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.
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.”
The move indicated that the drug had cleared more rigorous hurdles since it was given emergency authorization in May.
The hotly contested strategy of deliberate exposure, known as a human challenge trial, could speed up the process of identifying effective coronavirus vaccines.
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.
All the weak points of American health care — testing delays, communication breakdowns, inequity — are working against this potential treatment.
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.
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.
The two-drug combination invented by college students is one of many potential therapies being tested for this paralyzing fatal condition.
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.
The bones are among the hardest to replace in the body. A trial of the new technique in humans is about to begin.
The drugmaker’s experimental antibody treatment is similar to the one President Trump received from Regeneron.
Big profits beckon for pharmaceutical companies, which are already using their work on vaccines to fight efforts in Washington to curb drug prices.
As America retreats from world affairs, Russia is promising other nations help on the pandemic.
Come spring, Americans may have their choice of several so-so coronavirus vaccines — with no way of knowing which one is best.
The months ahead will be difficult. But the medical cavalry is coming, and the rest of us know what we need to do.
Emergency-use authorizations, a formerly obscure corner of regulatory law, have become a centerpiece of the government’s response to the pandemic.
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.
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.
The guidelines make it highly unlikely that a coronavirus vaccine will be given emergency authorization by Election Day.
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.
Speed and scale may matter more than absolute effectiveness when it comes to tests, masks, treatments and vaccines.
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.
No patients were affected, but the incident was another reminder of the risks in the increasingly common assaults on computer networks.
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.
Despite slim chances that its vaccine will be ready by October, Pfizer has big incentives to hint that it might be.
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.”
Drug company workers, government officials and others have been injected. More will be soon, bewildering experts who worry about potential ill effects.
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.
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.
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.
Unlike some of its competitors, Johnson & Johnson’s vaccine does not need to be frozen and may require just one shot instead of two.
The new guidelines underscore the fact that a vaccine is highly unlikely before the election.
We may not find out whether the vaccines prevent moderate or severe cases of Covid-19.
While scientists are rushing to develop an immunization for adults, no one has started the process yet for children.
A so-called monoclonal antibody lowered levels of the coronavirus and prevented hospitalizations. The research has not yet been vetted by independent experts.
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.
The company hopes to earn the trust of the public and of scientists who have clamored for details of its study.
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.
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.
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.
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.
Pharmaceutical companies and the government must step up their efforts to enroll a diverse group of volunteers.
With pledges of a coronavirus vaccine, China is on a charm offensive to repair strained diplomatic ties and bolster engagement with other countries.
A group of career scientists at the Food and Drug Administration vowed that their work would continue unimpeded and independent of political influence.
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.
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.
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.