Tag: vaccines

Vaccine Safety to Remain Unclear Until Millions Get Their Shots

Monitoring Covid-19 vaccines for safety issues will fall to a group of U.S. health agencies that also will have a hand in their rollout, a potential hurdle in persuading skeptics to get the shots, say former government officials who helped control an outbreak a decade ago.

The Centers for Disease Control and Prevention, the Food and Drug Administration, the Department of Veterans Affairs and other health agencies all have separate systems to track side effects and safety in people who get the first shots. But there are concerns the groups advising the agencies on all aspects of a vaccine may face public skepticism over their safety assessments at a time when vaccine hesitancy is a major concern.

“The same advisory committee that told them to get it are telling them it’s OK,” said Daniel Salmon, the director of vaccine safety for the National Vaccine Program Office during the 2009 H1N1 swine flu outbreak. “What are the optics of that?”

There’s also worry that a lack of unified oversight could make it more difficult to document and quickly act on safety issues. Meanwhile, the stalled presidential transition could complicate efforts even further, said Jesse Goodman, who led the FDA office that handled vaccines during the 2009 H1N1 outbreak.

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The coronavirus vaccine comes with more side effects than a flu shot. Experts urge people to get it anyway

The first coronavirus vaccine authorized in the United States may cause more side effects than the flu vaccine, but the most common reactions — soreness at the injection site, fatigue and headache — are mild or moderate in most people and fade after a few days, according to analyses of clinical trial data.

Infectious disease experts say most people can safely get the vaccine, but they should be prepared for some of these potential side effects.

“Any robust vaccine may generate some discomfort but it is worth the mild side effects — these side effects are not extraordinary — to be immune against this circulating new pandemic,” said Dr. Monica Gandhi, an infectious disease physician at UCSF.

The FDA granted emergency use authorization late Friday to the first vaccine in the U.S., developed by Pfizer and German firm BioNTech, which has been shown to be 95% effective at preventing COVID-19 illness.

Health care workers and residents of long-term care centers will be first in line to receive the vaccine in California, followed by essential workers. Mass vaccinations of the general public are expected in spring or summer 2021.

The Pfizer vaccine’s most common side effects were fatigue, headache, muscle pain and chills, according to an FDA analysis of Pfizer’s clinical trial data. Less common were joint pain, fever, diarrhea and vomiting. The vast majority of those symptoms were mild or moderate.

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Pfizer and Moderna could score $32 billion in Covid-19 vaccine sales — in 2021 alone

The imminent authorization of Pfizer’s Covid-19 vaccine in the United States is a momentous occasion for science, the economy and humanity. The milestone is also a major moneymaker for the companies that developed the vaccines.Wall Street analysts are projecting Pfizer and Moderna will generate $32 billion in Covid-19 vaccine revenue — next year alone.

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Allergy risk on Pfizer jab: Day before FDA meet to give green light to vaccine UK regulators warn people with ‘significant’ food and medicine allergies NOT to take it after two health workers suffer ‘anaphylactic reaction’

There are fears over how safe Pfizer’s COVID vaccine is after two British healthcare workers who were among the first in the world to receive it on Tuesday went into anaphylactic shock hours later, prompting British authorities to tell anyone with a ‘severe’ allergy to food or medicine not to get it. 

The FDA is due to meet tomorrow to discuss green-lighting the vaccine in America after being lambasted for taking a week longer than the Brits to get it off the ground. 

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Can’t make it up: Cornell University has a new vaccine mandate — and it only applies to white students!

Cornell University has a new flu shot mandate in order to try and keep flu cases down so healthcare resources stay open for Covid patients. But the mandate applies to white people only, because of course it does, because we live in a clown world that gets clownier by the day.

That’s right, at Cornell you can duck the mandatory flu shot by claiming your race as an exemption. Unless you’re white, obviously.

Cornell has a FAQ page “especially for people of color” that explains how victimized they’ve been by white people and thus how they can’t be expected to trust someone to require them to get vaccinated (or something?) and ends with an invitation for non-white people to send an email to the department for an exemption to the vaccine mandate.

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4 volunteers develop FACIAL PARALYSIS after taking Pfizer Covid-19 jab, prompting FDA to recommend ‘surveillance for cases’

Four trial participants who received the Pfizer Covid-19 vaccine experienced facial paralysis, according to the Food and Drug Administration. The FDA said the issue should be monitored as the jab becomes more widely available.

The potentially concerning cases were revealed after the US drug regulator published an analysis of the Pfizer-BioNTech vaccine ahead of a meeting to consider emergency use authorization for the jab in the United States. 

According to the documents, Bell’s palsy, a form of temporary facial paralysis, was reported by four participants during phase 3 trials. The individuals had been administered the jab, and no members of the placebo group experienced similar adverse effects. 

The condition resembles a stroke, with most sufferers watching helplessly as one side of their face droops and their muscles go limp. In some rare situations, both sides of the face may become paralyzed. It is unclear what causes Bell’s palsy, although the temporary paralysis usually goes away on its own. 

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Those who don’t get COVID-19 vaccine could face restrictions, Ontario officials say

Ontario’s health minister says getting a coronavirus vaccine won’t be mandatory, but those who don’t receive a shot could face restrictions.

Christine Elliott made the remarks during an update on the province’s COVID-19 vaccine distribution plans on Monday.

“We can’t force anybody to take the vaccine but I agree with the premier — we really encourage everyone who is able to, to have the vaccination,” Elliott said.

“There may be some restrictions in terms of travel or other restrictions that may arise as a result of not having a vaccination, but that’s going to be up to the person themselves to make that decision on the basis of what’s most important to them. But we do wish everyone to receive the vaccination.”

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Palantir’s Tiberius, Race, and the Public Health Panopticon

Operation Warp Speed, the “public-private partnership” created to produce and allocate COVID-19 vaccines to the American populace, is set to begin rolling out a mass-vaccination campaign in the coming weeks. With the expected approval of its first vaccine candidate just days away, the allocation and distribution aspects of Operation Warp Speed deserve scrutiny, particularly given the critical role one of the most controversial companies in the country will play in that endeavor.

Palantir Technologies, the company founded by Alex Karp, Peter Thiel, and a handful of their associates, has courted controversy for its supporting role in the US military occupation of Iraq and Afghanistan as well as its participation in the detention of “illegal” immigrants through their contracts with the Department of Homeland Security and in “predictive policing” law enforcement programs that disproportionately affect minority neighborhoods. Equally controversial, but perhaps lesser known, is Palantir’s long-standing and enduring ties to the CIA and intelligence community at large, which was intimately involved in the development of Palantir’s products that now run on the databases of governments and corporations around the world.

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