November 25 coronavirus news

With millions of Americans ignoring guidelines against holiday travel, the United States could see an explosion of Covid-19 infections in the weeks following Thanksgiving, CNN medical analyst Dr. Jonathan Reiner said Tuesday.

“One of the ways we think the Midwest was seeded with virus during the summer was with the Sturgis, South Dakota, motorcycle rally where people were infected and then dispersed out through the Midwest."

“Now imagine that on a massive scale -- people leaving from every airport in the United States, and carrying virus with them,” he added.

Why tests don't guarantee safe travel: Reiner cautioned that testing doesn’t always reveal whether someone is infected at a given point in time. For example, if a person is infected with Covid-19 and has a test a day or two later, there might not be enough viral RNA to detect the virus, he said.

So, testing as a litmus test for traveling won’t work, unless it reveals a positive result and the person stays home as a result, Reiner said.

White House warning: Reiner also said he’s opposed to White House plans for Christmas parties this year.

The US government’s Operation Warp Speed effort is trying to understand discrepancies in data coming out of trials of AstraZeneca’s experimental coronavirus vaccine, Moncef Slaoui, chief science adviser to the mission, said Tuesday.

It might be possible to adjust the US trial arm if it turns out a different dose of the vaccine works better, he said. 

AstraZeneca said Phase 3 trial data from testing in Britain and Brazil indicated the vaccine was 62% effective -- except for a batch tested in 3,000 volunteers that looked to be 90% effective in preventing infection. The vaccine, developed with the University of Oxford, is also being tested in the US but there’s no data from that arm of the trial yet.

AstraZeneca said surprisingly, the stronger effects were seen in volunteers who got a half dose of the vaccine, boosted by a full dose a month later. The 62% efficacy was seen in the majority of volunteers who got the proper dosing for both shots.

“We have been made aware of what's called now the half dose at the time it happened, was a change in the way the quantity of vaccine put in a vial was tested,” Slaoui said.

He seemed to indicate the half dose was given by mistake. “And when they realized there was an error or change in the approach, technique used, they corrected it. In the meantime, about 3,000 subjects were recruited, half in the placebo and half in the vaccine group.” 

That would skew the results. Clinical trials are carefully designed, and results that came from mistakes usually are not included in the final reports of those trials. But clinical trials can be adjusted if mistakes show a different dosing regimen, for instance, can provide better outcomes.

The United States set a record for the number of people currently hospitalized with Covid-19 on Tuesday, according to the Covid Tracking Project. 

As of Tuesday, 88,080 people are currently hospitalized with Covid-19, according to CTP. This is the highest number of Covid-19 hospitalizations the nation has ever experienced. 

According to CTP data, the highest hospitalization numbers are: 

Some areas of the United States will soon see their health care systems overwhelmed, as coronavirus hospitalizations surge around the nation, Dr. Robert Redfield, director of the US Centers for Disease Control and Prevention, said Tuesday. 

“In some areas, we are going to see the health care system overwhelmed,” Redfield said in an interview with Fox News.

But he said Americans are not defenseless against the virus, and can blunt the surge by practicing mitigation measures.

He said definitively that safety precautions, such as wearing masks, work.

“Hope’s on the way with a vaccine,” Redfield said, adding that until then, “We still need to really be vigilant about these mitigation steps, and stop the debate about whether they work or not.”

US Food and Drug Administration Commissioner Dr. Stephen Hahn said that discussions about whether to issue an emergency use authorization for a potential Covid-19 vaccine could take "days.”

Once the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meets on Dec. 10 to discuss Pfizer and BioNTech’s application for an emergency use authorization for their coronavirus vaccine, the FDA could deliberate for days on whether to issue an EUA.

"There are several steps to the vaccine authorization process. First, a company must apply to the FDA. Then, the FDA must go through the application and send it to an outside review board called the Vaccines and Related Biological Products Advisory Committee," Hahn said. "That committee meets on Dec. 10 and will send the FDA its comments and recommendations. Only then can the FDA make a final decision on a vaccine."

The United States could start distributing doses of a Covid-19 vaccine "soon after" Dec. 10, Health and Human Services Secretary Alex Azar said Tuesday.

The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee will meet on that date in December to discuss Pfizer and BioNTech’s application for an emergency use authorization for their coronavirus vaccine.

"We believe we can distribute vaccine to all 64 jurisdictions within 24 hours of FDA authorization. Then we hope administration could begin as soon as the product arrives," Azar said. "One of the private sector partners we've enlisted, CVS Health, has said that they expect to be vaccinating residents of nursing homes -- one of the top priority groups -- within 48 hours after FDA authorization."