POST 191. August 27, 2021. CORONAVIRUS. “Anthony Fauci, MD, chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the (booster shot) logistics.” This is not medical science, but perhaps Political Science?

for links to POSTS 1-191 in chronological order, highlight and click on

http://doctordidyouwashyourhands.com/2021/08/coronavirus-tracking-links-to-posts-1-191/

NOTE: I am not a scientist! So this is my effort to sort out mixed  messages on booster shots.

“The US Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.

The vaccine will be marketed as Comirnaty, the FDA said in its announcement on Monday. The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since mid-December for people age 16 and older, and in May, the authorization was extended to those 12 and older.

“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” according to the FDA.

Out of more than 170 million people in the United States fully vaccinated against Covid-19, more than 92 million have received the Pfizer/BioNTech vaccine.

“While this and other vaccines have met the FDA’s rigorous scientific standards for emergency use authorization, as the first FDA approved Covid-19 vaccine, the public can be confident that this vaccine meets the FDA’s gold standard for safety, effectiveness and manufacturing quality that we require for an approved product,” FDA Acting Commissioner Dr. Janet Woodcock said during a briefing on Monday, calling the approval “a pivotal moment” for the United States’ fight against the coronavirus pandemic.” (A)

“The United States will begin widely distributing Covid-19 booster shots next month as new data shows that vaccine protection wanes over time, top U.S. health officials announced Wednesday.,

It’s now “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,” 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.

“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.”…

The plan is subject to a formal recommendation from a CDC vaccine advisory committee and approval from the FDA, also a formality….

U.S. officials changed their message on boosters in recent days as cases continued to rise. Fauci said Thursday that everybody will “likely” need a booster shot at some point. On Friday, federal officials approved administering booster shots to Americans with weakened immune systems, which includes cancer and HIV patients and people who have had organ transplants….

During a press briefing Wednesday, Walensky said officials based their decision on studies that showed immunity from Pfizer and Moderna’s vaccines diminished over several months. One study in New York from May 3 through July 25 showed that the vaccine’s effectiveness in 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%.” (B)

“…if the FDA follows its usual protocol, the agency would first convene a meeting of its outside advisory committee, as it did when it originally granted emergency use authorization for each COVID-19 vaccine.

“We know in sort of 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,” says Dr. Jesse Goodman, a professor at Georgetown University’s School of Medicine who used to be the chief scientist at FDA.

Goodman says he worries that setting a start date for a booster program before the relevant data can be evaluated through the normal federal processes may put “the cart before the horse.”

The committee of outside experts typically hears presentations from the government, the product manufacturer and the public. Then, it often votes on whether the FDA should give a given product the green light. The agency doesn’t have to follow the committee’s advice, but it usually does.

Norman Baylor, a former director of the Food and Drug Administration’s Office of Vaccines Research and Review, says putting those committee meetings together in a month — as the administration’s Sept. 20 booster start date would imply — is “pushing it.”

The agency’s interim commissioner, Janet Woodcock, tweeted about the agency’s booster plans Wednesday afternoon, though she didn’t commit to convening the FDA’s Vaccines and Related Biological Products Advisory Committee.

“FDA supports the administration’s work to plan for the deployment of additional vaccine doses, or boosters, this fall,” she wrote. “FDA will undertake an independent scientific evaluation of the safety and efficacy of boosters for each vaccine.”

After an FDA authorization, the CDC’s independent vaccine advisory committee would also weigh the evidence and make a recommendation.” (C)

“The CDC has pushed back its advisory panel meeting to discuss COVID-19 booster shots for the general population by one week, as medical professionals are split over whether the shots are necessary, Bloomberg reported Aug. 19.

The CDC’s Advisory Committee for Immunization Practices originally was set to meet Aug. 24 to discuss the need for booster shots and possibly make a formal recommendation but will now convene over two days starting Aug. 30.” (D)

“Federal health officials are expected Wednesday to present evidence for why people are likely to need Covid-19 boosters eight months after their second doses of a vaccine, according to sources with the Centers for Disease Control and Prevention.

The eight-month time frame is most likely based on findings from both the U.S. and abroad looking at how the vaccines have held up over time — and whether they can stand up to the hypertransmissible delta variant of the coronavirus that has overtaken the country.

“Delta is forcing this discussion” on boosters, said Dr. Colleen Kraft, associate chief medical officer at Emory University Hospital in Atlanta.

The variant now accounts for nearly 100 percent of new Covid-19 cases in the U.S., according to the CDC. The seven-day average of Covid-19 cases has soared by 700 percent since the beginning of July, when delta became the dominant strain in the U.S.

Questions remain about how well the vaccines fare against the delta variant, as well as whether protection simply wanes over time. Indeed, experts said they are eager to see any new data that led to the government’s proposed timeline for booster shots…

That’s a concern, particularly with how contagious the delta variant is, said an expert in pulmonary and critical care, Dr. Benjamin Singer, an assistant professor of medicine at the Northwestern University Feinberg School of Medicine.

The variant has been associated with breakthrough infections, and while such infections are rare and generally much less severe, studies indicate that fully vaccinated people can spread the virus if infected.

As for why the booster shots would be recommended at eight months, Singer said, “it’s not entirely clear, but it’s probably a combination of waning immunity over time and the fact the current circulating variants are just that much more contagious and spread that much more easily.”…

Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children’s Hospital Center for Vaccine Development, said, “All we’re getting is snippets of data on the Israel Ministry of Health website.” He said he was curious whether, in addition to a decline in efficacy against mild infections, there was a significant drop in protection against hospitalizations for vaccinated people over time…

A recent study from the Mayo Clinic, however, also suggested waning immunity from the vaccines. The research, which hasn’t yet been published in a peer-reviewed journal, found that protection against infection during the height of the delta variant’s spread fell to 76 percent among those who had received the Moderna shots and 42 percent among those who got the Pfizer shots.”  (E)

“A person’s immune system is a complicated puzzle, with antibodies in a person’s blood stream as only one piece.

Scientists said they are looking at other clues too, including closely watching COVID-related hospitalizations involving vaccinated people.

Pfizer and BioNTech, which partnered to develop the nation’s first vaccine, said it has early data suggesting that a booster dose anywhere from six to 12 months after the initial vaccination will help maintain a high level of protection. Their data have not been shared publicly yet.” (F)

“After all that, World Health Organization (WHO) chief scientist Soumya Swaminathan suggested that prioritizing booster shots in wealthier countries like the U.S. could lead to more variants, and other scientists have come out saying it’s still too soon. The onslaught of new information has caused some confusion. These are some of the most pressing questions.

Who will need a third shot and when?

First up for the third shots are a limited number of individuals the CDC considers moderate to severely immunocompromised. The third shots are available for these individuals today.

For the rest of the population, for whom the vaccine is gradually losing some efficacy, the Biden administration hopes to start offering the shots near the end of September, starting with the same groups that were vaccinated earliest during the first vaccine rollout: healthcare workers and people over the age of 65. You’ll become eligible for your third shot eight months after you received the second jab, so aside from the immunocompromised patients going first, it’ll look a lot like the previous rollout. The administration still needs an advisory committee from the CDC to review evidence and make recommendations and for the FDA to authorize the plan.

The immunocompromised patients are going first, explains Onisis Stefas, a chief pharmacy officer at Northwell Health in New York City, because they’re not losing immunity—many of them never mounted a strong immune response to begin with. Additionally, if you’re immunocompromised “you have less of a chance of fighting off an infection like the coronavirus.” meaning if you do get infected, you’ll likely fare worse than a someone with an intact immune system…

The August 18 announcement that everyone will need a third shot came on the heels of two main findings. The first is that immunity gained from the vaccines seems to wane over time. Data from Israel, which was the first to vaccinate most of its population with the Pfizer vaccine shows that more than half of infections are occurring in individuals who have been vaccinated…

The second major finding is that while the vaccines still protect most patients from hospitalization and death, the new Delta variant can infect vaccinated individuals. And those individuals can spread the disease to others, albeit for a shorter period than unvaccinated individuals who are infected.” (G)

“Several countries have decided to provide booster shots to older adults and people with weak immune systems. European Union officials said on Wednesday they do not yet see a need to give booster shots to the general population.

Other experts said the U.S. plan requires thorough vetting by the FDA and a panel of outside advisers to the CDC. A meeting of those advisers to discuss boosters set for Aug. 24 is being rescheduled, the CDC said on Thursday on its website.

The Department of Health and Human Services, which oversees the CDC and FDA, did not immediately respond to a request for comment.

Some experts questioned the focus on booster shots when around 30% of eligible Americans have yet to get even a first vaccine dose, despite new COVID-19 cases and deaths surging across the country.

“The more important thing, I think, at this point than boosters is making sure we get the vaccine in any arm that hasn’t had one as fast as we can,” said Dr. Dan McQuillen, an infectious disease specialist in Burlington, Massachusetts, and the incoming president of the Infectious Diseases Society of America.

All experts interviewed by Reuters also emphasized the need to inoculate the vast number of people around the world who have yet to access COVID-19 vaccines.

“You could end up in situation where you are chasing your tail, giving more and more boosters in the U.S. and Western Europe, while more dangerous variants are coming from other places,” said Dr. Isaac Weisfuse, epidemiologist and adjunct professor at Cornell University Public Health.

“In reality you should be vaccinating the rest of the world to avoid new variants.”” (H)

“Current data does not indicate that COVID-19 booster shots are needed, the World Health Organization (WHO) said on Wednesday, adding that the most vulnerable people worldwide should be fully vaccinated before high-income countries deploy a top-up.

The comments came just before the U.S. government said it planned to make the booster shots widely available to all Americans starting on Sept. 20 as infections from the Delta variant of the coronavirus rise. read more

WHO chief scientist Soumya Swaminathan, asked about the need for boosters to increase protection against the disease, told a Geneva news conference: “We believe clearly that the data today does not indicate that boosters are needed.”

WHO senior adviser Bruce Aylward, referring to booster shots being administered in high-income countries, told reporters: “There is enough vaccine around the world, but it is not going to the right places in the right order.”

Two doses should be given to the most vulnerable worldwide before boosters are administered to those fully-vaccinated, he said, adding: “We are a long, long way from that.”” (I)

“A spokesperson from the Department of Health and Human Services tells National Geographic that regulators are taking all data into consideration—including those from research labs, clinical trials, and pharmaceutical companies like Pfizer. “We appreciate the information they shared, and officials continue to engage in a science-based rigorous process to consider whether, when, or for whom a booster might be necessary.”

In fact, contrary to Pfizer’s study, new laboratory data has emerged suggesting that the Pfizer vaccine offers protection that could last for years. So what exactly is going on? Here’s a look at what the data shows about how long immunity lasts among the fully vaccinated—and what scientists want to know before they recommend giving anyone another dose…

While the existing data does offer reassurance that the vaccines remain protective—and booster shots aren’t needed—scientists and regulators alike point to the need for more academic studies to untangle exactly how the immune system is responding to the COVID-19 vaccines.

“I think what we’re going to see, over the next six months or so, a lot of studies outlining what those other components of the immune response look like in both healthy people and in some of our vulnerable populations,” Wherry says. “We really just need a lot more information on multiple layers of the immune response to vaccination.”

It’s also important to keep an eye on public-health data, particularly the rate of hospitalizations and deaths among vaccinated people. Wherry says that, ideally, states will be able to pinpoint when those who are infected were first vaccinated to help identify when immunity seems to be waning.

The HHS spokesperson says regulators are monitoring all this new data as well. “The administration is prepared for booster doses if and when the science demonstrates that they are needed, and any recommendation by CDC and FDA would come after their thorough review process.”

All the same, Wherry says it can’t hurt to be prepared for the time when boosters are needed. “Right now you can have confidence that, if you’re fully vaccinated, your chances of getting severely ill from COVID are extremely low in the U.S.”” (J)

“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.”  (K)

“In Atlanta, CDC scientists are scrambling to comprehend what havoc the variant strains are wreaking, how well the vaccines are working, and what forecast ought to end up on the president’s desk. For several months, the CDC has refereed a sort of artificial intelligence conference of modelers and forecasters from all over the United States, mostly academics. Each epidemic modeling team uses its own methodology to track the U.S. epidemic and forecast where it’s headed. Some of the teams are very cautious and consistently lowball the scale of future trends. Some routinely tend to the opposite extreme. The CDC grinds it all up to reach a sort of projection consensus. And so far, these forecasts have been scary correct.

In its latest modeling mashup, the CDC forecast predicts that the new delta-driven surge won’t peak until October, possibly not until Thanksgiving. By late August, at least 2,500 Americans will die, every week, bringing the nation’s cumulative mortality to some 660,000.

With a forecast so grim, it’s time for a Hail Mary move. And that would be the mass third-dose vaccination of every American over 60 years of age, coupled with a return to mask-wearing and social distancing and a massive escalation in genomic surveillance nationwide. Anything less means ceding the battlefield to the virus.” (L)

“Some predicted that boosters could reduce serious infections among immunocompromised people or others at high risk for complications. But to make a real dent in reducing transmission — the key to ending the pandemic — those who haven’t gotten vaccinated at all will have to get their first doses, Singer said.

“The boosters probably have a limited impact on reducing the worst impacts, because it’s really unvaccinated people who are making up the supermajority of hospitalizations, ICU admissions and deaths,” Singer said. “If you have less infection, including breakthrough infections, you might break that train of transmission, but if you’re looking now, most of the transmission is occurring among people who have had zero vaccines.”” (M)

“Dr. Melanie Swift, who has been leading the vaccination program at Mayo Clinic in Rochester, Minnesota, says getting more shots into people who haven’t yet been vaccinated at all is “our best tool, not only to prevent hospitalization and mortality from the delta variant, but to stop transmission.” Every infection, she says, “gives the virus more chances to mutate into who knows what the next variant could be.”

“People who took the vaccine the first time are likely to line up and get their booster,” Swift says. “But it’s not going to achieve our goals overall if all their unvaccinated neighbors are not vaccinated.”” (N)

“Vaccine makers Pfizer Inc. and Moderna Inc. are on track to notch billions more in sales than previously expected, as new booster-shot strategies and concerns about the Delta variant push demand, and the companies raise prices in the U.S. and elsewhere.

The Biden administration on Wednesday urged adult Americans who received two doses of messenger RNA vaccines from Pfizer or Moderna to get a third dose eight months later.

Pfizer and partner BioNTech SE Covid-19 vaccine sales are expected to reach $74 billion through next year, excluding Germany and Belgium, 17% more than previous estimates, according to Ronny Gal, a Sanford Bernstein pharmaceuticals analyst.

Meanwhile, the analyst projects Moderna will ring up $35 billion during the span, 25% more sales than previously forecast.

The sums are further evidence the coronavirus pandemic is proving to be a significant moneymaking opportunity for vaccines, a business many drugmakers had abandoned because it was seen as requiring heavy investment while offering limited growth and carrying legal risks.” (O)

“”I am strongly in favor of this booster strategy, and hope that what it will herald is a phase in the pandemic where we will empower patients, in consultation with their physicians, to make the best choices for themselves,” said Leana Wen, an emergency physician and public health professor at George Washington University. “Some may be comfortable with the level of protection against severe disease afforded by the existing vaccines; others will want to reduce symptomatic infection by getting a boost. People need to consider their own medical circumstances, exposures, and risk tolerance when it comes to booster doses.”” (P)

“Since the first inoculations emerged about 1,000 years ago, vaccines have been saving millions of lives. For many years, we haven’t thought twice about them or the benefits they give us. As infants, we receive vaccines against polio; tetanus, diphtheria and pertussis; measles, mumps and rubella; hepatitis A and B; and more diseases that — as a result — don’t trouble us, or cause illness or death. The smallpox vaccine was used so effectively that the disease was eradicated…

And yet, the COVID-19 vaccines that are the culmination of years of research that we were able to apply to rapidly meet this global public health emergency, are greeted with skepticism. It’s become clear that fear of booster side-effects may also be emerging. However, research by Johns Hopkins and vaccine scientists at Moderna is indicating that booster-dose side effects will not be more severe than those caused by the original vaccine

The many 100-year history of positive benefits conferred by vaccines should at last signal to Americans that it is time to not only accept but also to normalize the COVID-19 vaccines.  As COVID-19 mutates and new, more contagious variants emerge, the virus itself is showing us that we can’t be complacent, and the administration will be making the right decision when it calls for boosters. We need to do everything we can to fight COVID-19, funding and putting into place programs that develop and make the latest boosters widely available. We will need them.” (Q)

“Why officials are recommending an eight-month timeline is not yet clear. “I was concerned to see the [reports] last night coming from the White House” rather than career scientists at the FDA or the CDC, Jason Schwartz, of the Yale School of Public Health, told me prior to this morning’s announcement. Decisions about dosing, timing, and the like are “best left to the scientific officials who have the right skills and tools to think about the evidence,” he said.” (R)

“Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults next month, experts weighed in on the evidence for choosing an 8-month cut-off, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.

Timing came up more than once at the August 18 White House briefing announcing the booster plans. Reporters asked about the start time of September 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.

Anthony Fauci, MD, chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.” (S)

“Clinicians who administer COVID-19 vaccines off-label to children under 12 years would be violating their provider agreement, risking liability for adverse events and potentially forfeiting payment.

Health officials laid out the possible consequences after the Food and Drug Administration (FDA) granted licensure to the Pfizer-BioNTech vaccine Comirnaty on Monday.

“Ordinarily … when a medical product is approved, physicians often do use off-label prescribing. However, this is a different situation,” Acting FDA Commissioner Janet Woodcock, M.D., said at a press conference. “The vaccine is being distributed under a provider agreement by the U.S. government through the CDC (Centers for Disease Control and Prevention), and there are many considerations that would pertain to off-label prescribing for the recipient and so forth.”

Vaccine providers must adhere to requirements of the CDC, its vaccine committee and the FDA. The FDA licensed the vaccine as a two-dose series for people ages 16 years and older. It also can be used for adolescents as young as 12 years under emergency use authorization (EUA). Some people ages 12 years and older who are immunocompromised are eligible for a third dose.

If vaccine providers use the vaccine off-label, the CDC said they could lose immunity from claims, eligibility for federal compensation after an adverse event, eligibility to provide COVID-19 vaccines and payment.

The AAP also is discouraging off-label use of the vaccine as clinical trials are still underway in children under 12 years.

“We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients,” Yvonne A. Maldonado, M.D., FAAP, chair of the AAP Committee on Infectious Diseases, said in a statement. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.”” (T)

“The next time your doctor writes you a prescription, consider this: The medication may not be approved for your specific condition or age group.

But you probably shouldn’t call the medical board. The practice, called “off-label” prescribing, is entirely legal and very common. More than one in five outpatient prescriptions written in the U.S. are for off-label therapies.

“Off-label” means the medication is being used in a manner not specified in the FDA’s approved packaging label, or insert. Every prescription drug marketed in the U.S. carries an individual, FDA-approved label. This label is a written report that provides detailed instructions regarding the approved uses and doses, which are based on the results of clinical studies that the drug maker submitted to the FDA.

“Many people may be surprised to know that the FDA regulates drug approval, not drug prescribing, and … doctors are free to prescribe a drug for any [reason they think is medically appropriate],” says G. Caleb Alexander, MD, MS, a medical ethics advocate and assistant professor of medicine at the University of Chicago Medical Center. “Off-label use is so common, that virtually every drug is used off-label in some circumstances.”” (U)

PREQUELS

POST 182. July 26, 2021. CORONAVIRUS. Alabama Gov. Kay Ivey (R): “Folks supposed to have common sense.”…“But it’s time to start blaming the unvaccinated folks, not the regular folks. It’s the unvaccinated folks that are letting us down.” ““Beginning in mid-September, New York City will require all of its 340,000 municipal workers, including police, firefighters and teachers, to either be vaccinated against COVID-19 or tested weekly.”

http://doctordidyouwashyourhands.com/2021/07/post-182-july-26-2021-coronavirus-alabama-gov-kay-ivey-r-folks-supposed-to-have-common-sense-but-its-time-to-start-blaming-the-unvaccinated-folks-not-the/

POST 188. August 15, 20201. CORONAVIRUS. “According to an internal CDC briefing….an estimated 1.1 million people have already gotten unauthorized booster shots…”….”If it is left up to the honor system, I think many Americans will suddenly wake up and find themselves immunocompromised enough to get a 3rd dose,”

http://doctordidyouwashyourhands.com/2021/08/post-188-august-15-20201-coronavirus-according-to-an-internal-cdc-briefing-an-estimated-1-1-million-people-have-already-gotten-unauthorized-booster-shots/

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