Stephen Colbert: Mike Pence Is ‘America’s Spare Tire’

“That’s right, the coronavirus is spreading through the Coronavirus Task Force. But don’t worry, the White House is now forming a task force to figure out what went wrong with the task force.” — JIMMY FALLON

“Seriously, it doesn’t instill a lot of confidence that the head of the Coronavirus Task Force’s office got the coronavirus. It’s like if the Avengers got mugged.” — JIMMY FALLON

“As far as we know, the virus cannot be transmitted between humans and poodles so he should be OK.” — JIMMY KIMMEL

“Yep, the only place the coronavirus is rounding the corner is in the halls of the White House.” — JIMMY FALLON

“Meanwhile, when Pence saw he was trending online, he was like, ‘Oh, no — do I have another fly on my head?’” — JIMMY FALLON

“That’s right, Pence will continue to campaign, ’cause not even Covid can stop people from seeing the electricity and raw sexual magnetism that is Mike Pence in person.” — JIMMY FALLON

“We wish them all a speedy recovery, of course we do, both from the virus and from thinking it was ever a good idea to work for Mike Pence.” — JAMES CORDEN

“Despite all of this, Pence himself still has not tested positive because even the virus isn’t interested in Mike Pence.” — JAMES CORDEN

“It’s like the coronavirus won the Super Bowl, except it already made trips to Disneyland and the White House.” — JIMMY FALLON

“In response this weekend, the White House dispatched chief of staff and last boy picked for the white pride kickball game, Mark Meadows. Yesterday, Meadows went on CNN to reassure a worried nation that you’re on your own.” — STEPHEN COLBERT

“The White House’s new plan to stop the virus is to stop trying to stop it.” — JIMMY KIMMEL

“Interesting, so the plan is to just let coronavirus spread freely throughout America? It’s interesting how zen Trump’s people are about this, you know, because with an immigrant child who came over the border, they’re like: ‘Zero tolerance! One is too many! We have to deport!’ But with a virus that’s killing hundreds of thousands of Americans they’re like: ‘Look, man, the virus is just trying to make a better life in our lungs. Who are we to stop it?’” — TREVOR NOAH

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FDA Commissioner Stephen Hahn on COVID Vaccine Safety

And then, finally, we’ve been working with the manufacturers around the quality of their manufacturing, the consistency of it. So that if a vaccine were to be authorized or approved, we could immediately know that quality manufacturing is in place. And again, that process normally takes months.

The last thing to mention is that there’s been manufacturing done at risk, meaning that companies have started manufacturing their vaccines [before the trials are complete], so that if an authorization or approval occurs, the vaccine is ready to go. And as you can see, this really shrinks the development time. But all the steps necessary to ensure safety and efficacy have taken place. And of course, that’s the next thing that we need to see — the data from the phase 3 clinical trials — before any consideration of authorization or approval takes place.

What happens after you see this data? Can you talk about the approval process and what the FDA will be looking for in the phase 3 trial results?

We have made every attempt to be transparent about this, and will continue to do so, so that all Americans understand what we’re doing from a regulatory point of view.

These phase 3 clinical trials are large trials with 30,000 or more participants, and they compare the active vaccine with a placebo to determine whether an infection occurs in a person participating in the trial — because what you’re looking for is a vaccine to prevent infection [with the coronavirus, SARS-CoV-2]. That’s the effectiveness side of things, and in our guidance for vaccine manufacturers [posted to the FDA’s website in June], we were very clear about the criteria: We said the floor for effectiveness would be 50 percent. [This means that the vaccine should be effective at preventing a coronavirus infection or decreasing its severity in at least 50 percent of vaccine recipients. For comparison, the influenza vaccine is between 40 percent and 60 percent effective.]

We also said that safety would be of the utmost importance to us, and on the safety side of things, we’re looking for side effects. Most recently in our guidance for emergency use authorization, we said that we need to see at least two months of follow-up for 50 percent of the participants after they get the final dose of the vaccine. Looking back at other vaccines, our scientists determined that two-month window was when the overwhelming majority of side effects would be seen.

What’s the difference between standard FDA approval and an emergency use authorization when it comes to a vaccine?

When the developers of the vaccine are in their clinical trials, they determine when their data are mature, and there’s an independent board, called a data safety monitoring board, that helps the manufacturers look at the data and determine whether they reached specified criteria. Then, they’ll apply to the FDA for either emergency use authorization (EUA) or a biological license application (BLA), which is the typical process for vaccine approval. Normally, it

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