Pfizer/BioNTech Covid vaccine approved by panel clearing way for FDA authorization for emergency use – as it happened | US news – Daily Oil Gas newspaer online market news

Summary

From Lauren Araratani, and me:

The Food and Drug Administration vaccine advisory committee meeting voted to approve the Pfizer-BioNTech vaccine for distribution. Pfizer answered questions from outside experts about the efficacy of the vaccine. The FDA is expected to follow the committee’s recommendations and authorize the vaccine, which could be administered to healthcare workers and nursing home residents within days.
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 a clear 11th-hour attempt to overturn the election.
Joe Biden will nominate Susan Rice as director of the Domestic Policy Council, a group that will be charged with implementing many of Biden’s campaign promises, and Denis McDonough as secretary of Veteran Affairs. Both were top officials in the Obama administration.
A leaked recording of a meeting Biden had with civil rights leaders revealed the president-elect believes the “Defund the Police” movement has allowed the GOP to “beat the living hell” out of Democrats during the election. Biden was responding to their requests to use executive orders to carry out policy measures Democrats are pushing for.

Updated
at 8.17pm EST

A legal brief seeking to overturn the election result, signed by 106 Republican members of Congress, is written by Phillip Jauregui, who was formerly the lawyer for disgraced senate candidate Roy Moore.

Several women have accused Moore of sexual assault, including two who were minors during the time of the assaults. A former chief justice of the supreme court of Alabama and US Senate candidate, Moore admitted to pursuing minors.

When Moore was running for Senate, Jauregui attempted to cast doubt on allegations from accuser Beverly Young Nelson, who presented proof that Moore signed her high-school yearbook, before he sexually assaulted her when she was 16.

Here’s more on the brief, and the case to overturn election results:

Updated
at 8.11pm EST

7.23pm EST19:23

The Trump administration, which had arranged five federal executions before the president leaves office, plans to kill Brandon Bernard – a 40-year-old man who activists say was wrongfully convicted.

Bernard was 18 at the time of the crime he as been convicted of occurred.

Sherrilyn Ifill, the president and director-counsel the NAACP Legal Defense and Educational Fund, called the planned killing a “national disgrace”.

Sherrilyn Ifill
(@Sifill_LDF)

The planned killing of #BrandonBernard tonight is a national disgrace. https://t.co/vA6bbG9h0R

December 11, 2020

Read more:

Updated
at 8.12pm EST

6.50pm EST18:50

Letter-writers look to get out the vote in Georgia – with a personal touch

Matthew Cantor reports:

Each election season as campaigns ramp up get-out-the-vote efforts, socially awkward Americans face a dilemma: is it possible to help salvage democracy without having to cold-call anyone?

The letter-writing organization Vote Forward offers a solution. This year, the non-profit says, it inspired more than 182,000 people to send more than 17m personalized letters encouraging others to exercise their rights.

“We’re thrilled with how it went,” said Scott Forman, Vote Forward’s founder. “Early this year we set what felt at the time like an insanely ambitious goal of writing 10m letters, which is an order of magnitude more than we had done in previous years,” he said. “It was pretty wild to see how it got a little bit viral.”

Forman said avoiding tricky conversations was part of the reason he started the program: “I’m not really that enthusiastic in wanting to knock on doors or make phone calls.” During a global pandemic, face-to-face interactions become even less feasible, making the operation – launched in 2017 – feel somewhat prescient.

Now the organization, with just six staff members, has a new task: getting out the vote, especially among underrepresented groups, for Georgia’s crucial Senate runoff elections, which will determine the balance of power in the chamber – and thus shape Joe Biden’s presidency.

Read more:

6.22pm EST18:22

From Tom McCarthy, Martin Belam and agencies:

News that vaccines can be doled out soon had been dampened by the steep coronavirus death toll. The US recorded its highest level of coronavirus deaths in a single day on Wednesday, just two weeks after the Thanksgiving holiday period when health experts warned Americans not to travel or gather.

According to the Johns Hopkins University tracker, 3,124 Covid-19 deaths were recorded in the United States on Wednesday, with an additional 221,276 cases identified. It is the first time the US has recorded more than 3,000 deaths in a single day.

Read more:

6.11pm EST18:11

Joe Biden released a statement on the FDA panel’s vote.

“Jill and I grieve with everyone mourning a loved one lost to this deadly virus,” he said. “But today’s approval by the Food & Drug Administration of the Pfizer/BioNTech Covid-19 vaccine is a bright light in a needlessly dark time.”

Biden noted that “vaccines don’t equal vaccinations”.

“Our challenge now is to scale up manufacturing and distribution to distribute 100 million shots in the first 100 days of my administration,” he said. “Before I take office, we need the Trump administration to purchase the doses it has negotiated with Pfizer and Moderna and to work swiftly to scale manufacturing for the US population and the world. And, we will need Congress to fund our distribution efforts.”

Updated
at 7.05pm EST

5.59pm EST17:59

Jessica Glenza

As we noted below, the FDA advisory committee’s vote was not without dissent.

Four of the 22-voting member panel voted against issuing an emergency authorization, after a late debate about whether to remove 16- and 17-year-olds from the authorization.

Some experts argued the data on this subgroup was “thin” and that the panel should recommend further study. But others said the safety and efficacy data to date was enough for emergency use, not least because this group is unlikely to get the vaccine for months because of supply constraints.

“We have clear evidence of benefit and all we have on the other side is theoretical risk,” said Dr Paul Offit, a vaccine expert at Philadelphia Children’s Hospital.

Another major concern for the panel was how to continue blinded placebo-controlled trials if the FDA issues an emergency authorization, as it is expected to. That is because once an emergency authorization is issued, it would be unethical to keep trial participants from finding out whether they received a placebo, and ultimately getting the vaccine.

Updated
at 6.18pm EST

5.50pm EST17:50

Jessica Glenza

If the FDA follows the panel’s recommendation and grants emergency approval, the US would be the third country in the world to have authorized the use of the Pfizer/BioNTech vaccine in the broader public behind the UK and Canada, and it will be the most populous country to do so.

In more data on the vaccine released in the New England Journal of Medicine on Thursday, Pfizer and BioNTech said the vaccine was 95% effective in a randomized controlled trial of more than 43,000 people. An accompanying editorial in the journal described the vaccine’s development as a “triumph” for science.

“Most vaccines have taken decades to develop, but this one is likely to move from conception to large-scale implementation within a year,” wrote Dr Eric J Rubin, the editor-in-chief of the journal, who co-authored the editorial.

The vaccine uses messenger RNA technology to introduce the body to the spike protein found on the outside of the coronavirus to provoke an immune response. It requires two doses, administered three weeks apart.

Scientists are still studying how long the vaccine will protect people, the safety and efficacy of the vaccine in children and pregnant women, and the rate of asymptomatic disease in vaccine recipients.

The FDA could approve the vaccine for emergency use at any time after the advisory committee meeting, and the Trump administration is pushing for speedy approval. But the FDA must signal it is giving safety and efficacy concerns due consideration. Vaccines in general have a higher bar for approval than many medicines, because they are given to healthy adults.

Read more:

5.40pm EST17:40

FDA panel approves Pfizer vaccine

The Food and Drug Administration’s advisory panel on the coronavirus vaccine has voted to authorize the Pfizer/BioNTech vaccine.

The FDA is now expected to follow the panel’s recommendation, and when it does, millions of doses of the jab can be shipped across the US. Healthcare workers and nursing home residents will be the first to get inoculated. Later on this month, the FDA will also consider a vaccine developed by Moderna – which will also go first to health workers and care home residents.

Seventeen panelists voted to approve, 4 voted against and 1 abstained.

Updated
at 6.03pm EST

5.21pm EST17:21

The Supreme Court ruled unanimously today that three Muslim men can sue against FBI officials after being put on no-fly lists.

The men said that the FBI asked them to become informants for a terrorism-related investigation. They declined, citing their religious beliefs and a hesitation to spy on their community. As a result, the men allege, they were put on a no-fly list that prohibits people from boarding flights that are outbound from or pass over the United States.

The Justice Department argued that the men should not be able to sue individual agents, saying that an ability to do so would inhibit their ability to do their jobs, saying that “well-intentioned federal employees would thus be forced to navigate a minefield of liability”.

But the Supreme Court ruled that the Religious Freedom Restoration Act of 1993, which prohibits the government from burdening a person’s exercise of religion without a compelling interest, allows claims for money damages against government officials in individual capacity.

5.15pm EST17:15

Today so far

Here’s a quick recap of everything that’s happened so far today:

The Food and Drug Administration is holding a vaccine advisory committee meeting today, the result of which will determine whether the Pfizer-BioNTech vaccine will be approved for distribution. Pfizer has been answering questions from outside experts about the efficacy of the vaccine.
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 a clear 11th-hour attempt to overturn the election.
Joe Biden will nominate Susan Rice as director of the Domestic Policy Council, a group that will be charged with implementing many of Biden’s campaign promises, and Denis McDonough as secretary of Veteran Affairs. Both were top officials in the Obama administration.
A leaked recording of a meeting Biden had with civil rights leaders revealed the president-elect believes the “Defund the Police” movement has allowed the GOP to “beat the living hell” out of Democrats during the election. Biden was responding to their requests to use executive orders to carry out policy measures Democrats are pushing for.

Updated
at 6.00pm EST

4.43pm EST16:43

States respond to Texas lawsuit attempting to overturn election results

Four attorneys general of battleground states have hit back against a lawsuit that seeks to overturn the results of the election by claiming the states mishandled their elections.

Texas attorney general Ken Paxton filed a lawsuit to the supreme court alleging Wisconsin, Georgia, Pennsylvania and Michigan did not seriously investigate voter fraud, though there was no evidence of widespread voter fraud in the election.

Donald Trump and 17 Republican-led states backed the lawsuit, which is a clear 11th-hour attempt at trying to overturn the election in Trump’s favor, though all 50 states have certified their election results. The Trump campaign and local Republican parties have been instigating lawsuits in attempts to change the election since the results were announced over a month ago, but the vast majority have died in court.

The attorneys general from the four states echoed each other in their rebukes of the lawsuit, offer choice words in their court filings about Texas’ lawsuit.

Josh Shapiro, Pennsylvania’s Democratic attorney general, wrote in the state’s filing that Texas is asking the court “to reconsider a mass of baseless claims”, saying the lawsuit adds to the “cacophony of bogus false claims” about the election. Dana Nessel, Michigan’s Democratic attorney general, wrote that the Texas challenge is “without factual foundation or a valid legal basis”.

Meanwhile, Georgia’s Republican attorney general wrote that Texas’ claims are “far-reaching” and “the breathtaking remedies it seeks are impossible ground in legal principles”.

The supreme court may wait for Texas’ response to the states’ rebuttal or it could make a ruling before the state gets a chance to file such a response.

Updated
at 5.15pm EST

4.21pm EST16:21

Jessica Glenza

Let’s go through some of the details of the vaccine being considered by the US Food and Drug Administration’s (FDA) vaccine advisory committee.

The FDA advisory panel is considering whether to recommend the vaccine for emergency use authorization, often called EUA. That would allow the vaccine to be distributed to the public, but is a lower bar than full approval and only valid during the public health emergency – in this case the Covid-19 pandemic.
Supplies will be very limited at first. The US Centers for Disease Control and Prevention (CDC) has already recommended the first people to receive the vaccine – health workers and long-term care residents.
The vaccine appears highly effective. According to data published in the New England Journal of Medicine on Thursday, the vaccine appears to be 95% effective in preventing Covid-19 a trial of more than 43,000 people. The study looked at a two-shot regimen.
The vaccine is a messenger RNA vaccine, which provokes immunity by introducing the immune system to the spike protein on the coronavirus.
The trial was a randomized, placebo-controlled observer-blinded trial that split participants evenly between people who received two shots of a placebo, and two shots of the vaccine – currently called “BNT162b2”.
The study looked specifically at people 16 years and older. In future studies, Pfizer intends to look at vaccine safety and efficacy in children as young as 12.
Side effects included headache, fatigue and fever, which resolved within a couple days. The government intends to use several surveillance programs to collect information on side effects, called “adverse events”, for years after the vaccine is distributed. It will also begin a surveillance study on healthcare workers specifically.
The FDA recommended continued surveillance for Bell’s palsy, or facial paralysis. There is no current evidence that the vaccine causes facial paralysis, but four cases among vaccine recipients in the trial.
The FDA found only one possible serious adverse effect related to the vaccine, which was a shoulder injury. Other serious adverse events, such as a case of appendicitis, were found not to be unrelated to the vaccine.
Trial participants were followed for a median of two months after they received either the vaccine or a placebo. Most adverse vaccine reactions take place within six weeks.
Scientists are still studying how long immunity lasts, a concept known as “durability”, and the rate of asymptomatic disease in people who receive the vaccine.
There is very little data on safety and efficacy in pregnant and lactating women, but there is also no evidence it is harmful to pregnant women or the fetus. For that reason, FDA officials suggest pregnant women should discuss the vaccine with their healthcare provider, when it becomes available to them.
The panel is expected to recommend an emergency use authorization, and the FDA is expected to grant emergency use rights. The New England Journal of Medicine, which published Pfizer’s results today, called the new vaccine a “triumph” of science.

Updated
at 4.36pm EST

4.00pm EST16:00

Joan E Greve

More than 100 female leaders in the Native American community and entertainment industry have signed on to a letter calling on Joe Biden to nominate congresswoman Deb Haaland as interior secretary.

“As women who have worked to protect our democracy and advance the promise of this country, we are hopeful and relieved that you will be leading us into a bright future,” the letter says.

“It is in this spirit that we, Native American women and Indigenous peoples’ allies, write to urge you to appoint Congresswoman Deb Haaland as Secretary of the Department of the Interior.”

Among those who have signed on to the letter are singer Cher, actress Kerry Washington and feminist activist Gloria Steinam.

If nominated and confirmed, Haaland, a progressive congresswoman from New Mexico, would be the first Native American to lead the interior department.

“We believe it is critical at this time for the first Native American to serve in the President’s Cabinet, so we can begin to shift the focus back to caring for future generations and returning to a value system that honors Mother Earth,” the letter says. “We believe that person is Congresswoman Deb Haaland.”

Progressive groups have pushed for Haaland’s nomination, but some Democratic leaders have expressed hesitation about pulling another House member into Biden’s cabinet, given the party’s very narrow margin in the chamber after last month’s elections.

3.37pm EST15:37

The New Hampshire House Speaker, Dick Hinch, who was sworn into his role just last week, died yesterday from Covid-19.

News of Hinch’s death yesterday was unexpected. A statement announcing his death did not include a cause of death, but said that Hinch, who was 71, was “a loving husband, father, family man, and veteran who devoted his life to public service”. Hinch’s office said his death was an “unexpected tragedy”.

A medical examiner today announced that Hinch had died from Covid-19.

In response, the state’s acting Speaker Sherman Packard and Senate President Chuck Morse said they are “committed to protecting the health and safety of our fellow legislators and staff members who work at the statehouse in Concord”. Their statement said they will be working with the state’s health department to see if there are any additional Covid-19 protocols that can be put in place “to ensure the continued protection of our legislators and staff”.

New Hampshire House Speaker Dick Hinch Photograph: Elise Amendola/AP

3.15pm EST15:15

Biden says ‘Defund the Police’ gave momentum to GOP to ‘beat the living hell out of us’ in election

In a meeting with civil rights leaders, president-elect Joe Biden said that Republicans “beat the living hell out of us” during the election because of the “Defund the Police” movement, according to the Intercept, which got ahold of leaked audio from the meeting

In the meeting, held Tuesday, the civil rights leaders urged Biden to use executive orders to carry out policy measures Democrats are pushing for.

In the meeting, Biden pushed back against the idea of using broad-sweeping executive orders, saying “executive authority that my progressive friends talk about is way beyond the bounds”.

He said pressure on his incoming administration on police reform could hurt the runoff elections in Georgia, which would get Democrats a majority in the Senate if won, saying that Republicans have used the “Defund the Police” movement to sway some moderates toward the GOP.

“That’s how they beat the living hell out of us across the country, saying that we’re talking about defunding the police. We’re not. We’re talking about holding them accountable,” he said.

“Defund the Police” has recently been criticized by moderate Democrats, including former President Barack Obama and House Majority Whip James Clyburn, a Democrat from South Carolina, who said that the phrase hurt Democratic candidates and could damage the Black Lives Matter movement.

Ryan Grim
(@ryangrim)

Civil rights leaders warned Biden that picking Vilsack could backfire in Georgia, where Shirley Sherrod is still a hero. He responded by saying the real threat in the runoffs was “defund the police.” https://t.co/NSykP8rN0L

December 10, 2020

Updated
at 4.14pm EST

2.54pm EST14:54

Jessica Glenza

An advisory committee to the US Food and Drug Administration (FDA) is currently hearing testimony from Pfizer, which is arguing the agency should should approve its Covid-19 vaccine on an emergency basis.

At the hearing, experts are now questioning Pfizer about the data it has provided, and tire kicking is expected to continue through the afternoon. But some key themes are already emerging.

Pfizer has developed a vaccine that appears highly effective in Phase II/III trials, but those results need to continue to be monitored in the real world for both efficacy, the length of immune protection (durability) and long-term safety. To do this, the CDC has amped up several vaccine monitoring programs, and is taking a whole government approach.
The data presented by Pfizer clearly still has skeptics – as was evident during the public comment period. But even experts well known for their criticism of the FDA, such as Dr. Sidney Wolf of the nonprofit group Public Citizen, were in support of distributing the vaccine to the public on an emergency basis.
Pfizer plans to apply for full approval of the vaccine in April 2021, after six months of monitoring of participants. But it faces a hurdle in keeping trial participants enrolled, many of whom may want to know whether they received a placebo, and then obtain the vaccine themselves.
Perhaps the most important takeaway from the hearing is the underlying reason the vaccine is being considered – the pandemic is “essentially out of control” in the US, according to Pfizer’s senior vice president of vaccine research and development, Dr. Kathrin Jansen. “Modeling from the CDC shows that a vaccine with high efficacy can save many lives. However, the pandemic vaccine must be introduced before the peak of cases will impact.”

2.29pm EST14:29

Nearly 50 GOP lawmakers sent a letter yesterday to Federal Reserve Chair Jerome Powell discouraging him from implementing measures that would test lenders’ vulnerability to impacts due to climate change, which may encourage banks to cut ties with the oil and gas industry, reported Politico today.

“This is less about predicting financial stress and more about creating financial stress for politically incorrect, disfavored industries,” US Representative Andy Barr, a Republican from Kentucky, told Politico.

Since last month, Powell has made it clear that climate change could play a role in financial regulation because of its potential to impact the financial system.

“In our oversight of the financial system, we will account for all material risks and try to protect the economy and the public from those risks. Climate change is one of those risks,” he said at a November 5 press conference. “The science and art of incorporating climate change into our thinking about financial regulation is relatively new.”

2.07pm EST14:07

Doug Emhoff, the spouse of Kamala Harris who is set to be the first second gentleman in US history, will be joining the faculty at Georgetown Law School, the university announced today.

Georgetown said that Emhoff will serve as a “Distinguished Visitor from Practice, drawing in part on his deep expertise in media and entertainment matters to teach related coursework, starting with ‘Entertainment Law Disputes’ in the upcoming spring semester.” Emhoff said last month that he will permanently leave DLA Piper, the law firm he joined in 2017. Emhoff has been a corporate lawyer for over a decade.

This also means that both Joe Biden and Harris’ spouses will be teaching at least during the first year they will be in office. Jill Biden, the future First Lady, said that she will continue teaching at Northern Virginia Community College, where she is an English professor.