- On Monday, Pfizer announced that late-stage trials for its coronavirus vaccine have, so far, been more than 90% effective.
- The company, along with its partner BioNTech, are expected to apply for an emergency authorization from the Food and Drug Administration later this month.
- Still, more data from Pfizer’s ongoing third-phase trials must be collected, and these results must ultimately be peer-reviewed by other experts in the field before the vaccine is proven to be both safe and effective.
- Following the news, Vice President Mike Pence cited the Trump administration’s Operation Warp Speed as a key factor in Pfizer’s success, but as Pfizer stated, it has refused to accept government funding for vaccine research and development.
Pfizer Says Vaccine 90% Effective
Pfizer and the German biotechnology firm BioNTech said on Monday that their joint coronavirus vaccine is more than 90% effective.
Notably, this is the strongest indication yet that a safe and effective coronavirus vaccine could soon be made available for millions of people. It’s also setting a record pace. Vaccines typically take years to develop.
“I would say it’s a historical moment,” Kathrin Jansen, the head of vaccine research and development at Pfizer, told The New York Times. “Something like this has never happened before.”
“The results are really quite good, I mean extraordinary,” said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, according to The Washington Post.
The trial, which is currently in phase 3, involves over 43,500 people. Of those people, half were given two doses of the vaccine trial and half were given a placebo.
In total, 94 of the people in the study have contracted COVID-19 (defined by Pfizer’s researchers as testing positive and displaying symptoms). Notably, Pfizer’s 90% efficacy figure comes from determining whether each of these 94 people was given the actual vaccine or a placebo. For the vaccine candidate to be 90% effective, that would mean at least 85 of those people must have come from the placebo group.
To note, the goal of vaccines are to prevent people from catching a virus, such as COVID-19 — not to treat people who’ve already been infected.
Pfizer to Apply for Emergency Authorization
Even though Pfizer’s announcement is a very hopeful sign, this data still needs to be peer-reviewed by other experts in the field.
Among the crucial questions that must be answered, scientists will need to determine how long this vaccine candidate offers protection and how it performs on high-risk groups, such as those with weakened immune systems. They will also need to evaluate whether the 94 cases documented by Pfizer were mostly mild or severe, as well as how cases differed between those who received the vaccine and those who received the placebo.
The trial itself also isn’t over. Pfizer and BioNTech will continue to collect data until 164 people in the trial contract COVID-19 — 70 more people. That could take a few weeks. Notably, it could also mean that the 90% efficacy finding could change.
Nonetheless, Pfizer and BioNTech plan to submit an emergency authorization application to the Food and Drug Administration after the third week of this month, possibly sometime during the week of Thanksgiving.
The companies are waiting until then because they say that’s around the time they expect to have two full months of safety follow-up data, as well as data on their manufacturing process.
Even though they’re officially waiting, Pfizer and BioNTech have already ramped up the production of their vaccine. According to The Washington Post, they hope to manufacture 50 million doses by the end of the year. Since the vaccine comes in two doses, that’d be enough for 25 million people. Beyond that, Pfizer and BioNTech have a goal of 1.3 billion doses by the end of 2021.
If Pfizer’s data does turn out to be as good as it suggests, that may bode well for another company conducting late-stage trials: Moderna. Moderna’s vaccine is very similar to Pfizer’s, as both use RNA to generate immunity against the coronavirus.
Pfizer Did Not Receive Government Support
Like many medical experts, politicians have been optimistic about these results. President-Elect Joe Biden, for example, congratulated “the brilliant men and women who helped produce this breakthrough and to give us such cause for hope.”
In his statement, Biden also stressed the need to continue wearing masks, noting that Americans have died from COVID-19 at a rate of 1,000 people per day over the past week.
Meanwhile, President Trump celebrated the vaccine’s reported efficacy rate and the bump in the stock market that this news brought. To note, in addition to investors’ reaction to Pfizer, the stock market also saw initial gains Monday because Biden has now been projected to win the presidency.
In another tweet, Vice President Mike Pence celebrated Pfizer’s 90% efficacy projection; however, Pence also seemed to suggest that Pfizer and BioNTech’s success was because of a partnership with the U.S. government.
In reality, unlike other vaccine developers that are also in late-stage trials, Pfizer never accepted any money from the government for vaccine research or development.
The “public-private partnership” Pence is referring to in his tweet is known as Operation Ward Speed, the Trump administration’s initiative aimed at developing a coronavirus vaccine.
“We were never part of the Warp Speed,” Jansen told The New York Times. “We have never taken any money from the U.S. government, or from anyone.”
In fact, the very reason Pfizer chose not to engage in Warp Speed was to remain independent and devoid of political influence.
“We have always said that science is driving how we conduct ourselves — no politics,” Jansen told The Times.
To note, in July, the U.S. government did reach a deal to buy 100 million doses from Pfizer for nearly $2 billion. That contract also included an option for the government to buy 500 million more doses. Nonetheless, that is much different than trying to claim that Operation Warp Speed is the reason why Pfizer has a seemingly effective vaccine.
See what others are saying: (The Washington Post) (The New York Times) (INSIDER)
Supreme Court Sides With High School Cheerleader Punished for Cursing on Snapchat
The justices ruled that the student’s year-long suspension from her school’s cheer team over an expletive-filled Snapchat was too severe because her post was not disruptive.
SCOTUS Rules in Free Speech Case
The Supreme Court ruled Wednesday that a Pennsylvania school district violated the First Amendment when it handed a cheerleader a year-long suspension from her team after she sent friends an expletive-filled Snapchat outside school grounds.
The case in question centered around a snap sent in 2017 by now-18-year-old Brandi Levy in which she expressed frustration at not making her high school’s varsity cheer squad. The snap, sent on a Saturday from a convenience store, shows Levy and a friend flipping off the camera with the caption: “F— school, f— softball, f— cheer, f— everything.”
That post was sent to around 250 people, including other cheerleaders at her school. When her coaches were alerted to the post, they suspended her from cheerleading for a year.
Levy and her family, represented by lawyers from the American Civil Liberties Union, sued the school district, arguing that it had no right to punish her for off-campus speech.
A federal appeals court agreed with that argument, ruling that schools could not regulate speech outside school grounds. That decision marked the first time that an appeals court had issued such a broad interpretation of the Supreme Court’s landmark 1969 student speech ruling.
In that case, SCOTUS allowed students to wear black armbands in protest of the Vietnam War, declaring that they do not “shed their constitutional rights to freedom of speech or expression at the schoolhouse gate.”
The high court did specify that disruptive speech on school grounds could be punished.
Off-Campus Speech Questions Left Unresolved
In Wednesday’s decision, the justices agreed that Levy’s punishment was too severe because her speech did not meet the test of being disruptive. However, they did not uphold the appeals court decision that schools never have a role in disciplining students for off-campus speech.
“The school’s regulatory interests remain significant in some off-campus circumstances,” Justice Stephen Breyer wrote in the opinion for the court’s majority. “Thus, we do not now set forth a broad, highly general First Amendment rule stating just what counts as ‘off campus’ speech and whether or how ordinary First Amendment standards must give way off campus.”
Breyer also added that specific question would be left for “future cases.”
In the sole dissent, Justice Clarence Thomas objected to that approach, arguing that Levy’s language met the threshold for speech that is disruptive and thus can be regulated off-campus based on past precedent. His colleagues’ ruling, he wrote, “is untethered from anything stable, and courts (and schools) will almost certainly be at a loss as to what exactly the court’s opinion today means.”
Both opinions are significant because while the majority decision focused more narrowly on whether the speech, in this case, was disruptive, the justices appear to be opening up space for a case that centers more specifically around the power of schools to regulate student speech off-campus.
Still, Levy and the ACLU cheered the decision as a victory for student speech off-campus, despite the court’s lack of ruling on the subject.
“Young people need to have the ability to express themselves without worrying about being punished when they get to school,” Levy said in a statement.
“The school in this case asked the court to allow it to punish speech that it considered ‘disruptive,’ regardless of where it occurs,” ACLU’s legal director David Cole added in separate remarks. “If the court had accepted that argument, it would have put in peril all manner of young people’s speech, including their expression on politics, school operations, and general teen frustrations.”
See what others are saying: (The Washington Post) (NPR) (The Associated Press)
Biden To Outline Actions Aimed at Combatting the Recent Rise in Violent Crime and Gun Violence
The president’s orders come the same day the Associated Press released data showing that a record number of gun sales were stopped last year because of background checks.
President Biden Issues Orders on Violent Crime Rise
President Biden will outline several actions on Wednesday that his administration plans to take to curb the recent rise in violent crime and gun violence.
That includes tougher enforcement policies for federal gun control laws, as well as new guidelines for how cities and states can use COVID-19 relief funds to combat gun violence. For instance, those guidelines will allow for the hiring of more police officers, paying officers overtime, buying equipment, and funding additional “enforcement efforts.”
Biden’s plan also includes investing in community-based intervention programs for both potential perpetrators and potential victims of gun violence and helping felons adjust to housing and work after leaving prison.
Background Checks Stop Record Number of Sales
Hours ahead of Biden’s announcement, the Associated Press reported that background checks blocked a record 300,000 gun sales last year, according to newly obtained FBI data provided by a nonprofit that advocates for gun control.
In fact, the numbers are staggering compared to previous years. For example, background checks that successfully blocked gun sales last year amounted to nearly twice that of 2019.
Notably, about 42% of those blocked sales were explicitly because would-be buyers had felony convictions on their records.
Still, it’s important to note that these stats don’t necessarily mean less guns are being successfully bought. While the rate of barred buyers has increased somewhat from around 0.6% to 0.8% since 2018, the U.S. also saw a record number of gun sales last year.
Nearly 23 million guns were bought in 2020 alone, according to the consulting firm Small Arms Analytics. Alongside that record, the country saw another record when it came to the rate of gun violence.
Because of that, Everytown for Gun Safety — the group that gave the AP the new background check data — reiterated its belief in the need for stronger gun control regulation.
“There’s no question that background checks work, but the system is working overtime to prevent a record number of people with dangerous prohibitors from being able to buy firearms,” Sarah Burd-Sharps, the group’s director of research, told the AP. “The loopholes in the law allow people to avoid the system, even if they just meet online or at a gun show for the first time.”
Unsurprisingly, gun rights advocates have pushed against that idea, and some have even pushed against this new data on background checks. As Alan Gottlieb — founder of the group the Second Amendment Foundation — argued, the higher number of denials could be partially because of false positives.
“A day doesn’t go by that our office doesn’t get complaint calls from people who’ve been denied wrongly,” he told the AP.
See what others are saying: (USA Today) (Associated Press) (Reuters)
California Plans Unprecedented $5.2 Billion Rent Forgiveness Program
State lawmakers are also debating on whether to extend the eviction moratorium, which is set to end next week, to ensure that Californians are not evicted before their debts can be paid off by the state.
Rent Relief in the Works
The California State Legislature is in the final stages of negotiating an unprecedented $5.2 billion rent forgiveness program to pay off unpaid rent accumulated during the pandemic.
It is not entirely clear yet who would receive the money, which comes from an unexpected budget surplus and federal stimulus funds. After speaking to a top aide for Gov. Gavin Newsom (D), the Associated Press reported that the $5.2 billion figure would cover all rent.
However, the same aide told The New York Times that the state had federal funds “to help pay the rent of low-income people.”
The outlet also explicitly reported that the program “would be available to residents who earn no more than 80 percent of the median income in their area and who can show pandemic-related financial hardship.”
Newsom offered little clarity, retweeting multiple stories and posts on the matter, including The Times article as well as others that said “all” rent would be paid.
Regardless, the program would be the most generous rent forgiveness plan in American. Still, there remains an unresolved question of extending the statewide eviction moratorium that ends June 30.
Eviction Ban Complications
Starting the new program and distributing all the money will take some time, and California has been struggling to keep up with demand for more modest rent relief programs.
According to a report from the California Department Housing and Community Development, just $32 million of $490 million in requests for rental assistance through the end of May had been paid.
State legislators are debating extending the protections and are reportedly close to a deal, but nothing is set in stone yet.
Tenants rights groups say the move is necessary to ensure struggling Californians are not evicted before their debts can be paid off by the state, and some housing advocates want to keep the moratorium in place until employment has reached pre-pandemic levels.
Landlords, however, have said it is time to end the ban, pointing to the state’s rapid economic recovery, which added 495,000 new jobs since February, as well as Newsom lifting all restrictions on businesses last week.
But according to Opportunity Insights, an economic tracker based at Harvard, while it is true that employment for middle- and high-wage jobs has now surpassed pre-pandemic levels, the rates for low-income workers are down nearly 40% since January of last year.
As a result, many of the people who have months or even a year of unpaid rent have barely been able to chip away at what they owe.
State Recovery Spurred by Revenue Surplus
Newsom’s new program comes as the governor has proposed a $100 billion recovery package — also drawing from the budget surplus and unspent federal funds — that would pour funds into numerous sectors including education, homelessness, and much more.
California is not the only state that has newfound reserves. According to The Times, at least 22 states have surplus revenue after pinching pennies during the pandemic. Some are still deciding what to do with the funding, but others have already begun to invest it into education, construction, the arts, and more.
While many economists have said these funds will be incredibly helpful tools to get economic recovery back on track and aid those hurt most by the pandemic, Republicans in Congress have argued to those surpluses should go towards paying for President Joe Biden’s infrastructure plan.
The Biden Administration and most Congressional Democrats have remained adamant that the states keep their extra funding to implement recovery-centered programs. White House spokeswoman Emilie Simons reiterated that belief Monday, telling reporters that state surpluses will not alter America’s infrastructure needs and emphasizing that many states are still struggling economically.
“This crisis has adversely impacted state and local governments, and that is not fully captured by one economic indicator,” she said.