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Politics Overnight Health Care — Presented by Carequest — Key CDC panel backs Moderna, J&J boosters

07:00  22 october  2021
07:00  22 october  2021 Source:   thehill.com

Next on FDA's agenda: Booster shots of Moderna, J&J vaccines

  Next on FDA's agenda: Booster shots of Moderna, J&J vaccines WASHINGTON (AP) — With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it's their turn. Federal regulators begin tackling that question this week. On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra shots of Moderna or Johnson & Johnson vaccines should be dispensed and, if so, who should get them and when. (AP Photo/Steven Senne, File) Federal regulators begin tackling that question this week.

FDA Authorizes Many More Boosters . The Food and Drug Administration (FDA) amended its emergency use authorization for all COVID-19 vaccines on Wednesday to allow the combination of boosters for patients who initially received a different vaccine. The federal agency also authorized booster shots for The additional Johnson & Johnson dose would be available at least two months after vaccination for everyone 18 years of age and older. The broader eligibility for the J & J injection is a reflection that the vaccine offers a lower level of protection than the Moderna and Pfizer injections.

The CDC said the most common side effects people reported after getting Covid vaccine boosters included pain at the injection site, fatigue, fever and headache. The data available for J & J was more limited, but people reported fever, fatigue and headache after receiving a second dose of that vaccine, according to the agency. In a separate presentation, Dr. Macaya Douoguih, head of clinical development and medical affairs for J & J 's vaccines division Janssen, said there is no data to suggest people are at increased risk of a rare but serious blood clot condition after receiving a second dose.

Welcome to Thursday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.

Overnight Health Care — Presented by Carequest — Key CDC panel backs Moderna, J&J boosters © Getty Images Overnight Health Care — Presented by Carequest — Key CDC panel backs Moderna, J&J boosters

Sports players and entertainers continue to face decisions on how to handle COVID-19 requirements. The Australian immigration manager said tennis player Novak Djokovic needs to be vaccinated to participate in the Australian Open, while country star Travis Tritt said he's canceling shows at concert venues that require masks, testing or vaccination.

Overnight Health Care — Presented by The National Council for Mental Wellbeing — FDA panel advises Moderna booster shot for high-risk people

  Overnight Health Care — Presented by The National Council for Mental Wellbeing — FDA panel advises Moderna booster shot for high-risk people Welcome to Thursday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.What's the best way to get Moderna to share its vaccine with poor countries? According to Jimmy Kimmel, the U.S. should buy the formula, and then give it to McDonald's. "Sharing is caring!" An FDA advisory panel voted to recommend a booster dose of Moderna's COVID-19 vaccineWhat's the best way to get Moderna to share its vaccine with poor countries? According to Jimmy Kimmel, the U.S. should buy the formula, and then give it to McDonald's.

More Americans would be eligible for booster doses of COVID-19 vaccines and could get any brand of vaccine they choose, according to a recommendation Wednesday from the Food and Drug Administration. FDA panel endorses booster for single-shot vaccine. Democrat and Chronicle (Rochester) See more videos. SHARE. SHARE. TWEET. SHARE. EMAIL. What to watch next. Manchin denies reports he's considering leaving Democratic Party. FOX News. NYC says all city employees including officers, firefighters need to be vaccinated. NBC News.

Boosters for Moderna ’s two-dose vaccine and J & J ’s single-dose shot may be taken by Americans over 65, as well as those over 18 with a higher risk of severe COVID or exposure to the virus. Dosing for the Moderna booster will be less than its two-dose regiment and will be permitted six months after the The committee in late September did not support a Pfizer booster for people in high-risk workforces but was overruled by CDC director Rochelle Walensky. There's no indication the director wouldn't do the same if the panel voted narrowly again. Though the agency’s recommendations hold a large influence

And a Centers for Disease Control and Prevention (CDC) advisory panel voted to recommend that some Moderna and all Johnson & Johnson coronavirus vaccine recipients be able to get booster shots.

For The Hill, we're Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8.

Let's get started.

CDC advisory panel unanimously endorses more COVID-19 vaccine boosters

a person in a blue shirt © Provided by The Hill

A Centers for Disease Control and Prevention (CDC) advisory panel recommended the agency allow Moderna and Johnson & Johnson coronavirus vaccine booster doses to be administered, the latest step toward expanding access to extra doses nationwide.

FDA panel recommends authorizing Moderna booster shot

  FDA panel recommends authorizing Moderna booster shot A key Food and Drug Administration panel on Thursday voted in favor of recommending booster doses of Moderna's COVID-19 vaccine for a large swath of the population.Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously, 19-0.The agency's vaccine advisory committee said boosters should be recommended for people over 65, people between the ages of 18 and 64 who are at high risk of severe COVID-19, as well as people who are at risk of serious COVID-19 because of their jobs, or living situation.The population recommended for Moderna's booster is the same population that Pfizer's booster was authorized for last month.

BREAKING NEWS: CDC advisory committee unanimously recommends approval of Moderna and Johnson & Johnson booster doses as well as 'mix and match' of vaccines. The authorization of 'mix and match' boosters comes after researchers from the National Institutes of Health (NIH) presented data at an FDA advisory committee meeting on Friday showing people who got Johnson & Johnson's Covid vaccine had higher antibody levels if they get a Pfizer-BioNTech or Moderna booster shot.

Boosters for the Pfizer-BioNTech vaccine were OK’d in September for people 65 and older and for high-risk workers. The Advisory Committee on Vaccine Practices of the Centers for Disease Control and Prevention meets to discuss whether to recommend a third shot after the two-dose series of Moderna and a second shot after the “one and done” J & J vaccine. If it recommends them, the CDC ’s director typically signs off within a day, potentially making them available as soon as Friday. A bigger question is whether the committee will recommend that people be allowed to mix and match booster doses.

The committee backed widening booster accessibility for people who initially received Moderna or Johnson & Johnson after the CDC previously approved the Pfizer-BioNTech booster shots for specific populations.

The panel, in a 15-0 vote, endorsed a third shot for certain populations at least six months after their second dose of an mRNA vaccine, either Moderna or Pfizer-BioNTech. It also unanimously suggested allowing a second dose for all adults who initially received Johnson & Johnson at least two months after their first shot.

What the votes mean: The vote brings recommendations for Moderna recipients in line with those who got the Pfizer-BioNTech vaccine and opens up opportunities for Johnson & Johnson recipients to get another shot.

The panel did not take a position on whether any vaccine booster was better, and did not recommend giving people the flexibility to mix and match, after the Food and Drug Administration (FDA) amended its emergency use authorization to permit mix-and-match booster doses. The panel was not able to express a preference for people using a different brand for a booster, but they asked CDC to give more details in clinical guidance. So mixing and matching will be allowed, but there wasn't an official recommendation.

FDA OKs mixing COVID vaccine boosters, backs Moderna, J&J boosters

  FDA OKs mixing COVID vaccine boosters, backs Moderna, J&J boosters The CDC still needs to sign off before booster shots of the Moderna and Johnson and Johnson vaccines become available. A vaccine advisory panel, meeting Thursday, will consider the same expansion of boosters, which would then need approval from the CDC's director. People who got the Pfizer-BioNTech vaccine can already get a booster shot if they meet certain criteria. The Moderna booster dose would be half the original dose, at 50 micrograms, while doses of the other vaccines would remain unchanged. Plenty of booster doses will be available for people who want them, the White House has said.

But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel later this week before finalizing official recommendations for who should get boosters and when. The latest moves would expand by tens of millions the number of Americans eligible for Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna ’s MRNA, -0.18% booster will be half the dose that’s used for the first two shots

The panel also recommended a second shot of the J & J vaccine for all recipients of the one-dose inoculation at least two months after receiving their first. The FDA and U.S. Centers for Disease Control and Prevention ( CDC ) were under some pressure to authorize the additional shots after the White House announced plans in August for a widespread booster campaign. An CDC advisory committee on Thursday will make its recommendations about which groups of people should get the Moderna and J & J boosters , which the agency's director will use to inform her final decision.

What's next: CDC Director Rochelle Walensky will next consider the committee's suggestions before ruling on these boosters.

If she approves the other two booster populations, about 99 million Americans in total will be considered eligible to get a booster. ​​The director generally goes along with the recommendations, but she overruled aspects of the committee's decision in a rare departure on the Pfizer booster.

Read more here.

A MESSAGE FROM CAREQUEST

  Overnight Health Care — Presented by Carequest — Key CDC panel backs Moderna, J&J boosters © Provided by The Hill

'MIX AND MATCH' BOOSTERS COULD POSE LOGISTICAL HURDLES FOR STATES

The CDC is poised to let people get a different booster than their primary shot. Experts say it will give doctors and states flexibility, and smooth over confusing messages over boosters.

However, public health officials have expressed concern about more transient populations, like migrants and the homeless, who received the one-shot regimen of the Johnson & Johnson vaccine. These groups, experts say, may be harder to reach for a second dose.

States are ready to go find those people, but acknowledge it could be difficult.

CDC panel backs Moderna, Johnson & Johnson COVID-19 vaccine boosters

  CDC panel backs Moderna, Johnson & Johnson COVID-19 vaccine boosters A Centers for Disease Control and Prevention (CDC) advisory panel recommended the agency allow Moderna and Johnson & Johnson coronavirus vaccine booster doses to be administered, the latest toward expanding access to extra doses nationwide. The CDC's Advisory Committee on Immunization Practices (ACIP) advised widening booster accessibility to people who initially received Moderna or Johnson & Johnson after the CDC previously approved the Pfizer-BioNTech booster shots for specific populations.

"We very well might miss some of those people in this next round, but we continue to work on ways that we can provide access and messaging, so that you know we are able to connect to people," West Virginia COVID czar Clay Marsh said.

Other medical professionals hope that the federal government issues a more nuanced guidance on mixing booster shots, with a focus on receiving a dose of a person's original series.

Experts said if people need a booster, they may be better off getting the same vaccine as their initial series. But in some places, like nursing homes, access to the original vaccine may not be possible.

Federal officials have been trying to balance the differing and sometimes contradictory messages surrounding the Biden administration's booster campaign. While the administration initially told the public everyone over the age of 18 who wanted a booster could get one, the reality is more complicated.

Read more here.


Video: FDA authorizes J&J and Moderna booster shots ahead of CDC panel meeting (CBS News)

DeSantis to call special session of legislature to fight vaccine mandates

  Overnight Health Care — Presented by Carequest — Key CDC panel backs Moderna, J&J boosters © Provided by The Hill

Florida Gov. Ron DeSantis (R) announced Thursday that he is calling a special session of the state legislature to pass bills aimed at fighting COVID-19 vaccine mandates.

More people are getting boosters right now than first vaccine shots: CDC

  More people are getting boosters right now than first vaccine shots: CDC The number of Americans getting their booster shots is outpacing those who are getting their first vaccine dose, according to new data released by the Centers for Disease Control.According to the latest data, 189.9 million people are fully vaccinated in the U.S. and 11.6 million people have received their booster dose since it was authorized in August.An average of roughly 340,000 people are getting a booster shot on a daily basis, compared to a daily average of 157,605 who received their first vaccine shot for the week ending Tuesday, government data shows, according to The Washington Post.

DeSantis has been in an escalating clash with the Biden administration over vaccine mandates.

Earlier this month he announced that he planned to sue over the requirements and he said at a press conference on Thursday that he also wants to enact protections for workers against employers' vaccine mandates through legislation.

"In Florida, your right to earn a living is not contingent upon whatever choices you're making in terms of these injections," DeSantis said.

Among several ideas he floated: "If anyone has been forced to do an injection and has an adverse reaction, that business should be liable for that, any damages, you have to do it because that's on them, it wasn't an individual choice."

Many health experts have praised COVID-19 vaccine mandates as a key step in getting more people vaccinated after voluntary efforts like incentives hit a ceiling, and have pointed to the track record of millions of shots given already to show the vaccines are very safe and effective.

"When the vaccines first came out, we worked very hard to provide it, particularly to our elderly, but we said from day one: we will make it available for all, but we will mandate it on none because ultimately we want individuals to make the determinations about what is right for them," DeSantis said.

Big picture: Republicans across the country have fought back against vaccine mandates. In September, every GOP senator voted for an amendment to block Biden's regulation on businesses.

Read more here.

GOP SENATORS CALL ON BIDEN TO BACK DOWN FROM VACCINE MANDATES

Overnight Health Care: Moderna says booster likely needed before winter | Fauci: Booster shots for immunocompromised 'very high priority' | Vaccinations rise as cases surge

  Overnight Health Care: Moderna says booster likely needed before winter | Fauci: Booster shots for immunocompromised 'very high priority' | Vaccinations rise as cases surge Welcome to Thursday's Overnight Health Care. The message from Maryland Gov. Larry Hogan (R): "Just get the damn vaccine." If you have any tips, email us at nweixel@thehill.com psullivan@thehill.com jcoleman@thehill.comFollow us on Twitter at @NateWeixel, @PeterSullivan4, and @JustineColeman8.Today: It's about boosters. Moderna says boosters are likely going to be needed before the winter, and Anthony Fauci indicated the administration is looking to move on the issue at least for one group. Meanwhile, the White House says it hasn't actually decided on a vaccine mandate for incoming foreign travelers.

A group of Republican senators on Thursday sent a letter to the White House calling on President Biden to back down from his COVID-19 vaccine mandate policies.

The senators, led by Dan Sullivan (R-Alaska) and Tommy Tuberville (R-Ala.), said the administration's executive order requiring all federal employees and contractors to be vaccinated, as well as a forthcoming Labor Department rule that will require many companies to implement coronavirus vaccination or testing protocols for their workers, are unconstitutional.

The White House has sought to argue that GOP governors like DeSantis and Texas's Greg Abbott are putting politics ahead of health, while opponents of mandates have cast the White House as abridging personal freedoms and of overreach.

Health experts have praised mandates as an effective way to get people vaccinated, and the White House has fully leaned into them as a way to turn the tide of the pandemic, after initially steering clear of federal intervention.

Not public yet: The Labor Department rule has yet to be published. Groups are racing to meet with the White House to get clarity, and it could be issued at any day. But the delay since the WHite House initially announced it was coming, an durgent, shows how complicated the policy is likely to be.

Read more here.

A MESSAGE FROM CAREQUEST

  Overnight Health Care — Presented by Carequest — Key CDC panel backs Moderna, J&J boosters © Provided by The Hill

Democrats jostle over health care priorities for scaled-back package

House Majority Whip James Clyburn (D-S.C.) is seen before an enrollment ceremony for the Extending Government Funding and Delivering Emergency Assistance Act on Thursday, September 30, 2021. © Provided by The Hill House Majority Whip James Clyburn (D-S.C.) is seen before an enrollment ceremony for the Extending Government Funding and Delivering Emergency Assistance Act on Thursday, September 30, 2021.

Jockeying is intensifying over a range of competing health care priorities as Democrats shrink their social spending package in an attempt to shore up enough support to advance the legislation.

California virus cases stop falling, governor urges caution

  California virus cases stop falling, governor urges caution SACRAMENTO, Calif. (AP) — California Gov. Gavin Newsom rolled up his sleeve Wednesday and received a coronavirus vaccine booster shot, a move he encouraged others to take as the state heads into the time of year that in 2020 ushered in the deadliest spike of COVID-19 cases. Much has changed since then — 88% of those 18 and older in California have received at least one dose of a vaccine that didn’t exist last fall and millions have survived contracting the virus and have a level of natural immunity, though it’s unclear for how long. © Provided by Associated Press Gov.

​​Sen. Bernie Sanders (I-Vt.) is pushing for expanding Medicare to include dental, vision and hearing benefits, saying the provisions are "not negotiable."

But House Majority Whip James Clyburn (D-S.C.) says that expanding Medicaid for low-income people living in the 12 GOP-led states that have so far declined the expansion should take precedence, noting that Medicare includes coverage for "millionaires and billionaires."

Sen. Joe Manchin (D-W.Va.), a key centrist vote, has also expressed concern with expanding Medicare benefits, saying he wants to shore up the finances of the current Medicare program before expanding it.

Speaker Nancy Pelosi (D-Calif.), meanwhile, has prioritized a third health care move: extending enhanced financial assistance to help people afford premiums under the Affordable Care Act (ACA), a key part of her legacy.

With the overall size of President Biden's Build Back Better package shrinking, Democrats are searching for ways to fit in all of the health care priorities, leading to tensions in the party over the differing initiatives.

Democrats are discussing making the Medicare, Medicaid and ACA provisions all temporary as a way to save money and avoid completely eliminating any one of them. But even with this approach, lawmakers have indicated there are still contentious debates that need to be worked out.

Read more here.

WHAT WE'RE READING

    • WHO estimate: 115,000 health workers have died from Covid-19, as calls for vaccine access grow (Stat)
    • Moscow is going back into lockdown as Covid-19 deaths multiply in Russia (CNN)
    • UK PM says sticking with current plan for COVID-19 despite high case numbers (Reuters)

STATE BY STATE

  • As COVID rages on Rikers, staffing crisis delays vaccine mandate for jail staff (Gothamist)
  • DC's Harllee Harper is using public health tools to prevent gun violence. Will it work? (Kaiser Health News)
  • New study reveals why Provincetown did not become a COVID super-spreader event (Boston Globe)

OP-EDS IN THE HILL

  • To vaccinate America's children equitably, utilize community leaders

That's it for today, thanks for reading. Check out The Hill's healthcare page for the latest news and coverage. See you Friday.

California virus cases stop falling, governor urges caution .
SACRAMENTO, Calif. (AP) — California Gov. Gavin Newsom rolled up his sleeve Wednesday and received a coronavirus vaccine booster shot, a move he encouraged others to take as the state heads into the time of year that in 2020 ushered in the deadliest spike of COVID-19 cases. Much has changed since then — 88% of those 18 and older in California have received at least one dose of a vaccine that didn’t exist last fall and millions have survived contracting the virus and have a level of natural immunity, though it’s unclear for how long. © Provided by Associated Press Gov.

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