Two Companies Restart Virus Trials in U.S. After Safety Pauses

AstraZeneca and Johnson & Johnson have restarted their late-stage trials after finding that serious illnesses in a few volunteers appeared not to be related to the vaccines.

#astrazeneca-plc, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #johnsonjohnson, #vaccination-and-immunization, #your-feed-healthcare, #your-feed-science

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The Trump Administration Shut a Vaccine Safety Office Last Year. What’s the Plan Now?

The office was dedicated to the long-term safety of vaccines. Experts say plans to track coronavirus vaccines are fragmented and “behind the eight ball.”

#clinical-trials, #coronavirus-2019-ncov, #electronic-health-records, #public-private-sector-cooperation, #science-and-technology, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare, #your-feed-science

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America and the Coronavirus: ‘A Colossal Failure of Leadership’

In its destruction of American lives, treasure and well-being, this pandemic marks the greatest failure of U.S. governance since Vietnam.

#coronavirus-2019-ncov, #disease-rates, #presidential-election-of-2020, #quarantines, #united-states-economy, #united-states-politics-and-government, #vaccination-and-immunization, #workplace-hazards-and-violations

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South Korea Tries to Quell Anxiety Over Flu Shots After 13 Unexplained Deaths

Health officials say there is no link between the deaths and the flu vaccines. But the deaths, after two recent vaccine recalls, have raised safety fears among the public at a critical time.

#anaphylactic-shock, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #csl-ltd, #deaths-fatalities, #influenza, #recalls-and-bans-of-products, #seoul-national-university, #south-korea, #vaccination-and-immunization

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To Test Coronavirus Vaccines, UK Study Will Intentionally Infect Volunteers

The hotly contested strategy of deliberate exposure, known as a human challenge trial, could speed up the process of identifying effective coronavirus vaccines.

#clinical-trials, #coronavirus-2019-ncov, #great-britain, #imperial-college-london, #johnson-boris, #science-and-technology, #vaccination-and-immunization

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How the F.D.A. Stood Up to the President

After months of caving to pressures from the White House, Commissioner Stephen Hahn and a band of agency scientists have eked out a few victories.

#clinical-trials, #coronavirus-2019-ncov, #hahn-stephen-m-1960, #health-and-human-services-department, #regulation-and-deregulation-of-industry, #science-and-technology, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare

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How an Ill-Fated Fishing Voyage Helped Us Understand Covid-19

The threat posed by the virus makes randomized controlled trials extremely difficult. That means “real-life experiments” are especially important.

#antibodies, #coronavirus-2019-ncov, #research, #vaccination-and-immunization

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5 Ways Families Can Prepare as Coronavirus Cases Surge

As winter approaches, we still need to be vigilant about taking precautions.

#anxiety-and-stress, #content-type-service, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #disease-rates, #parenting, #vaccination-and-immunization

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Coronavirus Vaccine: Pfizer Says It Won’t Seek Authorization Before Mid-November

Friday’s announcement represents a shift in tone for the company and its leader, who has repeatedly emphasized the month of October in interviews and public appearances.

#bourla-albert, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #pfizer-inc, #presidential-election-of-2020, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-science

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As the Virus Surges, Stark Differences Over What Is Around the Corner

President Trump’s health secretary voiced optimism on Sunday that vaccines and treatments would soon save the day, but governors and experts issued bleak warnings about the public letting down its guard.

#azar-alex-m-ii, #burgum-douglas, #clinical-trials, #coronavirus-2019-ncov, #disease-rates, #governors-us, #pritzker-j-b, #states-us, #vaccination-and-immunization

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Coronavirus Vaccine Makers Are Not Mass-Slaughtering Sharks

Some coronavirus vaccines rely on a shark-based product, but that doesn’t mean you shouldn’t get immunized.

#conservation-of-resources, #coronavirus-2019-ncov, #cosmetics-and-toiletries, #glaxosmithkline-plc, #sharks, #vaccination-and-immunization

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Coronavirus Reinfections Are Real but Very, Very Rare

A case in Nevada has spurred new concerns that people who have recovered from the infection may still be vulnerable. That’s unlikely, experts say.

#coronavirus-2019-ncov, #disease-rates, #europe, #immune-system, #lancet-infectious-diseases-the-journal, #nevada, #united-states, #vaccination-and-immunization, #your-feed-science

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Facebook Bans Anti-Vaccination Ads, Clamping Down Again

The social network, which prohibits misinformation related to the coronavirus, has also banned other types of content in recent days.

#advertising-and-marketing, #computers-and-the-internet, #corporate-social-responsibility, #facebook-inc, #online-advertising, #rumors-and-misinformation, #vaccination-and-immunization

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Heidi Larson Knows How to Build Trust in Vaccines

For the founder of the Vaccine Confidence Project, squashing viral rumors means building trust — and avoiding the term “anti-vaxxer.”

#autism, #centers-for-disease-control-and-prevention, #computers-and-the-internet, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #ebola-virus, #epidemics, #facebook-inc, #gavi-alliance, #kano-nigeria, #larson-heidi, #london-england, #measles, #medicine-and-health, #mumps, #nigeria, #piot-peter, #polls-and-public-opinion, #rumors-and-misinformation, #social-media, #united-nations-childrens-fund, #vaccination-and-immunization, #wakefield-andrew, #your-feed-health, #your-feed-science

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Covid-19 Vaccines Offer Drug Makers Chance at Salvation, Financial and Beyond

Big profits beckon for pharmaceutical companies, which are already using their work on vaccines to fight efforts in Washington to curb drug prices.

#astrazeneca-plc, #clinical-trials, #coronavirus-2019-ncov, #curevac-gmbh, #drugs-pharmaceuticals, #glaxosmithkline-plc, #gorsky-alex, #johnsonjohnson, #merckcompany-inc, #novavax-inc, #pfizer-inc, #sanofi-sa, #vaccination-and-immunization

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With Russia’s Coronavirus Vaccine, Putin Jumps Ahead of Trump

As America retreats from world affairs, Russia is promising other nations help on the pandemic.

#clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #general-assembly-un, #putin-vladimir-v, #russia, #trump-donald-j, #united-states-international-relations, #vaccination-and-immunization, #world-health-organization

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The Race for a Super-Antibody Against the Coronavirus

A network of scientists is chasing the pandemic’s holy grail: an antibody that protects against not just the virus, but also related pathogens that may threaten humans.

#antibodies, #astrazeneca-plc, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #einstein-albert-college-of-medicine, #elderly, #eli-lilly-and-company, #factories-and-manufacturing, #food-and-drug-administration, #immune-system, #nursing-homes, #regeneron-pharmaceuticals-inc, #roche-holding-ag, #sars-severe-acute-respiratory-syndrome, #trump-donald-j, #united-states, #united-states-army-medical-research-institute-of-infectious-diseases, #vaccination-and-immunization, #walker-laura, #your-feed-science

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The First Covid Vaccine Will Not Make Life Normal Again

Come spring, Americans may have their choice of several so-so coronavirus vaccines — with no way of knowing which one is best.

#clinical-trials, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #food-and-drug-administration, #national-institutes-of-health, #placebos, #public-private-sector-cooperation, #research, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare, #your-feed-science

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A Dose of Optimism, as the Pandemic Rages On

The months ahead will be difficult. But the medical cavalry is coming, and the rest of us know what we need to do.

#clinical-trials, #coronavirus-2019-ncov, #deaths-fatalities, #dexamethasone-drug, #disease-rates, #drugs-pharmaceuticals, #vaccination-and-immunization

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In Terms of Child Mortality, It’s a Good Time for Public Health

Despite the crises of 2020, parents can realistically expect that children born today will outlive them. That wasn’t always the case.

#antibiotics, #babies-and-infants, #children-and-childhood, #cholera, #epidemics, #infant-mortality, #parenting, #smallpox, #vaccination-and-immunization

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Can Trump Really Speed Approval of Covid Treatments?

Emergency-use authorizations, a formerly obscure corner of regulatory law, have become a centerpiece of the government’s response to the pandemic.

#clinical-trials, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #vaccination-and-immunization, #your-feed-health, #your-feed-healthcare, #your-feed-science

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15% of Virus Tests Are Positive, and Few Wear Masks in One Orthodox Suburb

Several towns with large ultra-Orthodox Jewish populations are seeing coronavirus case rates that are among the highest in New York.

#coronavirus-2019-ncov, #cuomo-andrew-m, #hasidism, #jews-and-judaism, #kiryas-joel-ny, #lakewood-nj, #monsey-ny, #orange-county-ny, #prayers-and-prayer-books, #rockland-county-ny, #shutdowns-institutional, #sukkot-jewish-holiday, #vaccination-and-immunization

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Trump’s Covid Treatments Were Tested in Cells Derived From Fetal Tissue

The “cell lines” used to develop monoclonal antibodies, as well as remdesivir and vaccines, began with fetal tissue decades ago.

#abortion, #antibodies, #astrazeneca-plc, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #eli-lilly-and-company, #ethics-and-official-misconduct, #fetal-tissue, #health-and-human-services-department, #house-committee-on-oversight-and-government-reform, #johnsonjohnson, #moderna-inc, #regeneron-pharmaceuticals-inc, #united-states, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-science

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A Dose of Vaccine Reality

The F.D.A. releases guidelines that had been trailed by politics: This is your morning tip sheet.

#coronavirus-2019-ncov, #food-and-drug-administration, #trump-donald-j, #vaccination-and-immunization

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Where Is the Coronavirus Pandemic Headed?

The coronavirus “is not going to be over by fall,” our health reporter Donald G. McNeil Jr. says. But on vaccines and other interventions, he finds reasons for optimism.

#coronavirus-2019-ncov, #quarantines, #trump-donald-j, #united-states, #vaccination-and-immunization, #white-house-coronavirus-outbreak-2020

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‘I Won’t Be Used as a Guinea Pig for White People’

Mistrust of vaccines runs deep in African-American communities. Against formidable odds, Father Paul Abernathy and his teams are trying to convince residents of Pittsburgh’s historic Black neighborhoods to volunteer for trials testing a Covid-19 shot.

#black-people, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #pittsburgh-pa, #race-and-ethnicity, #research, #rumors-and-misinformation, #vaccination-and-immunization, #your-feed-healthcare

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In Reversal, White House Approves Stricter Guidelines for Vaccine Makers

The guidelines make it highly unlikely that a coronavirus vaccine will be given emergency authorization by Election Day.

#clinical-trials, #coronavirus-2019-ncov, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare

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White House Blocks New Coronavirus Vaccine Guidelines

The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House chief of staff objected to provisions that would push approval past Election Day.

#azar-alex-m-ii, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #hahn-stephen-m-1960, #meadows-mark-r-1959, #office-of-management-and-budget-us, #regulation-and-deregulation-of-industry, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare

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Moncef Slaoui Talks to Kara Swisher About the Coronavirus Vaccine and Working for Trump’s Operation Warp Speed

Dr. Moncef Slaoui, the head of Operation Warp Speed, talks to Kara Swisher about a data-driven timeline, sticking to the science and battle rhythms.

#coronavirus-2019-ncov, #debates-political, #slaoui-moncef-m, #trump-coronavirus-positive-result, #vaccination-and-immunization

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Against the Coronavirus, Imperfect Measures Do the Most Good

Speed and scale may matter more than absolute effectiveness when it comes to tests, masks, treatments and vaccines.

#clinical-trials, #content-type-service, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #deaths-fatalities, #dexamethasone-drug, #disease-rates, #drugs-pharmaceuticals, #food-and-drug-administration, #masks, #protective-clothing-and-gear, #remdesivir-drug, #tests-medical, #united-states, #vaccination-and-immunization

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How to Identify the Different Symptoms of the Flu and Covid-19

With fears of a “twindemic” in the United States this fall, here’s a guide to understanding what’s making you feel terrible.

#centers-for-disease-control-and-prevention, #colds, #content-type-service, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #doctors, #fever, #influenza, #masks, #quarantine-life-and-culture, #tests-medical, #vaccination-and-immunization

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Will Pfizer’s Vaccine Be Ready in October? Here’s Why That’s Unlikely.

Despite slim chances that its vaccine will be ready by October, Pfizer has big incentives to hint that it might be.

#astrazeneca-plc, #bourla-albert, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #johnsonjohnson, #moderna-inc, #pfizer-inc, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare, #your-feed-science

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Studies Begin to Untangle Obesity’s Role in Covid-19

People with extra weight may struggle to mount a robust immune response to the coronavirus — and may respond poorly to a vaccine.

#coronavirus-2019-ncov, #diet-and-nutrition, #obesity, #race-and-ethnicity, #vaccination-and-immunization, #weight, #your-feed-healthcare

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As Europe’s Coronavirus Cases Rise, So Do Voices Crying Hoax

As health officials warn of a second major wave, growing numbers of people are dismissing the threat as media hype and sometimes embracing conspiracy theories.

#conspiracy-theories, #coronavirus-2019-ncov, #europe, #hoaxes-and-pranks, #masks, #politics-and-government, #vaccination-and-immunization

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China Gives Unproven Covid-19 Vaccines to Thousands, With Risks Unknown

Drug company workers, government officials and others have been injected. More will be soon, bewildering experts who worry about potential ill effects.

#china, #clinical-trials, #coronavirus-2019-ncov, #politics-and-government, #vaccination-and-immunization

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Novavax Enters Final Stage of Coronavirus Vaccine Trials

The Maryland company, which has never brought a vaccine to market, has started its Phase 3 trial in the United Kingdom, with plans to begin in the United States in October.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #great-britain, #influenza, #johnsonjohnson, #moderna-inc, #novavax-inc, #pfizer-inc, #research, #united-states, #vaccination-and-immunization

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New York Will Review Virus Vaccines, Citing Politicization of Process

New York officials do not play a role in the approval of a vaccine, but could delay distribution if they believed the vaccine was not safe.

#coronavirus-2019-ncov, #cuomo-andrew-m, #food-and-drug-administration, #new-york-city, #new-york-state, #vaccination-and-immunization

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Johnson & Johnson Begins Phase 3 Trial of Covid-19 Vaccine

Unlike some of its competitors, Johnson & Johnson’s vaccine does not need to be frozen and may require just one shot instead of two.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #johnsonjohnson, #moderna-inc, #pfizer-inc, #research, #vaccination-and-immunization, #your-feed-healthcare

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F.D.A. to Release Stricter Guidelines for Emergency Vaccine Authorization

The new guidelines underscore the fact that a vaccine is highly unlikely before the election.

#clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-health, #your-feed-healthcare

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Coronavirus Vaccine Trials Could Suffer From Shortcuts

We may not find out whether the vaccines prevent moderate or severe cases of Covid-19.

#astrazeneca-plc, #clinical-trials, #coronavirus-2019-ncov, #moderna-inc, #pfizer-inc, #united-states, #vaccination-and-immunization

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When Will We See a Covid-19 Vaccine for Kids?

While scientists are rushing to develop an immunization for adults, no one has started the process yet for children.

#children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #parenting, #pediatric-inflammatory-multisystem-syndrome-pims, #vaccination-and-immunization

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How to Ship a Vaccine at –80°C, and Other Obstacles in the Covid Fight

Developing an effective vaccine is the first step. Then comes the question of how to deliver hundreds of millions of doses that may need to be kept at arctic temperatures.

#astrazeneca-plc, #biontech-se, #carbon-dioxide, #centers-for-disease-control-and-prevention, #corning-inc, #coronavirus-2019-ncov, #fedex-corporation, #ice, #moderna-inc, #pfizer-inc, #shortages, #united-parcel-service-inc, #vaccination-and-immunization

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When Will You Be Able to Get a Coronavirus Vaccine?

Despite the president’s repeated claims that a vaccine will be available in October, scientists, companies and federal officials all say that most people won’t get one until well into next year.

#advisory-committee-on-immunization-practices, #astrazeneca-plc, #centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #johnsonjohnson, #moderna-inc, #novavax-inc, #pfizer-inc, #redfield-robert-r, #shortages, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial

The company hopes to earn the trust of the public and of scientists who have clamored for details of its study.

#clinical-trials, #coronavirus-2019-ncov, #moderna-inc, #vaccination-and-immunization

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I Am the Joan of Arc of Coronavirus Vaccine Trials

Side effects, you ask? So far, just a sense of having contributed to the salvation of humanity.

#coronavirus-2019-ncov, #hospitals, #vaccination-and-immunization

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Should We Fast-Track a Vaccine for the Coronavirus?

It’s complicated.

#coronavirus-2019-ncov, #food-and-drug-administration, #medicine-and-health, #trump-donald-j, #vaccination-and-immunization

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Trump Scorns His Own Scientists Over Virus Data

A public scolding of the C.D.C. chief was only the latest but perhaps the starkest instance when the president has rejected not just the policy advice of his public health officials but the facts and information that they provided.

#biden-joseph-r-jr, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #guterres-antonio, #health-and-human-services-department, #masks, #presidential-election-of-2020, #redfield-robert-r, #senate, #trump-donald-j, #united-nations, #united-states-politics-and-government, #vaccination-and-immunization

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Biden, Seizing on Worries of a Rushed Vaccine, Warns Trump Can’t Be Trusted

Thrusting the issue of a coronavirus vaccine to the center of the campaign, Joe Biden said he trusted vaccines, but not a politicized development process. His comments came as the president publicly rebuked the top federal scientist.

#biden-joseph-r-jr, #coronavirus-2019-ncov, #presidential-election-of-2020, #trump-donald-j, #vaccination-and-immunization

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How Flu Shots Can Help in the Fight Against Covid-19

Experts worry that the two diseases could overwhelm the health care system and create a new shortage of hospital beds and personal protective equipment.

#coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #influenza, #masks, #medicine-and-health, #respiratory-diseases, #vaccination-and-immunization

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Stop Expecting Life to Go Back to Normal Next Year

Americans will need to take pandemic precautions well into 2021 — yes, even after a vaccine arrives.

#coronavirus-2019-ncov, #coronavirus-reopenings, #influenza, #vaccination-and-immunization

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