Hospital suspends 178 health care workers for failing to get COVID vaccine

Multistory glass-and-steel hospital.

Enlarge / An American flag flies outside the Houston Methodist Hospital at the Texas Medical Center (TMC) campus in Houston, Texas, on Wednesday, June 24, 2020. (credit: Getty | Bloomberg)

As of Tuesday, 178 health care workers employed by a Houston-based hospital system are on a two-week unpaid suspension after failing to meet the hospital system’s mandate to be fully vaccinated against COVID-19 by Monday, June 7.

Houston Methodist CEO Marc Boom announced the mandate in April, telling hospital staffers that if they failed to get vaccinated, they would be fired. The 178 suspended employees now have the two unpaid weeks to become fully vaccinated before termination. They can do so by getting the one-shot COVID-19 vaccine by Johnson & Johnson or a second dose of either of the two mRNA vaccines. Boom noted in a letter to employees sent Tuesday that 27 of the 178 suspended employees have received one dose of vaccine.

The Texas hospital system stood out in issuing the vaccination mandate. Many employers have shied away from mandates, though more employers have followed Houston Methodist’s lead in recent weeks. Overall, the mandate appears successful: about 97 percent of the hospital’s nearly 26,000 employees are fully vaccinated. Boom reported that 24,947 staffers were fully vaccinated, while 285 received a medical or religious exemption, and 332 were granted deferrals for pregnancy and other reasons.

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US may miss July 4 vaccination target as number of daily doses plummet

A mostly deserted convention center.

Enlarge / A deserted walk-in COVID-19 mass vaccination site at the Convention Center in downtown Washington, DC, on June 1, 2021. (credit: Getty | ANITA BEATTIE )

The rate of COVID-19 vaccinations in the US has now slowed to a crawl after weeks of decline in the number of doses given out each day. The continued trend threatens to further drag out the devastating pandemic. It also now imperils a goal set just last month by President Joe Biden to have 70 percent of American adults vaccinated with at least one dose by July 4.

On Monday, the country’s seven-day average of doses administered per day was again below 1 million, where it has been now for several days. The average hasn’t been this low since January 22. In mid-April, the average peaked at nearly 3.4 million doses a day, following a record of over 4.6 million doses administered in a single day.

With less than a month to go until Independence Day, there’s a real possibility that the US will fall shy of Biden’s 70-percent goal. Currently, about 63.7 percent of adults in the country have received at least one dose. But a chunk of daily doses are now going to adolescents ages 12 to 17, who became eligible for vaccination last month. And total vaccination numbers are still on a significant decline. If current trends hold, the US may only have about 67 percent of adults vaccinated with at least one dose by the Fourth of July, according to one analysis conducted by USA Today.

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Moderna’s data in kids ages 12-17 “consistent with a vaccine efficacy of 100%”

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

Moderna’s COVID-19 vaccine appears safe and highly effective in adolescents ages 12 to 17, according to the top-line results of a small clinical trial the company announced Tuesday.

The company plans to submit the trial data to the US Food and Drug Administration early next month, seeking authorization for expanded use in the age group.

If the FDA grants the authorization, Moderna’s vaccine will be the second COVID-19 vaccine available for use in kids as young as 12 in the US. Earlier this month, the FDA authorized the Pfizer-BioNTech vaccine for use in adolescents ages 12 to 15. (The Pfizer-BioNTech vaccine was initially authorized for use in people ages 16 and up, while Moderna’s was initially authorized for use in people ages 18 and up.)

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Ohio’s 53% vaccination surge tied to $1M lottery; NY and MD announce lotteries

Maryland Governor Larry Hogan stands next to a person dressed as a lottery ball during a press conference on May 20 announcing the state's VaxCash promotion.

Enlarge / Maryland Governor Larry Hogan stands next to a person dressed as a lottery ball during a press conference on May 20 announcing the state’s VaxCash promotion. (credit: Patrick Siebert)

The governors of New York and Maryland on Thursday each announced big cash lotteries to entice their residents to get vaccinated against COVID-19. The announcements came as westward-neighbor Ohio celebrated the success of its “Vax-a-Million” lottery campaign, which helped boost week-to-week vaccination numbers 53 percent.

The lotteries appear to be part of a growing trend of states and officials offering cash prizes or other incentives to combat slumping vaccination rates. The country’s seven-day average for daily vaccinations has dropped to around 1.8 million, down from a peak of nearly 3.4 million in mid-April.

In a White House COVID-19 press briefing Friday, Senior White House Advisor Andy Slavitt said that, based on the data the administration has seen, the lotteries “appear to be working.”

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Need for annual COVID shots hinges on how many people get vaccinated now

A masked man rolls up his sleeve to receive an injection.

Enlarge / Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, receives the Moderna Inc. COVID-19 vaccine during an event at the NIH Clinical Center Masur Auditorium in Bethesda, Maryland, on Tuesday, Dec. 22, 2020. (credit: Getty | Bloomberg)

As COVID-19 vaccination efforts continue across the United States, many are wondering how long protection from the shots might last. And if protection is relatively short-lived, what does that mean for the years ahead? Will we need boosters? Will COVID-19 vaccines become an annual jab like the seasonal flu shot?

In back-to-back public interviews, top infectious disease expert Anthony Fauci provided the current outlook based on the latest data. Boosters are looking likely, but it’s still unclear when we’ll need them, with current speculation landing in the range of a year or so after the previous vaccination. Whether we’ll need them every year seems, for now, dependent on how many people get vaccinated this year.

Boosters

Speaking at an Axios virtual event Wednesday, Dr. Fauci emphasized that “we don’t know exactly when” a booster will be required. We know that the current vaccines remain protective for at least six months—“and likely considerably more,” Fauci added.

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Pfizer’s COVID vaccine can stay in normal fridge for up to a month, FDA says

A pharmacist holding a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19.

Enlarge / A pharmacist holding a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit: Getty | JEAN-FRANCOIS MONIER)

The US Food and Drug Administration on Wednesday announced a big change in the way doses of Pfizer-BioNTech’s COVID-19 vaccine can be handled. From now on, undiluted vials of the mRNA vaccine can stay at normal refrigerator temperatures for up to a month rather than the previous limit of just five days.

The change has the potential to significantly ease storage issues and promote the use of the highly effective vaccine, which has been hindered in some settings by its ultra-cold storage requirements.

For long-term storage, the vaccine still requires ultra-cold freezer temperatures—between -80°C to -60°C (-112°F to -76°F). But the vials can be transported and temporarily stored at normal freezer temperatures—between -25°C to -15°C (-13°F to 5°F)—for up to two weeks. According to yesterday’s update, the undiluted vials can then be thawed and kept at normal refrigerator temperatures—between 2°C to 8°C (35°F to 46°F)—for up to a month. Once the vials are diluted and ready for use, they must be used within six hours, according to the FDA’s detailed handling guide.

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CDC defends its abrupt reversal on masks after backlash from experts

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. (credit: Getty | Bloomberg)

Criticism and confusion have erupted following the Centers for Disease Control and Prevention’s abrupt recommendation last Thursday that fully vaccinated people can immediately shed masks in most settings. The agency is yet again on the defense over its mask guidance.

Mask usage has been one of the most contentious issues throughout the pandemic—and that seems unlikely to change anytime soon. Just last Tuesday, CDC Director Rochelle Walensky faced a grilling from Senate Republicans, who suggested that the agency was being too slow and too conservative in its health guidance, particularly on the issue of outdoor mask use.

At the time, the agency recommended that fully vaccinated people should continue to wear masks in many uncrowded indoor settings as well as in crowded outdoor settings. “We will continue to recommend this until widespread vaccination is achieved,” Walensky said in an April 27 briefing. On that day, around 29 percent of the US population was fully vaccinated.

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Rare, flesh-eating “black fungus” rides COVID’s coattails in India

A person wrapped in white protective gear steps out of the back of a van.

Enlarge / A health worker exits an ambulance outside a quarantine center in the Goregaon suburb of Mumbai, India, on Tuesday, April 27, 2021. (credit: Getty | Bloomberg)

As the pandemic coronavirus continues to ravage India, doctors are reporting a disturbing uptick in cases of a rare, potentially fatal fungal infection among people recovered or recovering from COVID-19.

The infection is called mucormycosis, or sometimes “black fungus” in media reports, and it appears to be attacking COVID-19 patients through the nose and sinuses, where it can aggressively spread to facial bones, the eyes, and even the brain (rhinocerebral mucormycosis). In other cases, the fungus can also attack the lungs, breaks in the skin, and the gastrointestinal system or spread throughout the body in the blood stream.

A classic feature of mucormycosis is tissue necrosis—the death of flesh, essentially—which, in the rhinocerebral form of the disease, can lead to black, discolored lesions on and in the face, particularly on the bridge of the nose and the roof of the mouth. Mucormycosis is fatal in around 50 percent of cases.

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#black-fungus, #covid-19, #diabetes, #immunocompromised, #india, #infectious-disease, #mucormycosis, #public-health, #science

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AstraZeneca’s troubled vaccine not renewed in EU; Pfizer gets big, new deal

Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.

Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. (credit: Getty | Photonews)

The European Union has declined to renew orders for AstraZeneca’s COVID-19 vaccine, an EU official said Sunday. The decision comes after a series of production and safety troubles with AstraZeneca’s vaccine—and news on Saturday that the EU signed a deal to have Pfizer and BioNTech provide up to 1.8 billion doses of their vaccine between 2021 and 2023.

Last month, the EU took legal action against AstraZeneca, alleging that the company had failed to live up to its contract to supply the bloc with doses. The contract ends in June.

“We did not renew the order after June,” European Internal Market Commissioner Thierry Breton said in a Sunday French radio interview, which was reported by Reuters. “We’ll see what happens,” he added, leaving open the possibility of future orders.

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#astrazeneca, #biontech, #covid-19, #eu, #fda, #infectious-disease, #pfizer, #public-health, #science, #sinopharm, #vaccine, #who

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9,000 fliers may have had reused swabs jammed up their noses in Indonesia

A gloved hand rams a cotton swab into an unhappy person's face hole.

Enlarge / BANGKA BELITUNG ISLANDS, INDONESIA – DECEMBER 21, 2020: Health workers carry out a rapid antigen test on a passenger at Deapti Amir Airport, Pangkal Pinang City. (credit: Getty | Roni Bayu)

Since last December, more than 9,000 airline passengers who took a coronavirus rapid test as they flew out of Kualanamu International Airport in Medan, Indonesia, may have been tested by having previously used cotton swabs jammed into their noses.

Medan police arrested four workers and a local manager of the major pharmaceutical company Kimia Farma, which was working in conjunction with the airport to help perform the tests. The Medan-based Kimia Farma employees were allegedly washing and repacking cotton swabs for the tests while pocketing up to 1.8 billion rupiah (~$125,000), local police said.

Airline passengers in Indonesia are required to present a negative COVID-19 test result before boarding, and many opt for the convenience of being tested at the airport. Since the alleged swab scam began in December, Kimia Farma workers were testing between 100 and 200 passengers a day at the airport, some with fresh tests and others with tests that apparently involved reused swabs.

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#covid-testing, #covid-19, #indonesia, #infectious-disease, #public-health, #science, #swab

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Biden shifts strategy as national vaccination rate continues to slow

An older man in a suit gestures while addressing an unseen crowd.

Enlarge / US President Joe Biden speaks in the State Dining Room of the White House in Washington, DC, on Tuesday, May 4, 2021. (credit: Getty | Bloomberg)

By July 4—two months from today—the Biden administration wants to have 70 percent of American adults vaccinated with at least one dose of a COVID-19 vaccine and 160 million adults fully vaccinated.

Currently, over 147.5 million people have received at least one shot, which is 44 percent of the overall population and includes 56 percent of adults (people ages 18 and up). Over 105 million people are fully vaccinated, which is nearly 32 percent of the overall population and includes nearly 41 percent of adults.

The administration’s new goal would mean that close to 100 million shots would have to go out in the next 60 days or so, President Joe Biden said in an address Tuesday afternoon.

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Brazil rejects Sputnik V vaccine, says it’s tainted with replicating cold virus

Vials of the Sputnik V vaccine against COVID-19 are seen at the Boris Trajkovski sports hall in Skopje as the country starts its vaccination campaign, after months of difficulties on April 16, 2021.

Enlarge / Vials of the Sputnik V vaccine against COVID-19 are seen at the Boris Trajkovski sports hall in Skopje as the country starts its vaccination campaign, after months of difficulties on April 16, 2021. (credit: Getty | ROBERT ATANASOVSKI)

Health regulators in Brazil say that doses of Russia’s Sputnik V COVID-19 vaccine contain a cold-causing virus capable of replicating in human cells.

The unintended presence of the virus in the vaccine can “lead to infections in humans and can cause damage and death, especially in people with low immunity and respiratory problems, among other health problems,” Brazil’s Health Regulatory Agency, Anvisa, said Wednesday in a translated statement.

Russia has unequivocally denied the claim, lobbed legal threats at Anvisa, and accused the respected regulators of being politically motivated to reject the vaccine.

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#brazil, #covid-19, #drug-regulation, #infectious-disease, #russia, #science, #sputnik-v, #vaccine

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To entice vaccine-hesitant, Biden touts maskless activities for vaccinated

The most powerful man on Earth speaks into multiple microphones.

Enlarge / President Joe Biden speaks on the North Lawn of the White House in Washington, DC, on Tuesday, April 27, 2021. (credit: Getty | Bloomberg)

The Centers for Disease Control and Prevention on Tuesday updated masking guidelines for people who have been fully vaccinated, now saying that they no longer need to wear a mask when outdoors with members of their household or when attending small, outdoor gatherings with unvaccinated people.

“Today is another day we can take a step back to the normalcy of before,” CDC Director Rochelle Walensky said in a press briefing Tuesday. “There are many situations where fully vaccinated people do not need to wear a mask, particularly if they are outdoors.”

The new guidance by the CDC lays out several examples of when fully vaccinated people can safely bare their faces.

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#biden, #cdc, #covid-19, #infectious-disease, #mask, #public-health, #science

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US COVID vaccinations fall nearly 11% in a week as demand wanes

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. (credit: Getty | Patrick Fallon)

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.

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Contractor that ruined 15M doses of J&J vaccine hiked price of another by 800%

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. (credit: Getty | Saul Loeb)

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.

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More J&J troubles: Vaccine manufacturing halted and more possible clot cases

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. (credit: Getty | Saul Loeb)

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.

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At 38.5% vaccinated, US may be running low on people eager for a shot

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. (credit: Getty | Bloomberg)

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.

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99.992% of fully vaccinated people have dodged COVID, CDC data shows

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. (credit: Getty | Bloomberg)

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.

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The very common vaccine ingredient at the center of J&J, AstraZeneca drama

Adenoviruses seen via transmission electron microscopy.

Enlarge / Adenoviruses seen via transmission electron microscopy. (credit: Getty | BSIP)

Out of an abundance of caution, US officials on Tuesday recommended pausing use of Johnson & Johnson’s COVID-19 vaccine. Officials linked the vaccine to six peculiar illnesses in which people developed life-threatening blood clots in combination with low levels of blood platelets, the cell fragments in blood that form clots. One person died from their condition and another is in critical condition.

It’s unclear if the vaccine caused the illnesses. Even if it did, the illnesses would represent an exceedingly rare side effect. The six cases occurred among more than 6.8 million people in the US who received the Johnson & Johnson vaccine. That would make it a side effect seen in fewer than one in a million. The risk of hospitalization and death from COVID-19, which the vaccine protects against, easily exceeds those odds. Without question, the benefits of the vaccine outweigh the potential risks.

Still, with robust supplies of vaccine from Moderna and Pfizer-BioNtech—neither of which have been linked to these unusual cases—US officials took the cautious route of pausing Johnson & Johnson’s vaccine while they investigate the cases further and inform clinicians about how to spot and treat any others that may arise. This latter point is critical because if doctors try to use standard blood clot treatments in these vaccine-linked cases, the outcomes can be fatal.

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It’s too late for vaccines to save Michigan, CDC director explains

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. (credit: Getty | Bloomberg)

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.

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Florida sues USA, CDC to get people back on cruise ships

Florida Gov. Ron DeSantis speaks to the media about the cruise industry during a press conference at PortMiami on April 8, 2021 in Miami, Florida.

Enlarge / Florida Gov. Ron DeSantis speaks to the media about the cruise industry during a press conference at PortMiami on April 8, 2021 in Miami, Florida. (credit: Getty | Joe Raedle)

The state of Florida has filed a lawsuit against the United States of America and the Centers for Disease Control and Prevention, claiming that the health agency’s guidance for the cruise industry is “arbitrary and capricious” and that it should be immediately dubbed “unlawful.”

“Today, Florida is fighting back,” Florida Gov. Ron DeSantis (R) said in a news conference at Miami’s seaport Thursday, in which he announced the lawsuit. “We don’t believe the federal government has the right to mothball a major industry for over a year based on very little evidence and very little data. And I think we have a good chance for success.”

The lawsuit comes just days after the CDC released updates to its Conditional Sailing Order (CSO), which the cruise industry called “unduly burdensome” and “largely unworkable.”

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#cdc, #covid-19, #cruises, #desantis, #florida-man, #infectious-disease, #lawsuit, #public-health, #science

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US COVID cases “disturbingly high” as Michigan sees dire spike

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. (credit: Getty | Bloomberg)

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.

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#b-1-1-7, #cases, #cdc, #covid-19, #infectious-disease, #michigan, #pandemic, #public-health, #sars-cov-2, #science, #surge

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Cruise industry salty over CDC plan to keep travelers safe from COVID at sea

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. (credit: Getty | Carl Court)

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.

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#cdc, #covid-19, #cruise, #infectious-disease, #no-sail, #public-health, #science, #ship

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Coronavirus variant that spreads easily doesn’t do so by surviving in air better

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. (credit: Getty | Noam Galai)

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.

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#b-1-17, #covid-19, #infectious-disease, #public-health, #sars-cov-2, #science, #transmission, #variant, #virus

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Real-world data shows vaccines kicking butt—including against scary variant

A healthcare worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine inside the Viejas Arena on the campus of San Diego State University in San Diego, California, US on Thursday, April 1, 2021.

Enlarge / A healthcare worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine inside the Viejas Arena on the campus of San Diego State University in San Diego, California, US on Thursday, April 1, 2021. (credit: Getty | Bloomberg)

In a small trial, the Pfizer/BioNtech vaccine fully protected people from symptomatic COVID-19 caused by the worrisome B.1.351 coronavirus variant widely circulating in South Africa, the companies announced in a press release.

Though researchers will need more data to confirm the result, it is just the latest bit of positive news to come out this week about how the vaccines are performing with real-world conditions and in real-world settings.

On Monday, the Centers for Disease Control and Prevention released real-world data showing that the Pfizer/BioNTech mRNA vaccine and Moderna mRNA vaccine were, collectively, 90 percent effective at preventing infections in fully vaccinated health care, frontline, and essential workers.

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Factory mix-up spoils 15 million doses of J&J COVID vaccine

A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California.

Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. (credit: Getty | Mario Tama)

About 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine were ruined, and future vaccine shipments will be delayed. This all follows a mix-up at a manufacturing facility in Baltimore, according to multiple media reports.

Johnson & Johnson had partnered with Emergent BioSolutions to manufacture the active ingredient of its vaccine. But according to two US officials who spoke with Politico, workers at the West Baltimore facility mixed up the ingredients in Johnson &Johnson’s vaccine with those for a different coronavirus vaccine. Emergent BioSolutions is also a manufacturing partner of AstraZeneca, according to the New York Times, which first reported the problem.

The mishap with Johnson & Johnson’s vaccine began before the Food and Drug Administration had authorized the facility to produce the vaccine. Now, that authorization has been delayed and shipments are stalled.

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Trial started for vaccine against one of the scariest coronavirus variants

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

Researchers have given out the first jabs of a tweaked version of Moderna’s COVID-19 vaccine, one aimed at fighting one of the most concerning coronavirus variants—the B.1.351 variant, first identified in South Africa.

The jabs are part of an early trial of the tweaked vaccine, which is being run by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The agency aims to enroll around 210 healthy adults in the trial by the end of April.

“The B.1.351 SARS-CoV-2 variant, first identified in the Republic of South Africa, has been detected in at least nine states in the United States,” NIAID Director Anthony Fauci said in an announcement. “Preliminary data show that the COVID-19 vaccines currently available in the United States should provide an adequate degree of protection against SARS-CoV-2 variants. However, out of an abundance of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine.”

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Pfizer: COVID vaccine shows “100% efficacy” in adolescents 12-15

Jonathan, a 16-year-old teenager, receives a dose of the Pfizer-BioNtech COVID-19 coronavirus vaccine at Clalit Health Services, in Israel's Mediterranean coastal city of Tel Aviv on January 23, 2021.

Enlarge / Jonathan, a 16-year-old teenager, receives a dose of the Pfizer-BioNtech COVID-19 coronavirus vaccine at Clalit Health Services, in Israel’s Mediterranean coastal city of Tel Aviv on January 23, 2021. (credit: Getty | Jack Guez)

Adolescents aged 12 to 15 were completely protected from symptomatic COVID-19 after being vaccinated with the Pfizer/BioNtech mRNA vaccine in a small Phase III clinical trial, Pfizer reported in a press release Wednesday.

The company also said that the vaccine was well tolerated in the age group, spurring only the standard side effects seen in people aged 16 to 25. The vaccine is already authorized for use in people aged 16 and over.

The vaccine appeared more effective at spurring defensive immune responses in adolescents aged 12 to 15 than in the 16- to 25-year-old group, producing even higher levels of antibodies that were able to neutralize SARS-CoV-2. In a measure of neutralizing antibodies, vaccinated youths in the new trial had geometric mean titers (GMTs) of 1,239.5, compared with the GMTs of 705.1 previously seen in those aged 16 to 25, Pfizer noted.

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Experts sound alarm of possible new COVID surge as US cases once again rise

A health advisory sign on a beach in Florida.

Enlarge / A health advisory sign on a beach in Florida. (credit: Getty | Jeff Greenberg)

In mid-January, US cases of COVID-19 were in a nosedive from a towering record of over 315,000 new cases in a single day earlier in the month. And now, the pace of vaccinations has reached a heartening clip of 2.5 million per day. There’s almost a whiff of freedom from our pandemic confines in the sweet spring breeze.

But as anxious as we all are to return to normal life, the pandemic is not yet done with us.

The dramatic decline in cases ended weeks ago and plateaued at a disturbingly high level, matching daily case numbers seen in mid-October, at the base of the winter surge. Meanwhile, more transmissible variants of the pandemic coronavirus are swirling around the country. The B.1.1.7 variant—estimated to be around 50 percent more transmissible than earlier versions of the virus—is expected to become the predominant virus circulating in the US next month.

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After dramatic rebuke, AstraZeneca lowers vaccine efficacy estimate—a little

A vial of the AstraZeneca/Oxford vaccine is pictured at a coronavirus vaccination centre at the Wanda Metropolitano stadium in Madrid on March 24, 2021.

Enlarge / A vial of the AstraZeneca/Oxford vaccine is pictured at a coronavirus vaccination centre at the Wanda Metropolitano stadium in Madrid on March 24, 2021. (credit: Getty | Gabriel Bouys)

Brushing aside a dramatic rebuke from government researchers and independent experts, AstraZeneca on Wednesday night announced that a new analysis found its COVID-19 vaccine to be 76 percent effective at preventing symptomatic COVID-19—down from the 79 percent efficacy estimate it announced in a press release Monday.

The new estimate is still high, according to an independent board of experts tasked with overseeing the vaccine’s trial and data analysis. The trial’s Data and Safety Monitoring Board (DSMB) sent a highly unusual letter to AstraZeneca soon after the Monday press release, noting that trial data it had seen during February and March meetings suggested that the vaccine’s efficacy was actually between 69 percent and 74 percent.

“The DSMB is concerned that AstraZeneca chose to use data that was already outdated and potentially misleading in their press release,” the letter stated. “The point that is clear to the board is that the [vaccine efficacy number]… they chose to release was the most favorable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process.”

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Authorities raise red flags about AstraZeneca’s vaccine press release

Authorities raise red flags about AstraZeneca’s vaccine press release

Enlarge (credit: Getty| NurPhoto)

A board of independent experts tasked with monitoring the data and safety of AstraZeneca’s COVID-19 vaccine trial has raised a red flag about the company’s Monday press release, which trumpeted that the vaccine was 79 percent effective at preventing symptomatic COVID-19.

In the wee hours of Tuesday, the National Institute of Allergy and Infectious Diseases released an unusual statement indicating that the trial’s Data and Safety Monitoring Board (DSMB) had been in touch with the federal agency as well as the company. The statement read:

The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.

In an interview with Good Morning America Tuesday morning, NIAID director and top infectious disease expert Anthony Fauci tried to add more context to the situation. He noted that the DSMB, which has access to all of the data from the AstraZeneca trial, was left surprised by what the company said in its press release.

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AstraZeneca vaccine: 79% effective and no rare blood clots in US trial

Vials of the AstraZeneca COVID-19 vaccine are seen during the opening of a vaccination centre in Cyprus, on March 22, 2021.

Enlarge / Vials of the AstraZeneca COVID-19 vaccine are seen during the opening of a vaccination centre in Cyprus, on March 22, 2021. (credit: Getty | Etienne Torbey)

Exceeding expectations, AstraZeneca’s two-dose COVID-19 vaccine appeared highly effective against symptomatic and severe disease in a new late-stage trial conducted partly in the US. The company said it is now seeking emergency use authorization from the Food and Drug Administration. However, the vaccine may still be dogged by doubts.

The Phase III trial conducted in the US, Peru, and Chili found that the vaccine was 79 percent effective at preventing symptomatic disease, the company reported early Monday. Previous trial results suggests efficacy could be as low as 62 percent.

In the new 32,449-person trial, two-thirds of participants were dosed with the vaccine while the remaining third was given a placebo. There were five cases of severe disease in the trial, all in the placebo group. None of the vaccinated participants required hospitalization.

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Under pressure, CDC drops school spacing to 3 ft in many classrooms

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. Susan Walsh/AP/Bloomberg via Getty Images

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. Susan Walsh/AP/Bloomberg via Getty Images (credit: Getty | Bloomberg)

With universal masking, just 3 feet of distancing is safe for students in many classrooms, the Centers for Disease Control and Prevention announced in updated guidance released on Friday.

According to the new recommendations, elementary schools with universal masking policies are advised to maintain at least 3 feet of distancing between students in classrooms, regardless of the current level of community transmission of SARS-CoV-2.

Middle and high schools with universal masking are also advised to maintain at least 3 feet of distancing between students in classrooms if community transmission is currently low, moderate, or substantial. If the community transmission is high and student cohorting/podding is not possible, then distancing of at least 6 feet should be maintained in middle and high school classrooms.

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Amid panic over AstraZeneca vaccine, WHO urges countries to keep using it

Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020.

Enlarge / Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020. (credit: Getty| NurPhoto)

The World Health Organization is urging countries to continue using AstraZeneca’s COVID-19 vaccine as unfounded fears linking the shots to blood clots continue to spread wildly.

More than a dozen countries have recently suspended or curtailed use of the vaccine, including Germany, France, Italy, and Spain. Sweden and Luxembourg were among the latest to pause vaccinations on Tuesday.

The suspensions were prompted by a handful of reports that people developed blood clots sometime after receiving the vaccine. A few of the people later died.

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Study finds 3-ft distancing in schools is enough—but debate is far from over

Spring Township, PA - August 21: A first grade classroom where the desks are spaced out for social distancing.

Enlarge / Spring Township, PA – August 21: A first grade classroom where the desks are spaced out for social distancing. (credit: Getty | Ben Hasty)

The most sensitive and heated topic of the entire pandemic is—without a doubt—the welfare of our children. How can we best protect them from this devastating virus? What role do they play in spreading it? How can we even come close to meeting all their health, developmental, educational, and social needs as we try to navigate our topsy-turvy reality?

The path to daycare and school might as well be rerouted through a minefield. And the hazards don’t end when you reach the front doors. This nightmare has only been exacerbated by media reports of single studies that yanked parents, educators, and caretakers from one extreme to the other: Don’t worry, children are completely unaffected by the virus and don’t spread it! No, wait, they’re actually superspreaders, who can develop a deadly multisystem inflammatory syndrome!

More than a year into the pandemic, it’s very clear that the inflammatory syndrome (MIS-C) is rare. And although children can certainly catch and spread the virus, mounting studies continue to find that children generally have less severe disease than adults. Also, a consensus has emerged that schools do not tend to be hotbeds of virus transmission. While having schools open has been linked to higher community spread, studies have found basic precautions can be effective at limiting spread within schools.

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Many Republicans are refusing COVID vaccines. Experts are trying to change that

A woman in a MAGA hat holds up a sign reading COVID 19 vaccination equals death.

Enlarge / A Donald Trump supporter holds an false anti-vaccine sign while protesting in Washington, DC, on Tuesday, Jan. 5, 2021. (credit: Getty | Bloomberg)

While the Biden administration anticipates having enough COVID-19 vaccine doses to vaccinate all adults by May 1, health experts and policy advisors are trying to figure out how to actually get those shots into the arms of people—particularly people who are hesitant or distrustful of the vaccines, many of whom are Republicans.

For most of the country—about 69 percent—getting vaccinated and being able to return to some normal activities is an easy sell. Over 21 percent of people in America have already gotten at least one dose of an authorized vaccine. Three vaccines are currently authorized for use in the US, all of which are highly effective and safe. For the remaining pro-vaccine people, it’s just a matter of time before they can get one. In fact, many people around the country are anxiously trying to get in line and scouring online sign-up websites for an open vaccination slot.

But about 30 percent of adults are not getting in line, according to a poll by the Pew Research Center reported March 5. About 15 percent of people said they would probably not get vaccinated and an additional 15 percent said they would definitely not get a shot. That’s enough people to dash any hopes of ending the pandemic through vaccination. It’s also enough to ruin the Biden administration’s plans of celebrating our independence from the virus on July 4.

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COVID-19 could become a persistent, seasonal plague, experts warn

Empty vials of the Pfizer COVID-19 vaccine are seen at a first-come, first-serve drive-thru vaccination site operated by the Lake County Health Department on January 28, 2021 in Groveland, Florida. Seniors 65 and older waited in line for hours to be vaccinated.

Enlarge / Empty vials of the Pfizer COVID-19 vaccine are seen at a first-come, first-serve drive-thru vaccination site operated by the Lake County Health Department on January 28, 2021 in Groveland, Florida. Seniors 65 and older waited in line for hours to be vaccinated. (credit: Getty | NurPhoto)

Some experts speculate that the pandemic coronavirus will one day cause nothing more than a common cold, mostly in children, where it will be an indistinguishable drip in the steady stream of snotty kid germs. Such is the reality for four other coronaviruses that have long stalked school yards and commonly circulate among us every cold and flu season, to little noticeable effect.

But that sanguine—if not slightly slimier—future is shaky. And the road to get there will almost certainly be rocky. For the pandemic coronavirus to turn from terror to trifle, we have to build up high levels of immunity against it. At the population level, this will be difficult—even with vaccines. And with the uncertainty of how we’ll pull it off, some experts are cautioning that we should prepare for the possibility that the pandemic coronavirus, SARS-CoV-2, will stick with us for the near future, possibly becoming a seasonal surge during the winter months when we’re largely indoors.

“The prospect of persistent and seasonal COVID-19 is real,” write public health expert Christopher Murray of the University of Washington and infectious disease expert Peter Piot of the London School of Hygiene and Tropical Medicine. In a recent commentary in the Journal of the American Medical Association, the two warn that if that happens, it “could require both health system change and profound cultural adjustment for the life of high-risk individuals in the winter months. There is an urgent need to prepare for such a scenario.”

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Fully vaccinated Americans can safely visit unvaccinated family, CDC says

Fully vaccinated Americans can safely visit unvaccinated family, CDC says

Enlarge (credit: Getty | UniversalImagesGroup)

People who are fully vaccinated can safely have private visits with unvaccinated people who have a low risk for severe COVID-19, the Centers for Disease Control and Prevention announced today in highly anticipated guidance for vaccinated people.

In the guidance, the CDC considers people fully vaccinated once they have waited two weeks after their second dose of either the Pfizer/BioNTech vaccine or the Moderna vaccine, or two weeks after a single dose of the Johnson & Johnson vaccine. Though it may still be possible for fully vaccinated people to contract the pandemic coronavirus, have an asymptomatic or mild infection, and possibly spread the virus, the risk is considered low.

As such, once people are fully vaccinated, they can meet in private indoor settings—such as a home—with other fully vaccinated people without masks and without physical distancing.

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Under intense pressure, WHO skips summary report on coronavirus origin

Liang Wannian (2nd L) and Peter Ben Embarek (3rd R) both members of the WHO-China joint study team, shake hands after the WHO-China joint study press conference in Wuhan, central China's Hubei Province, on Feb. 9, 2021.

Enlarge / Liang Wannian (2nd L) and Peter Ben Embarek (3rd R) both members of the WHO-China joint study team, shake hands after the WHO-China joint study press conference in Wuhan, central China’s Hubei Province, on Feb. 9, 2021. (credit: Getty | Xinhua News Agency )

Facing intense international pressure and criticism, the World Health Organization has abandoned plans to release a summary report of its investigation into the possible origin of the pandemic coronavirus, SARS-CoV-2.

Instead, the health agency of the United Nations is skipping the summary report and plans to release a full report the week of March 15. The WHO had previously said it would release a summary report in mid-February.

“By definition, a summary report does not have all the details,” Dr. Ben Embarek, a WHO expert who led the investigation, told The Wall Street Journal. “So since there [is] so much interest in this report, a summary only would not satisfy the curiosity of the readers.”

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CDC to release guide for life after vaccination—with normalcy still far off

A woman in a suit speaks from a podium.

Enlarge / Dr. Rochelle Walensky, President Joe Biden’s pick to head the Centers for Disease Control. (credit: Getty | Chip Somodevilla)

The Centers for Disease Control and Prevention is expected to release guidance this week—possibly as early as Thursday—on activities that are considered safe for people who have been fully vaccinated against COVID-19.

But, while much of the country is hankering for some return of normalcy, the guidance is unlikely to deliver any satisfying taste of it. People who are fully vaccinated will be advised to continue adhering to most public health measures, such as mask wearing and physical distancing in most settings. Though they will get the greenlight for limited social gatherings, those should be kept small and home-based, and they should only include other fully vaccinated adults, according to early reports.

In a press conference Monday, top infectious disease expert Anthony Fauci laid out an example:

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B.1.1.7 variant now 10% of US cases—and cases are once again ticking up

President Joe Biden, first lady Jill Biden, Vice President Kamala Harris, and second gentleman Doug Emhoff participate in a moment of silence and candle light ceremony at sundown with 500 candles for the 500,000 dead from the COVID-19 pandemic, at the South Portico at the White House on Monday, Feb. 22, 2021 in Washington, DC.

Enlarge / President Joe Biden, first lady Jill Biden, Vice President Kamala Harris, and second gentleman Doug Emhoff participate in a moment of silence and candle light ceremony at sundown with 500 candles for the 500,000 dead from the COVID-19 pandemic, at the South Portico at the White House on Monday, Feb. 22, 2021 in Washington, DC. (credit: Getty | The Washington Post)

After weeks of dramatic decline, COVID-19 cases in the US have hit a plateau—and in some places are ticking up. Officials are sounding the alarm in hopes of averting a fourth surge in the devastating pandemic.

“We at CDC consider this a very concerning shift in the trajectory,” Rochelle Walensky, director of the Centers for Disease Control and Prevention, said in a press briefing last week. Though cases are down from their astronomical peak in early to mid January, the overall numbers are still quite high, matching averages seen in late October, at the base of the holiday surge.

“Things are tenuous,” she noted. “Now is not the time to relax restrictions.”

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We’ll likely have a 3rd COVID vaccine soon; J&J vaccine clears last hurdle

A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California.

Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. (credit: Getty | Mario Tama)

After a day-long meeting Friday, an advisory panel for the US Food and Drug Administration voted 22 to 0 to recommend issuing an Emergency Use Authorization for Johnson & Johnson’s single-shot, refrigerator-stable COVID-19 vaccine.

If the FDA accepts the panel’s recommendation and grants the EUA—which it likely will—the country will have a third COVID-19 vaccine authorized for use. Earlier this week, FDA scientists released their review of the vaccine, endorsing authorization.

Agency watchers expect the FDA to move quickly on the decision, possibly granting the EUA as early as tomorrow, February 27. The FDA moved that fast in granting EUAs for the two previously authorized vaccines, the Moderna and Pfizer/BioNTech mRNA vaccines.

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A 3rd shot? A new booster? Vaccine makers race to trials to beat variants

COVID-19 vaccine at a vaccination center in Madrid on Feb. 26, 2021.

Enlarge / COVID-19 vaccine at a vaccination center in Madrid on Feb. 26, 2021. (credit: Getty | NurPhoto)

With worrisome coronavirus variants seemingly emerging and spreading everywhere, lead vaccine makers are wasting no time in trying to get ahead of the growing threat.

This week, Moderna and partners Pfizer and BioNTech announced they have kicked off new vaccine clinical trials aimed at boosting the effectiveness of their authorized vaccines against new, concerning SARS-CoV-2 variants—primarily B.1.351, a variant first identified in South Africa.

In a set of studies published last week in the New England Journal of Medicine, both the Moderna mRNA vaccine and Pfizer/BioNTech mRNA vaccine spurred antibodies in vaccinated people that could neutralize the B.1.351 variant. But the levels of those neutralizing antibodies were significantly lower than what was seen against past versions of the virus. (Both vaccines performed well against the B.1.1.7 variant, first identified in the UK, which is expected to become the dominant strain in the US next month.)

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CDC unveils site to help you find COVID-19 vaccine—but only in 4 states

A registered nurse practitioner holds up a sign and a flag asking for another patient to dose with the Pfizer Covid-19 vaccine as well as a more vaccine doses at a vaccination site in Seattle, Washington on January 24, 2021.

Enlarge / A registered nurse practitioner holds up a sign and a flag asking for another patient to dose with the Pfizer Covid-19 vaccine as well as a more vaccine doses at a vaccination site in Seattle, Washington on January 24, 2021. (credit: Getty | Grant Hendsley)

In its efforts to help Americans get vaccinated against COVID-19, the US Centers for Disease Control and Prevention is quietly working on a new website that will let people see every location in their community offering COVID-19 vaccinations, how many shots each of those locations has for the current day, and provide links to set up vaccination appointments.

That’s the ideal, at least; there’s a lot of work to do to get there.

Right now, the site—vaccinefinder.org—only has the full lists of vaccine providers for four states—Alaska, Indiana, Iowa, and Tennessee. Those lists include providers at hospitals, clinics, public health centers, doctor’s offices, drug stores, and grocery store pharmacies.

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Johnson & Johnson’s vaccine safe and effective, FDA review concludes

A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California.

Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. (credit: Getty | Mario Tama)

Johnson & Johnson’s single-shot COVID-19 vaccine is effective and has a “favorable safety profile,” according to scientists at the Food and Drug Administration.

The endorsement comes out of a review released by the regulatory agency Wednesday. The FDA has been looking over data on Johnson & Johnson’s vaccine since February 4, when the company applied for Emergency Use Authorization. The agency’s green light is a positive sign ahead of this Friday, February 26, when the FDA will convene an advisory committee to make a recommendation on whether the FDA should grant the EUA. The FDA isn’t obligated to follow the committee’s recommendation, but it usually does.

If Johnson & Johnson’s vaccine is granted an EUA, it will become the third COVID-19 vaccine available for use in the US. The other two vaccines are both two-dose, mRNA-based vaccines, one made by Pfizer and its German partner BioNTech and the other from Moderna, which developed its vaccine in collaboration with researchers at the US National Institutes of Health.

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Garden-variety germs may explode in COVID’s wake, study suggests

Masked girls in matching uniforms wait for school to begin.

Enlarge / Young children go back to kindergarten following COVID-19 lockdown. (credit: Getty | TPG)

In our cushy COVID bubbles, our immune systems may be getting soft.

Physical distancing, lockdowns, masking, and spirited sanitizing all mean we are coming into contact with fewer garden-variety germs than normal. This year’s flu season was basically cancelled.

While that may seem like a welcome reprieve from seasonal ailments and pesky sniffles, experts fear that our immune systems may be losing their defensive edge in the lull. And with the usual microscopic suspects lying in wait for our return to some sense of normalcy, it could mean that nasty bursts of common colds and flu-like illnesses are in our post-COVID futures—ones that may not be avoidable even if we carry on with some of our COVID precautions.

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Pfizer vaccine doesn’t need ultra-cold storage after all, company says

A picture taken on January 15, 2021 shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19.

Enlarge / A picture taken on January 15, 2021 shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit: Getty | JEAN-FRANCOIS MONIER)

In a bit of good news, Pfizer and BioNTech announced today that their highly effective COVID-19 vaccine does not require ultra-cold storage conditions after all and can be kept stable at standard freezer temperatures for two weeks.

The companies have submitted data to the US Food and Drug Administration demonstrating the warmer stability in a bid for regulatory approval to relax storage requirements and labeling for the vaccine.

If the FDA greenlights the change, the warmer storage conditions could dramatically ease vaccine distribution, allowing doses to be sent to non-specialized vaccine administration sites. The change would also make it much easier to distribute the vaccine to low-income countries.

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“Shameful and inhumane”: DeSantis threatens to withhold vaccine amid criticism

Florida Gov. Ron DeSantis speaks during a press conference about the opening of a COVID-19 vaccination site at the Hard Rock Stadium on January 06, 2021, in Miami Gardens, Florida.

Enlarge / Florida Gov. Ron DeSantis speaks during a press conference about the opening of a COVID-19 vaccination site at the Hard Rock Stadium on January 06, 2021, in Miami Gardens, Florida. (credit: Getty | Joe Raedle)

As large swaths of the country face snags in COVID-19 vaccine distribution due to crippling snow and ice, some communities in Florida may face snags due to political windstorms from their governor, Ron DeSantis.

DeSantis was criticized this week after the state unveiled plans to open a “pop-up” clinic near Tampa that would offer vaccine doses only to residents in affluent, mostly white, mostly Republican areas of Manatee County. The clinic will vaccinate 3,000 residents of just two ZIP codes in the county, which were reportedly hand-selected by DeSantis and County Commissioner Vanessa Baugh—instead of being selected using the Sunshine State’s vaccine lottery system.

Plans for the clinic were born from a deal struck between DeSantis, Baugh, and real estate developer Rex Jensen, according to the Bradenton Herald. DeSantis reportedly reached out to Jenson, who agreed to host the clinic on his development, Lakewood Ranch. The master-planned community covers much of the two selected ZIP codes served by the clinic. The ZIP codes also overlap with Baugh’s district.

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Ebola outbreak erupts in Guinea as cases tick up in the DRC

Health care workers wearing personal protective equipment stand in a tent with patient beds at an Ebola Treatment Center in Coyah, Guinea, on Thursday, Sept. 10, 2015.

Enlarge / Health care workers wearing personal protective equipment stand in a tent with patient beds at an Ebola Treatment Center in Coyah, Guinea, on Thursday, Sept. 10, 2015. (credit: Getty | Bloomberg)

Two unrelated Ebola outbreaks have erupted in two countries that have already faced some of the worst of the deadly viral disease.

Health officials in Guinea on Sunday declared an Ebola outbreak in Gouéké in N’Zerekore prefecture, located in the southeast area of the country. Officials have linked seven people to the outbreak so far, including three deaths. Six people fell ill with an Ebola-like illness after attending a funeral. Three of those cases have been confirmed, and two of the six have died.

The outbreak marks the first time Ebola has been found in Guinea since 2016, when the largest Ebola outbreak ever recorded ended. The outbreak, which spanned 2014 to 2016, tallied more than 28,600 cases and over 11,000 deaths. Guinea was one of the three hardest-hit countries in the outbreak.

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FDA now reviewing a third COVID vaccine, made by Johnson & Johnson

The head office of Janssen pharmaceutical company on February 5, 2021 in Leiden, the Netherlands. The American mother company of Janssen, Johnson & Johnson, has requested quick approval in the United States for the coronavirus vaccine that was developed by Janssen Vaccines in Leiden.

Enlarge / The head office of Janssen pharmaceutical company on February 5, 2021 in Leiden, the Netherlands. The American mother company of Janssen, Johnson & Johnson, has requested quick approval in the United States for the coronavirus vaccine that was developed by Janssen Vaccines in Leiden. (credit: Getty | BSR Agency)

Johnson & Johnson on Thursday announced it has applied to the US Food and Drug Administration for an Emergency Use Authorization for its one-shot COVID-19 vaccine.

If the EUA is granted, the vaccine will be the third authorized for use in the US against the pandemic coronavirus, likely boosting the vaccine supply in the coming months and helping to hasten immunization country-wide.

J&J’s application to the FDA comes just a week after the company revealed top-line results of its Phase III clinical trial, which found the vaccine to be 66 percent effective overall at preventing moderate and severe COVID-19. J&J’s vaccine—made by its vaccine developer Janssen Pharmaceuticals—was 85 percent effective at preventing severe disease. In the trial, severe disease was defined as testing positive for the virus as well as having signs consistent with severe systemic illness, respiratory failure, shock, or organ failure, or being admitted to an intensive care unit, or dying. The company reported that no one who received the vaccine was hospitalized or died during the trial.

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#authorization, #coronavirus, #covid-19, #fda, #infectious-disease, #johnson-johnson, #pandemic, #public-health, #science, #vaccine

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