AstraZeneca suspends coronavirus vaccine trial after unexplained disease in volunteers | Health

“As part of an ongoing, randomized, global trial of the Oxford Coronavirus Vaccine, our standard review process caused a suspension of vaccination to allow review of safety data. The company said in a statement sent to CNN.

Company Test that vaccine, Developed at Oxford University in the United Kingdom, it is called the Oxford vaccine and has been developed in the United States, United Kingdom, Latin America, Asia, Europe and Africa.

“This is a routine action that must be taken whenever one of the trials has a potentially unexplained illness and must be taken to ensure that the integrity of the trial is maintained.” The statement added.

“In large trials, illness happens by accident, but this needs to be individually confirmed and carefully confirmed. To minimize the potential impact on the trial timeline, 1 We strive to expedite the review of one event. We are committed to the safety of our participants and the highest standard of conduct in our exams.”

AstraZeneca at the beginning of Tuesday, Sign the pledge They have promised not to seek premature government approval for the coronavirus vaccine. They promised to wait until there was enough data to show that the vaccine worked safely.

“We, a signed biopharmaceutical company, want to articulate our ongoing commitment to develop and test potential vaccines for COVID-19 according to high ethical standards and sound scientific principles. I read the statement. Signed by CEOs of AstraZeneca, BioNTech GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory processes by which the COVID-19 vaccine may be evaluated and ultimately approved.” They added.

The AstraZeneca vaccine is one of three late-stage coronavirus vaccines in the US Phase 3 trial. The Data and Safety Oversight Board (DSMB) can usually monitor adverse events in the trial and order the suspension or discontinuation of the trial, but AstraZeneca does not disclose who discontinued the trial. Hmm.

Common adverse events in vaccine trials include fever, headache, injection site pain, and muscle aches.

Both regulators and companies strive to make people credible in the vaccine approval process. The US Food and Drug Administration must give an emergency license or full approval to a vaccine before it can be distributed in the United States.

President Trump has repeatedly said he thinks he will have at least one vaccine ready by the election day on November 3. Most groups working on vaccines say it’s very unlikely, but Biontech CEO and co-founder Ugur Sahin said the vaccine his company is developing at Pfizer early Tuesday. Ready to get regulatory approval By mid-October.

If Tony Forch of the National Institute of Allergy and Infectious Diseases finds strong evidence that the vaccine worked before the study was completed, he calmly discontinues the study so that more people can do it. Get a vaccine that says it is technically possible to recommend. But Forch, sadly, this was unlikely to happen before December.

However, discussions of early approvals and reports of the White House’s pressure to speed along the vaccine worried the general public and former FDA authorities. Former FDA board member Robert Calif told CNN last week that he was worried before Mr. Covid-19 that he would pressure Trump to make the FDA’s desired decision.

“One of the things I’ve been using pins and needles for in the last four years was that Trump could literally do this with drugs, devices or vaccines whenever he wanted,” from January 2016. Mr. Calif, who served as commissioner until January 2018, said.

Fauci and FDA Commissioner Dr. Stephen Hahn said they would not fall into political interference.