COVID-19 vaccine booster tensions mount between White House, CDC and FDA

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Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20. 

But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary. 

Two departing senior FDA vaccine officials recently co-wrote an article published in The Lancet arguing that insufficient evidence exists to justify the case for boosters. “Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” the paper argues. In addition, while the public could ultimately benefit from boosting, administering boosters before they are required could lead to an uptick in adverse events, according to The Lancet art…

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United, Abbott partner to use rapid COVID-19 test for international travel

Abbott’s BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]United Airlines and Abbott announced a collaboration to use the latter’s BinaxNOW COVID-19 home test to make international travel more seamless.

Recent CDC guidelines permit travelers to self-administer a rapid antigen test under the real-time supervision of a telehealth service and use the verified negative result to board an international flight to the U.S., according to a news release.

The collaboration will combine Abbott’s BinaxNOW COVID-19 test and the NAVICA app to provide testing and make international travel to the U.S. safer and easier for travelers amid the ongoing pandemic.

“We appreciate the private sector proactively helping travelers have access to easy, reliable COVID-19 test options,” CDC Director Dr. Rochelle P. Walensky said in the release. “Comprehensive testing that is easy, rapid, accurate and trusted is a fundamental strategy for preventin…

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More than 5 million skipped getting second COVID-19 vaccine dose

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The percentage of people who failed to get the second dose of Pfizer or Moderna COVID-19 vaccines is growing, according to recent CDC data. Some five million people, or almost 8% of people who got the first vaccine dose, missed getting the second.

In mid-March, 3% of people were overdue for their second dose.

People who missed getting their second vaccine dose provided several explanations. Some wanted to avoid adverse events, which are more common after the second dose. Others believed a single dose offered sufficient protection.

Get the full story from our sister site, Pharmaceutical Processing World. 

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FDA, CDC lift pause on J&J COVID-19 vaccine

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern.

On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the U.S., six recipients experienced cases of a rare and severe type of blood clot. Of those blood clot cases, one death was recorded.

Get the full story at our sister site, Pharmaceutical Processing World.

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Feds halt J&J COVID-19 vaccine due to blood clot concern

The FDA and CDC issued a joint statement today recommending the pause in the administration of the Johnson & Johnson COVID-19 vaccine.

As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood clot have been reported. The CDC and FDA are reviewing data involving these cases.

Get the full story at our sister site, Drug Discovery & Development.

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Biden to put $12B toward COVID testing

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The Biden administration today pledged $10 billion for school COVID-19 screenings and $2.25 billion for screenings and diagnostic testing among underserved populations.

The money is part of the $1.9 trillion American Rescue Plan Act that Biden signed into law last week.

The Department of Health and Human Services will divvy up the $10 billion among the states to fund screening tests of teachers, staff and students to help schools to reopen safely for in-person instruction. Screening tests are used to test asymptomatic people for COVID-19. The money will be deployed quickly to help schools reopen for the remainder of this year, according to an HHS news release.

Get the full story on our sister site, Medical Design & Outsourcing.

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How decontamination could solve the COVID-19 mask shortage problem

With cold and flu season rapidly approaching, public health officials worry about a resurgence of COVID-19 and personal protective equipment shortages. Protecting frontline workers will likely include decontaminating face masks.

(Image courtesy of Brian McGowan on Unsplash)

A spike in COVID-19 cases this fall and winter could leave healthcare facilities with renewed shortages of personal protective equipment — particularly masks.

Hundreds of frontline healthcare workers have died from the virus since the pandemic struck in China in 2019, bringing the need for effective face masks into sharp relief. But despite the efforts of 3M and other companies worldwide to boost production of the most effective filtering masks — N95s — there still might not be enough.

Get the full story on our sister site, Medical Design & Outsourcing.

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