US waits on FDA to authorise Covid vaccine after panel gives approval – live updates

In the Southern California oceanside city of Manhattan Beach, one arm of government is urging residents to stay home except for essential needs while another is encouraging them to get out and shop and even providing places where they can sit down to relax, eat takeout and watch the sun set on the Pacific.

It’s one example of confusing messages from governments as most of California is under a broad shutdown order that includes an overnight curfew to try to stem record-breaking coronavirus cases that threaten to overwhelm the hospital system.

The Associated Press report that while state and county health officials are pleading with residents to stay home and only mingle with those in their household, the order allows all retailers to remain open with 20% capacity and encourages people to get outside to exercise.

Manhattan Beach Mayor Suzanne Hadley said her community saw an opportunity to aid local businesses while meeting the stipulations of the order. The solution: repurposing city-owned patio areas set up to allow restaurants to serve diners outdoors – which no longer is allowed – into “public seating areas” where downtown shoppers can relax.

“Shopping for a Christmas gift, buying a to-go meal, watching a sunset are allowed, and even the outdoor activities are encouraged by the state,” she said.
Manhattan Beach in is Los Angeles County, the state’s largest with 10 million residents and disproportionately large numbers of California’s coronavirus cases, hospitalizations and deaths.

On Thursday, when the state set a one-day record of 220 deaths, county Health Director Barbara Ferrer said if people don’t follow orders to stay home except for essential needs and not mingle with people outside their households “we are running a risk that could have catastrophic consequences, with hospitals becoming overwhelmed and severely ill patients not able to get the care they need.”

“We need to get back to what we did in the spring, at the beginning of the pandemic, when few people went out and we took seriously our responsibility to care for each other,” she said.

The shutdown order by Gov. Gavin Newsom took effect last weekend, but it seems to be having a minimal effect on daily life. It allows many more activities than the March shutdown that made the state a model on how to respond to the pandemic.

Over at CNN, Christina Maxouris says that while the US is closer to a vaccine, that is unlikely to impact the dark and deadly days ahead. She writes:

The vote by the FDA committee, Dr. Anthony Fauci said, is a “very important step.”

“We want to make sure that we impress the American public that decisions that involve their health and safety are made outside of the realm of politics, outside of the realm of self-aggrandizement and are made in essence, by independent groups,” Fauci told CNN Thursday night.

While the green light for a Covid-19 vaccine will offer a light at the end of the tunnel, leading experts have warned the worst days of the pandemic are still ahead for the US.

Hospitalization numbers break records daily – with Thursday reporting the highest number of Covid-19 patients nationwide since the pandemic’s start: more than 107,200. A CNN analysis of newly released data from the US Department of Health and Human Services showed that at least 200 hospitals across the US were at full capacity last week. And more than 90% of ICU beds were occupied in a third of all hospitals.

“We are in the time frame now that probably for the next 60 to 90 days, we’re going to have more deaths per day than we had in 9/11,” CDC director Dr. Robert Redfield said. “This is going to be a real unfortunate loss of life, as all that we’ve had so far, and the reality is the vaccine approval this week is not going to really impact.”

Read more here: CNN – The US is a step closer to a Covid-19 vaccine authorization. But that’s unlikely to impact the dark and deadly days ahead

What happens next with the FDA and the Pfizer vaccine? Well, it cleared the hurdle of being approved by the vaccines committee yesterday – with a couple of dissenting voices, as the Washington Post notes:

The committee voted yes, 17 in favor, four against and one absention. Panel members did not have an opportunity to explain their votes, but at least two dissenters objected to inclusion of 16- and 17-year-olds, given what they described as the low risk of severe disease in that age group and how few had participated in the trial.

“I would have voted ‘yes’ most enthusiastically had the language been ‘ … 18 years of age and older,’ ” said David Kim, director of the division of Vaccines in the Office of Infectious Disease and HIV/AIDS Policy in the Department of Health and Human Services.

Assuming that the formal approval for emergency use comes soon, the US could be administering the shots early next week, or even, at a push, by the weekend.

If as expected, the FDA follows quickly with an emergency authorization, the shots will start being moved to the states within 24 hours, according to officials at Operation Warp Speed. Inoculations could begin early next week.

After the FDA authorization, an advisory committee to the Centers for Disease Control and Prevention will vote on whether to recommend the vaccine and for which groups. First in line to be inoculated are health care personnel and residents and staff of long-term care facilities, according to its previous recommendations. But states will have the final say on who gets the first shots and where they are administered. Those considerations are complicated by extreme logistics challenges, including the sub-Antarctic storage temperatures the vaccine requires.

The two-shot vaccine, which has been shown to be 95 percent effective in randomized trials involving thousands of people, has already been approved by the United Kingdom, Canada, Bahrain and Saudi Arabia. US officials, however, have hewed to a more rigorous approval process that they believe will boost confidence in the vaccine among the general public.

“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” said Doran Fink, deputy director of the FDA’s Division of Vaccines and Related Products. “That is what FDA physicians and scientists, all of us career public health servants, have been doing over days, nights, weekends and, yes, over the Thanksgiving holiday.”

Read more here: Washington Post – FDA advisers recommend Pfizer-BioNTech coronavirus vaccine, with agency action expected soon

Hi, and welcome to our live coverage of US politics for Friday. Here’s a catch up on where we are, and some of what we might see today:

• The Food and Drug Administration vaccine advisory committee meeting voted to approve the Pfizer-BioNTech vaccine for distribution. The FDA is expected to follow the committee’s recommendations, meaning the vaccine could be administered to healthcare workers and nursing home residents within days.
• There were 224,452 new coronavirus cases yesterday, and 2,768 further deaths. The total death toll has now passed 290,000.
• Pennsylvania, Oklahoma and Virginia were among states taking new measures to halt the spread, while there remains no nation strategy to combat Covid from the Trump administration.
• Four attorneys general responded to a Supreme Court lawsuit that claims that they mishandled their election. In their filings, the AGs said the lawsuit, filed by the Texas attorney general, is baseless in facts and is just an attempt to overturn the election.
• Joe Biden will nominate Susan Rice as director of the Domestic Policy Council and Denis McDonough as secretary of Veteran Affairs. Both were top officials in the Obama administration.
• Congressional bickering seems to be overwhelming attempts to get any kind of coronavirus economic relief package passed.
• Joe Biden and Kamala Harris were named as Time magazine’s person of 2020.