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Experts Warn Covid-19 Vaccine Approval Process Should Be Kept Out of the Fast Track

2020-09-03T13:45:57.684Z


The emergency use authorization allows the FDA to give the green light to unapproved medical products without going through the lengthy complete process required for full approval, but experts ask ...


The vaccine against covid-19 could be advanced 1:29

(CNN) -

While many are waiting for a vaccine to control COVID-19, a leading vaccine expert has warned against an emergency use authorization (US) to put a vaccine on the US market as soon as possible.

"How can you justify a poor or minor review for something that would be injected into tens of millions, perhaps hundreds of millions of Americans?" Said Dr. Peter Hotez, professor and dean of Tropical Medicine at Baylor College of Medicine, in a series of posts on social media, this Wednesday.

The EUA allows the Food and Drug Administration (FDA) to give the green light to unapproved medical products without going through the lengthy, complete process required for full approval.

But Hotez urged federal health agencies to "follow that process" for such a significant vaccine.

  • Novavax's coronavirus vaccine is safe, published results show

The vaccine against covid-19 could be advanced 1:29

Three vaccines for the coronavirus that has infected more than 6.1 million Americans are currently in phase 3 testing in the United States, which experts have called incredibly fast.

Officials have insisted that no vaccine will be distributed to the public until it is effective and safe, but differ on when it could be.

Many, including the director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, say early 2021 would be a good estimate, while other officials point to the next few months.

President Donald Trump has predicted that a vaccine will be available in time for the November 3 election, and the U.S. Centers for Disease Control and Prevention (CDC) told the public health officials across the country to prepare to distribute one by the end of October.

But health experts say those predictions are unrealistic.

"This is like the Boy Scout motto, 'Be Prepared,'" said Dr. Francis Collins, director of the National Institutes of Health.

Even if it is highly unlikely, if everything went well and we had an answer by then and we knew we had a vaccine that was safe and effective, wouldn't you want people to be ready to figure out how to distribute it?

That's all the CDC says. "

  • Independent Expert Committee Proposes Four-Phase Plan to Assign Future Coronavirus Vaccine

FDA Commissioner Issues Vaccine Warning 0:43

Fauci urges the nation to avoid crowds on Labor Day weekend

With the Labor Day weekend coming up, Fauci pleaded with Americans not to repeat the mistakes of previous holidays.

“We know from previous experience that when it comes to holiday weekends (July 4, Memorial Day), there is a tendency for people to be somewhat careless about public health measures that we continue to recommend a and again, ”Fauci said in an interview with MSNBC's Andrea Mitchell on Wednesday.

Many previous celebrations resulted in outbreaks of cases, a fate that Fauci said can be avoided.

"You can have a nice weekend, but you can do a couple of fundamental things that we talk about all the time," he said.

"Masks, physical distance, avoiding crowds, [being] outdoors much more than indoors, washing hands, those kinds of simple things."

Kentucky Gov. Andy Beshear made the same request as the state prepares to host the Kentucky Derby over Labor Day weekend, which will take place without fans in the stands.

"Please, let's not look back and say something as special as what this weekend can be, which ended up being the moment when this virus got out of control," Beshear said.

Los Angeles cuts hospitalizations in half in 5 weeks

The precautions have pushed the number of hospitalizations of coronavirus patients in Los Angeles to its lowest levels since early April, Mayor Eric Garcetti announced at a news conference Wednesday night.

«Today, 1,062 Angelenos are in the hospital due to covid-19.

To put that in perspective, in the last five weeks alone, we have cut our hospitalizations by more than half, ”Garcetti said.

On Wednesday, Los Angeles County reported 1,457 new COVID-19 cases, bringing the total since the start of the pandemic to 243,935.

The county also reported 51 new deaths, 12 of which occurred in the city of Los Angeles, bringing the total to 5,878.

California has the highest number of reported infections of any state, with more than 720,000 cases.

Los Angeles will now allow county schools to provide on-campus services for a small number of students in kindergarten through 12th grade who need "learning support," Garcetti said.

And early Wednesday, Los Angeles County announced the reopening of hair salons and barber shops with a limited capacity of 25%.

But the mayor was quick to point out that residents should not confuse improved hospitalization and infection rates and any reopening of businesses with "getting back to normal," reiterating that countywide restrictions will remain in effect.

This is how nurses fight covid-19 in Los Angeles 2:57

Sending infected college students home is 'the worst thing I could do'

New covid-19 focal points continue to appear in the United States, with worrying trends in the Midwest and in universities across the country.

More than 25,000 cases of COVID-19 have been reported in colleges and universities in 37 states, according to a CNN tally, as of Wednesday.

But it's not just college students who get more infections.

The number of new cases among children has increased 17% in two weeks, according to the American Academy of Pediatrics and the Association of Children's Hospitals.

While deaths from covid-19 are rare among children and young adults, many young people are suffering the long-term effects of the disease.

And even those with no symptoms can easily spread the coronavirus to other people.

That's why colleges and universities shouldn't send infected students home, Fauci said.

Keep them at the university, in a place that is far enough away from the other students.

But don't make them go home, because they could be spreading it in their home state, "Fauci told NBC's" Today "show in an interview broadcast Wednesday.

- CNN's Steve Almasy, Topher Gauk-Roger, Holly Yan, Annie Grayer and Maggie Fox contributed to this report.

covid-19 coronavirus vaccine

Source: cnnespanol

All news articles on 2020-09-03

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