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Infectious disease Archives ✔️ News For Finance
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Nurses wait at empty tables for more patients to arrive to receive a dose of the Moderna Covid-19 vaccine at a pop-up vaccination site in Gardena, California on April 17, 2021.
Enlarge / Nurses wait at empty tables for more patients to arrive to receive a dose of the Moderna Covid-19 vaccine at a pop-up vaccination site in Gardena, California on April 17, 2021.

Though COVID-19 vaccines are now open to all US adults, vaccinations in the country are on the decline.

In the past week, the rolling seven-day average of daily vaccinations has slipped nearly 11 percent, falling from a high on April 13 of nearly 3.4 million shots per day to the current average of just over 3 million. And scores of counties across the US have begun declining shipments of vaccine doses, according to reporting by The Washington Post.

It’s the first time since the nationwide vaccination effort began last December that the country has seen a sustained decline in vaccinations—except for a brief dip in February which was linked to winter weather-related delays and cancellations.

Multiple factors may explain the current drop in shots. The dip coincides with a pause in the use of the Johnson & Johnson vaccine. That pause may explain some—but not all—of the drop over the past week. However, health officials say extra supply of Moderna and Pfizer-BioNTech vaccines have largely compensated for the Johnson & Johnson pause. Plus, recent polls suggest that the pause has not significantly affected vaccine hesitancy.

Instead, experts suspect that the biggest factor for the decline is simply waning demand. With 52 percent of US adults having already received at least one shot, and more than 34 percent are fully vaccinated, the country may be running low on adults eager for a shot.

In a recent survey by the Kaiser Family Foundation, 20 percent of Americans said they would definitely not get a vaccine or only get one if it was required. An additional 17 percent surveyed said they would “wait and see” about getting vaccinated. Likewise, in an Axios-Ipsos Coronavirus poll released April 20, a total of 30 percent of respondents said they were “not very likely” or “not at all likely” to get a vaccine. That total is unchanged from before the Johnson & Johnson pause.

“We can do better”

The slowing vaccinations and the consistent poll results suggest that state and local health officials may be bumping up against the vaccine hesitant and vaccine skeptical portions of the country.

“We’re past that point of vaccine eagerness, well into vaccine hesitancy, and having supply drive what we do is a mistake,” Philip Keiser, the top health official in Galveston County on the Gulf Coast of Texas, told the Post. Only about a third of eligible residents in the county have been vaccinated, but Keiser requested that the state hold back vaccine supply. Keiser said he is working on targeted outreach, including holding events in hard-to-reach communities and schools to try to boost vaccine interest.

Many other local health officials as well as the Biden Administration are now working on such targeted approaches to lower obstacles and soften vaccine views in resistant communities. Top health officials told Politico that they’re aware that the efforts may not work, but that they’re trying anyway. Without the 20 to 30 percent of US adults who are reluctant to get vaccinated, it will be difficult if not impossible for the country to bring disease transmission to a halt. That means the pandemic could continue to drag on.

“A few months from now, if that’s what happens, the people who are in the hospital, in the ICU getting sick and dying, are going to be those who didn’t get immunized. And it’ll be pretty obvious that’s the case,” Francis Collins, director of the National Institutes of Health, told Politico. “And I don’t want that to be the wake-up call. We can do better than that. But that could be the downstream scenario if we’re not successful in conveying all the reasons why it’s time for action now.”

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.
Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

Things are not looking good for Emergent BioSolutions, the contract manufacturer that ruined 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine and millions more doses of AstraZeneca’s COVID-19 vaccine at its production facility in Baltimore.

The Food and Drug Administration on Wednesday released a searing inspection report of the facility, finding a slew of significant violations and failings.

Meanwhile, federal lawmakers have opened a multi-pronged investigation into whether Emergent used ties to the Trump administration to get billions of dollars in federal contracts despite a history of failing to complete contracts, inadequately training staff, persistent quality-control issues, and an “unjustified” 800% price increase for an anthrax vaccine.

In a letter sent to Emergent’s top executives Tuesday, Rep. Carolyn Maloney, chairwoman of the House Committee on Oversight and Reform, and Rep. James Clyburn, chairman of the Select Subcommittee on the Coronavirus Crisis, laid out the investigation, writing:

Emergent received $628 million in June 2020 to establish the primary US facility for manufacturing vaccines developed by Johnson & Johnson and AstraZeneca. Dr. Robert Kadlec, who served as Assistant Secretary for Preparedness and Response under President Trump and previously worked as a consultant for Emergent, appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfill the contract.

800% drain

But the investigation stretches back much farther than the start of the pandemic—through years of questionable federal contracts.

In 1998, Emergent (then called BioPort) bought the license to an anthrax vaccine. The vaccine, BioThrax, was approved by the FDA in 1970 but remains the only FDA-approved vaccine for anthrax. As such, Emergent is the sole supplier of anthrax vaccine for the federal government’s Strategic National Stockpile (SNS). When Emergent bought the vaccine in 1998, a dose went for about $3.35. By 2010, the price was up to $28 a dose. Now, the price is over $30, and average wholesale prices are even higher, reaching $90 per dose, the lawmakers note.

“Emergent has raised the government purchasing price of the anthrax vaccine by 800% since acquiring the drug in 1998,” the lawmakers write in their letter. “As a result, through most of the last decade, nearly half of the SNS’s budget has been spent purchasing Emergent’s anthrax vaccine. These spiraling costs contributed to shortages of critical supplies, including ventilators, reusable respirator masks, and other personal protective equipment, which severely impacted the government’s ability to respond to the coronavirus crisis.”

This drain on the SNS budget was particularly apparent during the pandemic—which Robert Kadlec, the former Emergent consultant, himself acknowledged.

Kadlec was nominated in 2017 by President Trump to lead the Office of the Assistant Secretary for Preparedness and Response (ASPR). Following his confirmation, Emergent received millions of dollars in federal contracts from ASPR, including contracts for the SNS that were awarded without competitive bidding, the lawmakers note in their letter.

In 2020—just before the pandemic hit the US—Kadlec’s office awarded Emergent around $3 billion in long-term contracts for anthrax and other bioterrorism threats. According to the lawmakers, Kadlec later suggested this was a bad move, saying: “If I could spend less on anthrax replenishment, I could buy more N95s. I could buy more ventilators. I could buy more of other things that quite frankly I didn’t have the money to buy.”

Failures and an inspection

Aside from the skyrocketing prices, the lawmakers suggest Emergent didn’t even deserve the contracts in the first place. In 2012, the Department of Health and Human Services awarded Emergent a $163 million contract to renovate its (currently troubled) Baltimore manufacturing plant. The idea was for the plant to become a manufacturing hub for rapidly producing vaccine in the event of an infectious disease outbreak or bioterror attack. Part of the contract stipulated that Emergent would be required to do a test run, producing 50 million doses of a pandemic influenza vaccine in the span of four months, and obtain manufacturing approval from the FDA by June 2020.

Emergent failed to meet those requirements.

Reading the FDA’s inspection report of Emergent’s Baltimore facility, it’s clear why. During the nine-day inspection, which ended April 20, FDA inspectors logged a long list of problems at the facility.

First on the list is that Emergent failed to thoroughly investigate how the millions of Johnson & Johnson and AstraZeneca doses became contaminated. The agency concluded that, without a thorough review of what happened, it’s possible that other finished batches of vaccine may also be ruined. “There is no assurance that other batches have not been subject to cross contamination,” the inspectors wrote.

The FDA inspectors went on to note unsanitary conditions, paint peeling off of the walls and floors, residue on equipment, improperly trained staff, and numerous opportunities for vaccine products to be contaminated.

The potential for cross contamination—spread of viral ingredients back and forth between Johnson & Johnson’s vaccine and AstraZeneca’s vaccine—appeared rampant at the facility. Inspectors witnessed Emergent employees dragging unsealed, non-decontaminated bags of medical waste across different manufacturing areas. In some cases, employees tossed bags of medical waste, unsealed, into a service elevator. Emergent did not have proper written procedures for how to decontaminate waste, the inspection report notes. Security footage also caught employees moving from different areas of the facility without following proper procedures for donning and removing protective gowns.

At the request of the FDA, vaccine production at the Baltimore facility has been halted since April 16.

In a statement Wednesday, Emergent said that the FDA’s findings “provide direction on the necessary steps to improve operations.” The company went on:

The FDA’s feedback will help us continue to improve and strengthen the supply chain for Johnson & Johnson’s COVID-19 vaccine. While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's Covid-19 vaccine, in Baltimore, Maryland, on April 9, 2021.
Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s Covid-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

The US Food and Drug Administration last week asked Emergent BioSolutions to stop making Johnson & Johnson’s COVID-19 vaccine at its troubled facility in Baltimore, according to a regulatory filing Emergent released Monday.

The FDA had begun an inspection of the contract manufacturer’s facility on April 12 but requested on April 16 that production be halted “pending completion of the inspection and remediation of any resulting findings,” the filing reads. Any vaccine materials already made at the plant will be held in quarantine.

The production halt follows news last month that a mishap at the plant led to the ruin of 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine. The ruined doses had reportedly been contaminated with ingredients from AstraZeneca’s COVID-19 vaccine, which was also being manufactured at the plant at the time.

The accident was a major stumbling block for Johnson & Johnson’s vaccine production—but not a consumer safety issue. All of the doses of Johnson & Johnson’s vaccine that has been used in the US so far have been produced in the Netherlands. The Emergent facility in Baltimore had not yet been authorized by the FDA for vaccine production when the doses were ruined, and none of the spoiled doses completed the production process.

Early this month, the Biden administration put Johnson & Johnson in charge of the facility and ordered AstraZeneca’s vaccine production out to prevent further cross-contamination problems. At the time, the company said that, despite the setback, it still expected to meet its commitment to deliver nearly 100 million doses of its vaccine to the US government by the end of May. But the current production pause again raises questions of whether the company will still be able to meet that goal.

“At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries” the company told Reuters.

In a statement to Politico, Emergent said:

While we await the FDA’s full feedback, we are working with J&J and the FDA on strengthening the supply chain for this vitally important vaccine… We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes.

Pause beyond pause

For now, Biden officials say they have enough vaccine supply from Moderna and Pfizer-BioNTech to continue the current pace of vaccinations, which has exceeded 3 million doses a day recently.

Regardless of the production pause, use of Johnson & Johnson’s vaccine was already on pause as federal health experts and advisors review data linking the vaccine to an extremely rare but dangerous blood-clotting condition.

Last week, the FDA and the Centers for Disease Control and Prevention said that, out of more than 6.8 million vaccine doses administered, they had identified six cases of the unusual condition, which leads to dangerous life-threatening blood clots in combination with low levels of platelets. One person died of the condition, and another was said to be in critical condition.

A vaccine advisory committee for the CDC, called ACIP, held an emergency meeting last week but punted on making any recommendations for use of Johnson & Johnson’s vaccine going forward. Instead, the committee scheduled another public meeting for this Friday, April 23 from 11 am to 5 pm EDT where it will review further data and analyses.

In a White House press briefing Monday, CDC director Rochelle Walensky said that the agency had received additional reports of blood-clotting cases possibly linked to the vaccine.

There have been “a handful of cases, not an overwhelming number of cases,” Walensky said in the briefing. “We are working through and adjudicating them and verifying whether they do in fact reflect a true case.” The CDC and the FDA will then present their findings to ACIP on Friday, she said.

Residents wear protective masks while waiting to be vaccinated at a West Virginia United Health System Covid-19 vaccine clinic in Morgantown, West Virginia, U.S., on Thursday, March 11, 2021.
Enlarge / Residents wear protective masks while waiting to be vaccinated at a West Virginia United Health System Covid-19 vaccine clinic in Morgantown, West Virginia, U.S., on Thursday, March 11, 2021.

The US logged another 4 million or so vaccinations Friday, bringing the total doses administered in the country over 200 million at the time of writing. Over 127 million adults—38.5 percent of the US population—have received at least one shot. Over 80 million adults—24 percent of the US population—are now fully vaccinated.

The seven-day rolling average of US vaccinations per day is now around 3.35 million and the Biden administration is on track to make its latest goal of 200 million vaccinations within the first 100 days in office.

Even with a current pause in use of Johnson & Johnson’s vaccine, Biden officials expect availability of vaccine to remain strong.

“Vaccines produced by Moderna and Pfizer are still widely available,” Rochelle Walensky, director of the Centers for Disease Control and Prevention, said in a White House COVID-19 press briefing Friday. “We continue to work with pharmacies, states, and FEMA to make sure the vaccine supply remains robust across the country as we approach April 19th, when all Americans above age 16 or 18—depending on the vaccine received—will be eligible for vaccination.”

Walensky and other officials stressed in the briefing how critical it is to keep up the pace of vaccinations. “Even as we accelerate our efforts to get shots in arms, more dangerous variants are growing, causing increases in cases with people without immunity,” Andy Slavitt, a senior White House adviser on the pandemic, said in the briefing. “This increases the urgency for you to get vaccinated.”

But the latest survey results and vaccination distribution data are pointing in the opposite direction. Together they suggest that the US may be close to running out of people eager for their shot and that the robust pace of vaccination in the country may soon wane.

The latest data from the Kaiser Family Foundation’s ongoing COVID-19 vaccine survey suggests that enthusiasm for vaccines continues to increase. In February, 55 percent of people said they had already gotten at least one dose or plan to get one as soon as possible. That figure rose to 61 percent in March. But the percentage of people saying they “definitely” will not get vaccinated has held fairly stable, currently standing around 13 percent. The fraction of people who say they’ll only get vaccinated if they’re required to do so has also stayed put at around seven percent.

Worrying signs

The data further suggests that in some demographics and locations, the most eager have largely already gotten their vaccines.

By age group, the most enthusiastic to get vaccinated are those ages 65 and older. An impressive 81 percent of the 65+ groups reported they have either already gotten vaccinated or will soon. But, most are already vaccinated. Sixty-four percent of the 65+ group reported that they have already gotten at least one shot. And just seventeen percent say they’re still waiting to get one as soon as possible.

There’s less enthusiasm in the younger groups, suggesting demand will be slower for these groups. The least inclined demographic is the 18 to 29 age group, in which less than 50 percent said they have either already gotten vaccinated or will as soon as possible. And 15 percent of the groups said they were already vaccinated.

There’s a similar scenario building in rural areas. In the KFF survey, a total of 55 percent of rural residents said they have either already gotten vaccinated or will soon, with 39 percent of the age group falling in the “already gotten” category. Only 31 percent of urban respondents said they had already received a vaccine, but an additional 35 percent said they planned to get vaccinated as soon as possible.

“This suggests that vaccine uptake in rural communities is currently outpacing urban and suburban areas but may begin lagging behind more populated areas as they experience increased access,” KFF noted.

The finding may be linked to a partisan divide. Rural areas often swing Republican, and Republicans have consistently been among the most resistant to vaccination across many surveys. In the latest KFF data, 29 percent of Republicans reported that they would “definitely not” get vaccinated.

An analysis released last week by Surgo Ventures, a nonprofit health-data organization, suggested that given the lower enthusiasm of those not-yet vaccinated, vaccine uptake will slow beginning next month. The “supply-demand shift for the vaccine will happen earlier than expected—as early as the end of April,” the organization concluded.

“This analysis shows that despite the general vaccine enthusiasm we are seeing now in the United States, things are going to get really difficult really soon,” Surgo Ventures CEO, Sema Sgaier, said in a statement. “Without significant investment in addressing people’s barriers and making vaccines available to those below 18, reaching herd immunity will be a real challenge.”

Slowdowns

So far, some real-world data seems to be backing up the worries. An analysis by Bloomberg of vaccine distribution and administration in all 50 states suggests that some areas and states are seeing unused doses pile up. Though a band of states in the south—Alabama, Georgia, and Mississippi, among others—have consistently struggled to use their vaccine supply. There are also states like West Virginia, which has seen use decline.

Early in the pandemic, West Virginia had been lauded for its fast and efficient vaccination rollout. Around February 19, it was logging that just about seven percent of its vaccine supply had gone unused. Today, that figure is 26 percent.

Clay March, the state’s COVID-19 vaccine czar, told Bloomberg that in that time frame, vaccination efforts have shifted from focusing on older populations to people in their teens to mid-30s. “We’re seeing more incidents of more people needing more convincing or needing more time to make their decision,” Marsh said. ​​​​​​“We’re right on that interface of having more vaccine than arms to put them in.”

Similarly, officials with the Southern Nevada Health District announced Thursday that they too were having troubling keeping up the vaccination pace and would be shutting down a mass vaccination site on May 5.

“On Tuesday specifically, we did about 7,700 [vaccinations at the closing site], but today we’ll do roughly about 2,000, mostly second doses,” local official Greg Cassell, said at a press briefing Thursday. “Numbers are falling off and we’re looking at different options going forward of how we’re going to operate to continue to vaccinate the community”

Cassell added that health officials are planning on setting up “strike teams” that will set up smaller vaccination sites at various locations to try to get 300 to 500 people vaccinated a day.

Residents wait in an observation area after receiving Covid-19 vaccines at a vaccination site in Richmond, California on Thursday, April 15, 2021.
Enlarge / Residents wait in an observation area after receiving Covid-19 vaccines at a vaccination site in Richmond, California on Thursday, April 15, 2021.

Cases of COVID-19 are extremely rare among people who are fully vaccinated, according to a new data analysis by the Centers for Disease Control and Prevention.

Among more than 75 million fully vaccinated people in the US, just around 5,800 people reported a “breakthrough” infection, in which they became infected with the pandemic coronavirus despite being fully vaccinated.

The numbers suggest that breakthroughs occur at the teeny rate of less than 0.008 percent of fully vaccinated people—and that over 99.992 percent of those vaccinated have not contracted a SARS-CoV-2 infection.

The figures come from a nationwide database that the CDC set up to keep track of breakthrough infections and monitor for any concerning signs that the breakthroughs may be clustering by patient demographics, geographic location, time since vaccination, vaccine type, or vaccine lot number. The agency will also be keeping a close eye on any breakthrough infections that are caused by SARS-CoV-2 variants, some of which have been shown to knock back vaccine efficacy.

So far, the vaccines appear to be highly effective and working as expected, according to the CDC’s analysis—which the agency provided to Ars via email.

The vast majority of people in the US have been vaccinated with one of the mRNA vaccines, made by Moderna and Pfizer-BioNTech, which both had around 95 percent efficacy in Phase III clinical trials. Less than five percent of people in the US have received the Johnson & Johnson adenovirus-based vaccine, which had a slightly lower efficacy of 72 percent in the US.

The extraordinary calculation that 99.992 percent of vaccinated people have not contracted the virus may reflect that they all simply have not been exposed to the virus since being vaccinated. Also, there’s likely cases missed in reporting. Still, the data is a heartening sign.

“COVID-19 vaccines are effective and are a critical tool to bring the pandemic under control,” the agency said in its email. “To date, no unexpected patterns have been identified in case demographics or vaccine characteristics.”

Keep masking up for now

Many of the breakthroughs occurred in older people, who are well-known to be more vulnerable to COVID-19. More than 40 percent were in people ages 60 and above. However, the agency noted that there were breakthrough infections scattered through every age group that is currently eligible for vaccination.

“We see [breakthroughs] with all vaccines,” top infectious disease expert Anthony Fauci said in a press briefing earlier this week. “No vaccine is 100 percent efficacious or effective, which means that you will always see breakthrough infections regardless of the efficacy of your vaccine.”

Vaccines can fail in some people because of a variety of factors, including immune status, health status, age, and medications they’re on. There’s also the possibility that something went wrong with the vaccines themselves, such as improper storage, delivery, or composition, Fauci explained.

“However,” Fauci added, “even if a vaccine fails to protect against infection, it often protects against serious disease.” He highlighted the case of the 2019-2020 flu vaccine, which was only bout 39 percent effective. Despite this, and the fact that only about 52 percent of people got their immunization, the vaccine was estimated to have prevented 105,000 flu hospitalizations and 6,300 flu deaths.

In the CDC’s data on breakthrough COVID-19 infections, the agency found that 29 percent of the infections were asymptomatic. Only seven percent of the 5,800 breakthrough cases resulted in hospitalization and there were only 74 deaths. That suggests the death rate among breakthrough cases is around one percent and, among all fully vaccinated people, around 0.0001 percent.

Though the risk is small, there is still risk. The CDC emphasized that everyone should get vaccinated when its their turn and, once vaccinated, should continue following health precautions for now, such as “wearing a mask, staying at least 6 feet apart from others, avoiding crowds and poorly ventilated spaces, and washing their hands often.”

A woman adjusts her face mask while sitting in front of a microphone.
Enlarge / Rochelle Walensky, director of the US Centers for Disease Control and Prevention (CDC), adjusts her protective mask during a Senate Health, Education, Labor, and Pensions Committee hearing in Washington, DC.

Highly effective COVID-19 vaccines are simply too slow to stop surges like the one underway in Michigan, Rochelle Walensky, director of the Centers for Disease Control and Prevention, said Monday.

Dr. Walensky’s explanation during the White House COVID-19 press briefing comes amid mounting requests and calls for federal authorities to flood Michigan with vaccine supply. The state has seen a 400 percent spike in cases since March 5, when state officials eased restrictions on residential gatherings and occupancy limits for bars, restaurants, venues, and stores. Since then, the highly transmissible B.1.1.7 coronavirus variant has also increased in prevalence. Now, the state’s seven-day average for new daily cases is over 7,377, and hospitals are filling up.

On March 30, when the surge was already in full swing, Michigan Gov. Gretchen Whitmer appealed to the White House for additional vaccine shipments. However, the White House declined, opting to stick to its largely population-based strategy for dolling out vaccine supply to each state and jurisdiction.

Experts quickly decried the move, saying that an increase in vaccine doses could help bring an end to the surge in cases. In an interview on CBS’s Face The Nation Sunday April 11, former Food and Drug Administration commissioner and Pfizer board member Dr. Scott Gottlieb echoed his calls for the White House to boost Michigan’s vaccine allotment. “It’s a request that’s been made for weeks now, and I think we should have done it weeks ago,” he said. “We need to get in the habit of trying to surge resources into those hotspots to put out those fires of spread.”

But Walensky pushed back on that idea Monday, noting that it takes weeks for people to build up protective immune responses from vaccines. With the mRNA vaccines made by Pfizer-BioNTech and Moderna—the two most common vaccines used in the US right now—people don’t reach full protection until two weeks after their second dose, which occurs three and four weeks after their first, respectively.

Reality check

“We know that if vaccines go in arms today, we will not see an effect of those vaccines, depending on the vaccine, for somewhere between two to six weeks,” Walensky said. She continued:

So when you have an acute situation, [an] extraordinary number of cases like we have in Michigan, the answer is not necessarily to give vaccine. In fact, we know that the vaccine will have a delayed response. The answer to that is to really close things down, to go back to our basics, to go back to where we were last spring, last summer and to shut things down, to flatten the curve.

Walensky emphasized the use of lockdowns, social distancing measures, testing, and contact tracing as the primary responses to surges like Michigan’s. As before, she noted that the CDC has surged other resources to Michigan, including teams to help deal with specific outbreaks and hasten the use of the vaccine doses already distributed to the state.

Meanwhile, the B.1.1.7 variant is continuing to spreading in states across the country, Andy Slavitt, a senior White House adviser on the pandemic, said during the press briefing. It is now the predominant lineage of the virus nationwide. The White House doesn’t want to prioritize Michigan, potentially compromising vaccination campaigns in others states, Slavitt explained. The current strategy provides the “ability to vaccinate people quickly in each of those states,” Slavitt said, “rather than taking vaccines and shifting it to play whack-a-mole, [which] isn’t the strategy that public health leaders and scientists have laid out.”

The points were largely echoed in a press briefing by the World Health Organization also on Monday, which emphasized that globally, the pandemic is growing exponentially. There have now been seven consecutive weeks with increases in cases and four weeks of increasing deaths. Several concerning variants are driving outbreaks in various regions. “This is not the situation we want to be in 16 months into a pandemic, where we have proven control measures,” WHO technical lead Maria Van Kerkhove said in the briefing.

Vaccinations are underway, she noted, but their full impact is not yet in effect. For now, she and the WHO director-general echoed Walensky, imploring people to get back to the basics of physical distancing, mask-wearing, ventilation, hand hygiene, and avoiding crowds—until vaccination efforts are farther along.

“We need headlines around the tools that we have right now that can prevent infections and save lives,” Van Kerkhove said. “We are in a critical point… It is time right now where everyone has to take stock and have a reality check about what we need to be doing.”

An A frame sign tells diners in a downtown patio how to behave.
Enlarge / A sign requiring protective face masks in Detroit, Michigan, on Sunday, March 21, 2021.

Even as the pace of vaccination in the US nears a heartening 3 million per day, the country hovers on the brink of a fourth surge, with current cases lingering at a “disturbingly high level,” according to top infectious disease expert Anthony Fauci.

The current seven-day average of new daily cases is now over 63,000—levels seen at the base of the record winter surge. “When you’re at that level, there is the risk of getting a surge back up,” Fauci said in an interview with CNN.

Adding to the precarious situation is the highly transmissible B.1.1.7 coronavirus variant, first identified in the UK. It is now the predominant strain of SARS-CoV-2 in the US, Rochelle Walensky (director of the Centers for Disease Control and Prevention) said in a White House Press Briefing Wednesday.

“These trends are pointing to two clear truths,” Walensky said. “One, the virus still has hold on us—infecting people and putting them in harm’s way—and we need to remain vigilant. And, two, we need to continue to accelerate our vaccination efforts.”

Now, many experts are eyeing Michigan as a potential bellwether for the fate of the rest of the country. As the variant spreads there, the state is seeing a spike in cases, hospitalization, and deaths, rivaling numbers seen in the winter peak. The B.1.1.7 variant has been detected in 46 of the state’s 83 counties.

Michigan’s case rates are up 375 percent since its previous low on February 19, the Michigan Department of Health and Human Services said in a recent data update. According to the CDC, the state has a seven-day case rate of 492 per 100,000 people, the highest case rate in the country. Next is New Jersey, with a seven-day-case rate of 328 per 100,000.

Michigan has seen nearly 50,000 cases in the last seven days, also the highest in the country. It currently has a seven-day rolling average of around 7,000 new cases a day, an 89 percent increase from a week ago, according to tracking by The New York Times.

Surge plans

Hospitalizations are above 3,000 in the state, a 124 percent increase from two weeks ago, and the number of patients filling intensive care units has increased 41 percent just in the last week, according to the MDHHS. State projections estimate that ICU use will exceed that seen in the winter peak by Monday, March 12. MDHHS Director Elizabeth Hertel told reporters Wednesday that hospitals are now looking into implementing their surge plans.

Deaths are also rising now, with an average daily deaths around 36. Since a low on March 9, deaths have increased 75 percent in the state.

The CDC has deployed teams of its public health workers to help with the statewide surge. “We are working closely with the state of Michigan and the state health officials there,” Walensky said Wednesday. The CDC is helping to investigate outbreaks in correctional facilities and youth sports teams. It’s also working to monitor the spread of B.1.1.7 and shift the state’s vaccine supply to the hardest hit areas.

Some experts have questioned whether the Biden administration should send a surge supply of vaccines to the state to try to head off the variant and the spike in cases. Currently, the federal government largely doles out doses based on each state and jurisdiction’s population. But last month, Michigan Gov. Gretchen Whitmer had asked for a boost in supply to avert the state’s surge. The White House declined the request, however, according to The Washington Post.

In the press conference Wednesday, Andy Slavitt, a senior White House advisor on the pandemic, told reporters that, for now, the administration is largely sticking to its population-based distribution plan.

“We have a long way to go today to get the country to a place where each of our states has reached the number of vaccinations that the population can handle,” Slavitt said. “Clearly, we will get to a place where targeted strategies will work. But right now, I would commit to you that we’re doing both.”

A person wearing a face make walks along a port on a sunny day with the Princess Diamond cruise ship docked in the background.
Enlarge / YOKOHAMA, JAPAN – FEBRUARY 10: A member of the media wears a face mask while walking past the Diamond Princess cruise ship.

The cruise industry is rather salty about the latest federal guidance for safe pandemic sailing, calling it “burdensome” and “unworkable. “

The new guidance is an updated phase of the Framework for Conditional Sailing Order (CSO), released April 2 by the Centers for Disease Control and Prevention. While it does not mandate vaccinations for all staff and cruisegoers, it does recommend the shots and requires added layers of health measures to try giving any onboard COVID-19 outbreaks the heave-ho—which is exceedingly difficult to do on the tightly packed, highly social vessels.

Among several changes, the guidance requires cruise operators to increase how frequently they report the number of COVID-19 cases onboard, upping reporting from weekly to daily. It also requires cruise lines to implement new routine testing for crew members. Additionally, the guidance requires that cruise lines have agreements set up with port authorities and local health authorities to ensure that, in the event of an outbreak, there will be coordination and infrastructure necessary to safely quarantine, isolate, and treat passengers and crew on land.

Once those requirements are met, cruise operators can run mock cruises with volunteer passengers and, if all goes well, apply for a “Conditional Sailing Certificate.”

In a statement released Monday, the prominent industry trade group Cruise Lines International Association released a statement calling the new guidance “unduly burdensome, largely unworkable.”

Disappointing

The CLIA claims the health guidance “deprives US workers from participating in the economic recovery” and provides “no discernable path forward or timeframe for resumption” of cruises originating in the country. The group ended its statement by urging the Biden administration to “consider the ample evidence that supports lifting the CSO this month to allow for the planning of a controlled return to service this summer.”

Likewise, Norwegian Cruise Line Holdings CEO Frank Del Rio told The Washington Post in an interview Monday that the company was “disappointed,” by the CDC’s latest guidance. “We thought it was a step backward, quite frankly,” Del Rio said.

The cruise executive sent a letter to CDC director Rochelle Walensky on Monday, touting the cruise company’s own plan to safely resume cruising, which includes mandatory vaccination for all passengers and employees. Del Rio balked at the agency’s additional requirements, regardless of vaccination status.

The CDC is unlikely to be moved on the subject. In its announcement of the guidance, the agency noted that “Cruising safely and responsibly during a global pandemic is difficult. While cruising will always pose some risk of COVID-19 transmission, following the phases of the CSO will ensure cruise ship passenger operations are conducted in a way that protects crew members, passengers, and port personnel, particularly with emerging COVID-19 variants of concern.”

In the early days of the pandemic, cruise ships were among the first high-profile victims of COVID-19 and experienced devastating outbreaks that gained international attention. Among the most memorable was the Diamond Princess, which was quarantined for weeks at a Japanese port in February 2020 amid a blazing outbreak. At one point, the luxury liner had the largest cluster of COVID-19 outside of China, where the pandemic began. In all, 712 of the ship’s 3,711 passengers and crew were infected, 37 required intensive care, and nine died.

People practice social distancing in white circles in Domino Park in Williamsburg during the coronavirus pandemic on May 17, 2020, in New York City.
Enlarge / People practice social distancing in white circles in Domino Park in Williamsburg during the coronavirus pandemic on May 17, 2020, in New York City.

The B.1.1.7 coronavirus variant is estimated to spread about 50 percent more than previous versions—but it doesn’t seem to manage that higher transmissibility by surviving in the air better than other versions of the virus, according to a new study.

In lab experiments looking at virus survival in artificially produced aerosolized particles, a B.1.1.7 lineage virus had about the same survival rate as a strain of the virus that was circulating in Wuhan, China in January 2020, according to the study, which published recently in The Journal of Infectious Diseases.

For the study, government researchers created aerosolized particles that mimic those spewed from deep in a person’s lungs, then tested how well the viruses survived in those particles under different temperature, humidity, and light conditions.

Just like the Wuhan virus lineage, the B.1.1.7 virus lost 90 percent of its infectivity after about 6.2 hours in darkness. In simulated sunlight conditions, the two lost 90 percent of infectivity in about 11 minutes. The researchers concluded that the viruses “would be rapidly inactivated by natural sunlight in real-world scenarios.”

The researchers also looked at two other virus variants—one that has a mutation linked to increased transmissibility (which is shared in B.1.1.7) and another has a mutation linked to a better ability to infect human cells. Both of those variants also performed about the same as B.1.1.7 and the Wuhan lineage virus. However, they lost 90 percent infectivity in about seven to eight minutes in simulated sunlight, a slight but statistically significant difference, the researchers note.

In all, the data supports what experts have already hypothesized based on other data. That is, that the more transmissible viruses are not spreading more easily because they linger longer in the air or can travel farther. Instead, they are likely spreading more because they either produce more virus in people’s airways—meaning people are simply expelling more infectious virus at once or over time—and/or the viruses are better at infecting cells, thus it takes fewer viral particles to start an infection (smaller infectious dose). The data also suggests that masking and the current distancing recommendations are still effective at reducing the spread of the more transmissible variants.