POST 149. April 10, 2021. CORONAVIRIUS. “From Michigan to Massachusetts, COVID-19 cases and hospitalizations are on the rise again. Deaths will soon follow. “ ”.. the Biden administration is facing renewed calls to delay second vaccine doses and blanket more of the U.S. population with an initial shot.”

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We have a way to respond and save lives: vaccinations, which prevent infection and have also shown they are effective in preventing transmission. There will be enough vaccines by summer to vaccinate every American, including children as young as 12. But summer is not here yet. And the recent spoilage of 15 million doses of Johnson & Johnson’s one-dose vaccine means we will need 30 million more doses of two-shot vaccines soon, to make up for the loss.

The supply we need is right in front of us. We need only to adopt the sensible, evidence-based policy used in the United Kingdom: Vaccinate as many people as possible with just one dose, by delaying the second dose of Pfizer and Moderna vaccines. Having adopted this strategy, the U.K. has vaccinated 46% of the population and effectively avoided a second surge of the highly contagious B.1.1.7 variant. This is the same strain that is spreading through Michigan, Minnesota and other surging states.

Still time to save South and California

The United States does not have far to go. About 110 million Americans have received at least one shot. We need to vaccinate 40 million more people to reach the U.K. level. We are administering nearly 3 million doses a day. If we temporarily delay second doses and continue at that rate, we can get to the U.K. level in about two weeks. That is our best hope of quelling the fourth wave ignited by the B.1.1.7 variant.  Because we did not start this strategy earlier, it is probably too late for Michigan, New York, New Jersey and the other Northeastern states. But it might be just in time for the South and California — the next places the more infectious strain will go if historical patterns repeat…

Some complain that postponing second doses is not “following the science.”..

Others worry that postponing second doses encourages the development of new variants…

Still others complain that postponing second doses will prompt hesitancy or confusion. (A)

“As Covid-19 cases spike and coronavirus variants continue to spread, the Biden administration is facing renewed calls to delay second vaccine doses and blanket more of the U.S. population with an initial shot.

Advocates of a strategy focused on first doses include Democratic and Republican senators, Trump administration surgeon general Jerome Adams, and at least four physicians or epidemiologists who advised President Biden on pandemic response issues prior to his inauguration, including the prominent surgeon and author Atul Gawande.

Despite the new advocacy, and its own warnings of “impending doom,” the Biden administration has given no indication it will budge. But the shift in opinion underscores the growing alarm at a possible fourth wave of U.S. Covid-19 cases — and frustration with the federal government’s lack of flexibility…

Gawande wrote this week that the Biden administration should delay second vaccine doses until 12 weeks following the first dose, as opposed to the current three- or four-week interval. Two other members, Emanuel and Michael Osterholm, have argued for delaying second doses since February. A fourth, Céline Gounder, recently announced she was reconsidering her stance after months of vocally opposing the strategy.

The latest push comes as U.S. case rates have begun to tick upward, and as some states, including Michigan, have begun to experience a surge in hospitalizations reminiscent of July 2020 and January 2021. The U.S. has reported roughly 60,000 new cases per day for the last week, far below the country’s January peak but similar to last summer’s surge.

The Biden administration has stayed the course despite new evidence suggesting that even a single dose of the vaccines manufactured by Moderna or the Pfizer-BioNTech partnership is highly effective at reducing Covid-19 infections. Risk of infection, according to a recent study, falls by 80% two weeks after an initial shot. The figure increases to 90% two weeks after a second dose.

A growing number of public health experts have used the new data to argue that the strategy is clear-cut. In the short term, they contend, giving twice as many people 80% protection against the virus would do dramatically more to stop the spread than giving the current number 90% protection…

Tony Fauci, the country’s chief infectious diseases researcher, has argued that there isn’t solid evidence to back a delayed-dose strategy. Even if an initial first dose gives good protection against Covid-19, he said at a recent White House briefing, it’s unclear how long that protection would last.

Beyond posing an unnecessary risk to individuals’ immunity, Fauci has also warned that pivoting midway through the vaccine rollout could send the message that there’s no need to return for a second shot, whether it’s three or 12 weeks after their first.

Fauci has also warned that delaying second doses could help foster the growth of “escape” variants, or strains of the SARS-CoV-2 virus that are more likely to evade existing vaccines’ protectiveness.

A paper published this week in Nature, however, argued the opposite: There is little evidence that so-called “dose-sparing” strategies help to select for escape variants. The math, its authors note, is simple.

“[If] individuals who receive half as much vaccine (one versus two doses, or half the quantity of antigen per dose) achieve more than half the protection from clinical infection of those given a full regimen, then spreading the vaccine among more individuals will produce greater reductions in the number of clinical infections,” they wrote.” (B)

“When you’re talking about doing something that may have real harm, you need empirical data to back that,” said Dr. Céline R. Gounder, an infectious-disease specialist at Bellevue Hospital Center and a member of Mr. Biden’s coronavirus advisory board. “I don’t think you can logic your way out of this.”…

Sarah E. Cobey, an epidemiologist and evolutionary biologist at the University of Chicago, said she thought that the United States had lost a precious opportunity to save many lives with such a strategy. “We’ve missed a window, and people have died,” she said.

But even now, Dr. Emanuel said, it’s worth delaying doses. The United States is giving out roughly three million vaccines a day, but nearly half are going to people who have already received one shot. The nation’s entire supply, he argued, should instead be going to first-timers.

If that happened, it would take two or three weeks for the United States to catch up with Britain, according to his team’s calculations. The extra protection would not just save the lives of the vaccinated but would help reduce transmission of the virus to people yet to get any protection.

Still, some scientists say it’s premature to credit the delayed vaccination schedule for Britain’s drop in cases.

“They’ve done a few other things, like shut down,” Dr. Fauci said.

“I think the real test will be whether we see a rebound in cases now that the U.K. is reopening,” Dr. Gounder said.

Instead of experimenting with vaccination schedules, critics say it would be wiser to get serious about basic preventive measures like wearing masks. “It’s crucial that we don’t just reopen into a big national party,” Dr. Borio said.

She and others are also worried by recent studies that show that a single dose of Moderna or Pfizer-BioNTech does not work as well against certain variants, such as B.1.351, which was first found in South Africa.

“Relying on one dose of Moderna or Pfizer to stop variants like B.1.351 is like using a BB gun to stop a charging rhino,” said John P. Moore, a virologist at Weill Cornell Medicine.

Dr. Moore said he also worried that delaying doses could promote the spread of new variants that can better resist vaccines. As coronaviruses replicate inside the bodies of some vaccinated people, they may acquire mutations that allow them to evade the antibodies generated by the vaccine.

But Dr. Cobey, who studies the evolution of viruses, said she wasn’t worried about delayed doses breeding more variants. “I would put my money on it having the opposite effect,” she said.

Last week, she and her colleagues published a commentary in Nature Reviews Immunology in defense of delaying doses. Getting more people vaccinated — even with moderately less protection — could translate into a bigger brake on the spread of the virus in a community than if fewer people had stronger protection, they said. And that decline wouldn’t just mean more lives were saved. Variants would also have a lower chance of emerging and spreading.

“There are fewer infected people in which variants can arise,” she said.” .” (C)

“Delaying the dose could make way for more people to get their first shots and stem the coronavirus’s spread, proponents say. Opponents say there’s not enough data to show if that one-shot protection is long-lasting enough. And they worry that changing timing now could confuse people, undermine trust and lead to more widespread hesitancy to get the vaccine…

Arguing for delay

Those numbers justify temporarily postponing second doses to ensure that more people get their first shots, says Robert Wachter, who heads the Department of Medicine at the University of California, San Francisco.

“That’s not a hard math question,” he says. “You’ll save far, far more lives — on the order of tens of thousands more lives — giving those extra vaccine doses to people for their first shot, getting them from zero to 85 percent protected, than using that same capacity [for] giving people their second shot and getting them from 85 to 95 [percent efficacy].”

The real driving force behind proposals to delay the second shots is that there just isn’t enough vaccine to go around. It’s all about getting jabs into as many arms as possible, Skowronski says.

Postponing the second dose doesn’t mean cancelling it, she says. It’s just a delay that could allow for more widespread distribution of the vaccine, especially to people at high risk of hospitalization and death from COVID-19.

Even though no one knows how long protection from a single shot will last, immunity doesn’t disappear overnight. That buys time, she says.

“We should be ensuring as many people as possible, by whatever means possible, get the first dose before we double back and try to top up with a second dose,” Skowronski says. “Every second dose we administer is essentially depriving someone else of the substantial protection they could have got from that vaccine supply as a first dose.”

Arguing against delay

Yes, the data overall suggest the first doses work pretty well, but scientists don’t know how durable that protection is, says virologist Onyema Ogbuagu. That may not be as much of a problem in countries like Israel and the United Kingdom, which have been vaccinating people pretty quickly. But in the United States, the vaccine rollout has been creeping and crawling, Ogbuagu says. Because of that slow progress, “you could be six months or 10 months into vaccination and the first people you vaccinated could become vulnerable again.”

The second shot should make immunity last longer. “The role of the second dose is, without question, an advantage,” he says. “It optimizes the efficacy and durability.” Ogbuagu, who oversees COVID-19 clinical trials at Yale School of Medicine, was involved in testing the Pfizer vaccine’s efficacy.

Earlier Phase I and II safety trials also tested people’s immune responses to the mRNA vaccines. Those data showed that antibody levels after the first shot are respectable but often don’t get close to matching levels seen in people who have recovered from COVID-19, Ogbuagu says. “But the pattern after the second dose is just so striking, antibody levels just skyrocket,” often exceeding levels from recovered patients, he says.

He also notes that the dosing data from the AstraZeneca trial came from a part of the study wasn’t planned and other unknown things might be influencing the outcome, A new clinical trial mixing the Pfizer and AstraZeneca vaccines will test in which order the shots should be given, and whether a four- or 12-week interval between doses produces better efficacy. That trial will produce more reliable data on which to base a decision about shot schedules. For now, though, “we have to deal with the unknowns,” he says, “and I think the benefits of giving that second shot outweigh giving just the first one and hoping for the best.”

There’s another big worry: Even under a best case scenario, some people are bound to get sick after getting vaccinated. The vaccines aren’t perfect and some new variants of the coronavirus can evade antibodies generated by the jabs. Some researchers are concerned that delaying a second dose could help produce new variants (SN: 1/14/21).

And if infections happen while monkeying with untried dosing intervals, it could undermine public confidence in the shots, worries Nicole Lurie, a strategic adviser for the Coalition for Epidemic Preparedness Innovations, an organization that funds vaccine development.

It may feed a narrative that health officials didn’t fully follow the science as promised, Lurie says. If public confidence erodes to the point that people turn down vaccines, “then in the long run, you’re doing the nation a disservice.”  (D)

“One dose may not always be enough

The study found that one-dose strategies may, as expected, reduce case numbers in the short term by more rapidly immunizing a greater number of individuals. However, if immune responses after one dose are less robust, subsequent epidemic peaks may be larger.

“More optimistically, we find that as vaccine capacity increases, increasing vaccination rates or changing the dosing regime to closer to the recommended two-dose schedule can mitigate these longer term epidemiological effects, which is important for public health planning,” adds Wagner…

“At least one variant has already emerged that may be adapted for partial immune escape,” notes Holmes. “Simple theory underlines that the evolution and transmission of variants by infected hosts with intermediate levels of immunity may be important. Therefore, the strength and duration of immunity, and particularly the effect of these on retransmission, are key parameters to determine” adds Grenfell.

One intuitive finding that the paper emphasizes is that very low rates of vaccine administration may be associated with larger case numbers and, possibly, more elevated potential for viral adaptation. “This strongly underlines the importance of equitable global vaccine distribution, as immune escape in one location will rapidly spread,” explains C. Jessica E. Metcalf, a co-author on the paper, and an Associate Professor in EEB and the School of Public and International Affairs at Princeton and an associated faculty member at the High Meadows Environmental Institute.

“The models are relatively simple conceptually, but they illustrate the complexities of the problem and highlight the challenges that we still face,” notes Michael Boots, a Professor of Integrative Biology at UC Berkeley who was not affiliated with the present study. “This important piece of work provides a framework that we can use to inform our approach going forward and moreover identifies the key knowledge gaps that we need to address,” adds Boots.” (E)

“Washington will rush federal resources to support vaccinations, testing and treatments, but not vaccines, to Michigan in an effort to control the state’s worst-in-the-nation COVID-19 outbreak, the White House said Friday…

President Joe Biden outlined the federal actions late Thursday in a call with Whitmer to discuss the dire situation in the state, according to senior administration officials. The response will not include a “surge” of vaccine doses, a move Whitmer has advocated and which is backed by Michigan legislators and members of Congress.

Instead, Biden talked about how the federal government was planning to help Michigan better utilize doses already allocated to the state, as well as to increase testing capacity and provide more medications used to treat the sick.

Whitmer, a Democrat, confirmed that she asked Biden on the call to send more vaccine doses to Michigan, particularly the single-dose Johnson & Johnson shot.

“I made the case for a surge strategy,” she said. “At this point, that’s not being deployed, but I am not giving up.”

“Today it’s Michigan and the Midwest,” she added. “Tomorrow, it could be another section of our country. I really believe that the most important thing we can do is put our efforts into squelching where the hot spots are.”

Doses are allocated to states proportionally by population, but Whitmer has called for extra doses to be shifted to states, like hers, that are experiencing a sharp rise in cases. The Biden administration isn’t ready to make such changes.

“We’re going to stick with the allocation system of allocating by state adult population,” said White House COVID-19 coordinator Jeff Zients, calling it “the fair and equitable way” to distribute vaccines. He said the administration was looking to help Michigan administer more of its vaccines efficiently…

Federal officials said providing more doses would not be as immediately effective in curbing Michigan’s virus spike as increasing testing, restoring measures like mask wearing, and foregoing high-risk activities. That’s because vaccines take at least two weeks to begin providing immunity.

Biden told Whitmer that his administration stands ready to send an additional 160 Federal Emergency Management Agency and CDC personnel to Michigan to assist in vaccinations, on top of the 230 federal personnel already deployed to the state to support pandemic response operations.

He’s also directing the administration to prioritize the distribution of doses through federal channels, like the retail pharmacy program and community health centers, to areas of the state Whitmer identifies.

“We are at war with this virus, which requires leaders from across the country to work together,” said White House spokesperson Chris Meagher. “We’re in close contact with Gov. Whitmer, who is working hard to keep Michigan safe, and working in close coordination through a range of options that can help stop the spread of the virus.”

Michigan ranked 35th among states in its vaccination rate. About 40% of Michigan residents ages 16 and older have gotten at least one vaccine dose.

The governor’s recommended high school closure drew mixed reaction in education circles. Her administration closed high schools for a month during the state’s second surge late last fall.

“Research has shown schools can be safe places for in-person learning, so long as community spread is under control — but with higher risk in our communities comes higher risk in classrooms,” said Michigan Education Association President Paula Herbart, whose union urged a similar two-week suspension of in-person learning at elementary and middle schools and colleges.

Restaurants, meanwhile, questioned Whitmer’s recommendation not to eat inside but welcomed the call for more vaccines.

“We trust our operators to continue to provide a safe environment indoors or out in the coming weeks and we trust Michiganders to do their part to act responsibly and respectfully to help us all achieve that outcome,” said Justin Winslow, president and CEO of the Michigan Restaurant & Lodging Association.” (F)

“When it comes to getting the coronavirus vaccine, Mississippi residents have an abundance of options. On Thursday, there were more than 73,000 slots to be had on the state’s scheduling website, up from 68,000 on Tuesday.

In some ways, the growing glut of appointments in Mississippi is something to celebrate: It reflects the mounting supplies that have prompted states across the country to open up eligibility to anyone over 16.

But public health experts say the pileup of unclaimed appointments in Mississippi exposes something more worrisome: the large number of people who are reluctant to get vaccinated.

“It’s time to do the heavy lifting needed to overcome the hesitancy we’re encountering,” said Dr. Obie McNair, an internal medicine practitioner in Jackson, the state capital, whose office has a plentiful supply of vaccines but not enough takers.

Though access remains a problem in rural Mississippi, experts say that the state — one of the first to open eligibility to all adults three weeks ago — may be a harbinger of what much of the country will confront in the coming weeks, as increasing supplies enable most Americans who want the vaccine to easily make appointments.

The hesitancy has national implications. Experts say between 70 percent to 90 percent of all Americans must be vaccinated for the country to reach herd immunity, the point at which the virus can no longer spread through the population.

When it comes to rates of vaccination, Mississippi still has a way to go, with just a quarter of all residents having received at least one dose compared to the nationwide average of 33 percent, according to state data. Other southern states, among them Tennessee, Arkansas, Alabama and Georgia, have similarly low rates of vaccination. “(G)

“There will be 86% fewer Johnson & Johnson vaccine doses allocated to states next week, new data from the Centers for Disease Control and Prevention show, highlighting the company’s yo-yoing vaccine supply from week to week…

Next week, 1.5 million J&J doses will be distributed, including 700,000 doses that will go out through the state allocation system, and another 800,000 that will be handed out through other federal programs, which have grown significantly during the Biden administration.

Supply of the Johnson & Johnson vaccine has been lumpy since its FDA authorization on Feb. 27. The CDC allocated 2.8 million doses to states the next week, followed by no doses the week after that, according to the CDC’s state allocation database. Then, there were fewer than a half-million doses in each of the next two weeks. (The state allocation table is not a complete accounting of doses distributed, however, because many are allocated through other federal programs and not included in the data.)

It’s no secret that Johnson & Johnson has been having manufacturing difficulties. Although its Aug. 5 Operation Warp Speed contract says it expected to deliver 37 million doses by the end of March, that goal had shrunk to 20 million doses, as Dr. Richard Nettles, vice president of medical affairs for the company’s pharmaceutical division, told a congressional subcommittee on Feb. 23.

The Biden administration stepped in with help in early March, when it brokered a deal between J&J and a pharmaceutical, Merck, to increase the vaccine supply.”  (H)

“The U.K.’s bold call to delay giving people a second dose of a Covid-19 vaccine has put it out in front in the race to inoculate the world against the disease.

Behind that decision: a group of 16 scientists who advocated a controversial move to overrule some vaccine manufacturers’ guidelines in order to get more first doses to more people.

The gamble appears to have paid off, with incoming data pointing to durable protection against falling ill after just one vaccine dose. But while some countries, such as Canada, have followed the U.K.’s lead, others including the U.S. are refusing, saying to do so could pose a risk to public health.

The decision by British authorities holds lessons for other countries as they fight to contain the pandemic. Indeed, the dosing debate raises difficult questions about whether some governments and their scientific advisers—for instance in the European Union, where vaccination campaigns are painfully slow—are being too risk averse.

In December, as a highly infectious Covid-19 variant ripped across the U.K., the group of scientists sitting on Britain’s Joint Committee on Vaccination and Immunisation concluded that delaying a second vaccine dose by up to 12 weeks could save lives.” (I)

“The race to beat the coronavirus variants, and to get as many people vaccinated as quickly as possible has intensified a debate in the scientific community about what the best strategy is to end the pandemic.

The question at the heart of the debate: would delaying a second dose of the Pfizer and Moderna Covid-19 vaccine get more people protected more quickly?..

A January editorial published in the Annals of Internal Medicine explained the reason for the delayed dose strategy this way: “A single-dose SARS-CoV-2 vaccine approach deals directly with the shortage of vaccines by vaccinating twice the number of people while maximizing the probability of achieving herd immunity.”

The math is pretty simple, Dr. Michael Osterholm, the director for the Center for Infectious Disease Research and Policy at the University of Minnesota, said.

If you have two people in a room and you give one person two doses they get 90% protection, but the other person gets none. Give each a single dose, in three weeks they both have 80% protection.

“Right now, with the surge that’s about to occur, this is what we want to do right now,” Osterholm told CNN Monday. “Get as many people protected as we can so they don’t get severe illness and hospitalizations and death.”

Dr. Atul Gawande, a member of the Biden administration’s coronavirus transition team, and a surgeon who works at the Harvard’s School of Public Health, said that behavioral measures alone aren’t going to be enough to curb the spread, especially in places seeing surges like in the Midwest and Northeast.

“In these areas where we are having a surge, vaccine appointments go in minutes,” Gawande said. “We need to be vaccinating a lot more people.”

Gawande had been on the fence about it, but as more contagious variants have spread, he started to think a delayed second dose would protect the population more quickly. He said many more people in these areas will need to be vaccinated to bring an end to the surge. The strategy would also reduce the number of variants.

Dr. Ashish Jha had been calling for the delayed second dose strategy for months, but the Dean of Brown University’s School of Public Health now thinks it may be too late.

“By the end of May we’re going to have more vaccines than arms for them to go into,” Jha told CNN Monday. “I don’t know that strategy has quite the same value as it did before.”

Unless something changes with the supply, Dr. Kent Sepkowitz, an infectious disease specialist at Memorial Sloan Kettering Cancer Center in New York, agrees.

“If the stockpile is running low, than yeah, I think we ought to prioritize ‘pretty good’ vaccination for more people than ‘super duper’ protection for the fewer,” Sepkowitz told CNN Monday. “If, however, the vaccine supply isn’t so sparse, than I think we ought to plow ahead with what we’re doing.”…

Dr. William Schaffner, an infectious disease specialist at Vanderbilt University, said with so much supply at this point in the pandemic, the more effective strategy may be to concentrate on helping the hesitant get vaccinated.

“The eager beavers, the early acceptors, they’re still coming in, but we’re getting to the end of that group,” Schaffner said. “We’re now reaching out to the people who are more skeptical that they need the vaccine.”” (J)

PREQUEL

POST 133. February 23, 2021. CORONAVIRUS. “Going off your meds is a surefire way to aggravate your doctor. What if a whole country did it?” The United Kingdom has veered into uncharted territory by changing tack and introducing a revised COVID-19 vaccination protocol, one that involves distributing the second dose at 12 weeks, rather than the prescribed 21 days.”

http://doctordidyouwashyourhands.com/2021/02/post-133-february-23-2021-coronavirus-going-off-your-meds-is-a-surefire-way-to-aggravate-your-doctor-what-if-a-whole-country-did-it-the-united-kingdom-has-veered-into-uncharted/

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