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U.S. authorizes third shot of COVID-19 vaccines for the immunocompromised

Coronavirus Aug 13, 2021 08:55PM ET
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© Reuters. FILE PHOTO: Pulmonology physician Catherine Wentowski, treats a patient who has coronavirus disease (COVID-19) at the Ochsner Medical Center in Jefferson Parish, Louisiana, U.S., August 10, 2021. REUTERS/Kathleen Flynn

By Manas Mishra and Michael Erman

(Reuters) -U.S regulators authorized a third dose of COVID-19 vaccines by Pfizer (NYSE:PFE) Inc-BioNTech and Moderna (NASDAQ:MRNA) Inc on Friday for people with compromised immune systems who are likely to have weaker protection from the two-dose regimens.

The U.S. Food and Drug Administration amended https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised its emergency use authorization for both vaccines on Thursday, paving the way for people who have had an organ transplant, or those with a similar level of weakened immune system, to get an extra dose of the same shot they have initially received.

An advisory panel to the U.S. Centers for Disease Control and Prevention (CDC) voted to recommend the additional shots, and the agency's director signed off on that recommendation on Friday. Immunocompromised individuals can begin receving the shots immediately, according to an agency spokesperson.

Mixing of mRNA vaccines is permitted for the third shot if their original vaccine is not available.

Patients will not need a prescription or the signoff of a healthcare provider in order to prove they are immunocompromised and receive the additional dose, according to officials.

"It will be a patient's attestation, and there will be no requirement for proof or prescription or a recommendation from an individual's healthcare provider," CDC official Dr. Amanda Cohn said, speaking before the advisory panel.

There is growing concern about breakthrough infections in vulnerable populations in the United Stats as the country sees a huge spike in new infections from the contagious Delta variant of the coronavirus.

The vulnerable group makes up less than 3% of U.S. adults, Rochelle Walensky, director of the CDC, had said before the authorization.

"After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines," Janet Woodcock, the FDA's acting commissioner, wrote in a tweet https://twitter.com/DrWoodcockFDA/status/1426019820445868033 on Thursday.

Woodcock said that others who are fully vaccinated do not need an additional vaccine dose right now.

The FDA's decision does not apply to people who received the one-dose Johnson & Johnson (NYSE:JNJ) vaccine, the CDC said, because there is not enough data to support additional doses yet.

"We think that at least this is a solution for the very large majority of immunocompromised individuals, and we believe that we'll probably have a solution for the remainder in the not-too-distant future," FDA official Peter Marks told the CDC panel.

The FDA and the CDC are working to ensure that immunocompromised recipients of the J&J vaccine have optimal protection, the CDC said.

Dr. David Boulware, an infectious disease doctor at the University of Minnesota, backed the FDA decision, noting that most of the fully vaccinated patients he has seen in the hospital are immunocompromised.

Boulware said that the plan to let patients attest to their own status may lead to more people receiving the shots than intended.

"If it is left up to the honor system, I think many Americans will suddenly wake up and find themselves immunocompromised enough to get a 3rd dose," he said in an email.

BOOSTERS FOR YOUNG, HEALTHY

Scientists are still divided over the broad use of COVID-19 vaccine boosters among those without underlying problems as benefits of the boosters remain undetermined.

Pfizer has previously said the efficacy of the vaccine it developed with partner BioNTech drops over time.

Moderna has also said it sees the eventual need for booster doses, especially since the Delta variant has caused "breakthrough" infections in fully vaccinated people.

Reports of infections among vaccinated people and concerns about diminishing protection have galvanized wealthy nations to distribute booster shots, even as many countries struggle to access first vaccine doses.

The World Health Organization last week called for a moratorium on COVID-19 vaccine booster shots until at least the end of September.

Still, Americans have already started getting additional shots, even before the FDA has authorized them. According to the CDC, more than 1.2 million people have already received one or more additional doses of a COVID-19 vaccine already.

CDC officials also presented a set of guidelines to its advisory panel on Friday that it plans to use to help make its decision about whether Americans need further COVID-19 doses more broadly.

The CDC plans to hold another meeting of its Advisory Committee on Immunization Practices in the next several weeks where booster shots will again be discussed.

U.S. authorizes third shot of COVID-19 vaccines for the immunocompromised
 

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Comments (14)
Nicolas Duran
Nicolas Duran Aug 16, 2021 11:52AM ET
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Ivermectin
Chris Sundo
Chris Sundo Aug 14, 2021 5:43AM ET
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A third (and higher) chance to die accidentally from vaccination alone
Dovydas Narkus
Dovydas Narkus Aug 13, 2021 6:02AM ET
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More poison via booster shots. Research
Vv Pp
Vv Pp Aug 13, 2021 6:02AM ET
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🤦‍♀️
Benjamin USA
Benjamin USA Aug 13, 2021 6:02AM ET
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Hurr durr
digital Dave
digital Dave Aug 13, 2021 2:10AM ET
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Poison
Vv Pp
Vv Pp Aug 13, 2021 2:10AM ET
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🤦‍♀️
Prince Salman
Prince Salman Aug 13, 2021 12:44AM ET
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Remember half the people you know are below average.
carol ruszin
carol ruszin Aug 13, 2021 12:44AM ET
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Yep won't get vaccinated.
Jay Li FX
Jay Li FX Aug 13, 2021 12:26AM ET
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so i sell stock and buy gold....
Jerry Li
Jerry Li Aug 13, 2021 12:08AM ET
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don't take this one,mrna second had me in bed for the whole day, I am athletic type
Kiril Stoimenov
Kiril Stoimenov Aug 13, 2021 12:08AM ET
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Me too, it's the intended behavior. Better then hospitalized, right?
Jerry Li
Jerry Li Aug 13, 2021 12:07AM ET
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that's called *******
Michael Feeney
Michael Feeney Aug 12, 2021 11:56PM ET
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Yet still FDA wont give full non emergency authorization.. the very excuse stated by anti vaxers, so double down on vaxed and allow variants to emerge … Somethings got to give.
Daniel Timoldi
Daniel Timoldi Aug 12, 2021 11:56PM ET
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They cant until it works with kids under 12.
Michael Feeney
Michael Feeney Aug 12, 2021 11:56PM ET
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Daniel Timoldi right… and by the time its resolved it will have become a completely different disease born in the unvaxed masses
Don Blade
Don Blade Aug 12, 2021 11:56PM ET
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exactly-- and thats something SCIENTIST PRO VAX AND ANTI VAX both agree on!!  VACCINES will cause covid to mutate into other variants MUCH FASTER so we are all doomed anyways- gonna have to take this MRNA vaccine at some point.. CLEARLY they had this ****ready before the pandemic started....LIKE GATES said a few years ago- YOU WILL HAVE TO GET A VACCINE EVERY YEAR!! this is far from money issue- its gonna be a control 20year down they easily make moves when you are dependent to LIVE- BREATH on another drug YEAR IN AND YEAR OUT!! anyone having children nowadays is crazy
Joseph Mandeline
Joseph Mandeline Aug 12, 2021 11:50PM ET
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What an amazing business to be in. Zero downside risk from liability. Overpriced government contract. Politicians handling all the marketing. Free markets? mhmm
Anthony Cloud
Anthony Cloud Aug 12, 2021 11:50PM ET
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Dont forget about a large pool of dummies willing to take your crappy product
 
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