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By James Griffiths, Brett McKeehan and Amy Woodyatt, CNNUpdated 12:14 p.m. ET, February 13, 2021

https://www.cnn.com/world/live-news/coronavirus-pandemic-vaccine-updates-02-13-21/index.html

2 hr 30 min ago

FDA moved too fast to authorize coronavirus antibody tests, two top officials admit

From CNN Health’s Maggie Fox

The US Food and Drug Administration moved too quickly to allow the marketing of antibody tests for coronavirus without authorization last spring and ended up with a lot of tests that did not work well, two top officials said Saturday.

The FDA won’t be doing that again, and agencies need to prepare ahead of time for quick development of tests in pandemics, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health and Dr. Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, wrote in a joint commentary in the New England Journal of Medicine.

“Flawed” policy: At the time it seemed important to get antibody tests onto the market so researchers could assess just how widespread the virus was, they said. So, FDA published guidance in March allowing developers to market tests without emergency use authorization as long as the test was validated, and the tests carried warnings that they were not FDA-reviewed.

“In hindsight, however, we realized that the policy outlined in our March 16 guidance was flawed,” they wrote.

By April, they wrote, “the market was flooded with serology tests, some of which performed poorly and many of which were marketed in a manner that conflicted with FDA policy.”

Later, the FDA worked with the National Cancer Institute to evaluate antibody tests developed by university labs. That worked better, they said.

“Knowing what we know now, we would not have permitted serology tests to be marketed without FDA review and authorization, even within the limits we initially imposed,” Shuren and Stenzel wrote.

Lessons learned: “First, our experience with serology tests underscores the importance of authorizing medical products independently, on the basis of sound science, and not permitting market entry of tests without authorization,” they wrote.

Plus, the federal government needs to coordinate research better, and evaluate tests before they are needed so they can be checked quickly in an emergency.4 hr 54 min ago

Covid passports could deliver a “summer of joy,” Denmark hopes

From CNN’s Nina dos Santos, Antonia Mortensen and Susanne Gargiulo

Like many countries around the world, Denmark is desperate to reopen the parts of its economy frozen by the pandemic.

The kingdom of under 6 million people has become one of the most efficient vaccination distributors in Europe and aims to have offered its whole population a jab by June.

But before that target is reached, there’s pressure for life to return to normal for Danes already inoculated and to open up borders for Covid-immune travelers from overseas.

Morten Bødskov, Denmark’s acting finance minister, last week raised the prospect of a so-called coronavirus passport being introduced by the end of the month.

“Denmark is still hard hit by the corona pandemic,” he said. “But there are parts of Danish society that need to move forward, and a business community that needs to be able to travel.”

The government has since indicated that a February deadline might be ambitious, but the relatively small Scandinavian country could still become the world’s first to formally embrace the technology to open its borders in this controversial way.

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Covid passports could deliver a ‘summer of joy,’ Denmark hopes

Nina dos Santos, Antonia Mortensen and Susanne Gargiulo, CNN5 hr 32 min ago

For the first time in 100 days, the US is averaging fewer than 100,000 new Covid-19 cases per day

From CNN’s Amanda Watts and Haley Brink

For the first time in 100 days, the United States is averaging fewer than 100,000 new Covid-19 cases per day, according to data from Johns Hopkins University.

The nation has a current 7-day average of 96,609 new cases per day, according to JHU data. The last time this metric was below 100,000 was on Election Day, November 3, 2020. 

On November 3, the US saw an average of 925 deaths per day. Right now, the US is seeing an average of 3,024 deaths per day, which is more than a 200% increase in daily deaths since November.

 Over those 100 days — from November 3, 2020 to February 12, 2021 — the US tallied 18,141,364 new Covid-19 cases and 248,148 reported deaths, JHU data shows. 6 hr 19 min ago

The AstraZeneca coronavirus vaccine will be tested in kids as young as 6 

From CNN’s Maggie Fox and Jo Shelley

University researchers plan to start testing AstraZeneca’s coronavirus vaccine on children as young as six in Britain on Saturday. 

A team at the University of Oxford, which developed the vaccine, said it will test the vaccine on children and teens aged 6-17 there and at sites in London, Southampton and Bristol. 

Few trials of coronavirus vaccine involve children as yet. In the US, Pfizer/BioNTech’s and Moderna’s vaccines are being tested in children as young as 12. 

“This new trial, a single-blind, randomized Phase II trial, will enrol 300 volunteers, with up to 240 of these volunteers receiving the (AstraZeneca) vaccine and the remainder a control meningitis vaccine, which has been shown to be safe in children but is expected to produce similar reactions, such as a sore arm,” the Oxford team said in a statement. 

Grace Li, a pediatric researcher in the Oxford Vaccine Group, said in a statement: “We’ve already seen that the vaccine is safe and effective in adults, and our understanding of how children are affected by the coronavirus continues to evolve.”

While children are much less likely than adults to be hospitalized or die from Covid-19, children are as just as likely as adults to become infected.

“While most children are relatively unaffected by coronavirus and are unlikely to become unwell with the infection, it is important to establish the safety and immune response to the vaccine in children and young people as some children may benefit from vaccination,” added Dr. Andrew Pollard, chief investigator for the trial at Oxford. “These new trials will extend our understanding of control of SARS-CoV2 to younger age groups.” 7 hr 1 min ago

UK could live with Covid-19 “like flu,” says Health Secretary

From CNN’s Amy Woodyatt in London

The UK’s Health Secretary Matt Hancock said he hopes that vaccines and treatments for Covid-19 will turn the disease into something we “live with, like we do flu” by the end of the year. 

Hancock said he hoped that by the end of the year, Covid-19 “will become a treatable disease,” and that he anticipated new drugs to tackle the virus should arrive.

In an interview with the UK’s Daily Telegraph, Hancock said new treatments would be key in “turning Covid from a pandemic that affects all of our lives into another illness that we have to live with, like we do flu. That’s where we need to get Covid to over the months to come.”

Some 14 million people have received their first dose of the Covid-19 vaccine as of Thursday, according to the UK government, and more than 530,000 have received a second dose.

Hancock said he was “confident” that the vaccine would be offered to all adults in the UK by September.

Here’s some context: There have been more than 4 million confirmed cases of Covid-19 in the UK, according to figures from Johns Hopkins University.

In March last year, the UK government said it was hopeful the country could cap its coronavirus deaths at 20,000. But more than 116,500 have died, according to figures from JHU — and the country has one of the highest number of confirmed deaths in the world, proportionate to population.8 hr 14 min ago

At least 109 employees at a Colorado ski resort test positive for Covid-19

From CNN’s Leslie Perrot, Chris Boyette and Leah Asmelash

A ski resort in Colorado has had a Covid-19 outbreak, with more than 100 active infections among its employees.

The Colorado Department of Public Health and Environment announced the outbreak at Winter Park Resort in January but released the data in its weekly outbreak summary on Wednesday.

There are at least 109 employees with active infections, they said.

“It has been determined that these cases have not been traced back to transmission through interaction with visitors but, rather, from social gatherings outside of the workplace and congregate housing,” Grand County, Colorado, officials said Monday in a joint statement with Winter Park Resort.

With ski season in full swing in Colorado, other resorts have also reported Covid-19 cases. But the outbreak at Winter Park is currently the largest, according to CDPHE data.

“We have been working closely with public health authorities since the pandemic began,” said Jen Miller, communications manager at the ski resort. “We did extensive planning and had to get approval from the state on our operations before we could open on December 3.”

Cases linked to socializing and living situations: Most of the cases have been traced back to social gatherings outside of work and to congregate housing, Miller said.

Precautions, according to Miller, include: reconfiguring lift corrals and lift-loading procedures, extra staff, new signage reminding visitors about mask requirements, limitations on dining, a reservation system to manage visitation and the number of people at the resort, contactless lodging and a state-approved testing site for their 1,700 active employees.

But some visitors have reported that mask mandates were not being enforced.

When asked about those reports, Miller said, “We’ve done extensive work and continue to evolve our operations as necessary. I can’t speak to one individual’s experience, but we do appreciate feedback and will continue to make modifications with the health and well-being of our employees, guests and community as our top priority.”

Conor Cahill, press secretary for Colorado Gov. Jared Polis, said ski resorts across the state need to “do a better job planning for and managing surge weekends.”

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Nearly a third of US adults are undecided about the Covid-19 vaccine. They say friends and family could sway them

From CNN’s Madeline Holcombe

Though officials and health experts say the end of the Covid-19 pandemic will rely on a large proportion of Americans being inoculated, nearly a third of US adults say they have not decided if they will get the vaccine when it is offered to them.

Could be swayed: About 31% of US adults say they plan to “wait and see” how it works out for other people, according to a report released by the Kaiser Family Foundation (KFF) Friday. Many said that a close friend or family member getting vaccinated would be most likely to sway their decision.

Vaccinations have been ramping up across the country as officials race to get most Americans inoculated by the end of summer, aiming for a return to normality while trying to get ahead of the coronavirus variants.

To reach herd immunity, about 70-85% of Americans would need to be vaccinated, National Institute for Allergy and Infectious Disease director Dr. Anthony Fauci has estimated.

Though many states have complained that their supply of doses from the federal government does not meet their demand, the pace has quickened in recent weeks.

The US has averaged nearly 1.6 million doses administered per day over the past week, higher than the daily average of about 1.3 million last week, according to a CNN analysis of data published Thursday by the CDC.

And more than 6,500 retail pharmacies around the country opened appointments Friday for the 1 million doses they have been allocated.

Here’s some background: The United States recorded an additional 97,525 new coronavirus cases and 5,323 more deaths Friday, according to Johns Hopkins University’s tally.

Friday’s figures bring the national total to 27,490,037 cases and 480,767 deaths, across all 50 states, the District of Columbia, and US territories.

Read the full story here.10 hr 28 min ago

US records 97,525 more coronavirus cases and 5,323 related deaths

From CNN’s Alta Spells in Atlanta

The United States recorded an additional 97,525 new coronavirus cases and 5,323 more deaths Friday, according to Johns Hopkins University’s tally.

Friday’s toll includes more than 2,400 backlogged deaths from Ohio. The state’s health department said on February 10 that some 4,000 deaths “may have been underreported through the state’s reporting system” and would be added to future tallies.

“Process issues affecting the reconciliation and reporting of these deaths began in October. The largest number of deaths were from November and December,” the department said in a statement. “Although being reported this week, the deaths will reflect the appropriate date of death on the state’s Covid-19 dashboard.”

Friday’s figures bring the national total to 27,490,037 cases and 480,767 deaths, across all 50 states, the District of Columbia, and US territories.

So far, at least 69,014,725 vaccine doses have been distributed, with some 48,410,558 shots administered, according to the US Centers for Disease Control and Prevention.13 hr 5 min ago

Flights to Australian state of Victoria suspended during snap lockdown

From CNN’s Angus Watson in Melbourne

Flights to Victoria have been suspended as the Australian state begins a hard five-day lockdown, Premier Daniel Andrews said Saturday. 

No flights will be allowed into Victoria until next Thursday, other than those carrying more than 100 passengers who have already commenced travel to the state.

“A lot of people will be hurting today,” Andrews said at his daily news briefing, adding “we can’t have a situation where in two weeks’ time, we look back and wish we had taken these decisions now.” 

Victoria recorded one additional Covid-19 case Saturday, connected to the recent Holiday Inn cluster. A total of 14 confirmed cases of the UK variant have been linked to the cluster. 

The state entered the five-day “circuit breaker” lockdown at 11:59 p.m. local time on February 12.  13 hr 8 min ago

California to expand vaccine eligibility to millions with pre-existing conditions

From CNN’s Stephanie Becker and Cheri Mossburg

The US state of California is adding millions of people to its Covid-19 vaccination priority list, including residents “at high risk with developmental and other disabilities” and those with “serious underlying health conditions.”

The plan, outlined by state health officials in a briefing Friday, will begin March 15 and allow cancer patients, pregnant women, and other disabled individuals to join health care workers, seniors, teachers, and farm staff in line for a vaccine. The expansion could add as many as 6 million more Californians to the priority list.

It also broadens the ages from 65 and over to ages 16 to 64 in those categories.

California Health and Human Service Agency Secretary Dr. Mark Ghaly told reporters the March 15 start will give officials time to work out details on how to get vaccines to those with various disabilities and could include at-home visits.

Ghaly acknowledged the timing could be optimistic, cautioning “we are still dealing with the scarcity of vaccine. This week the drastic shortfall of vaccines in the state led to the closure of the mass vaccination centers in Los Angeles.”

The expanded list of those eligible includes people with cancer, chronic kidney disease, oxygen-dependent heart disease, Down Syndrome, immune-suppressed organ transplant recipients, pregnant women, people with sickle cell disease, severe obesity and certain type-2 diabetes.

Ghaly expressed concern about the inequity of distribution among communities of color and low-income areas. There are plans to reach out to community clinics, public health systems and what they’re calling “trusted messengers in communities that data shows are reluctant to get vaccinated.”

Senior state health officials acknowledged complaints from rural counties that they have not been given their fair share of vaccines. However, officials say these areas have historically been medically underserved and much of the early distribution was in areas with high numbers of medical workers.

Officials say the focus will now be shifting to rural areas in California’s agricultural community, which has been disproportionally impacted by the pandemic.

Officials also believe a focus on Californians with development disabilities and severe underlying conditions will allow more vaccinations in vulnerable settings, like jails, homeless shelters and areas where homeless reside.

The state estimates 13 million Californians are eligible for the Covid-19 vaccine, including 3 million health care workers, 3.4 million food and agricultural workers, 1.4 million in the education sector, a million in emergency services and more than 6 million people over the age of 65.

More: https://www.cnn.com/world/live-news/coronavirus-pandemic-vaccine-updates-02-13-21/index.html