=tw-nytimes

[Mary Wilson]

FDA advisory panel endorses Moderna’s Covid-19 vaccine, clearing way for authorization

DECEMBER 17, 2020

STAT live-blogged the meeting of the advisory panel, known as the Vaccines and Related Biological Products Advisory Committee. An archive is below.

... Another safety signal?

2:58 p.m.: Something a bit unexpected to add to the possible Covid vaccine side effects watch list: facial swelling in people who have had dermal fillers.

Rachel Zhang, an FDA medical officer who is presenting the agency’s analysis of the Moderna data to VRBPAC, reported that two people developed facial swelling after vaccination; both had a prior history of getting cosmetic injections of dermal fillers in their cheeks.

One person had undergone the procedure two weeks before being vaccinated; the second had most recently had dermal fillers injected about six months before being vaccinated.

A third person in the vaccine arm of the Moderna trial developed lip angioedema — swelling — about two days after vaccination. This person had received prior dermal filler injections in the lip, Zhang said.

“Interestingly, that subject reported a similar reaction after a previous influenza vaccine,” she noted.

In all three cases, the swelling was localized and resolved itself after treatment with antihistamines or steroids. Zhang said the FDA team did a literature review and found earlier reports where people with dermal filler injections reacted with temporary swelling to vaccinations.

“We’re planning to note this in the prescribing information.”

https://www.statnews.com/2020/12/17/moderna-vaccine-fda-panel/

[Emily]

Sounds like any immune stimulation can trigger dermal filler swelling at times.

https://www.sciencedirect.com/science/article/abs/pii/S0190962220301523

https://onlinelibrary.wiley.com/doi/10.1111/jocd.13531

[Mary Wilson]

("Just putting it out there. We seem to forget, myself included")

The People’s Vaccine—Moderna’s Coronavirus Vaccine Was Largely Funded By Taxpayer Dollars

Dec 3, 2020,11:00am EST
Judy Stone

... The other problem is that it is not really “Moderna’s vaccine.” It would be more appropriately called the “People’s vaccine,” as Peter Maybarduk, director of Public Citizen’s Access to Medicines Program, has noted. It’s “the NIH’s vaccine. It is not merely Moderna’s vaccine. Federal scientists helped invent it and taxpayers are funding its development. We all have played a role. It should belong to humanity.”

https://www.forbes.com/sites/judystone/2020/12/03/the-peoples-vaccine-modernas-coronavirus-vaccine-was-largely-funded-by-taxpayer-dollars/?sh=435eb4856303