Fight over hospital’s COVID-19 vaccine mandate ends with 153 workers out of a job

Multistory glass-and-steel hospital.

Enlarge / Houston Methodist Hospital at the Texas Medical Center campus in Houston, Texas. (credit: Getty | Bloomberg)

After staging weeks of protest and being called “reprehensible” by a federal judge, 153 workers of a Houston-based hospital system lost their jobs Tuesday for refusing to get vaccinated against COVID-19.

Houston Methodist hospital system had placed 178 employees on a two-week, unpaid suspension on June 7 for failing to meet the hospital system’s vaccination mandate, which it had set on April 1. The unpaid two-week suspension was essentially the employees’ last chance to get vaccinated before facing termination.

During that time, some of the workers “became compliant with the policy,” a hospital spokesperson told the Houston Chronicle Tuesday. But 153 did not and either quit during their suspension or were fired on Tuesday. Houston Methodist CEO Marc Boom had previously noted in a letter to employees that 27 of the 178 suspended workers had received one dose of a COVID-19 vaccine going into the suspension.

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After ruining 75M J&J doses, Emergent gets FDA clearance for 25M doses

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 is making progress in its efforts to sort out the fiasco at Emergent BioSolutions’ Baltimore facility, which, at this point, has ruined more than 75 million doses of COVID-19 vaccines stemming from what the regulator identified as significant quality control failures.

In March, news leaked that Emergent ruined 15 million doses of Johnson & Johnson’s vaccine as well as millions more doses of AstraZeneca’s vaccine. The spoilage happened when Emergent cross-contaminated batches of the two vaccines with ingredients from the other.

Last week, the FDA told Emergent to trash about 60 million more doses of Johnson & Johnson’s vaccine due to similar contamination concerns, The New York Times reported.

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Experts “extremely worried” about Delta variant as US death toll hits 600,000

A serious woman in military fatigues prepares an injection.

Enlarge / Combat medics from Queen Alexandra’s Royal Army Nursing Corps vaccinate members of the public at a rapid vaccination centre, set up outside Bolton Town Hall on June 09, 2021 in Bolton, England. (credit: Getty | Christopher Furlong )

By many metrics, the US is currently doing relatively well against the pandemic coronavirus. National tallies of cases, hospitalizations, and deaths are all at lows not seen since early last year. Several states have hit the goal of having 70 percent of adults vaccinated with at least one dose, and many areas are easing or lifting health restrictions in response to squashed transmission levels.

But those hard-fought gains are accompanied by a grim milestone today: the national death toll reached 600,000. That’s roughly the population size of Milwaukee or Baltimore. And experts are voicing concerns that the state of the pandemic could once again take a turn for the worse in the US.

New threat

The menacing coronavirus variant B 1.617.2 first seen in India—now dubbed Delta by the World Health Organization—is spreading rapidly around the globe, including in the US. It is estimated to be even more contagious than the worrisome B.1.1.7 variant first seen in the UK. That variant, now dubbed Alpha, is estimated to be about 50 percent more transmissible than the original coronavirus that mushroomed out of Wuhan, China, at the start of 2020. Delta is estimated to be 50 percent to 60 percent more contagious than Alpha.

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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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China ramps up vaccinations as other countries back away from its vaccines

Vials of the Sinopharm vaccine in Beijing on June 1.

Enlarge / Vials of the Sinopharm vaccine in Beijing on June 1. (credit: Getty | Xinhua News Agency)

Despite a sluggish start, China is now vaccinating its people against COVID-19 at an impressive clip, currently averaging nearly 20 million doses administered per day. As of Friday, the country had given more than 720 million vaccinations since mid-December, with nearly 400 million of those were given in May alone.

The dramatic ramp up comes at an awkward time, however. Early adopters of China’s vaccines have seen dramatic surges in COVID-19 cases—despite high vaccination rates—and are now backing away from the country’s offerings.

In Bahrain, for instance, officials are now offering high-risk people who have already received two doses of China’s Sinopharm vaccine a third vaccine dose—but one made by Pfizer-BioNTech. The apparent vote of no confidence by officials is striking: Bahrain was one of the first countries to back and rollout Sinopharm’s vaccine, and it has had a highly successful vaccination campaign. Nearly 58 percent of the Persian Gulf country has received at least one dose of a vaccine, and most of the vaccines given in Bahrain are from Sinopharm. But the country is now seeing its worst wave of COVID-19 yet and the government has recently issued a two-week lockdown to try to get transmission under control.

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Russia tried to spread dangerous lies about Pfizer vaccine, France suspects

Pointy towers at sunset.

Enlarge / The Kremlin in Moscow, Russia, on Friday, Dec. 11, 2020. (credit: Getty | Bloomberg)

French authorities are investigating whether the Russian government is behind an effort to spread dangerous lies about Pfizer-BioNTech’s COVID-19 vaccine as part of a disinformation campaign peddled to French bloggers and influencers.

In recent days, several French influencers have publicly noted receiving partnership proposals from a dodgy agency, called Fazze, over email or social media. The proposals, written in broken English, offered enticing lumps of money if the influencers spread entirely false claims and doubts about COVID-19 vaccines. Among the proposed claims is the dangerous falsehood that people who received the Pfizer-BioNTech vaccine have a death rate three times higher than those who received the vaccine by AstraZeneca.

French news outlet Numerama obtained a copy of one of the emailed offers, which directed influencers to “Tell that mainstream media ignores this theme and you decided to share it with your subscriber [sic].” The offer also said to “put a question like ‘Why some governments actively purchasing Pfizer vaccine, which is dangerous to health of the people[sic]?’” The offer directed influencers to end their messages by encouraging subscribers to “draw their own conclusions.”

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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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Efficacy of Chinese vaccines is “not high”—officials back 3rd dose

A vial and boxes of the Sinopharm Group Co Ltd. Covid-19 vaccine.

Enlarge / A vial and boxes of the Sinopharm Group Co Ltd. Covid-19 vaccine. (credit: Getty | Bloomberg)

Officials in Beijing are reportedly planning to roll out third doses of China’s COVID-19 vaccines. These shots have long been dogged by doubts of their efficacy.

According to a report by The Washington Post, health experts in China say that protection from the vaccines may not last after six months and that people who are at high risk of COVID-19 should get a third dose. Now, state-run media outlets suggest Beijing is on board with the suggestion and is preparing to offer the third doses.

Last week, both the United Arab Emirates and Bahrain said they would offer third doses of China’s Sinopharm vaccine to try to boost protection. UAE is offering the extra shots to anyone who was vaccinated six or more months ago. Bahrain is offering third doses to high-risk groups.

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White House teams up with dating apps to give vaccinated users free perks

With vaccination rates slowing in the U.S., the White House is getting creative about getting shots in arms. Beyond protecting yourself and others from from a deadly disease, the latest incentive to get vaccinated could help you find love (or get laid).

The White House COVID-19 response team announced Friday that a number of popular dating apps would offer new perks for users who get vaccinated, with Tinder, Bumble, Hinge, Match, OkCupid, BLK, Chispa, Plenty of Fish and Badoo all participating in the promotional push. The White House hopes to make inroads with the 50 million users across those dating apps where they’re already spending time.

On Tinder, anyone who adds a sticker to their profile promoting their vaccination status between June 2 and July 4 will be gifted a free Super Like. (Proof of vaccination isn’t necessary, but really, you should get vaccinated if it’s available where you live.) Tinder and other apps will also add vaccination site resources from Vaccine.gov to help people figure out where they can get the shot nearby.

“Nothing like fireworks to signal a new spark and a new start for those looking to meet new people IRL this summer,” Tinder CEO Jim Lanzone said.

According to OkCupid, getting vaccinated might help with that. The company found that people who displayed their vaccination status were 14 percent more likely to find a match. On OkCupid, vaccinated users will get a free boost, a perk that promotes their profile to potential matches. The other apps participating in the White House initiative are handing out their own premium perks to give users a competitive edge.

The effort is part of a push by the White House to get 70 percent of adults vaccinated by the Fourth of July. To reach more Americans, the Biden administration has also coordinated with popular entertainment companies like NASCAR and country music channel CMT to promote vaccination.

“Social distancing and dating were always a bit of a challenging combination,” White House Senior COVID Advisor Andy Slavitt said during a press event Friday. He characterized the vaccine push through dating apps as those companies “responding to the president’s call to action” rather than calling it an official partnership.

“We have finally found the one thing that makes use all more attractive,” Slavitt said. “A vaccination.”

#4th-of-july, #biden-administration, #ceo, #disease, #iac, #jim-lanzone, #okcupid, #president, #social, #social-software, #software, #tc, #tinder, #united-states, #vaccination, #vaccine, #white-house

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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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States won’t receive J&J doses next week amid ongoing production failures

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)

States will not receive shipments of Johnson & Johnson’s one-shot COVID-19 vaccine next week, according to a report by Politico.

White House officials told governors in a call Tuesday that there are no new doses available for order. It’s unclear if the federal government will be able to distribute doses through other channels, such as those that provide vaccines directly to pharmacies and community health centers.

The dried-up supply is just the latest trouble for Johnson & Johnson, which has consistently struggled to produce its vaccine in the US.

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FDA authorizes Pfizer’s COVID-19 vaccine for 12- to 15-year-olds

An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020.

Enlarge / An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS)

The US Food and Drug Administration has authorized the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents between the ages of 12 to 15, the agency announced Monday evening.

In the announcement, acting FDA Commissioner Janet Woodcock called the authorization “a significant step in the fight against the COVID-19 pandemic” that will bring the country “closer to returning to a sense of normalcy and to ending the pandemic.”

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, echoed that sentiment. He called the ability to vaccinate children and teens “a critical step” in the fight against COVID-19.

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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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FDA reportedly plans to authorize Pfizer’s COVID vaccine for teens 12-15 in days

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 Food and Drug Administration is planning to authorize the use of Pfizer-BioNTech’s COVID-19 vaccine in adolescents 12 to 15 years old later this week or early next week, according to a report by The New York Times.

The Times cited unnamed federal officials who did not have authorization to speak publicly about the FDA’s plans. If the FDA does authorize use of the vaccine in the teen group in the week, the Centers for Disease Control and Prevention’s vaccine advisory panel will likely meet a day later to review the clinical trial data and make a recommendation on use, the Times reported.

On March 31, Pfizer announced that the vaccine completely protected adolescents ages 12 to 15 against COVID-19 in a small Phase III clinical trial. The vaccine was also well-tolerated in the age group, producing mainly standard side effects.

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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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Contractor that ruined 15M doses of J&J vaccine is holding up vaccine to India

Funeral pyres of people who died of COVID-19 being prepared simultaneously at Gazipur crematorium on April 26, 2021 in New Delhi, India.

Enlarge / Funeral pyres of people who died of COVID-19 being prepared simultaneously at Gazipur crematorium on April 26, 2021 in New Delhi, India. (credit: Getty | Raj K Raj)

India’s skyrocketing surge of COVID-19 cases has launched the country into the most harrowing crisis yet in the pandemic.

While international aid pours into the country, many have called for the US to donate millions of doses from its stockpile of AstraZeneca’s COVID-19 vaccine to India, which has vaccinated less than 2 percent of its population and is running out of doses.

AstraZeneca’s vaccine is widely used around the world, including in India, but it is not yet authorized for use in the US. Even if it does earn authorization here, Biden administration officials say it’s unlikely that the US will need the vaccine, given the healthy quantity of supplies of the three COVID-19 vaccines already authorized in the country made by Moderna, Pfizer-BioNTech, and Johnson & Johnson.

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CDC, FDA lift pause of J&J vaccine after advisors vote in support of use [Updated]

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida. (credit: Getty | Paul Hennessy)

Update 4/23/2021 7:00pm ET: The Centers for Disease Control and Prevention and the Food and Drug Administration announced late Friday that the pause on the use of Johnson & Johnson’s one-shot COVID-19 vaccine is now lifted.

The announcement comes just hours after a panel of CDC advisors voted largely in favor of resuming use, reaffirming its recommendation that it be used in all adults.

The two agencies paused use on April 13 after six women developed dangerous blood clots after receiving the vaccine. Though the CDC confirmed nine additional cases during the 11-day pause, the agencies and their advisors determined that the benefits of the vaccine greatly outweigh risks of the extremely rare condition.

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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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Pause of J&J vaccine was the right call, say 88% of polled Americans

A large streetside sign for a Johnson and Johnson vaccine.

Enlarge / General exterior view of the head office of Janssen pharmaceutical company on April 15, 2021 in Leiden, Netherlands. (credit: Getty | BSR Agency)

About 88 percent of Americans support the pause of Johnson & Johnson’s COVID-19 vaccine, and the pause did not increase vaccine hesitancy, according to fresh data from the Axios-Ipsos Coronavirus poll.

The finding is likely to hearten public health experts, who have faced criticism and concern that the pause could erode confidence in vaccine safety and fortify already high-levels of vaccine hesitancy in the country.

The Centers for Disease Control and Prevention, along with the Food and Drug Administration, recommended a pause in the use of the Johnson & Johnson vaccine on April 13 after linking the one-dose vaccine to six cases of a rare blood-clotting condition, one of which was fatal. The six cases occurred among more than 6.8 million people given the vaccine, suggesting that if the blood clots are, in fact, a side effect of the vaccine, they are an extremely rare side effect.

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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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CDC expert panel punts on deciding fate of J&J COVID vaccine

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida. (credit: Getty | Paul Hennessy)

An advisory committee for the Centers for Disease Control and Prevention declined to vote on the fate of Johnson & Johnson’s COVID-19 vaccine Wednesday, likely leaving in place a pause on the vaccine’s use until the committee reconvenes in seven to 10 days.

The CDC’s Advisory Committee on Immunization Practices, or ACIP, expects that the coming week or so will provide additional data and analyses on the vaccine’s potential risks. Until it has more information, ACIP opted to provide no new recommendations on the use of the vaccine.

On the table, however, was everything from recommending against use of the vaccine altogether; recommending that only certain groups receive the vaccine, such as only men or only people over a certain age; or recommending that the pause be lifted and use continue in all adults as before.

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J&J COVID vaccine use paused due to one-in-a-million complication

Image of a woman receiving a vaccine.

Enlarge / A nurse practitioner named Heidi Johnson administers a vaccine from Johnson & Johnson. (credit: Tom Williams / Getty Images)

On Tuesday morning, the US Food and Drug Administration and the Centers for Disease Control and Prevention issued a release acknowledging an extremely rare clotting disorder was associated with the use of the Johnson & Johnson COVID vaccine. The problem is actually less than a one-in-a-million issue; in data from the US, where 6.8 million doses of this vaccine have been used, there have only been six instances of the clotting problem detected.

Because the clots call for an unusual treatment, however, the organizations are calling for a pause in administering the shot. This will provide them with time to ensure the medical community is aware of the appropriate treatment.

This is not the first vaccine to create extremely rare clotting issues. They’ve also been seen following use of the AstraZeneca vaccine. The problem appears to be caused by the harmless virus (an Adenovirus) that carries a single gene from SARS-CoV-2 in order to elicit an immune response.

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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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AstraZeneca vaccine linked to rare blood clots, EU regulators conclude

Extreme close-up photo of small, clear vials.

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

European medical regulators on Wednesday concluded that there is a strong link between AstraZeneca’s COVID-19 vaccine and life-threatening conditions involving the unusual combination of blood clots and low levels of blood platelets.

As such, the conditions should be listed as a “very rare side effects” of the vaccine, according to the European Medicines Agency, a regulatory agency of the European Union.

The conclusion was based on the EMA’s in-depth review of 86 blood-clotting events among around 25 million people vaccinated with the AstraZeneca vaccine in Europe and the UK. Of the 86 blood-clotting events, 18 people died. Most—but not all—of the cases occurred in women under the age of 60.

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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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#biontech, #coronavirus, #covid-19, #infectious-disease, #pfizer, #public-health, #sars-cov-2, #science, #vaccine, #variant

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Facebook launches profile frames that help you encourage friends to get the Covid-19 vaccine

As Covid-19 vaccines are becoming more readily available to larger groups of the U.S. population, Facebook has teamed up with the U.S. Department of Health and Human Services (HHS) and Centers for Disease Control and Prevention (CDC) to launch new Facebook profile frames that allow users to share their support for getting vaccinated with their family and friends. The effort follows a similar launch in the U.K. through a partnership with National Health Services (NHS), which has already resulted in a quarter of Facebook users in the U.K. having seen a Facebook friend with the profile frame.

At launch, users in the U.S. can pick between frames which include banners that say either “Let’s Get Vaccinated” or “I Got My Covid-19 Vaccine” in English or Spanish. The banner will appear overlaid on the edge of their profile picture next to a blue bubble that reads “We Can Do This.”

Although there were already a variety of vaccine-promoting profile frames to choose from on Facebook, these were all third-party efforts until now. The new frames were created, in part, by Facebook, which will allow the company to better track their usage over time.

Image Credits: Facebook

In the weeks ahead, Facebook says it will show people a summary in their News Feed of all your friends, family members and people you follow who are using the new Covid-19 vaccine profile frames. For that reason, adopting the first-party frames will be important, if you want to be a part of that list that’s shown to others.

Facebook notes that it’s launching the frames because research shows how social norms can have a major impact on people’s attitude and behavior when it comes to their health — a notable assertition, given that the company wants otherwise downplay the power its network has when it comes to the spread of disinformation or anti-vax sentiments.

For this effort, Facebook believes, and the research supports, that when people see others who they know and trust getting the vaccine, and they’ll be encouraged to do the same. This can be particularly effective when it comes to encouraging those who were otherwise unsure about getting the vaccine.

Leveraging social media to encourage vaccinations has been part of the CDC’s toolkit as well, which is why you likely saw several photos from healthcare workers and essentials workers sharing their vaccination photos and talking about their experience. The CDC had also provided a sets of sample social media graphics and messages that could be used by organizations that wanted to promote vaccinations across Facebook, Twitter and LinkedIn.

The new profile frames are rolling out starting today to Facebook users in the U.S.

#centers-for-disease-control-and-prevention, #covid-19-vaccine, #facebook, #science, #social, #social-media, #united-states, #vaccination, #vaccine

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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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#biden, #biden-administration, #covid-19, #fda, #infectious-disease, #johnson-johnson, #pandemic, #public-health, #science, #vaccine

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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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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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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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#covid-19, #infectious-disease, #public-health, #science, #vaccine, #who

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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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#anti-vaccine, #covid-19, #infectious-disease, #politics, #public-health, #republican, #science, #vaccine, #vaccine-hesitancy

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Facebook to label all COVID-19 vaccine posts with pointer to official info

Facebook will soon label all posts discussing the coronavirus vaccination with a pointer to official information about COVID-19, it said today.

It also revealed it has implemented some new “temporary” measures aimed at limiting the spread of vaccine misinformation/combating vaccine hesitancy — saying it’s reducing the distribution of content from users that have violated its policies on COVID-19 and vaccine misinformation; or “that have repeatedly shared content debunked as False or Altered by our third-party fact-checking partners”.

It’s also reducing distribution of any COVID-19 or vaccine content that fact-checking partners have rated as “Missing Context”, per the blog post.

While admins for groups with admins or members who have violated its COVID-19 policies will also be required to temporarily approve all posts within their group, it said. (It’s not clear what happens if a group only has one admin and they have violated its policies.)

Facebook will also “further elevate information from authoritative sources when people seek information about COVID-19 or vaccines”, it added.

It’s not clear why users who repeatedly violate Facebook’s COVID-19 policies do not face at least a period of suspension. (We’ve asked the company for clarity on its policies.)

“We’re continuing to expand our efforts to address COVID-19 vaccine misinformation by adding labels to Facebook and Instagram posts that discuss the vaccines,” Facebook said in the Newsroom post today.

“These labels contain credible information about the safety of COVID-19 vaccines from the World Health Organization. For example, we’re adding a label on posts that discuss the safety of COVID-19 vaccines that notes COVID-19 vaccines go through tests for safety and effectiveness before they’re approved.”

The incoming COVID-19 information labels are rolling out globally in English, Spanish, Indonesian, Portuguese, Arabic and French (with additional languages touted “in the coming weeks”), per Facebook.

As well as soon rolling out labels “on all posts generally about COVID-19 vaccines” — pointing users to its COVID-19 Information Center — Facebook said it would add additional “targeted” labels about “COVID-19 vaccine subtopics”. So it sounds like it may respond directly to specific anti-vaxxer misinformation it’s seeing spreading on its platform.

“We will also add an additional screen when someone goes to share a post on Facebook and Instagram with an informational COVID-19 vaccine label. It will provide more information so people have the context they need to make informed decisions about what to share,” Facebook added.

The moves follow revelations that an internal Facebook study of vaccine hesitancy — which was reported on by the Washington Post yesterday after it obtained documents on the large-scale internal research effort — found a small number of US users are responsible for driving most of the content that’s hesitant about getting vaccinated.

“Just 10 out of the 638 population segments [Facebook’s study divided US users into] contained 50 percent of all vaccine hesitancy content on the platform,” the Post reported. “And in the population segment with the most vaccine hesitancy, just 111 users contributed half of all vaccine hesitant content.”

Last week the MIT Technology Review also published a deep-dive article probing Facebook’s approach to interrogating, via an internal ‘Responsible AI’ team, the impacts of AI-fuelled content distribution — which accused the company of prioritizing growth and engagement and neglecting the issue of toxic misinformation (and the individual and societal harms that can flow from algorithmic content choices which amplify lies and hate speech).

In the case of COVID-19, lies being spread about vaccination safety or efficacy present a clear and present danger to public health. And Facebook’s PR machine does appear to have, tardily, recognized the extent of the reputational risk it’s facing if it’s platform is associated with driving vaccine hesitancy.

To wit: Also today it’s announced the launch of a global COVID-19 education drive that it says it hopes will bring 50M people “closer to getting vaccinated”.

“By working closely with national and global health authorities and using our scale to reach people quickly, we’re doing our part to help people get credible information, get vaccinated and come back together safely,” Facebook writes in the Newsroom post that links directly to a Facebook post by founder Mark Zuckerberg also trailing the new measures, including the launch of a tool that will show U.S. Facebook users where they can get vaccinated and provide them with a link to make an appointment.

Facebook said it plans to expand the tool to other countries as global vaccine availability steps up.

Facebook’s vaccine appointment finder tool (Image credits: Facebook)

Facebook has further announced that the COVID-19 information portal it launched in the Facebook app in March last year which points users to “the latest information about the virus from local health ministries and the World Health Organization” is finally being brought to Instagram.

It’s not clear why Facebook hadn’t already launched the portal on Instagram. But it’s decided to double down on fighting bad speech (related to vaccines) with better speech — saying Instagram users will get new stickers they can add to their Instagram Stories “so people can inspire others to get vaccinated when it becomes available to them”.

In other moves being trailed in Facebook’s crisis PR blitz today it has touted “new data and insights” on vaccine attitudes being made available to public officials via COVID-19 dashboards and maps it was already offering (the data is collected by Facebook’s Data for Good partners for the effort at Carnegie Mellon University and University of Maryland as part of the COVID-19 Symptom Survey).

Albeit, it doesn’t specify what new information is being added there (or why now).

Also today it said it’s “making it easy to track how COVID-19 vaccine information is being spread on social media through CrowdTangle’s COVID-19 Live Displays“.

“Publishers, global aid organizations, journalists and others can access real-time, global streams of vaccine-related posts on Facebook, Instagram and Reddit in 34 languages. CrowdTangle also offers Live Displays for 104 countries and all 50 states in the US to help aid organizations and journalists track posts and trends at a regional level as well,” Facebook added, again without offering any context on why it hadn’t made it easier to use this tool to track vaccine information spread before.

Its blog post also touts “new” partnerships with health authorities and governments on vaccine registration — while trumpeting the ~3BN messages it says have already been sent “by governments, nonprofits and international organizations to citizens through official WhatsApp chatbots on COVID-19”. (As WhatsApp is end-to-end encrypted there is no simple way to quantify how many vaccine misinformation messages have been sent via the same platform.)

Per Facebook, it’s now “working directly with health authorities and governments to get people registered for vaccinations” (such as in the city and province of Buenos Aires, Argentina, which is using WhatsApp as the official channel to send notifications to citizens when it’s their turn to receive the vaccine).

“Since the beginning of the COVID-19 pandemic, we have partnered with ministries of health and health-focused organizations in more than 170 countries by providing free ads, enabling partners to share their own public health guidance on COVID-19 and information about the COVID-19 vaccine,” Facebook’s PR adds in a section of the post which it’s titled “amplifying credible health information and resources from experts”.

#artificial-intelligence, #coronavirus, #covid-19, #facebook, #health, #instagram, #misinformation, #social, #vaccine, #whatsapp

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Tossing vaccine priority list, Biden tells states to open eligibility by May 1

An older man in a suit speaks into a microphone on a podium.

Enlarge / US President Joe Biden speaks on the anniversary of the start of the COVID-19 pandemic, in the East Room of the White House in Washington, DC, on March 11, 2021. (credit: Getty | Mandel Ngan)

On the first anniversary of the global COVID-19 pandemic, US President Joe Biden announced that he will direct states to open vaccine eligibility to all American adults no later than May 1, a dramatic acceleration of the national immunization plan that has been sluggish and, at times, chaotic.

“That’s much earlier than expected,” Biden said in a televised, prime-time address. It doesn’t mean every American over age 18 will have their shot by then, Biden cautioned, but you’ll be able to get in line.

The announcement means that carefully crafted prioritizations for vaccines will soon no longer apply. The White House COVID-19 Response Team landed on May 1 for the deadline after concluding that national vaccination efforts would be far-enough along by the end of April to make the prioritizations obsolete anyway.

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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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Merck/J&J deal may help US get enough vaccine for all adults by end of May

An older man in a suit speaks at a podium with a presidential seal.

Enlarge / US President Joe Biden delivers remarks on the government’s pandemic response, including the recently announced partnership between Johnson & Johnson and Merck to produce more Johnson & Johnson vaccine, as US Vice President Kamala Harris (L) looks on at the White House in Washington, DC on March 2, 2021. (credit: Getty | Jim Watson)

With a White House-brokered deal, vaccine giant Merck has agreed to help Johnson & Johnson boost its COVID-19 vaccine production, which is woefully behind on its manufacturing schedule.

President Joe Biden announced today that, with the new deal, the country is on track to have enough COVID-19 vaccine doses to vaccinate every adult in the country by the end of May—two months ahead of earlier plans.

“About three weeks ago, we were able to say that we’ll have enough vaccine supply for adults by the end of July,” the president said in an afternoon address. “And I’m pleased to announce today, as a consequence of the stepped-up process that I’ve ordered and just outlined, this country will have enough vaccine supply—I’ll say it again—for every adult in America by the end of May. By the end of May. That’s progress—important progress.”

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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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#covid-19, #eua, #fda, #infectious-disease, #johnson-johnson, #pandemic, #sars-cov-2, #science, #vaccine

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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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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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Pfizer-BioNTech’s COVID-19 vaccine just got a lot easier to transport and distribute

The COVID-19 vaccine developed by Pfizer and BioNTech now has less stringent and extreme transportation requirements than it debuted with. Originally, the mRNA-based vaccine had to be maintained at ultra-low temperatures throughout the transportation chain in order to remain viable – between -76°F and -112°F. New stability data collected by Pfizer and BioNTech, which has been submitted to the U.S. Food and Drug Administration (FDA) for review, allow it to be stored at temps between 5°F and -13°F – ranges available in standard medical freezers found in most clinics and care facilities.

The vaccine should remain stable for up to two weeks at that temperature, which vastly improves the flexibility of its options for transportation, and last-mile storage in preparation for administration to patients. To date, the vaccine has relied largely on existing “cold-chain” infrastructure to be in place in order for it to be able to reach the areas where it’s being used to inoculate patients. That limitation hasn’t been in place for Moderna’s vaccine, which is stable at even higher, standard refrigerator temperatures for up to a month.

This development is just one example of how work continues on the vaccines that are already being deployed under emergency approvals by health regulators across the U.S. and elsewhere in the world. Pfizer and BioNTech say they’re working on bringing those storage temp requirements down even further, so they could potentially approach the standard set by the Moderna jab.

Taken together with another fresh development, study results from Israeli researchers that found just one shot of the ordinarily two-shot Pfizer-BioNTech vaccine could be as high as 85 percent effective on its own, this is a major development for global inoculation programs. The new requirements open up participation to a whole host of potential new players in supporting delivery and distribution – including ride-hailing and on-demand delivery players with large networks like Amazon, which has offered the President Biden’s administration its support, and Uber, which is already teamed up with Moderna on vaccine education programs.

This also opens the door for participation from a range of startups and smaller companies in both the logistics and the care delivery space that don’t have the scale or the specialized equipment to be able to offer extreme ‘cold-chain’ storage. Technical barriers have been a blocker for some who have been looking for ways to assist, but lacked the necessary hardware and expertise to do so effectively.

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Notable Health seeks to improve COVID-19 vaccine administration through intelligent automation

Efficient and cost-effective vaccine distribution remains one of the biggest challenges of 2021, so it’s no surprise that startup Notable Health wants to use their automation platform to help. Initially started to help address the nearly $250 billion annual administrative costs in healthcare, Notable Health launched in 2017 to use automation to replace time-consuming and repetitive simple tasks in health industry admin. In early January of this year, they announced plans to use that technology as a way to help manage vaccine distribution.

“As a physician, I saw firsthand that with any patient encounter, there are 90 steps or touchpoints that need to occur,” said Notable Health medical director Muthu Alagappan in an interview. “It’s our hypothesis that the vast majority of those points can be automated.”

Notable Health’s core technology is a platform that uses robotic process automation (RPA), natural language processing (NLP), and machine learning to find eligible patients for the COVID-19 vaccine. Combined with data provided by hospital systems’ electronic health records, the platform helps those qualified to receive the vaccine set up appointments and guides them to other relevant educational resources.

“By leveraging intelligent automation to identify, outreach, educate and triage patients, health systems can develop efficient and equitable vaccine distribution workflows,” said Notable Health strategic advisor and Biden Transition COVID-19 Advisory Board Member Dr. Ezekiel Emanuel, in a press release.

Making vaccine appointments has been especially difficult for older Americans, many of whom have reportedly struggled with navigating scheduling websites. Alagappan sees that as a design problem. “Technology often gets a bad reputation, because it’s hampered by the many bad technology experiences that are out there,” he said.

Instead, he thinks Notable Health has kept the user in mind through a more simplified approach, asking users only for basic and easy-to-remember information through a text message link. “It’s that emphasis on user-centric design that I think has allowed us to still have really good engagement rates even with older populations,” he said.

While the startup’s platform will likely help hospitals and health systems develop a more efficient approach to vaccinations, its use of RPA and NLP holds promise for future optimization in healthcare. Leaders of similar technology in other industries have already gone on to have multi-billion dollar valuations, and continue to attract investors’ interest.

Artificial intelligence is expected to grow in healthcare over the next several years, but Alagappan argues that combining that with other, more readily available intelligent technologies is also an important step towards improved care. “When we say intelligent automation, we’re really referring to the marriage of two concepts: artificial intelligence—which is knowing what to do—and robotic process automation—which is knowing how to do it,” he said. That dual approach is what he says allows Notable Health to bypass administrative bottlenecks in healthcare, instructing bots to carry out those tasks in an efficient and adaptable way.

So far, Notable Health has worked with several hospital systems across multiple states in using their platform for vaccine distribution and scheduling, and are now using the platform to reach out to tens of thousands of patients per day.

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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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Scary 22% vaccine efficacy in South Africa comes with heaps of caveats

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)

Dismal preliminary data on AstraZeneca’s COVID-19 vaccine in South Africa—where the B.1.351/ 501Y.V2 coronavirus variant is spreading widely—lead the government there to rethink its vaccination rollout and raised further international concern about the variant.

But the small study has so many limitations and caveats, experts caution that drawing any conclusions from it is difficult.

The study, which has not been published or peer-reviewed but presented in a press conference Sunday, began in June and enrolled only around 2,000 participants, about half of which received a placebo. Early in the study—before B.1.351 emerged—the vaccine appeared over 70 percent effective at preventing mild-to-moderate cases of COVID-19. That is largely in line with the conclusion of an international Phase III trial released by AstraZeneca and vaccine co-developer Oxford University, which showed mixed results for the replication-deficient adenovirus-based vaccine but an overall efficacy of around 70 percent.

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#astrazeneca, #clinical-trial, #coronavirus, #covid-19, #pandemic, #science, #south-africa, #vaccine, #variants, #who

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