FDA to Announce New COVID-19 Vaccine Standards for Approval

The Food and Drug Administration is set to announce new standards for approving a COVID-19 vaccine, according to a report.

This is part of an effort to boost confidence with the American people.

The FDA will ask manufacturers to follow clinical trial participants for at least two months to obtain an emergency authorization, according to a report.

In addition, trials will have to show proof surrounding more severe cases and older people.

This makes it unlikely that a vaccine will be released before the 2020 presidential election.

Moderna and Pfizer both started their trials in July.

Meanwhile, the enrollment process started about a month with the second round of shots being administered after three or four weeks in the trial.

The White House has said a vaccine could be approved by November.

U.S. President Donald Trump said earlier this month than an approval could be done within a matter of weeks.

Trump also noted during a press conference that distribution would likely start in October.

Centers for Disease Control Director Robert Redfield earlier told Congress that healthcare workers, first responders, and others at high risk would get the vaccine first.

This could probably be in January or even later this year.

However, it was unlikely to be available more broadly before spring or summer.

A poll showed that Americans have become increasingly hesitant to a potential vaccine.

Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, said that it is hard to imagine how an emergency use authorization could possibly before December.

Offit is also a member of the FDA's advisory board on vaccines.

Pew Research Center said last week that only 21 percent of U.S. adults say that they would get the vaccine.

It was down from 42 percent in May.

On the other hand, the percentage of people who said they would "probably" or "definitely" not receive the vaccine increased from 27 percent to 49 percent.

Trump's top advisers, Dr. Anthony Fauci, said that the administration could see results for a vaccine before the end of the year.

"I have said from the beginning, given the way the trials have emerged now, including the one on hold now, the projection that I've made - and will stick by it - is that we'll likely get an answer if it's safe and effective by the end of the year, likely November or December," he said was quoted in a report.

White House Deputy Press Secretary Judd Deere said that every decision the FDA has made during the Trump Administration has maintained the agency's gold standard for safety.

Deere added that it has also been data-driven to save lives.

Deere added that the false narrative that the media and Democrats have created is not only false but is a danger to the American public.

The said false narrative points to the reporting that politics in influencing COVID-19 vaccine approvals.

The press secretary also said that Trump believes all Americans should have access to proven, safe, and affordable treatment options.

Deere also said that the rapid research, development, trials, and scientific approvals are part of Trump's highest priority: the health and safety of the American people.

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