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A CIVID-19 vaccine could be available earlier than expected if the current clinical trials produce extremely positive results, saidDr. Anthony FauciThe nation is higher responsible for infectious diseases, in an interview on Tuesday with KHN. Read on and ensure your health and health of others, do not miss these Without signs that you have already had coronavirus.

Fucked if the vaccine is "safe and effective," Trials could stop

Although two ongoing clinical trials of 30,000 volunteers are expected to end by the end of the year, with an independent council has the power to end the tests earlier if the provisional results are extremely positive or negative.

The data supervisory board could say, "the data is so good at the moment that you can say that it is safe and effective," said Fauci. In this case, the researchers would have "a moral obligation" to terminate the beginning of the trial and to make the vaccine available to everyone in the study, including those who had received placebos - and speed up the process to give The vaccine at millions.

Fauci's comments come at a time of increasing concern as to whether the Trump administration's political pressure could influence federal and scientific regulators supervising the nation's response to the new coronavirus pandemic, and erode the confidence of the fragile public in vaccines. Importantvaccine expertssaid they fear Trump grows for aQuick vaccine approvalTo help gain re-election.

Fauci, Director of the National Institute of Allergies and Infectious Diseases, said he trusted independent members of the DSMB - who are not government employees - to high standards holding vaccines without being influenced by the Politics. The members of the Board of Directors are generally experts in science of vaccines and biostatistics who teach in major medical schools.

"If you make a decision about the vaccine, you'd better be sure that you have a very good proof that it is both safe and effective," said Fauci. "I am not concerned about political pressure. »

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The test process is rigorous

The Security Council periodically examines data from a clinical trial to determine whether it is ethical to pursue registered volunteers, which are distributed randomly to receive either an experimental vaccine or a placebo vaccine. Neither the volunteers nor the health workers who vaccinate them know who they pulled receive.

Manufacturers are testing three large-scale Covid vaccines from US tests. The first two studies - one conducted by Moderna and the National Institutes of Health and the other led by Pfizer and Biontech - started in late July. Each study has been designed to register 30,000 participants. Business leaders reported both tests registered about half in total.Astrazeneca, Which was running large-scale clinical trials in Britain, Brazil and South Africa, launched another large-scale vaccine study this week in the United States, involving 30,000 volunteers. Additional vaccine tests should begin this month.

In the tests of this size, the researchers know if a vaccine is effective after as little as150 to 175 infections, Dr. Robert Redfield, Director of Centers for Disease Control and Prevention, in an appeal with the journalists Friday.

"It may be surprising, but the number of events that must happen is relatively low," said Redfield.

At this time, only the Security Council has access to the test data, said Paul Mango, Deputy Chief of the Department of Health and Social Services Policies. As to when the test results are available, "we can not determine if it will be mid-October or December. »

Security tips put in "rules of arrest" at the beginning of a study, which makes their criteria for ending a very clear trial, Dr. Eric Topol, Executive Vice President of Research at Scripps Research San Diego and an expert on the use of medical research data.

Although the Security Council may recommend the judgment of a trial, the ultimate decision to terminate a study is made by scientists under execution of the trial, said Topol.

A vaccine manufacturer could then ask the Food and Drug Administration for an emergency authorization, which can be granted quickly, or continue the regular drug approval process, which requires more time and evidence.

security monitors can also stop a trial for security reasons, "If it looks like it's actually harmful to vaccine arm because of a large number of adverse events," said FaCi .

Fauci says people can trust the process because all the data that monitors used outside to make their decisions would be made public.

"All this must be transparent," said Fuci. "The only time you worry, it is if there is pressure to terminate the trial before having enough data on safety and efficiency."

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Political controversy surrounds vaccines

Topol and other scientists haveheavily criticizedThe FDA in recent weeks, accusing Commissioner Stephen Hahn to prostrate the political pressure of the Trump administration, which pushed the agency to approve COVID treatments faster.

Stop the early trials poses a number of risks, such as the manufacture of a more effective vaccine than it really has, Topol said.

"If you stop something earlier, you can get an exaggerated benefit that is not real", because less positive evidence is only released later, said Topol.

Stop study early could also prevent researchers from recruiting more minority volunteers. So far, only about 1 out of 5 test participants areBlack or Hispanic. Since blacks and Hispanics have been stronger than other groups in the pandemic, said Topol, it is important that they constitute a larger part of the vaccine tests.

Ending early vaccine testing, has also allowed security risks, said Dr. Paul Offit, a vaccine developer who serves on a NIH Advisory Committee on Vaccines and Covid Treatments.

A smaller and shorter essay might not detect significant vaccine side effects, which could be apparent only when millions of people have been immunized, said Offit, director of the Education Center vaccinie of the Children's Hospital of Philadelphia.

Researchers will continue to follow vaccinated volunteers for a full year to look for long-term side effects, said Redfield.

And Fuci recognized that the reduction of a short circuit could compromise public confidence in COVID vaccines. One in three Americans is not willing to obtain a Covid vaccine, according to a recent Gallum survey. As for yourself: stay healthy during this pandemic, and again, do not miss theseWithout signs that you have already had coronavirus.

Kn (Kaiser Health News) is a non-profit press service covering health problems. It is an independent KFF editorial program (Kaiser Family Foundation), which is not affiliated with Kaiser Permane.