December 12 coronavirus news

By Ben Westcott, Brett McKeehan, Amy Woodyatt, Fernando Alfonso III and Alaa Elassar, CNN

Updated 12:07 a.m. ET, December 13, 2020
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10:06 a.m. ET, December 12, 2020

FDA commissioner denies political pressure led to quick FDA authorization of Pfizer vaccine

From CNN's Maggie Fox

US Food and Drug Administration Commissioner Dr. Stephen Hahn denied on Saturday that political pressure led to a quicker than normal decision to issue emergency use authorization for Pfizer’s coronavirus vaccine.

The FDA issued the EUA Friday evening, a day after its Vaccine and Related Biological Products Advisory Committee voted to recommend the authorization. But as the FDA considered the vote, Hahn was summoned to the White House.

“First of all, the representations in the press that I was threatened to be fired if we didn’t get it done by a certain date is inaccurate,” Hahn said at a news conference held jointly Saturday with Dr. Peter Marks, who heads the FDA’s vaccine and biologicals branch. Dr. Marks and I have been very clear from the beginning that we are going to maintain the integrity of the scientific process. We are going to let our scientists do their job and review and go through the fairness of that review – the gold standard, if you will." 

The FDA said it reviewed not just Pfizer and BioNTech’s summary of their clinical trial involving around 40,000 volunteers, but went through to original source data. It showed the vaccine was safe and provided 95% protection.

“Our incredible team, heroic efforts, night and day worked to get this out the door,” Hahn said. “As Dr. Marks said, thousands of people are dying a day."

Hear FDA commissioner's answer when asked about political pressure: 

9:56 a.m. ET, December 12, 2020

It would be "foolhardy" to suggest 1 dose of Pfizer/BioNTech coronavirus vaccine is enough, FDA official says

From CNN's Jamie Gumbrecht

Dr. Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research, discusses the agency’s decision to grant emergency use authorization for Pfizer’s Covid-19 vaccine during a news conference on Saturday, December 12.
Dr. Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research, discusses the agency’s decision to grant emergency use authorization for Pfizer’s Covid-19 vaccine during a news conference on Saturday, December 12. Pool

Dr. Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, said during a news briefing on Saturday that there’s “been a lot of noise” about the protection provided by one dose of Pfizer/BioNTech’s coronavirus vaccine and whether that could help extend the vaccine supply.

The FDA’s stance is that people should take two doses. 

“The way the regimen was studied was that everyone, ultimately, or almost everyone received two doses of the vaccine, so we only know how people were protected with two doses of the vaccine,” Marks said. “We spent so much time carefully reviewing the data and basing our decisions on science, right, that it seems pretty foolhardy to just conjecture that one dose might be OK without knowing.”

Marks added: “So at least from the FDA perspective, we would be recommending that people complete the two-dose series so we actually know that they're truly protected at the rate of approximately 95% of efficacy."

Watch:

9:42 a.m. ET, December 12, 2020

UPS details extensive process that will be used to deliver the Covid-19 vaccine

From CNN's Gregory Wallace and Pete Muntean

Months of planning culminate this weekend with the first deliveries of Pfizer coronavirus vaccine doses – and the UPS executive overseeing his company’s efforts says it is an emotional experience.  

“Oh, probably the equivalent of going to your daughter's wedding, I guess,” said Wes Wheeler, the president of UPS Healthcare, told CNN. “It's been a lot of planning. A lot of a lot of phone calls, a lot of technology, a lot of alignment ... As an engineer, I like to do a lot of planning, so that when day one comes, it comes smoothly.” 

Wheeler said the process that soon gets underway at the Pfizer facility in Kalamazoo, Michigan, will be highly choreographed. 

“We have people embedded at the Pfizer location in Michigan, and they will be helping Pfizer to dispatch packages,” he explained. “They will be loaded onto a trailer, a dedicated trailer, with an escort. They will drive five hours to Louisville, Kentucky, and then there'll be dispatched around to the states that we’re assigned.”

In Louisville, many of the shipments will be loaded onto UPS planes. Wheeler said the company’s extensive delivery network means it can ship doses overnight for delivery by 10:30 the next morning. UPS is handling delivery to sites on the Eastern side of the U.S. 

The company is also creating 24,000 pounds of dry ice daily that are packed into special Pfizer containers to keep the vaccine at the required sub-zero temperature. 

“The day after the vaccines arrive, we deliver 40 pounds of dry ice to replenish what is sublimating from the box,” Wheeler said. “The Pfizer package is good for 10 days with it with the 50 pounds of dry ice in it. And with the 40 pounds that we send the following day. It'll give you another several days if necessary so the box becomes the storage medium at the dosing center.”

More details: Tracking devices on each container and truck send real-time information back to the UPS command center in Louisville. 

The tracking tags have four radios and a Bluetooth device that transmit data including GPS location, “atmospheric pressure, motion detection, light detection, and of course temperature,” he said. That data gives the company insight into the condition of each package and the dry ice inside of it. 

“We have eyes on these shipments all the way from origin to the final dosing destination,” he explained.   

 

10:26 a.m. ET, December 12, 2020

Pfizer/BioNTech Covid-19 vaccine trial volunteers can now know whether they received placebo

From CNN's Jacqueline Howard

Now that the Pfizer and BioNTech's Covid-19 vaccine has been authorized in the US, clinical trial participants can find out whether they received the vaccine or placebo, Dr. Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research, said during a virtual news conference on Saturday morning. 

"We have to balance the amount of blinded data that we received with the need to protect people," Marks said.

 

 

9:33 a.m. ET, December 12, 2020

"Science and data guided the FDA's decision," FDA commissioner says

From CNN's Jacqueline Howard

FDA Commissioner Dr. Stephen Hahn speaks during a news conference on Saturday, December 12.
FDA Commissioner Dr. Stephen Hahn speaks during a news conference on Saturday, December 12. Pool

The US Food and Drug Administration's emergency use authorization for Pfizer and BioNTech's Covid-19 vaccine was based on science and data, FDA Commissioner Dr. Stephen Hahn said during a virtual news conference on Saturday morning.

"Science and data guided the FDA's decision," Hahn said, adding that agency scientists and staff have worked around-the-clock to review data to get the vaccine authorized.

Hahn added that efficiency does not mean the cutting of corners while review teams continue to comb through data.

More context: The US government is now working to distribute Pfizer’s Covid-19 vaccine, after the FDA authorized it for emergency use on Friday, Hahn said.

“With this authorization, we know that our federal partners are already moving to distribute the first doses of the vaccine throughout the country,” Hahn said.

Hahn said the authorization is a significant milestone for families battling the coronavirus pandemic in the United States and around the world.

“While this year has been marked by tragedy, sadness and sacrifice, it is also a year that has generated unparalleled scientific achievement that will resonate for many future generations,” he added.

Hear FDA commissioner's remarks: 

8:46 a.m. ET, December 12, 2020

FDA news conference on Covid-19 vaccine will begin soon

The US Food and Drug Administration is scheduled to hold a press conference on the first Covid-19 vaccine authorization at 9 a.m. ET.

FDA Commissioner Dr. Stephen Hahn and Center for Biologics Evaluation and Research Director Dr. Peter Marks will be taking questions.

8:19 a.m. ET, December 12, 2020

US Covid-19 vaccine authorization is an "important milestone," BioNTech CEO says

From CNN's Fred Pleitgen

BioNTech CEO Ugur Sahin speaks with CNN in an exclusive interview.
BioNTech CEO Ugur Sahin speaks with CNN in an exclusive interview. CNN

The US Food and Drug Administration's emergency use authorization of Pfizer and BioNTech's coronavirus vaccine is a crucial step in developing the new-generation vaccine, BioNTech CEO Ugur Sahin said.

"This is a most important milestone," Sahin told CNN in an exclusive interview. "I am really happy that we had such a good meeting and the FDA authorized the vaccine so that we are able to make our vaccine available to the US population."

The FDA authorized the vaccine late Friday night after its advisers recommended the go-ahead. The US follows several other countries in authorizing the vaccine, including Britain, which has already immunized at least 2,000 people.

The EUA was fast by US regulatory standards -- especially for a vaccine using new technology.

How does it work? BioNTech's vaccine uses messenger RNA, genetic material that codes for a piece of the virus's spike protein -- the outside hook that attaches to the cells the virus attacks. This mRNA prompts the human body to produce little pieces of the protein, and then produce an immune response against it.

Clinical trials in more than 40,000 people showed it was 95% effective in preventing symptomatic disease.

"The most important result is that we expect that the vaccinated people will have a much lower risk of hospitalization. So that means we expect a lower risk of hospitalizations in the US," Sahin said. "We will not have a direct impact on the pandemic spread in the next few months since we need of course to reach a large proportion of the population to reduce the speed of the outbreak."

Pfizer has only been able to produce a few million doses for the US so far, so it will not immediately affect the pandemic, Sahin said. But after more people get vaccinated, the effects will kick in, he predicted.

Read the exclusive story here.

Watch:

7:09 a.m. ET, December 12, 2020

Covid-19 took the personal out of personal training. Here's how trainers adapted

From CNN's Amir Vera

Things were looking up for Jason Zenga in late 2019 and in early 2020.

The personal trainer worked out of a gym based in Santa Monica, California, where he taught classes twice a week. He also worked as an independent corporate trainer through a partnership with his friend, where they'd go to offices and train employees at companies across Los Angeles.

But business began to dry up in March, as local and federal governments began implementing stricter policies to mitigate the spread of the coronavirus. All of a sudden, the gym that employed Zenga closed. There were no offices to go to train employees at, and Zenga could only train the last few of his clients virtually. He had to apply for unemployment benefits.

"All the uncertainty was frustrating," Zenga told CNN.

Meanwhile, across the country, Atlanta-based trainer Bria Young found her business booming during the pandemic. When gyms began to close, Young transitioned to packaging workouts into online digital programs on her website, and began selling them.

"It completely flip-flopped, I didn't even need to go back to in-person training," Young told CNN. "I was able to find a new passion during this pandemic."

There's no question that the fitness industry has been upended by the pandemic -- and for some trainers like Zenga, the last 10 months have proved to be financially devastating.

For others, like Young, the pandemic has turned into a fruitful opportunity to pivot to virtual full time.

Read the full story:

6:00 a.m. ET, December 12, 2020

South Korean Prime Minister warns of tougher social distancing measures as coronavirus cases rise

From CNN’s Jake Kwon in Seoul

South Korean Prime Minister Chung Sye-kyun speaks during an emergency meeting on Covid-19 response in Seoul, South Korea on December 12.
South Korean Prime Minister Chung Sye-kyun speaks during an emergency meeting on Covid-19 response in Seoul, South Korea on December 12. Yonhap/EPA-EFE/Shutterstock

If the current trend in rising coronavirus cases continues, then raising the social distancing measure to the highest level would be unavoidable, South Korean Prime Minister, Chung Sye-kyun warned on Saturday.

He posted the warning on his verified Facebook account as he held an emergency meeting to discuss surging coronavirus cases on Saturday.

A raise in the alert level would mean a ban on gathering of more than 10 people, work from home for all non-essential employees and a shift to online for all schools and church services.

South Korea was widely praised as a Covid-19 success story, and initially managed to keep the pandemic largely under control.

But the nation reported 950 new cases of coronavirus on Saturday, marking the highest jump in single day cases since the beginning of the pandemic, according to the Korea Disease Control and Prevention Agency (KDCA).

Seoul Metropolitan Area accounts for the majority of the total with a record 669 new cases.

Currently the national alert level in South Korea is under Level 2 which is the third highest level. It’s higher for the Seoul Metropolitan Area – at under 2.5 – the second highest level.

Alert levels in South Korea range from 1, which denotes the least concerning situation, to 3 signifying the situation requires toughest measure. Each time the alert level is raised it goes up by 0.5.

"A very serious situation:" South Korean President, Moon Jae-in also warned that the surge in Covid-19 cases presents a “very serious situation."

"In fact, we cannot but say that it's an emergency situation,” he said on Saturday via a post on his verified Facebook and Twitter account.

In a press briefing on Saturday, KDCA official, Im Suk-yeong said 90 new coronavirus cases were found in a religious facility in the Western district of Seoul and 66 new cases were found in a nursing hospital in outskirts of Seoul.

An additional 14 cases were discovered while investigating a cluster originating in a restaurant in central Seoul, bringing the total cases linked to the restaurant to 230, she added.

Testing centers boost: In a bid to get a jump on the rising cases, 150 testing stations will be installed around Greater Seoul's high risk areas.

These will come online on December 14 and operate for three weeks, Im added.

The testing will be conducted anonymously to encourage public participation.

Im also said 810 government workers, including members of the military, police have been deployed to aid epidemiological investigation. 480 more workers will join the effort in the future.

Despite the stricter social distancing measures that came into effect on December 5 in the capital city of Seoul, movement of people has not reduced sufficiently, Im added.

Im warned the current trend will likely continue for a week before showing the result of the increased social distancing measures.