California halts injections of Moderna Covid vaccine batch due to ‘higher-than-usual number of adverse events’

California health officials are asking vaccine providers to stop administering a batch of Moderna’s Covid-19 jab, after an unusually high number of adverse reactions were linked to the drug.

Doses from Moderna Lot 041L20A are suspected of causing a “higher-than-usual number of adverse events” and should be shelved until a proper investigation can be conducted, the California Department of Public Health said on Sunday. 

State epidemiologist Dr. Erica S. Pan said in a statement that “fewer than 10 individuals” suffered “a possible severe allergic reaction” and required medical attention over the past 24 hours after being injected with the specific batch of vaccine. All of the incidents appear to have occurred at a single community clinic that was administering the lot. The site reportedly closed for several hours after the string of adverse reactions occurred, before switching to a different batch of the drug.

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Moderna CEO says the world will have to live with the coronavirus ‘forever’

The CEO of Covid-19 vaccine maker Moderna warned Wednesday that the coronavirus that has brought world economies to a standstill and overwhelmed hospitals will be around “forever.”

Public health officials and infectious disease experts have said there is a high likelihood that Covid-19 will become an endemic disease, meaning it will become present in communities at all times, though likely at lower levels than it is now.

Moderna CEO Stephane Bancel appeared to agree Wednesday that Covid-19 will become endemic, saying “SARS-CoV-2 is not going away.”

“We are going to live with this virus, we think, forever,” he said during a panel discussion at the JPMorgan Healthcare Conference.

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Experimental COVID-19 mRNA Vaccines Are Operating System Designed To Program Human DNA, Says Moderna

Messenger RNA (mRNA) is found in all living cells. These strands of genetic code act as chemical intermediaries between the DNA in our chromosomes and the cellular machinery that produces the proteins we need to function: mRNA provides the instructions this machinery needs to assemble these proteins.

Moderna’s mRNA-1273 is programmed to make your cells produce the coronavirus’ infamous spike protein that gives the virus its crown-like appearance (“corona” is crown in Latin) for which it is named.

Moderna has made public that mRNA platforms are an “operating system” designed to program human DNA and turn their cells into efficient drug delivery systems.

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Moderna COVID-19 vaccine may cause side effects for those with cosmetic facial fillers: FDA

People with cosmetic facial fillers could experience swelling and inflammation with one of the coronavirus vaccines, the FDA advisory committee noted.

According to the committee, several trial participants with fillers have already experienced side effects. A California-based dermatologist said the reaction was immunological, ABC7 reported on Thursday.

“Your immune system which causes inflammation is revved up when you get a vaccine, that’s how it’s supposed to work,” said Dr. Shirley Chi, who noted the side effects were easily treated by medical personnel.

“So it makes sense that you would see an immune response in certain areas where they see some substance that is not a naturally occurring substance in your body.”

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Doctor reportedly has severe allergic reaction to Moderna COVID-19 vaccine

Boston doctor suffered a serious allergic reaction to Moderna’s coronavirus vaccine, the first of its kind documented, a report said Friday.

Dr. Hossein Sadrzadeh, a geriatric oncologist at Boston Medical Center, became dizzy and felt his heart racing minutes after receiving the vaccine on Thursday, he told The New York Times.

“It was the same anaphylactic reaction that I experience with shellfish,” Dr. Sadrzadeh told the paper, noting that his tongue became numb, his blood pressure plummeted and he broke into a cold sweat.

“I don’t want anybody to go through that.”

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Moderna expects to make 20 million doses of coronavirus vaccine by 2020 end

Moderna said on Friday it was on track to produce 20 million doses of its experimental coronavirus vaccine by the end of the year, while maintaining its goal of readying 500 million to 1 billion doses in 2021.

Vaccines and treatments are seen as essential in controlling the Covid-19 pandemic that has shown no signs of slowing and killed over 944,000 people worldwide.

A handful of vaccines, including those from Pfizer and AstraZeneca, are also being tested in large studies.

Moderna had enrolled 25,296 participants out of a planned 30,000 in its late-stage study as of Wednesday.

The company is working with Switzerland’s Lonza Group and Spain’s Laboratorios Farmacéuticos Rovi to make the vaccine outside the United States.

Moderna has a vaccine supply deal in place with the U.S. for 100 million doses, and has finished advanced talks with the European Union for the vaccine.

The Centers for Disease Control and Prevention anticipates that 35 million to 45 million doses of vaccines from the first two companies to receive authorization will be available in the United States by the end of this year.

Moderna plans to seek emergency authorization for its vaccine’s use in high-risk groups if it proves to be at least 70% effective, its chief executive officer told Reuters earlier this week.

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Next Time You’re Called A “Crank” Or “Flat Earther” On Concerns About A ‘Rushed’ Coronavirus Vaccine, Show Them This

We detailed earlier that a number of US universities will enforce mandatory COVID-19 tests for all students wishing to return to campus through the Fall semester — with some lately announcing that this will be at a rate of two nasal swabs per week — which is a policy, no doubt uncomfortable for those having to endure such “routine” swabs, also appearing among companies for on-site personnel.

And in many parts of the country, cities and counties currently have mask laws requiring them in all public spaces. Given that over the past months the race has been on to develop and fast-track a coronavirus vaccine, the logical next step will be that students and employees provide proof they’ve received the vaccine before returning to work or school. Naturally, the idea of fast-tracking this process also amid a deeply politically charged climate has people concerned. And they should be, if Bill Gates’ latest appearance on CBS is any indicator of where things stand.

British veteran journalist Neil Clark had this reaction to the Bill Gates interview, which came days agoWhen anyone tries to gaslight you by calling you a ‘crank’ , a ‘tin-foil hat conspiracy theorist’ or ‘Flat Earther’ for having perfectly legitimate & sensible concerns over a rushed through ‘Coronavirus’ vaccine & its side effects, just send them this.

Even the mainstream media correspondent giving the interview appeared momentarily exasperated and incredulous that Bill Gates shrugged off credible reports of side effects as ultimately no big deal. When the anchor pressed him again on the safety of the vaccine, his answer appeared to be simply, trust us. Gates was asked:

Side effects from the Moderna vaccine sound concerning… we looked. After the second dose at least 80% of participants experienced a systemic side effect, ranging from severe chills to fevers. So are these vaccines safe?

“The FDA, not being pressured, will look hard at that,” Gates said, addressing the issue of possible side effects. “The FDA is the gold standard of regulators, and their current guidance on this — if they stick with that — is very very appropriate.”

Gates even goes on to candidly acknowledge the likelihood of side effects from the vaccine, which he admitted would “improve” over time. Does this sound comforting? Add to this that as part of his explanation he argues that for a vaccine to be effective it would have to be administered to the population on a mass scale, and globally:

“If what you’re trying to do is block all the transmission, then you need to get 70-80% coverage on a global basis. So it’s unbelievably big numbers,” he said.

Gates, who has been warning about the threat of a global pandemic since 2015, admitted that “there will be a lot of uncertainty” about the efficacy of any vaccine, but stressed that it’s a solution “that will improve over time.”

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Dr. Anthony Fauci isn’t ‘particularly concerned’ about the safety of Moderna coronavirus vaccine

White House coronavirus advisor Dr. Anthony Fauci said Monday he is “not particularly concerned” about the safety risk of a potential coronavirus vaccine by Moderna, despite the fact that it uses new technology to fight the virus. 

The vaccine, which entered a large phase-three human trial Monday, uses messenger ribonucleic acid, or mRNA molecules, to provoke an immune response to fight the virus. Scientists hope mRNA, which relays genetic instructions from DNA, can be used to train the immune system to recognize and destroy the virus. While early studies show promise, mRNA technology has never been used to make a successful vaccine before.

“It’s a novel technology. We are certainly aware of the fact that there’s not as much experience with this type of platform as there are with other standards,” Fauci, director of the National Institute of Allergy and Infectious Diseases, told reporters on a conference call alongside National Institutes of Health Director Dr. Francis Collins.

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Covid-19 Vaccines With ‘Minor Side Effects’ Could Still Be Pretty Bad

On Monday, vaccine researchers from Oxford University and the pharmaceutical company AstraZeneca announced results from a “Phase 1/2 trial,” suggesting their product might be able to generate immunity without causing serious harm. Similar, but smaller-scale results, were posted just last week for another candidate vaccine produced by the biotech firm Moderna, in collaboration with the U.S. National Institutes of Health.

As both these groups and others push ahead into the final phase of testing, it’s vital that the public has a clear and balanced understanding of this work—one that cuts through all the marketing and hype. But we’re not off to a good start. The evidence so far suggests that we’re getting blinkered by these groups’ PR, and so seduced by stories of their amazing speed that we’re losing track of everything else. In particular, neither the mainstream media nor the medical press has given much attention to the two vaccines’ potential downsides—in particular, their risk of nasty adverse effects, even if they’re not life-threatening. This sort of puffery doesn’t only help to build a false impression; it may also dry the tinder for the future spread of vaccine fear-mongering.

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Moderna COVID-19 vaccine induced adverse reactions in ‘more than half’ of trial participants

Ahighly anticipated clinical trial for a potential COVID-19 vaccine managed in part by the American drug company Moderna has resulted is some adverse effects in more than half of the trial’s participants, with one test group reporting “severe” symptoms. 

The trial, which is also being sponsored by the National Institute of Allergy and Infectious Diseases, administered the vaccine “as a 0.5-ml injection in the deltoid muscle” in two shots spaced about one month apart. Two separate groups received 25-microgram and 100-microgram doses, respectively. A third group with a 250-microgram dose was subsequently added. 

The vaccine “induced anti–SARS-CoV-2 immune responses in all participants,” the research team reported Tuesday in the New England Journal of Medicine. Researchers said that “no trial-limiting safety concerns were identified.” Yet a majority of participants still reported at least one side effect. 

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