International [U.S COVID Vaccine News] CDC to Lift COVID-19 Testing Requirement for international Travelers

[Arkain2K]

6 Things To Know If You're Immunocompromised And Considering A 3rd Shot
August 14, 2021

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People with compromised immune systems who already got two doses of the Pfizer or Moderna vaccines can now get a third shot to boost their protection from COVID-19.

This week's decision by federal health agencies is welcome news to many patients and their doctors who have been calling for this for months.

"I'm really excited," says Pat Beale, 59, of Boise, Idaho, who lives with a liver transplant and takes medicine that suppresses his immune system. He plans to get his third dose within the next week.

Data show that many immunocompromised patients, such as organ transplant recipients and others on immune-suppressing medications, have had weak responses to the initial doses of the vaccine.

For Dr. Marc Boom, who runs Houston Methodist Hospital, the authorization for third shots couldn't have come soon enough for patients in his hospital's large transplant program.

"We are immediately pulling in those people, getting them the doses," Boom says. He applauds the FDA's decision, but says the agency could have acted faster, noting that countries like Israel, France and the U.K. have already made this move.

Friday's recommendations from the Centers for Disease Control and Prevention leave some questions about exactly who is eligible for an additional dose and how to get it. Here's what we know so far.

1. Why should immunocompromised people get a third shot?

Having a compromised immune system puts you at higher risk of severe illness and death from COVID-19. Studies show that the initial vaccine doses are less effective for people with weakened immune systems, ranging from 59% to 72%, compared to 90% to 94% among people without serious immune deficiencies.

People with conditions that weaken the immune system are also far more likely to have a breakthrough infection than people in more normal health. One U.S. study shows 40% to 44% of hospitalized breakthrough cases are in immunocompromised people.

"If I was someone who was on one of the medications that was on the CDC list, you know, I would almost consider myself unvaccinated at this point," says Dr. David Karp, who heads the Division of Rheumatic Diseases at UT Southwestern Medical Center.

Karp says that even though the current delta surge has mostly hit unvaccinated people, vaccinated but immunosuppressed patients are also landing in hospitals with COVID-19.

"For this group of patients, you know, a third shot is going to improve their response to the vaccine and therefore lessen their chances of either contracting the disease or having a more serious disease," says Karp, who is also president of the American College of Rheumatology.

For patients like Valen Keefer, who is a liver and kidney transplant recipient in California, knowing there's a way to get a third shot is a relief.

"This is an amazing and such an important step and needed for a while for our transplant community," she says. "It's just been so hard to know what to do and when to do it."

2. Who should get third shots?

Only a very small group of people with weakened immune systems qualify for the third dose. The CDC is recommending it for moderately to severely immunocompromised people, including those who have:

• Been receiving active cancer treatment for tumors or cancers of the blood
• Received an organ transplant and are taking medicine to suppress the immune system
• Received a stem cell transplant within the last two years or are taking medicine to suppress the immune system
• Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
• Advanced or untreated HIV infection
• Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response

The recommendation is limited to adults 18 and older for the Moderna vaccine because that vaccine has not been authorized for adolescents as of yet. The Pfizer vaccine is authorized for adolescents 12 and older, and adults.

3. I don't know if I'm immunocompromised but I do have a chronic disease that makes me vulnerable to severe COVID-19 — should I be getting a third shot?

Many people may consider themselves at higher risk of serious illness from COVID-19 due to age or a pre-existing condition, and may want another dose of vaccine. But, for now, an additional shot is only recommended for people who meet the CDC's criteria for being immunocompromised.

People with other chronic conditions — even those that put them at higher risk for severe COVID-19 — are not authorized to get an additional dose at this point.

"This would not include long-term care facility residents, persons with diabetes, persons with heart disease — those types of chronic medical conditions are not the intent here," said Dr. Amanda Cohn at Friday's CDC committee meeting.

It's not clear yet whether or when a booster will be recommended more broadly to vulnerable populations, though this is already underway in other countries including Israel. Health officials are currently tracking how well immunity holds up in people enrolled in the vaccine clinical trials. Those trials will determine timing of booster shots, officials of both the FDA and CDC say.

4. Can I just sign up to get the shot or should I talk to my doctor first? And do I have to prove I'm immunosuppressed?

Start by talking with the health care provider you see for your immune-suppressing condition or its treatment. A doctor's note is not likely to be required at vaccine sites — a person just needs to inform the staff that they are moderately to severely immunocompromised. However, it's best to get your doctor's input before getting the shot, says Dr. Dorry Segev, a transplant surgeon and researcher at Johns Hopkins University who has been studying COVID-19 vaccination among organ transplant recipients.

He says that your doctor can help you determine if the benefits of getting a third shot outweigh any risks in your particular case. "My hope is that this will be an individual patient-provider shared decision," he says.

For people with compromised immune systems, "every time we activate the immune system, there is a risk," Segev cautions. For instance, transplant recipients could risk rejection of the organ. "These things need to be done in a very careful, deliberate, thoughtful way with people's medical teams," he says.

For patients with certain conditions, it may be necessary to pause their immune-suppressing medications temporarily to let the third dose of the vaccine take effect, explains Karp. So talk to your doctor about your situation and how to increase your chances of having the vaccine be effective.

5. If I get a third shot, how good is the protection?

There are many different reasons people can be immunosuppressed — it's often a combination of their age, their medical conditions, what treatments and drugs they're taking. While studies show that a third vaccine dose can boost antibody responses in some people, it's not universally guaranteed to work.

Immunocompromised people who get a third shot should still be aware they're not necessarily safe from COVID-19, warned Dr. Helen Keipp Talbot during the ACIP committee meeting.

"I think the reality is they'll be safer, but still at an incredibly high risk for severe disease and death." And everyone they spend time with also needs to be vaccinated, to protect them, Talbot says.

In a presentation to the committee, the CDC's Dr. Kathleen Dooling said immunocompromised people, including those who receive an additional dose, should continue to follow prevention measures, including wearing a mask, staying six feet apart from others they don't live with and avoiding crowds and poorly ventilated indoor spaces. And she also urged close contacts of immunocompromised people to get vaccinated if they're not already.

6. Do I need to get the same vaccine I got for my first two doses? And what do I do if I got the J&J vaccine?

The CDC recommends you get the same vaccine you got for your first two doses, so if you got the Pfizer or Moderna the first two doses, get that one for your third shot. But if that is not feasible, the CDC committee said an additional dose with the other mRNA vaccine is permitted.

Currently only the Pfizer and the Moderna vaccines are authorized for an additional dose. If you got the J&J, you still aren't eligible.

The FDA says that there wasn't enough data available to extend the authorization for an additional dose for the J&J shots. Representatives of both the FDA and the CDC said that they are "actively engaged" to determine the best course of action for recipients of the Johnson & Johnson vaccine and expect to know more "very shortly."

https://www.npr.org/sections/health...-immunocompromised-and-considering-a-3rd-shot

 

[Queen B]

Its really starting to look like the waning antibodies are the suspect in Israels case, the need for boosters

 

[Arkain2K]

UK regulator approves Moderna COVID-19 shot for 12 to 17-year-olds
By Yadarisa Shabong and Manas Mishra | August 17, 2021

The UK's health regulator has approved Moderna's COVID-19 vaccine for use in children aged 12 to 17 years, it said on Tuesday, weeks after Pfizer's shot was given the green light for deployment ahead of schools reopening.

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed the vaccine, known as Spikevax, is safe and effective in this age group, it said.

While most children develop mild or no symptoms with COVID-19, they are still able to spread the virus and some remain at risk of becoming seriously ill.

Moderna's vaccine was recommended for use in adolescents by European regulators in July and is awaiting U.S. authorisation. It is already approved for people over the age of 18 in the UK.

Britain's Joint Committee on Vaccination and Immunisation (JCVI) gave the go ahead on Aug. 4 for 16 and 17-year-olds to get their first dose of Pfizer's COVID-19 vaccine ahead of the reopening of schools for the new education year in September. read more

JCVI will make a decision on whether 12-17 year olds should be vaccinated with the shot made by Moderna as part of its deployment programme.

The MHRA said it did not identify any new side effects with the vaccine and that the safety data was comparable with that for young adults, with adverse events being mostly mild and moderate and including sore arms or fatigue.

The highly infectious Delta variant of the coronavirus has become the dominant type globally, sustaining a pandemic that has killed over 130,000 in Britain.

The vaccine developed by Pfizer Inc and German partner BioNTech's got MHRA's nod for use in children aged 12 to 15 on June 4.

https://www.reuters.com/world/uk/uk...rna-covid-19-shot-12-17-year-olds-2021-08-17/

 

[Queen B]

Official CDC Breakthrough Report is out

Nothing we didnt know.

Vaccines are around 50-70% effective in preventing Delta cases (vs 70% against other Covid), but 95% effective against hospitalizations

 

[Arkain2K]

Ah, I don't like this. Not only that it's not yet necessary at this point, but it's certainly going to greatly affects the global vaccine supply as well.

Biden: Booster shot for Pfizer and Moderna vaccines will be available for all adults on Sept 20
COURTNEY SUBRAMANIAN | USA TODAY | August 18, 2021

WASHINGTON – The Biden administration on Wednesday unveiled plans to begin offering COVID-19 booster shots on Sept. 20 for American adults who received the Pfizer or Moderna vaccines as cases of the highly contagious delta variant continue to spread across the country.

The U.S. will provide a third shot to Americans who received their second vaccine dose at least eight months ago, pending authorization from the U.S. Food and Drug Administration.

President Joe Biden announced the decision – along with a series of measures to boost vaccination rates at nursing homes and thwart states' plans to block mask mandates in schools – in remarks at the White House.

"This will boost your immune response. It will increase your protection from COVID-19," Biden said. "That's the best way to protect ourselves from new variants that could arise."

While mRNA vaccines like Pfizer and Moderna continue to be effective in reducing risk of hospitalization and death, federal officials said new data shows the vaccines' effectiveness decreases over time.

"Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout," top U.S. health officials said in a joint statement. "For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability."

People who received the single-dose of Johnson & Johnson vaccine will likely also need an extra shot, but officials said they're still collecting data as the federal rollout of the vaccine did not begin in the U.S. until March.

The initial doses will go to those who were fully vaccinated earliest in the vaccine rollout, including health care providers, nursing home residents and other seniors. The administration plans to also begin delivering booster shots directly to residents of long-term facilities, according to a joint statement by top U.S. public health officials including CDC Director Rochelle Walensky, FDA Acting Commissioner Janet Woodcock, U.S. Surgeon General Vivek Murthy and Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases.

The announcement comes as the delta variant now accounts for more than 98.8% of U.S. cases, according to the Centers for Disease Control and Prevention.

The CDC also released three studies Wednesday that Walensky said informed their booster decision, showing that while mRNA vaccines remain effective against hospitalization from the virus, protections against infection begin to wane after time.

The booster shots will be offered to fully vaccinated Americans aged 18 years and older, Murthy told reporters. He said officials are waiting on FDA review before providing guidance on vaccinated people between the ages of 12 and 17.

The shots will also be free, regardless of health insurance or immigration status, White House COVID-19 response coordinator Jeff Zients said.

Biden's remarks come less than a week after the CDC issued a recommendation for booster shots for some immunocompromised people, or about 3% of the U.S. population.

Biden pushes back on global criticism
The president and other administration officials contend the U.S. has enough supply to offer a third shot to Americans while also keeping its commitment to donate doses to low-income countries still struggling to inoculate their populations. But global health advocates argue the booster plan only exacerbates an inequity gap.

Earlier this month, WHO Director-General Tedros Adhanom Ghebreyesus called for a moratorium on booster shots in order to allow poorer countries to catch up.

Sarah Swinehart, senior director of communications for The ONE Campaign said the decision to offer boosters "will further exacerbate global vaccine inequities and prolong the pandemic at home and abroad."

"It’s outrageous that a healthy, vaccinated individual will be able to get a third shot before the elderly and health workers in low-income countries can get a single dose," she said. "The fact that the US and other wealthy countries are in need of booster shots is an indictment of the world’s failure to have a global plan to end this virus."

Biden acknowledged the U.S. needs to balance offering booster shots against its campaign to get more people vaccinated at home and abroad.

"We can take care of America and help the world at the same time," he said.

While the administration expects to administer 100 million booster shots to Americans in the coming months, Biden said the U.S. will donate more than 200 million additional doses to other countries – part of a pledge to donate more than 600 million vaccines worldwide.

The U.S. announced earlier this week that it is shipping its first batch of the 500 million Pfizer COVID-19 doses Biden pledged to purchase and donate to countries around the world. Nearly 500,000 doses of Pfizer were shipped Rwanda through the global sharing vaccine alliance known as COVAX.

New CDC studies
Walensky cited three studies published in the CDC's Morbidity and Mortality Weekly Report on Wednesday that helped convince health officials a third dose would be required in the coming months.

The trio of reports show the vaccines' effectiveness declined during the summer months, amid a rise in cases of the delta variant. The drop in effectiveness varies depending on the cohort, but the data consistently demonstrates a reduction.

A study of 10 million New Yorkers found effectiveness decreased from 92% in May to about 80% in late July, Walensky said. Data from Mayo Clinic Health System facilities showed the Pfizer-BioNTech vaccine’s effectiveness declined from 76% to 42% and Moderna's declined from 86% to 76%, she added.

Plus, reports from thousands of nursing homes showed effectiveness dropped from 75% in March to 53% on Aug. 1 among the most vulnerable populations during the months when delta was the dominant strain, she said.

But an analysis of patients at 21 hospitals in 18 states found "sustained high protection from severe COVID-19 requiring hospitalization" through July.

https://amp.usatoday.com/amp/8178505002

 

[Arkain2K]

U.S. to require nursing homes get staff fully vaccinated or lose federal funding
PUBLISHED WED, AUG 18 2021

U.S. officials plan to withhold federal funding from nursing homes that don't fully vaccinate their employees against Covid-19, a Biden administration official confirmed Wednesday to NBC News.

The new policy, which would withhold Medicare and Medicaid funding to nursing homes that don't comply, could take effect as early as next month, the official said, though the timing is fluid. It would impact about 15,000 nursing homes, which employ more than 1.3 million people nationwide.

The move comes as the highly contagious delta variant drives a surge in new cases nationwide, and federal officials say they are starting to see evidence of waning vaccine protection against mild and moderate disease.

Nationally, about 60% of nursing home staff are vaccinated – much lower than the 82.4% of residents who have gotten the shots, according to data compiled by Centers for Medicare & Medicaid Services. In some states, the percentage of nursing home staff who are vaccinated is even lower.

Some medical experts have asked the U.S. government to pressure nursing homes to vaccinate their staff, saying the unvaccinated employees put older residents – who are more likely to get severely ill or suffer from a so-called breakthrough infection – at greater risk.

"We need to go faster. That's why I'm taking steps on vaccination requirements where I can," President Joe Biden said at the White House Wednesday afternoon in a speech on Covid.

"This is no time to let our guard down," Biden said. "We just need to finish the job, with science, with facts and with confidence."

Earlier in the day, federal health officials announced they plan to make booster shots available to most Americans beginning the week of Sept. 20. They said it is "very clear" that immunity starts to fall after the initial two doses, and with the dominance of the delta variant, "we are starting to see evidence of reduced protection against mild and moderate disease."

"Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout," according to the statement signed by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci and other U.S. health leaders.

Nursing home residents, health-care providers and the elderly — the first groups to get vaccinated in December and January — are likely to be prioritized to get extra shots, according to National Institutes of Health Director Dr. Francis Collins.

https://www.cnbc.com/amp/2021/08/18...aff-get-shots-or-lose-government-funding.html

 

[genecop]

 

[Arkain2K]

mRNA booster shots are coming in the fall — but what about people who got the J&J Covid vaccine?
By Cory Stieg | Aug 18 2021

The United States is launching a new distribution program for Covid-19 booster shots — and if you're one of the nearly 14 million people who got the one-shot Johnson & Johnson vaccine, you probably have a few questions.

On Wednesday, top U.S. health officials — including CDC Director Dr. Rochelle Walensky and White House chief medical advisor Dr. Anthony Fauci — said booster shots will become available next month, citing data suggesting that vaccine-induced protection from the virus wanes over time. People who received two doses of an mRNA vaccine from Pfizer or Moderna are now eligible for a booster shot eight months after their last dose. Notably absent: a recommendation for anyone who received the J&J vaccine.

More data on whether or not J&J recipients will need boosters — and if so, what kind of vaccine — is expected in the coming weeks. "With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well," the U.S. Department of Health and Human Services said in a statement Wednesday.

But with Covid's delta variant surging, J&J recipients may feel a sense of urgency, and a need for answers sooner rather than later. Conflicting information is already running rampant: While the U.S. Food and Drug Administration is expected to evaluate the efficacy of a second J&J shot later this month, some infectious disease experts are already recommending a booster shot from one of the two approved mRNA vaccines.

"Patients cannot wait for perfect data," Dr. Leana Wen, an emergency physician and public health professor at George Washington University, tells CNBC Make It. "People who need additional protection now need to be given the option."

If you got the J&J vaccine and are wondering what to do, here's what experts want you to know:

Should you try and find a mRNA vaccine if you got J&J?

Determining whether or not you need a Covid booster is "a complex decision that takes into account your medical history, your family circumstances and who you're live with your Covid-19 exposures, as well as your risk tolerance," Wen says. An mRNA booster shot, for example, could lead to stronger side effects for some people, compared to their initial vaccinations. You should talk to your clinician or primary care doctor about your own personal circumstances before doing anything, Wen notes.

Some people may already be jumping the gun. CDC data indicates that millions of people went ahead and received an additional dose of Covid vaccine, "through some finagling of the system," despite the official recommendation, says Dr. William Schaffner, a professor of infectious diseases at the Nashville-based Vanderbilt University Medical Center. "Some of those undoubtedly are J&J vaccine recipients."

In San Francisco, it's already above-board: J&J recipients can request to get a supplemental dose of an mRNA vaccine.

The FDA is expected to grant full approval for the Pfizer and Moderna vaccines this fall, though the exact timeline is unclear. That would allow physicians and healthcare providers to prescribe mRNA boosters for people with immunocompromising health conditions, a potential boon for many who got the J&J shot. "That is really what needs to happen in this case: Clinicians need to be able to exercise their judgment in order to recommend what is best for their patients," Wen says.

How other countries are handling mix-and-match boosters

The J&J vaccine is a viral vector vaccine, which works by using a harmless version of a different virus, called a "vector," to deliver information to the body that helps it protect you, according to the CDC. That makes it is very similar to the AstraZeneca/Oxford vaccine, which is currently in use in Europe, the United Kingdom and Brazil — but not yet approved in the U.S.

Some countries, such as Germany and the U.K., are routinely giving doses of mRNA vaccines to people who got the AstraZeneca vaccine, Schaffner says, noting that the method seems to be working well with few side effects.

Wen suggests the U.S. will eventually move in a similar direction. "With evidence from other countries about the success of the mix-and-match approach with the AstraZeneca vaccine and Pfizer, it would seem very reasonable for there to be guidance for people who've got the J&J vaccine to get an mRNA booster at this time," she says.

The reason why there's no clear guidance for J&J recipients in the U.S. yet: timing. The mRNA vaccines from Pfizer and Moderna, which use genetic material to teach your cells how to make copies of the coronavirus' spike protein, were greenlit in December 2020 — giving researchers a head start on gathering data about how long protection lasts. The J&J vaccine, on the other hand, only received emergency use authorization in March 2021.

Ultimately, the CDC's Advisory Committee on Immunization Practices has to make a formal recommendation before Americans can consider following suit. "They have not been, what I would call, embracing of the European experience in helping inform what they do," Schaffner says. "Which is not to say they won't do that in the future. They've just been kind of sticklers."

https://www.cnbc.com/amp/2021/08/18...ovid-vaccine-need-to-know-about-boosters.html

 

[Arkain2K]

 

[Arkain2K]

It's unnecessary and immoral for a First World country to offer third shots to all their citizens (rather than just the immunocompromised or 60+) at a time when two shots are proven to be enough to protect against severe infections and hospitalization, while most of the world's population are still waiting for their first dose.

Scientists blast Biden's push for Covid vaccine booster shots as premature
By Berkeley Lovelace Jr. | AUG 19 2021



Scientists sharply criticized the Biden administration's push to widely distribute Covid-19 vaccine booster shots in the U.S. next month, saying the data provided by federal health officials on Wednesday wasn't compelling enough to recommend third shots to most of the American population right now.

U.S. health leaders say they are preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20. The plan, outlined Wednesday by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci and other health officials, calls for a third dose eight months after people get their second shot of either the Pfizer or Moderna vaccines.

They cited three new studies, released by the Centers for Disease Control and Prevention, that showed their protection against Covid diminished over several months. One study in New York from May 3 through July 25 showed that vaccine protection against infection dropped from around 92% to 80%. Another study by the Mayo Clinic showed that Pfizer's vaccine efficacy fell from around 76% to 42% while Moderna's declined from 86% to 76%.

"Taken together, you can see that while the exact percentage of vaccine effectiveness over time differs depending on the cohort and settings study, the data consistently demonstrate a reduction of vaccine effectiveness against infection over time," Walensky told reporters during a White House Covid press briefing.

But scientists and other health experts said the data they cited wasn't compelling, characterizing the administration's push for boosters as premature. While the data did suggest there was a reduction in protection against mild and moderate disease, the two-dose vaccines still held up well against severe disease and hospitalizations, scientists said.

For example, the New York study released by the CDC showed there were 9,675 infections among fully vaccinated adults, compared with 38,505 infections among unvaccinated adults during the period examined. Among the fully vaccinated people who were infected, 1,271 were hospitalized, accounting for roughly 15% of all Covid hospitalizations.

"People are still highly protected against severe disease, hospitalization, and death. This is what vaccines are supposed to do," said Dr. Anna Durbin, a vaccine researcher at Johns Hopkins University. "If we start seeing significant upticks of more severe disease and hospitalizations in vaccinated people, that would be a signal to consider boosters."

The body's immune system is complex, Durbin said. While the presence of antibodies induced by the vaccine may decline, resulting in a rise in breakthrough infections, the body has other mechanisms, like T cells, that may protect someone from getting seriously sick, she said.

"The data are showing that yes, we are seeing breakthrough infections but, the infections are mild or moderate colds," she said.

To be sure, federal health officials said the vaccines are still holding up against severe disease over time, even as their ability to prevent infections declines. They said, based on their latest assessment, "the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout."

There are some groups in the U.S. who would benefit from a third dose right now, according to Dr. Archana Chatterjee, a member of the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee.

Data does support the need for booster doses primarily among those who are moderate to severely immunocompromised, Chatterjee said. Federal health officials on Friday approved giving booster shots to such people – which include cancer and HIV patients and people who have had organ transplants – after data suggested they don't produce an adequate immune response after getting two doses.

As of now, "breakthrough infections in the general public tend to be asymptomatic or mild," she said.

People who are 65 or older or living in a long-term care facility may also benefit from a booster shot, said Dr. Isaac Bogoch, an infectious disease specialist at the University of Toronto,

Israel, a country U.S. officials have also cited in their push for boosters, has begun giving out third doses to the elderly after new data showed a reduction in the effectiveness of Pfizer's Covid vaccine against severe illness among people 65 and older who were fully vaccinated in January or February.

"Do we all need a third dose of a vaccine right now? No, we don't. Do some people need a third dose of a vaccine right now? Yes. Will we need a third dose of a vaccine in the near future? Maybe," Bogoch said in a phone interview.

Dr. Priya Sampathkumar, an epidemiologist at Mayo Clinic, agreed, saying a booster could be needed for the general public in the future, but not right now. "There isn't enough data to support the third booster for all at this point," she said.

Lawrence Gostin, director of the World Health Organization's Collaborating Center on National and Global Health Law, said federal health officials should put their focus elsewhere: the unvaccinated, both in the U.S. and around the world.

Earlier this month, the WHO asked wealthy nations to stop distributing booster shots until at least the end of September to give poorer countries the chance to vaccinate their populations with the first rounds of shots.

Shortly after the U.S. announced its booster plan, the international agency condemned wealthy nations that support boosters for the general public.

"Boosting the entire U.S. population while poor people are dying in poor countries is tone-deaf and is widely viewed as uncaring," Gostin said. "It's also a slap in the face to WHO after it called for a booster moratorium."

U.S. Surgeon General Dr. Vivek Murthy defended the administration's booster plan on CNBC on Wednesday, saying health officials decided to give boosters to the general public at the eight-month mark as a way "to stay ahead of this virus."

"We are making plans now, because number one, you've got to plan ahead, but two, we wanted the public to know what we were seeing the data, in our effort to be transparent and open with the public," Murthy told "The News with Shepard Smith."

During a White House briefing Tuesday, press secretary Jen Psaki said the administration believes it can boost the American population while ensuring the rest of the world gets vaccinated.

"We believe that is a false choice. We can do both," Psaki said, adding that the U.S. is contributing more vaccine doses than any other nation to fight Covid across the globe. "We will continue to be the arsenal for vaccines around the world. We also have enough supply and had long planned enough supply should a booster be needed for the eligible population."

https://www.cnbc.com/amp/2021/08/19/covid-booster-shots-scientists-blast-us-move-as-premature.html

 

[Arkain2K]

As U.S. promotes booster shots against Covid, moral questions arise over vaccine equity
"We're planning to hand out extra life jackets to people who already have life jackets, while we're leaving other people to drown without a single life jacket," a WHO official said.
By Erik Ortiz | August 18, 2021



The announcement Wednesday by top U.S. health officials that booster shots against Covid-19 will be offered to all Americans beginning next month has spurred renewed criticism about existing vaccine inequities and fears that the world's poorer nations will remain unprepared for new and potentially deadlier variants of the coronavirus.

As the Biden administration formally released its plan, officials and scientists with the World Health Organization and other international public health experts forcefully pushed back at it as "immoral" and "unconscionable."

"We're planning to hand out extra life jackets to people who already have life jackets, while we're leaving other people to drown without a single life jacket," Dr. Michael Ryan, the emergencies chief at WHO, told reporters.

Dr. Tedros Adhanom Ghebreyesus, the director-general of WHO, wrote in Time magazine last week that the public health agency supported a global moratorium on Covid-19 booster shots through at least the end of September so that vaccine supplies could be redirected toward immunizing at least 10 percent of the population of every country.

While federal health data shows that about half of the U.S. population is fully vaccinated against Covid-19, global health trackers estimate only 24 percent of the world's population is also fully inoculated, with just 1.3 percent of people in low-income countries having received at least one dose.

"It's unconscionable that some #COVID19 vaccine-producing companies are reporting record profits, and some countries are offering boosters, while so many people remain unprotected," Adhanom Ghebreyesus tweeted Tuesday. "No one is safe until everyone is safe."

Dr. Matshidiso Moeti, the regional director of Africa for WHO, expressed her concern Thursday that the vaccination disparities between richer and poorer countries will only worsen, telling reporters, "as some richer countries hoard vaccines, they make a mockery of vaccine equity.”

Israel said in July that it would begin offering a third shot of the Pfizer-BioNTech vaccine to people over 60.

U.S. health officials, however, believe action is needed now no matter the age group. With the highly transmissible delta variant raging across the country and leading to hospital bed shortages in several states amid evidence that vaccine protection appears to be waning over time, booster doses "will be needed to maximize vaccine-induced protection and prolong its durability," the officials said.

They added that the U.S. still has the capacity to help other nations by increasing efforts to supply vaccines and by "building further on the more than 600 million doses we have already committed to donate globally."

Rochelle Walensky, the director of the Centers for Disease Control and Prevention, addressed the criticism during an interview Thursday on the "TODAY" show that the U.S. appears to be prioritizing already-vaccinated Americans over shipping additional vaccines to other nations.

"I don't think this is a choice in terms of if we have to choose one or the other. We're going to do both and we have been doing both," Walensky said, adding that the U.S. anticipates giving 100 million booster shots by the end of the year, while distributing 200 million vaccines worldwide.

While some public health experts say a booster shot against Covid-19 will probably be warranted at some point, it may be too early to start promoting them for all people without fully understanding how effective they have been.

"Certainly, for individuals who are immunocompromised, it makes sense to get them boosters because they're not necessarily able to respond to the adequate dosing structure," Eleanor Murray, an epidemiologist and assistant professor at Boston University's School of Public Health, said. "But the data is not quite there in terms of how much waning immunity we might be expecting in people, and it's possible the changes in vaccine efficacy may have to do with the changes in behaviors of people."

For instance, Murray said, infection rates began increasing over the summer among vaccinated Americans as mask mandates and social gathering restrictions were lifted and people began traveling and resuming more normal routines.

She has argued that while boosters would "only slightly reduce" how many new people a single person infects with the delta variant, the better strategy would be to expend resources to increase the number of people who are fully vaccinated.

In addition, the virus that causes Covid-19 has already shown that it has been mutating, and epidemiologists worry that with cases of the virus moving and shifting through unvaccinated populations, potentially deadlier and more contagious strains will arise.

"When Covid-19 is uncontrolled and allowed to rip through populations, it has devastating consequences, as we saw in India," Dr. Madhukar Pai, the Canada research chair in epidemiology and global health at McGill University in Montreal, said in an email. "So, when vaccines are not widely available, we will see more and more countries with uncontrolled outbreaks and new variants emerging. This will keep the Covid-19 pandemic going for years."

https://www.nbcnews.com/news/amp/ncna1277092

 

[Krimzon]

suppose they release newer vaccines that fully prevent virus shedding, will folks who got the virus shedding version be required to take the improved vaccine? Or, are the vaccines now, the best edition of the vaccines we'll ever see?

a few antivaxxers i've spoken to expressed this sentiment, and expect new improvements to come out in the future. They think this is some sort of massive trial run lol

 

[Madmick]

July in Wisconsin-- giving an idea of the relative efficacy of vaccines against the Delta variant even after months of decaying strength (as has been shown in other studies):

 

[milliniar]

suppose they release newer vaccines that fully prevent virus shedding, will folks who got the virus shedding version be required to take the improved vaccine? Or, are the vaccines now, the best edition of the vaccines we'll ever see?

a few antivaxxers i've spoken to expressed this sentiment, and expect new improvements to come out in the future. They think this is some sort of massive trial run lol

So do you mean "viral shedding" from the vaccine itself which is a conspiracy and not something that happens.
Or do you mean there is expected to be a vaccine that if you get covid you won't be contagious?

 

[The Audience]

As U.S. promotes booster shots against Covid, moral questions arise over vaccine equity

The announcement Wednesday by top U.S. health officials that booster shots against Covid-19 will be offered to all Americans beginning next month has spurred renewed criticism about existing vaccine inequities and fears that the world's poorer nations will remain unprepared for new and potentially deadlier variants of the coronavirus.

As the Biden administration formally released its plan, officials and scientists with the World Health Organization and other international public health experts forcefully pushed back at it as "immoral" and "unconscionable."

If all of the public health folks are against this why is the administration pushing ahead with it?

 

[Arkain2K]

If all of the public health folks are against this why is the administration pushing ahead with it?

*sigh* I don't want this thread to take a political turn, but the Biden Administration clearly needs a distraction this week.

I'm 100% on board with giving a booster to the immunocompromised and 60+ since that demographic made up most of the severe break-through cases in this wave, but it's so wrong to be wasting millions of bonus doses on our fully-vaccinated general population when the rest of the world is begging for their first dose.

Not to mention it will give the uneducated anti-vaxxers another opportunity to spread fake news about how "vaccines are not effective", despite all the hospitalization data being published weekly across the country that proves them wrong over and over again.

 

[The Audience]

suppose they release newer vaccines that fully prevent virus shedding, will folks who got the virus shedding version be required to take the improved vaccine? Or, are the vaccines now, the best edition of the vaccines we'll ever see?

a few antivaxxers i've spoken to expressed this sentiment, and expect new improvements to come out in the future. They think this is some sort of massive trial run lol

Its hard to imagine how any vaccine is going to be able to guarantee 0% chance of infectious shedding, especially for a virus with such a high replication rate. I was quite interested in the nasal spray vaccines but one of the leading candidates was recently abandoned after seeing poor results.

 

[The Audience]

*sigh* I don't want this thread to take a political turn, but the Biden Administration clearly needs a distraction this week.

I'm 100% on board with giving a booster to the immunocompromised and 60+ since that demographic made up most of the severe break-through cases in this wave, but it's so wrong to be wasting millions of bonus doses on our fully-vaccinated general population when the rest of the world is begging for their first dose.

Not to mention it will give the uneducated anti-vaxxers another opportunity to spread fake news about how "vaccines are not effective", despite all the hospitalization data being published weekly across the country that proves them wrong over and over again.

Apparantly over 1m Americans have already had a 3rd dose , which kind of reflects the situation at the global scale where Pfizer are prioritising lucrative private contracts with high paying states like Israel over wider global distribution.

 

[Arkain2K]

Apparantly over 1m Americans have already had a 3rd dose , which kind of reflects the situation at the global scale where Pfizer are prioritising lucrative private contracts with high paying states like Israel over wider global distribution.

The only American demographic that's authorized by the FDA to get a booster are the people who actually needs it to keep them from being hospitalized, and Biden just take that ball and run with it.

Here's what Biden failed to mention in his presser: he set the Sept 20 date for the roll-out, despite the fact that the FDA has yet to review and approve Pfizer's 3rd shot authorization request for the general population (which was submitted just this Monday), while Moderna hasn't even ask at all.

Talk about doing things backwards, and that's the exact kind of knee-jerk actions by politicians that give rise to fake vaccine news and conspiracy theories among their partisan detractors.

U.S. officials’ decision on Covid-19 booster shots baffles — and upsets — some scientists
By Helen Branswell | Aug. 18, 2021

The Biden administration’s decision to start authorizing third doses of Covid-19 vaccine in September is being met with bafflement, concern, and even anger from a number of immunologists, vaccinologists, and people steeped in the normal way such decisions are made.

Many flat-out challenged the need for booster doses at this time. Others questioned the morality of administering third shots to Americans when most people on the planet haven’t received one. And some worried that a decision had been made before the Food and Drug Administration had ruled on the need for a booster or a key vaccine advisory committee had evaluated the data — typically the way vaccine policy is set.

The government’s top public health officials on Wednesday pointed to data showing that the mRNA vaccines developed by Pfizer-BioNTech and Moderna are no longer protecting as well against mild and moderate Covid-19 infections as evidence that “could” signal a decline in protection against serious disease.

But “could is not a very strong word … especially to make a policy decision on,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s Office of Vaccines, told STAT.

Anna Durbin, a vaccines researcher at Johns Hopkins University, said the vaccines continue to be highly effective in preventing hospitalizations, severe infections, and deaths among most vaccinees.

That they may not work as well over time in preventing mild illnesses among those vaccinated isn’t necessarily a sign the vaccines are failing, said Durbin, who insisted that people are going to need to accept that fact. “We cannot keep [boosting] and say: ‘We’re going to prevent colds in everybody,’ ” she said.

The decision to boost so early in the country’s use of the vaccines isn’t science-based, in Durbin’s view. “I think there’s this tidal wave building that’s based on anxiety. And I don’t think it’s based on scientific evidence that a booster is needed.”

To many experts, including Baylor, the sequencing of the decisions being made is also out of whack. While U.S. health officials said booster shots could start being offered the week of Sept. 20, the Food and Drug Administration has not even ruled yet on Pfizer’s application for approval of a third shot; it was filed only Monday. Moderna hasn’t yet asked the agency to authorize a third shot at all.

At present, the extra dose policy only applies to the Pfizer-BioNTech and Moderna vaccines; people who received the one-dose Johnson & Johnson vaccine continue to wait for guidance about whether they need another dose.

Meanwhile the Advisory Committee on Immunization Practices — which reviews data on vaccines and makes recommendations on their use to the Centers for Disease Control and Prevention — is set to meet next week to look at the data for a third dose. Before Wednesday’s announcement, there was no suggestion a vote might be taken next Tuesday; the group may need additional sessions to address the question.

Surgeon General Vivek Murthy insisted the booster dose program would only go ahead if sanctioned by the FDA and the ACIP, as the CDC advisory committee is known. But the fact that there is a fixed date for the start of the booster program led some to wonder if the outcome had already been decided.

“How did you pick the week of September 20?” asked Baylor. “Since this meeting hasn’t occurred and you don’t know what they’re going to say — this is an independent body — suppose they say: ‘We don’t think so.’ Then what are you going to do with that?”

Grace Lee, professor of pediatrics at Stanford University School of Medicine and ACIP chair, insisted the group will conduct the review the way it always does — in sessions that are open to the public.

“When we can review that data, when we can review it with the public, when we can deliberate on the decisions, we’ll provide our best scientific advice and opinions,” she told STAT. “We will give our best possible advice based on what we see.”

Jesse Goodman, a former chief scientist at the FDA who is now a professor of medicine at Georgetown University, was concerned about the administration’s decision to announce the plan before that process has played out. Goodman believes booster shots will eventually be needed, and that it is prudent to plan for that eventuality. But “I’m not sure we had enough [data] to pull the trigger right now,” he said.

“In the heat of the moment and when we’re all dealing with a real public health emergency, it becomes almost doubly important that we continually reassess and have the normal processes in place. And I do worry that we not put the cart before the horse,” said Goodman.

“I would have preferred that this had been vetted a little bit more,” said Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia, who is on an expert committee that advises the FDA on vaccines. “This just seems to be a declaration without the kind of vetting you would like to have seen.”

Like Goodman, Offit thinks boosters may eventually be needed. But he’s not convinced they are needed now. Almost all the evidence to date suggests protection against severe disease is still holding and may well last several years, he said.

“So the notion that we are trying to get ahead of it by boosting after eight months I think is premature,” he said, also arguing that using more doses in the U.S. will inevitably slow vaccination in low-income countries.

Scott Hensley, a vaccines researcher at the University of Pennsylvania’s Penn Institute for Immunology, shared those concerns.

“Anyone who thinks that vaccinating Americans with a third dose is not going to come at the expense of getting the vaccine to other places in the world — if that’s what you think, you’re just kidding yourself,” he said.

Hensley suggested the vaccines still appear to be doing what they were designed to do, even if some vaccinated people are having mild infections.

“A year and a half ago if someone told you you could have a vaccine that’s 90%, 95% effective at keeping you out of the hospital and keeping you alive, you would have jumped at that,” he said.

https://www.statnews.com/2021/08/18...ter-shots-baffles-and-upsets-some-scientists/

 

[Krimzon]

Its hard to imagine how any vaccine is going to be able to guarantee 0% chance of infectious shedding, especially for a virus with such a high replication rate. I was quite interested in the nasal spray vaccines but one of the leading candidates was recently abandoned after seeing poor results.

someone mentioned that virus shedding wasn't even a thing. Is it a thing? Do vaccinated folk infect other folks? According to 'experts', the vaccines don't stop the person from infecting others. If true, they expect there to be new variants forever and covid will never go away.