4.43pm EST16:43
Texas attorney general files 11th-hour election lawsuit against four states to the supreme court
3.15pm EST15:15
Biden says ‘Defund the Police’ gave momentum to GOP to ‘beat the living hell out of us’ in election
1.09pm EST13:09
Afternoon summary
10.34am EST10:34
Biden team announces Domestic Policy Council director and secretary of veteran affairs
8.36am EST08:36
853,000 Americans applied for jobless insurance last week
7.52am EST07:52
FDA chief on vaccine meeting: ‘An important day for all of America’
7.41am EST07:41
DoJ files lawsuit against Alabama over conditions in the state prisons
4.43pm EST16:43
Texas attorney general files 11th-hour election lawsuit against four states to the supreme court
Updated
at 4.49pm EST
4.21pm EST16:21
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
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
Source: US Politics - theguardian.com