Overnight Health Care: FDA adds new warning to J&J COVID-19 vaccine | WHO chief pushes back on Pfizer booster shot | Fauci defends Biden’s support for recommending vaccines ‘one on one’

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Today: The FDA is adding a warning to Johnson & Johnson’s COVID-19 vaccine, the WHO is pushing back on Pfizer’s calls for a booster dose, and a House panel wants information from Biogen about its controversial Alzheimer’s drug.

We’ll start with J&J:

FDA adds new warning to J&J COVID-19 vaccine

The Food and Drug Administration (FDA) is adding a label to Johnson & Johnson’s COVID-19 vaccine, warning that it has been linked to rare cases of Guillain-Barré syndrome (GBS), a neurological disorder in which the body’s immune system mistakenly attacks part of its nervous system.

There have been 100 preliminary reports following vaccination after approximately 12.5 million doses administered, FDA said in a statement. Of these reports, 95 of them were serious and required hospitalization. There was one reported death.

The cases have largely occurred about two weeks after vaccination and mostly in men, many aged 50 and older, the CDC said in a statement. The cases are rare, “but do likely indicate a small possible risk of this side effect following this vaccine,” the CDC said.

Notably, CDC added that they did not see a similar pattern with mRNA vaccines, after over 321 million doses administered in the United States. The agency said its vaccine advisory committee will discuss the issue at an upcoming meeting. 

The FDA noted that the vaccine is still safe and effective, and the known and potential benefits clearly outweigh the known and potential risks. 

J&J problems: The warning is the latest blow to the Johnson & Johnson vaccine, which was supposed to be an important part of the U.S. vaccination effort. But usage has lagged and the vaccine has been plagued by problems.  The CDC and FDA paused use of the vaccine for more than a week in April after it was linked to rare and potentially life-threatening blood clots.

The company has also suffered from serious production problems at its only U.S. manufacturing plant. 

Read more here

WHO chief pushes back on Pfizer booster shot

The leader of the World Health Organization (WHO) on Monday pushed back on calls from Pfizer for a third dose of vaccine, saying that instead the priority needs to be on vaccinating vulnerable people across the world who have not received any doses so far.

The comments from WHO Director-General Tedros Adhanom Ghebreyesus at a press conference on Monday come after Pfizer made waves late last week by saying it would apply for authorization for giving a third, “booster” dose of vaccine.

“Currently, data shows us that vaccination offers long lasting immunity against severe and deadly COVID-19,” Tedros said. “The priority now must be to vaccinate those who have received no doses and protection.”

He also named Moderna, the other major company providing doses in the United States.

“Instead of Moderna and Pfizer prioritizing the supply of vaccines as boosters to countries whose populations have relatively high coverage, we need them to go all out to channel supply to COVAX, the Africa Vaccine Acquisition Task Team and low- and middle-income countries, which have very low vaccine coverage,” he said.

WHO officials said the focus should be on getting the first two doses to health workers, the elderly and other vulnerable people across the world, before people in wealthier countries start getting third doses.

“We need to decide what our priority is,” said Mike Ryan, another top WHO official. “What part of ‘This is a global crisis,’ are we not getting?”

Read more here.

Fauci defends Biden’s support for recommending vaccines ‘one on one’

Anthony FauciAnthony FauciFlorida county mayor asks residents to wear masks regardless of vaccination Fauci and Birx warned Scott Atlas was ‘dangerous’ Overnight Health Care: FDA adds new warning to J&J COVID-19 vaccine | WHO chief pushes back on Pfizer booster shot | Fauci defends Biden’s support for recommending vaccines ‘one on one’ MORE on Monday defended the Biden administration’s support of door-to-door vaccination efforts, amid Republican attacks.

“When you get down to now a core, lesser group, you’ve got to go one on one, and that’s really what the president was talking about on trying to get some of these advisers, not federal officials, but community people to go out there and try and convince people why it’s so important for their own health, for that of their family and for that of the community, to go out and get vaccinated,” Fauci said on “CBS This Morning.”

“We really need to get more people vaccinated,” he added.

GOP attacks: Many Republicans have attacked President BidenJoe BidenPoll: Biden approval on coronavirus slips 2 percentage points Overnight Defense: Top US commander in Afghanistan departs | US sends delegation to Haiti after request for troops | Senate Dems propose .3B for Pentagon in Capitol security bill Protests escalate US-Cuba tensions MORE‘s comments earlier this month calling for a “door-to-door” vaccination push, saying it is government intrusion.

The White House has pushed back strongly, saying that it is not federal employees going door to door, but that it is important for community leaders to be doing outreach, and that Republicans are siding against providing life-saving information about vaccines.

The efforts have been ongoing since April, White House press secretary Jen PsakiJen PsakiOvernight Health Care: FDA adds new warning to J&J COVID-19 vaccine | WHO chief pushes back on Pfizer booster shot | Fauci defends Biden’s support for recommending vaccines ‘one on one’ COVID-19 case count spikes hit almost every state Haiti is ‘tinderbox’ foreign policy challenge for Biden MORE said last week.

“When people are critical of these tactics, it’s really a disservice to the country and to the doctors, faith leaders, community leaders and others who are working to get people vaccinated,” Psaki said.

Read more here

House panels press Biogen for documents on controversial Alzheimer’s drug

Two House committees on Monday requested a slew of documents from the pharmaceutical company Biogen as part of an investigation into the controversial approval of its Alzheimer’s treatment.  

House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) and House Oversight Committee Chairwoman Carolyn MaloneyCarolyn MaloneyOvernight Health Care: FDA adds new warning to J&J COVID-19 vaccine | WHO chief pushes back on Pfizer booster shot | Fauci defends Biden’s support for recommending vaccines ‘one on one’ House panels press Biogen for documents on controversial Alzheimer’s drug Overnight Health Care: FDA narrows use for controversial new Alzheimer’s drug after criticism | Pfizer to seek FDA authorization for booster of COVID-19 vaccine | House report: Drug companies spent more on buybacks, dividends than research MORE (D-N.Y.) wrote to Biogen CEO Michel Vounatsos on Monday requesting the documents concerning the Alzheimer’s drug, Aduhelm.  

“We are concerned by reports of an atypical approval process for Aduhelm amid significant questions about the drug’s clinical benefit, and the steep $56,000 annual price tag, which will have serious implications for seniors, federal health care programs, and future Alzheimer’s research,” the lawmakers wrote.  

The letter points to reporting from Stat finding that Biogen engaged in “a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm.” 

Among the documents requested are documents relating to Project Onyx and records of all calls and meetings between Biogen and Food and Drug Administration officials related to the drug. 

Background: The congressional letter is the latest turn in the controversy surrounding the FDA’s approval of the drug, both over the price and whether the evidence on its effectiveness justified approving it. 

Acting FDA Commissioner Janet Woodcock last week requested an inspector general investigation as well. 

Read more here

HHS spending bill moves on without Hyde Amendment

A key House subcommittee on Monday cleared a spending bill for the Department of Health and Human Services (HHS) without including a decades-old rider prohibiting funding for abortions, kicking off what is likely to be a long and bruising fight.

For the first time in 40 years, the Hyde Amendment was excluded from the spending bill introduced and then cleared by the House Appropriations labor and health and human services subcommittee.

Background: The Hyde Amendment bans federal programs such as Medicaid from covering the costs of abortion services. The ban has been added to federal spending bills every year since 1976. 

During the campaign, President Biden reversed his previous longtime support for the measure and pledged to end it after coming under intense pressure from fellow Democrats and advocacy groups. His $6 trillion budget request released in May does not include the amendment. 

“We are finally doing what is right for our mothers, our families, our communities by striking this discriminatory amendment, once and for all,” Rep. Rosa DeLauroRosa DeLauroOvernight Health Care: FDA adds new warning to J&J COVID-19 vaccine | WHO chief pushes back on Pfizer booster shot | Fauci defends Biden’s support for recommending vaccines ‘one on one’ HHS spending bill advances without Hyde Amendment Most congressional committees earn failing grades on oversight: analysis MORE (D-Conn.) said.

What’s next: The legislation now goes to the full Appropriations Committee for a markup and eventual vote.

But Republicans are ready for a fight, and are expected to try to reinstate the ban in the House during negotiations.

“Quite frankly, everyone in this room knows this bill will never pass the United States Senate without their inclusion,” said Rep. Tom ColeThomas (Tom) Jeffrey ColeOvernight Health Care: FDA adds new warning to J&J COVID-19 vaccine | WHO chief pushes back on Pfizer booster shot | Fauci defends Biden’s support for recommending vaccines ‘one on one’ HHS spending bill advances without Hyde Amendment Now that earmarks are back, it’s time to ban ‘poison pill’ riders MORE (Okla.), the subcommittee’s top Republican. 

Read more here

What we’re reading

Few options for Biden as vaccination pace hits a wall (Politico)

The rationing of a last-resort Covid treatment (The New York Times)

Government oversight of Covid air cleaners leaves gaping holes (Kaiser Health News)

State by state 

Utah governor admits mistake on vaccination milestone (Politico)

Most Kansas schools ditching mask rules even as delta variant is driving a COVID-19 resurgence (Kansas News Service)

Denver children aren’t tested enough for blood lead levels, state health officials say (The Denver Post)