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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F.D.A. Approves Remdesivir as First Drug to Treat Covid-19

The move indicated that the drug had cleared more rigorous hurdles since it was given emergency authorization in May.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #gilead-sciences-inc, #remdesivir-drug

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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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Antibody Treatments, Though Promising, Will Be in Short Supply

All the weak points of American health care — testing delays, communication breakdowns, inequity — are working against this potential treatment.

#antibodies, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #elderly, #eli-lilly-and-company, #food-and-drug-administration, #hospitals, #regeneron-pharmaceuticals-inc, #remdesivir-drug, #your-feed-healthcare, #your-feed-science

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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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Drug May Extend A.L.S. Patients’ Lives by Several Months, Study Finds

The two-drug combination invented by college students is one of many potential therapies being tested for this paralyzing fatal condition.

#als-assn, #amylyx-pharmaceuticals-inc, #amyotrophic-lateral-sclerosis, #clinical-trials, #cohen-joshua-b, #drugs-pharmaceuticals, #food-and-drug-administration, #klee-justin, #research, #your-feed-healthcare

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Russia approves second COVID-19 vaccine without data, clinical trials

A vaguely smug man in a suit sits in front of a flag.

Enlarge / Russia’s President Vladimir Putin. (credit: Getty | Mikhail Klimentyev )

Russian President Vladimir Putin on Wednesday announced the second dubious approval of a COVID-19 vaccine that has not been evaluated in clinical trials.

The vaccine, dubbed EpiVacCorona, is said to be a synthetic peptide-based vaccine, which uses fragments of the pandemic virus, SARS-CoV-2, to spur protective immune responses in those vaccinated. It was developed by Vector State Virology and Biotechnology Center, a former Soviet bioweapons research lab.

Like the first Russian-approved vaccine, whether EpiVacCorona is actually safe and effective is completely unknown. In a televised news conference, Putin said that early trials involving 100 people were successful. But researchers have not published any safety or efficacy data from those trials. Russian health officials have said they are still reviewing the vaccine for “safety and quality” but declined to provide any additional information on the vaccine, data, or approval process.

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#clinical-trials, #covid-19, #putin, #russia, #sars-cov-2, #science, #sputnik-v, #vaccine

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Scientists Synthesize Jawbones From Pig Fat

The bones are among the hardest to replace in the body. A trial of the new technique in humans is about to begin.

#animals, #bones, #clinical-trials, #columbia-university, #fat-tissue, #jaw-body-part, #liposuction, #pigs, #prostheses, #science-translational-medicine-journal, #stem-cells, #vunjak-novakovic-gordana

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Eli Lilly’s Antibody Trial Is Paused Over Potential Safety Concern

The drugmaker’s experimental antibody treatment is similar to the one President Trump received from Regeneron.

#astrazeneca-plc, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #eli-lilly-and-company, #johnsonjohnson, #your-feed-healthcare

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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 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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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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Regeneron Asks F.D.A. for Emergency Approval for Drug That Trump Claimed Cured Him

The company said that doses of the unproven treatment would be available for 50,000 patients. It’s impossible to know whether it helped the president.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #trump-donald-j, #your-feed-science

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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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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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Trump’s Covid Treatments Suggest a Serious Condition

Outside experts pointed to the therapies as signs that the president’s health may not be as good as his doctors said. His age, weight and gender put him at high risk.

#antibodies, #clinical-trials, #conley-sean-patrick, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #oxygen, #regeneron-pharmaceuticals-inc, #remdesivir-drug, #trump-coronavirus-positive-result, #trump-donald-j, #walter-reed, #walter-reed-national-military-medical-center, #your-feed-healthcare

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Clinical Trials Hit by Ransomware Attack on Health Tech Firm

No patients were affected, but the incident was another reminder of the risks in the increasingly common assaults on computer networks.

#clinical-trials, #computers-and-the-internet, #cyberattacks-and-hackers, #extortion-and-blackmail, #hospitals

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Will President Trump Get Antibody Treatments for Covid-19?

Regeneron and Eli Lilly wouldn’t say whether Mr. Trump would receive their experimental antibody drugs. Regeneron’s C.E.O. has known the president for years.

#antibodies, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #eli-lilly-and-company, #regeneron-pharmaceuticals-inc, #trump-coronavirus-positive-result, #united-states-politics-and-government, #your-feed-healthcare, #your-feed-science

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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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Flouting all standards, Russia plans to release early COVID-19 vaccine data

An older man in a suit speaks into an array of microphones.

Enlarge / MOSCOW, RUSSIA – AUGUST 14, 2020: Alexander Gintsburg, director of the Gamaleya Scientific Research Institute of Epidemiology and Microbiology of the Russian Healthcare Ministry that produces a COVID-19 vaccine. (credit: Getty | Vyacheslav Prokofyev)

A top Russian researcher behind the Sputnik V coronavirus vaccine defended using the vaccine before testing was complete and said he plans to release clinical trial data early—so early, in fact, the data is unlikely to be interpretable.

Alexander Gintsburg, head of the Gamaleya Institute that developed Sputnik V, laid out his thoughts on the vaccine and the pandemic in an interview with Reuters published Tuesday.

“People are dying just like during a war,” Gintsburg said as he sat in his wood-paneled office in Moscow, holding a crystal model of a coronavirus. “But this fast-tracked pace is not synonymous—as some media have suggested—with corners being cut. No way.”

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#clinical-trials, #covid-19, #infectious-disease, #russia, #sars-cov-2, #science, #vaccine

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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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Trump may reject FDA’s stricter regulations for COVID-19 vaccine

The Food and Drug Administration headquarters in White Oak, Maryland.

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly)

President Donald Trump on Wednesday said he may reject the Food and Drug Administration’s plan to issue stricter safety and efficacy standards for COVID-19 vaccines, calling the plan a “political move.”

The new standards are aimed at bolstering public confidence in the FDA and its vaccine review process, which has been severely damaged by many reports of political meddling and interference by the Trump administration. Those reports include claims that the FDA was pressured by the White House into allowing COVID-19 patients to be treated with unproven blood plasma and the anti-malaria drug hydroxychloroquine, which was personally touted by Trump. (The authorization of hydroxychloroquine was later revoked by the FDA.) Just last week, Trump’s secretary of health and human services, Alex Azar, revoked the FDA’s authority to sign new regulations.

Trump himself has continually undercut federal public health guidance and government scientists, particularly Robert Redfield, his director of the Centers for Disease Control and Prevention. Trump has also repeatedly pushed for a pre-election release of a vaccine, though experts have, in turn, repeatedly pointed out that such a speedy release is nearly impossible based on the timeline of the clinical trials underway and the amount of data needed to make even preliminary evaluations of safety and efficacy.

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#cdc, #clinical-trials, #covid-19, #fda, #infectious-disease, #pandemic, #public-health, #science, #trump, #vaccine

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Russia offers its untested COVID-19 vaccine for free to UN officials

A smirking man in a suit sits in front of a UN flag.

Enlarge / Russian President Vladimir Putin address the 75th session of the United Nations General Assembly, via teleconference call, in Moscow on September 22, 2020. (credit: Getty | MIKHAIL KLIMENTYEV)

Some United Nations staff are likely brushing up on their Russian—specifically how to say “Thanks, but no thanks” in the nicest way possible.

On Tuesday, Russian President Vladimir Putin offered UN staff free doses of the country’s COVID-19 vaccine, Sputnik V, which has not completed clinical trials for efficacy and has not been thoroughly vetted for safety.

Still, Putin suggested that his offer was prompted by the desire to give the people what they want: “Some colleagues from the UN have asked about this, and we will not remain indifferent to them,” he said during a speech Tuesday at this year’s (virtual) General Assembly.

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#clinical-trials, #covid-19, #efficacy, #putin, #russia, #safety, #sars-cov-2, #science, #sputnik-v, #un, #vaccine

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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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Eli Lilly Claims Experimental Drug Protects Covid-19 Patients

A so-called monoclonal antibody lowered levels of the coronavirus and prevented hospitalizations. The research has not yet been vetted by independent experts.

#antibodies, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #eli-lilly-and-company, #national-institutes-of-health, #united-states

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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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Vaccine Makers Keep Safety Details Quiet, Alarming Scientists

Researchers say drug companies need to be more open about how vaccine trials are run to reassure Americans who are skittish about getting a coronavirus vaccine.

#astrazeneca-plc, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #krumholz-harlan-m, #moderna-inc, #offit-paul-a, #oxford-university, #pfizer-inc, #research, #trump-donald-j, #vaccination-and-immunization

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AstraZeneca Partly Resumes Coronavirus Vaccine Trial After Halting It for Safety

The company said tests of its vaccine would start up again in Britain while remaining suspended in the U.S. and other countries. Pfizer, a competitor, announced an expansion of its trials.

#astrazeneca-plc, #biontech-se, #clinical-trials, #coronavirus-2019-ncov, #pfizer-inc, #research, #vaccination-and-immunization, #your-feed-science

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Trump Pressed for a Plasma Treatment. Officials Worry, Is a Vaccine Next?

New details of how the president has demanded faster action from health agencies help explain the intensifying concern that he could demand pre-Election Day approval of a vaccine.

#azar-alex-m-ii, #birx-deborah-l, #blood, #clinical-trials, #collins-francis-s, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #health-and-human-services-department, #kushner-jared, #marks-peter, #mayo-clinic, #meadows-mark-r-1959, #national-institutes-of-health, #presidential-election-of-2020, #republican-national-convention, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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Covering Ebola Didn’t Prepare Me for This: I Volunteered for the Covid-19 Vaccine Trial

George Washington University Hospital invited me to participate in Moderna’s vaccine trial because I am triple-risk: a Black woman, a Type 1 diabetic and asthmatic.

#clinical-trials, #content-type-service, #coronavirus-2019-ncov, #fauci-anthony-s, #george-washington-university, #immune-system, #moderna-inc, #placebos, #rna-ribonucleic-acid, #vaccination-and-immunization

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We Need to Recruit More Black Americans in Vaccine Trials

Pharmaceutical companies and the government must step up their efforts to enroll a diverse group of volunteers.

#black-people, #clinical-trials, #coronavirus-2019-ncov, #race-and-ethnicity, #vaccination-and-immunization

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From Asia to Africa, China Promotes Its Vaccines to Win Friends

With pledges of a coronavirus vaccine, China is on a charm offensive to repair strained diplomatic ties and bolster engagement with other countries.

#africa, #bangladesh, #china, #clinical-trials, #communist-party-of-china, #coronavirus-2019-ncov, #far-east-south-and-southeast-asia-and-pacific-areas, #politics-and-government, #vaccination-and-immunization

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F.D.A. Regulators Publish Rare Self-Defense Amid Rising Vaccine Pressure

A group of career scientists at the Food and Drug Administration vowed that their work would continue unimpeded and independent of political influence.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #trump-donald-j, #united-states-politics-and-government

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Inquiry Begins Into AstraZeneca’s Vaccine Trial

A participant in the company’s late-stage coronavirus vaccine trial reportedly developed severe neurological symptoms. Now experts must assess whether the vaccine was responsible.

#astrazeneca-plc, #clinical-trials, #coronavirus-2019-ncov, #great-britain, #vaccination-and-immunization, #your-feed-healthcare

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Pharma Companies Plan Joint Pledge on Vaccine Safety

The statement is meant to reassure the public that the companies will not seek a premature approval of vaccines under pressure from the Trump administration.

#astrazeneca-plc, #centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #medicine-and-health, #moderna-inc, #pfizer-inc, #presidential-election-of-2020, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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Russians Publish Early Coronavirus Vaccine Results

The first batch of public data from the “Sputnik V” vaccine showed that it was safe and produced an immune response. No one knows yet whether it prevents coronavirus infections.

#antibodies, #clinical-trials, #coronavirus-2019-ncov, #russia, #vaccination-and-immunization, #your-feed-healthcare, #your-feed-science

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