• Wednesday, Oct 21, 2020
  • Last Update : 07:13 pm

Fauci: Rushing out a vaccine could jeopardize testing of others

  • Published at 12:55 pm August 25th, 2020
Fauci
In this file photo taken on March 27, 2020, Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci attends the daily briefing on the novel coronavirus, COVID-19, in the Brady Briefing Room at the White House in Washington, DC AFP

Health experts have expressed concern President Donald Trump will apply pressure on FDA to deliver a vaccine before November 3 election

The top US infectious diseases expert is warning that distributing a Covid-19 vaccine under special emergency use guidelines before it has been proved safe and effective in large trials is a bad idea that could have a chilling effect on the testing of other vaccines.

Scientists and health experts have expressed concern that President Donald Trump will apply pressure on the US Food and Drug Administration (FDA) to deliver a vaccine before November to boost his chances of reelection.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, declined to comment on the president, but said there are risks in rushing out a vaccine despite the urgent need.

"The one thing that you would not want to see with a vaccine is getting an EUA [emergency use authorization] before you have a signal of efficacy," Fauci told Reuters in a phone interview.

"One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial," Fauci said.

Large-scale clinical trials of the leading vaccine candidates from Moderna Inc, Pfizer Inc and AstraZeneca Plc, which aim to enroll tens of thousands of volunteers, were launched in recent weeks. Johnson & Johnson last week said it hopes to include 60,000 subjects in its Phase III vaccine trial.

Trump stoked concerns of politicizing the regulatory approval process with an announcement on Sunday of an emergency use authorization for plasma from recovered Covid-19 patients to treat current patients before its benefits have been assessed in randomized, placebo-controlled clinical trials.

Trump had tweeted on Saturday that "deep state" elements at the FDA were delaying progress on drugs and vaccines until after the November 3 election in order to hurt his reelection bid.

Safe and effective vaccines are seen as essential to ending the pandemic that has claimed the lives of more than 800,000 people worldwide, over 177,000 of them in the United States.

But vaccine experts worry that the White House may apply pressure on the FDA to push out a vaccine via an EUA before it has been fully tested - a pathway that has never been used to approve a vaccine intended for widespread use.

"I would be very worried about using an EUA mechanism for something like a vaccine. It's very different from plasma therapy," said Dr Peter Hotez, an infectious disease expert and vaccine researcher at Baylor College of Medicine.

Fauci said the FDA's guidance on vaccines - both for full approval and for an EUA - explicitly requires a demonstration that it is both safe and effective.

An EUA is typically used for products to "diagnose, prevent and treat serious or life-threatening diseases where the known benefits outweigh the potential risks of the product," Fauci said.

An EUA might be appropriate once studies have shown safety and effectiveness, but before the FDA has completed its formal review of the company's marketing application, he said.

"To me, it's absolutely paramount that you definitively show that a vaccine is safe and effective, both," Fauci said. "We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective."


50
50
blogger sharing button blogger
buffer sharing button buffer
diaspora sharing button diaspora
digg sharing button digg
douban sharing button douban
email sharing button email
evernote sharing button evernote
flipboard sharing button flipboard
pocket sharing button getpocket
github sharing button github
gmail sharing button gmail
googlebookmarks sharing button googlebookmarks
hackernews sharing button hackernews
instapaper sharing button instapaper
line sharing button line
linkedin sharing button linkedin
livejournal sharing button livejournal
mailru sharing button mailru
medium sharing button medium
meneame sharing button meneame
messenger sharing button messenger
odnoklassniki sharing button odnoklassniki
pinterest sharing button pinterest
print sharing button print
qzone sharing button qzone
reddit sharing button reddit
refind sharing button refind
renren sharing button renren
skype sharing button skype
snapchat sharing button snapchat
surfingbird sharing button surfingbird
telegram sharing button telegram
tumblr sharing button tumblr
twitter sharing button twitter
vk sharing button vk
wechat sharing button wechat
weibo sharing button weibo
whatsapp sharing button whatsapp
wordpress sharing button wordpress
xing sharing button xing
yahoomail sharing button yahoomail