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Expect a bumpy ride this week when FDA advisers consider Covid-19 booster shots

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Nine months later, these counselors meet to discuss booster vaccinations and the situation is very different.

It won’t be a slam dunk.

When this advisory committee meets on Friday it will be presented with duel data, some suggesting boosters are needed, but other data suggesting there is no such need.

The advisors are also likely to discuss the nature of the Covid-19 boosters – whether they would work and what they are even supposed to achieve.

“It’s going to be a lot more chaotic than December,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University. Schaffner has followed the FDA’s deliberations closely as he serves on an advisory committee to the United States Centers for Disease Control and Prevention that will review the booster if the FDA approves Pfizer’s application.

To further complicate matters, the booster controversy has gotten political and even a little bitter.

Last month, President Joe Biden announced his administration’s intention to launch a booster program and even cited a specific schedule: the week of September 20. That aroused the ire of scientists who say the president had before the FDA and the CDC did their assessments.

Two FDA vaccine experts announced plans to leave the agency, while speculation the president’s announcement was a reason. On Monday, these FDA staff – two of the agency’s top vaccine experts – co-authored an article saying the data does not currently appear to support the need for booster vaccinations for the general public. It was an unexpected move as FDA staff are usually publicly silent about drug and vaccine applications.

Schaffner, an infectious disease expert at Vanderbilt University, was looking for the right word to explain the whole circumstances of Friday’s meeting.

“It’s – well, unconventional,” he said.

Are boosters needed at all?

An August panel of experts officially known as the FDA’s Advisory Committee on Vaccines and Related Biological Products will meet on Friday. Most of them are academic medical researchers and advise the FDA on approving new drugs and vaccines. Usually the agency takes their advice.

One of your first questions will likely be: Do we even need boosters? Maybe two syringes of Pfizer’s vaccine are enough?

Three separate articles published last week in the CDC’s Morbidity and Mortality Weekly Report suggest we don’t need boosters.

Two outgoing FDA executives among scientists who say Covid-19 vaccines currently show no need for a refresherAll three studies essentially concluded that the two doses did a good job of preventing people with Covid-19 from ending up in the hospital well into the summer. One study looked at data from 13 states and counties, another looked at data from nine states, and the third looked at data from five Veterans Affairs medical centers. With that in mind, a study in Qatar found that protection from hospitalization and death lasted for at least six months after the second dose. On the other hand, an Israeli study found that the power of vaccines to save people from contracting Covid-19 decreased over time. Looking at diseases in the second half of July, this study found that those who received their second dose of the Pfizer vaccine in March were 70% better protected from serious illnesses than those who received their second vaccination in January.

Many whimsical debates await on Friday about the strengths and weaknesses of each of these studies.

“We are using multiple sources of data to make this decision and they are only different from each other,” said Dr. Eric Rubin, Advisory Committee Member and Infectious Disease Expert at Harvard. “Some are better than others and everyone asked different questions, so there are a lot of comparisons between apples and oranges.”

What will Pfizer say?

Pfizer is expected to present three types of data at Friday’s meeting.

The first will show that antibodies to Covid-19 decreased over time after people received their second dose, and that a third dose increased antibodies about six months later.

This won’t necessarily impress the consultants. Dr. Paul Offit, one of the committee members, argues that antibodies are often broken down in the months after vaccination and that other parts of the immune system with better “memories” then step in to protect against the virus.

The booster introduction of the Biden administration on September 20 could initially be reduced to the Pfizer Covid-19 vaccine

The second set of data will be the Israeli study, which suggests that, over time, two shots of the vaccine were no longer as effective at keeping people out of the hospital.

The third set of data looks at whether a third syringe will help keep people away from the hospital.

Two countries – Hungary and Israel – have a major booster program under way. Israel has data showing that people over 60 who received a booster vaccination are more than ten times less likely to get seriously ill with Covid-19.

Israel has been so badly hit by a booster program that it hasn’t even waited for the FDA and CDC to weigh up whether it’s a good idea.

“I think there was a different sense of urgency in the two countries,” said Dr. Ran Balicer, Chairman of the Israel National Advisory Board on Covid-19. “We could have followed [the FDA] But in the situation we found ourselves in, it was clear that there was an urgent need for action. Decisions had to be made. ”

Two Israeli scientists are expected to present data at the advisory meeting on Friday.

Friction with the Biden administration

All this scientific back and forth will take place against the background of friction between committee members and the Biden administration.

FDA advisors told CNN that they don’t like that Biden announced a booster program even though the FDA and CDC did not consider a potential booster program.

“They completely undermined the process. They marginalized the FDA and marginalized the CDC,” Offit said. “You just can’t do it the way they did.”

Schaffner added that the action by the Biden government came as a surprise to doctors and scientists.

He compared it to when President Donald Trump suggested certain approaches such as the drug hydroxychloroquine as treatment options for Covid-19 last year, even though no studies had been conducted.

What Trump did “deeply angered the people,” said Schaffner, and “that something like this would not happen in the current administration was not to be expected.”

Rubin, Harvard’s infectious disease expert and FDA vaccine advisor, said he and his colleagues would not care what Biden said.

“I think it’s really important to point out that none of us work for the president directly, and what the president says doesn’t really affect our vote,” Rubin said in committee. “I feel that very strongly.”

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Pandemic

5 things to know for September 27: Covid-19, Congress, Germany, immigration, Huawei

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The best photos from the 2021 Tony Awards

Kristin Chenoweth and Idina Menzel play a duet.

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James Monroe Iglehart and Lin-Manuel Miranda watch backstage.

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Freestyle Love Supreme will perform during the finals.

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Jared Grimes and Daniel J. Watts dance on stage.

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Leslie Odom Jr. and Nicolette Robinson play a duet.

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Enter TITUS BURGESS and ANDREW RANNELLS.

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Spectators wear face masks during the 74th Annual Tony Awards.

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Bill Damaschke, left, and Carmen Pavlovic accept the award for the best musical for “Moulin Rouge! The Musical” by Chita Rivera and Sir Andrew Lloyd Webber.

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Chita Rivera and Sir Andrew Lloyd Webber present an award.

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Enter Leslie Odom, Jr. and Josh Groban.

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Brian Stokes Mitchell appears during an in-memoriam segment.

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From the left, Matthew López, Hunter Arnold and Tom Kirdahy accept the award for the best piece for “The Inheritance”.

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From left, Katie Kresek, Justin Levine, Matt Stine and Charlie Rosen embrace backstage after winning the award for best orchestration for “Moulin Rouge! The Musical”.

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Enter Ben Platt and Anika Noni Rose.

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Kenny Leon accepts the award for the best revival of a piece for “A Soldier’s Play”.

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John Legend, right, appears with the cast of “Ain’t Too Proud”.

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Anika Noni Rose walks in front of the Winter Garden Theater.

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David Byrne plays a song from “American Utopia”.

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Mary-Louise Parker accepts the award for the best performance by an actress in a leading role in a play for “The Sound Inside”.

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Stephanie J. Block and Jesse Tyler Ferguson speak on stage.

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Adrienne Warren accepts the award for the best actress in a leading role in a musical for “Tina – The Tina Turner Musical”.

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Jennifer Holliday will appear at the 74th Annual Tony Awards at the Winter Garden Theater in New York on September 26, 2021.

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Jenny Steingart and Anthony Veneziale receive a Special Tony Award for “Freestyle Love Supreme”.

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Aaron Tveit accepts the award for the best performance by an actor in a leading role in a musical for “Moulin Rouge! The Musical”.

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Andrew Burnap accepts the award for Best Performance by an Actor in a Leading Role in a play for “The Inheritance”.

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Wendell Pierce and Debra Messing speak on stage.

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Jennifer Nettles appears on stage.

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Sonya Tayeh accepts the award for the best choreography for “Moulin Rouge! The Musical”.

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Lin-Manuel Miranda speaks on stage.

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Ali Stroker appears on stage.

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Daphne Rubin-Vega speaks on stage at the 74th Annual Tony Awards.

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David Byrne, left, accepts a Special Tony Award for “American Utopia”.

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Presenter Audra McDonald opens the show.

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Perform on stage from left: Darlene Love, Matthew Morrison, Marissa Jaret Winokur, Chester Gregory and Kerry Butler.

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Matthew Morrison snaps a photo of the red carpet arrivals.

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Kathryn Gallagher, left, and Peter Gallagher.

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Chester Gregory

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The cast of “American Utopia”.

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Stephane San Juan, Angie Swan, Tendayi Kuumba and Jacquelene Acevedo take a selfie together.

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Guests arrive for the 74th Annual Tony Awards at the Winter Garden Theater.

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Pandemic

US has enough COVID-19 vaccines for boosters, kids’ shots

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Thanks to the robust supply in the US, President Joe Biden was able to promise an additional 500 million Covid-19 vaccinations from Pfizer this week to share with the world, doubling the United States’s global contribution. Relief groups and health organizations have urged the United States and other countries to improve access to vaccines in countries where even the most vulnerable have not had a chance.

One of the challenges that countries face is not to order too many cans and to leave them unused. Several states with low vaccination rates, including Idaho and Kansas, have reported throwing away thousands of expired doses or having difficulty using vaccines that are about to expire this fall.

While most vaccines can be left unopened on the shelf for months, the clock starts ticking as soon as a vial is opened. According to the US Food and Drug Administration, vaccines can only be used for six to 12 hours, depending on the manufacturer.

Moderna vaccines are available in 11 to 15 dose vials. Pfizer vials contain up to six doses and Johnson & Johnson vials contain five doses.

“We will see more cans that go unused over time,” said Wisconsin Health Secretary Karen Timberlake. “They come in multidose files. They don’t come in nice, neat individual portion packs. “

State health officials said they tried to request only what health care providers and pharmacies expect from federal supplies. Those numbers have declined since vaccines became generally available in the spring.

But US officials – hoping some of the unvaccinated people will change their minds – are trying to keep enough vaccines on hand for all Americans to get.

This balancing act is difficult and can cause dismay around the world as the US is sitting on unused vaccines while many countries in places like Africa cannot get enough vaccines.

“Someone who sits in a country with few resources to access vaccines and sees people in the US go to a pharmacy and get that vaccine and decide against it, it is bound to cause grief,” said Jen Kates, senior vice president and Director of Global Health and HIV Policy for the Kaiser Family Foundation.

Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, which represents health officials in all 50 US states, the District of Columbia and the US territories, said officials expect the available doses of COVID-19 vaccines and manufacturers’ ability to supply more will meet demand across the country.

“I think states have tried to plan as if everyone were being offered a refresher,” he said, suggesting that they were over-prepared for closer recommendations from the FDA and the Centers for Disease Control and Prevention.

California, for example, estimated earlier this month that it would need to deliver an additional 63 million doses by the end of 2022 – if initial vaccinations were approved for children under the age of 12 and boosters were open to everyone.

U.S. health officials late Thursday advocated booster shots of the Pfizer vaccine for all Americans aged 65 and over – along with tens of millions of younger people at higher risk from the coronavirus because of health conditions or work.

California has the lowest transmission rate of any state with nearly 40 million residents, and nearly 70% of eligible residents are fully vaccinated. This means that almost 12 million people are not or not fully vaccinated.

Dr. California Health Secretary Mark Ghaly said the state will rely largely on pharmacies and family doctors to provide refresher courses to seniors, while some large counties and health groups will use mass vaccination sites.

In Pennsylvania, more than 67% of residents over 18 are fully vaccinated. Acting Health Secretary Alison Beam said health officials now have “two missions”: continuing to convince people to get vaccinated and serving those who want a booster or initial vaccination.

“Pennsylvania is being prepared,” said Beam. “And we will have the right levels of vaccines and vaccinees to meet that demand.”

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Pandemic

0 deaths, 282 new cases of COVID-19 in ND, active cases statewide are 3,448

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The North Dakota Department of Health on Sunday morning confirmed 282 new cases of COVID-19 in the state during testing on Jan.

The number of currently active COVID-19 cases in the state is 3,448 as of September 25, 242 fewer than on September 24.

The last time active positives were this high was December 10, 2020 when 3,896 active cases were reported.

Active positive results peaked on November 13, 2020 at 10,409. By July 5, they dropped to 120, but have risen steadily since then.

Of the 282 new positive results on September 25th:

  • 58 were in Burleigh County
  • 46 were in Cass County
  • 29 were in Stark County
  • 24 were in Ward County
  • 20 were in Morton County
  • 19 were in Williams County
  • 12 were in McKenzie County

No deaths were reported on September 25. The North Dakota Department of Health says it is no longer providing public information on COVID-19 deaths by gender, age and location.

So far, a total of 1,604 people have died as a result of COVID-19 in North Dakota.

According to official death records, 1,312 of these are directly attributable to COVID-19. In another 277 deaths, COVID-19 is not the leading cause of death. A total of 15 death registers are pending.

Recoveries and active cases

The health department reports that 124,420 people of the 129,472 positive cases are considered recovered, an increase of 567 people from September 24th.

The number of people reported recovering from COVID-19 on September 25 (567) is higher than the number of new COVID-19 cases reported that day (282).

Hospital stays

130 people are currently hospitalized on September 25 due to COVID-19, 10 more than on September 24. A total of 5,134 people have been hospitalized since records of the pandemic began in March 2020.

Breakthrough infections and hospitalizations

As of September 25, the total number of North Dakotans fully vaccinated was 336,166. A total of 544 people who were fully vaccinated tested positive for COVID-19.

A total of 16 people who were fully vaccinated and tested positive for COVID-19 were hospitalized.

More information about this data can be found directly on the NDDoH website by clicking here.

Reinfections

As of September 25, there have been 500 reinfections with COVID-19 since June 27, 2021. The NDDoH does not report whether these people who received reinfection were vaccinated.

Other dates

COVID-19 cases have been reported in all 53 North Dakota counties since the persecution began.

Those aged 20 to 29 have the most positive cases among those tested so far.

According to the data, 65 percent of all North Dakotans have been tested for COVID-19.

The results listed today cover all tests performed the day before.

You can read more about the daily statistics and other information and resources related to COVID-19 on the North Dakota Department of Health website here.

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