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Preliminary Data Shows Covid-19 Vaccine is 90% Effective, Pfizer Says. More Data Still Needed Before the Vaccine Can Be Made Available.

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  • 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)

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Contradicting Studies Leave Biden’s COVID-19 Booster Plan Up in the Air

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While some studies show that the effectiveness of Pfizer and Moderna’s COVID vaccines decrease over time, other publications argue the decline is not substantial and a full-flung booster campaign is premature.


Booster Rollout in Flux

President Joe Biden’s plan to offer COVID-19 booster shots is facing serious hurdles just a week before it is set to roll out. Issues with the plan stem from growing divisions among the scientific community over the necessity of a third jab.

The timing of booster shots administration has been a point of contention for months, but the debate intensified in August when Biden announced that, pending regulatory approval, the government would start offering boosters on Sept. 20 to adults eight months after they received their second dose of Pfizer or Moderna.

The announcement was backed by the director of the Centers for Disease Control and Prevention (CDC), the acting commissioner of the Food and Drug Administration (FDA), and White House chief medical advisor Dr. Anthony Fauci, among others.

However, many scientists and other health experts both inside and outside of the government have continually criticized the plan. They have claimed the data supporting boosters was not compelling and argued that, while the FDA approved third doses for immunocompromised Americans, the push to give them to the general public was premature.

The plan also drew international backlash from those who argued the U.S. should not launch a booster campaign when billions of people around the world have not gotten their first dose yet. Earlier this month, the World Health Organization (WHO) extended its request that wealthy countries hold off on giving boosters until at least the end of the year.

Those arguments appeared to be bolstered when federal health regulators said earlier this month that they needed more time to review Moderna’s application for booster shots, forcing the Biden Administration to delay offering third shots to those who received that vaccine.

Now, Pfizer recipients will be the only people who may be eligible for boosters by the initial deadline, though that depends on a forthcoming decision from an FDA expert advisory committee that is set to vote Friday on whether or not to recommend approval.

Debate Continues in Crucial Week

More contradictory information has been coming out in the days leading up to the highly anticipated decision.

On Monday, an international group of 18 scientists, including some at the FDA and the WHO, published a review in The Lancet arguing that there is no credible data to show the vaccines’ ability to prevent severe disease declined substantially over time, so boosters are not yet needed for the general, non-immunocompromised public.

The experts claimed that any advantage boosters may provide does not outweigh the benefit of giving the extra doses to all those who are unvaccinated worldwide. 

On the other side, a study released Wednesday in The New England Journal of Medicine found that people who received a third shot of Pfizer in Israel were much less likely to develop severe COVID than those who just had the first two jabs.

The same day, both Pfizer and Moderna published data backing that up as well. Pfizer released an analysis that said data on boosters and the Delta variant from both Israel and the U.S. suggested “that vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose.” 

Moderna also published data, that has not yet been peer-reviewed, which also found its jab provided less immunity and protection against severe disease as time went on.

Further complicating matters was the fact that the FDA additionally released its report on Pfizer’s analysis of the need for a booster shortly after Pfizer’s publication. Normally, those findings would shine a light on the agency’s stance on the issue, but the regulator did not take a clear stand.

“Some observational studies have suggested declining efficacy of [Pfizer] over time […] while others have not,” the agency wrote. “Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death.”

Uncertain Future

It remains unclear what the FDA panel will determine when they meet Friday, or what a similar CDC expert panel that is expected to meet next week will decide regarding vaccination policies.

Notably, officials at the two agencies are not required to follow the recommendations of their expert panels, though they usually do.

Even if the FDA approves Pfizer’s application as it stands to give boosters to those 16 and older, people familiar with the matter said the CDC might recommend the third jabs only for people 65 and older or those who are especially at risk.

Regardless of what is decided, experts have said that it is absolutely essential for the agency to stand firm in its decision and clearly explain its reasoning to the public in order to combat further confusion and misinformation.

“F.D.A. does the best in situations when there are strongly held but conflicting views, when they’re forthcoming with the data and really explain decisions,” Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health told The New York Times. “It’s important for the F.D.A. not to say, ‘Here’s our decision, mic drop. It’s much better for them to say, ‘Here’s how we looked at the data, here are the conclusions we made from the data, and here’s why we’re making the conclusions.’”

See what others are saying: (The New York Times) (CNBC) (The Guardian)

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Kansas Lawmaker Accused of Kicking Teen in Groin Receives Suspended Sentence

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Before allegedly assaulting the teenager in class, the lawmaker and former substitute teacher ranted to students about God, the Bible, Masturbation, and more.


Samsel Displays Inappropriate Behavior

Kansas Rep. Mark Samsel (R) was given a 90-day suspended jail sentence and one year of probation Monday after pleading guilty to three misdemeanor charges of disorderly conduct. 

Samsel, a former high school substitute teacher in Wellsville, initially caused outrage in April after displaying bizarre classroom behavior. Footage recorded by students and published by the Kansas City Star showed Samsel ranting about the wrath of God, the Bible, masturbation, suicide, and other topics. At one point, he allegedly even pushed a student against a wall and kicked him in the groin.

While that specific altercation doesn’t appear to have been caught on video, student footage shows what seems to be the aftermath of the alleged assault.

“I’m simply built different, Mark. I don’t feel pain,” the student jokingly tells Samsel after picking himself up off the ground. Samsel responds by asking if the student is about to cry.

“You want to go to the nurse? She can check it for you?” Samsel adds.

“Make babies! Who likes making babies? That feels good, doesn’t it? Procreate,” Samsel said at another point in the video. “You haven’t masturbated? Don’t answer that question.”

Other notable quotes include, “Would you like me to introduce [you] to a sophomore who’s tried killing himself three times because he has two parents and they’re both females?,” and, “I could put the wrath of God on your right now because that is what he is trying to do. You should run and scream cause the devil’s getting the hell out of my classroom.”

After students reported his behavior, Samsel told local news outlets that he didn’t do anything wrong and that the situation was actually “planned.”

The kids and I planned ALL this to SEND A MESSAGE about art, mental health, teenage suicide, how we treat our educators and one another. To who? Parents. And grandparents. And all of Wellsville,” he also wrote on Snapchat, according to The Star.

However, he later told investigators that he what at his “wit’s end” with “misbehaving students.” Then last month, he announced via Facebook that he had sought mental health treatment and was giving up his substitute teaching license, describing the situation as an “isolated episode of mania with psychotic features’‘ prompted by “extreme stress, pressure and agitation.”

Samsel’s Sentence

Samsel faced additional consequences in conjunction with his suspended sentence and year of probation. He was also banned from using social media, unless for political purposes. He cannot have contact with the students who reported him and must write apology letters to those involved. He must also follow mental health treatment recommendations and take any prescribed medications

Samsel, for his part, apologized in his court appearance via Zoom, saying he never “intended for anyone to get hurt.”

Some parents seem happy with the sentence, like Joshua Zeck, who told the Star, “From the beginning, all I wanted was for Mark to get some help.”

“I don’t want to see anybody go to jail. So if this does him so good and he’s doing better, I’m happy to hear that,” Zeck continued.

Others in the community told the paper that his sentencing was too lenient, including Mary Woods, whose niece had class with Samsel the day of the incident.

“I don’t think that’s enough. He laid his hands on a kid. … He traumatized a lot of these kids. I think it’s bullsh*t, to say so myself.”

As far as whether Samsel will keep his job in the state legislature, Kansas House Speaker Ron Ryckman said that’s up to voters to decide.

See what others are saying: (The Kansas City Star)(Insider)(NBC News)

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Alabama Man Dies After Being Turned Away From 43 Hospitals Overwhelmed by COVID Patients, Family Says

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Alabama currently has the second-highest COVID hospitalization average and fourth-lowest vaccination rate in the country.


Full ICUs Allegedly Delay Care for Emergent Cardiac Patient 

The family of an Alabama man who died of heart issues is calling on people to get vaccinated after he was turned away by 43 hospitals in three states while having a cardiac emergency because all of their Intensive Care Units were at maximum capacity with COVID patients.

The man, 73-year-old Ray DeMonia, was taken to Cullman Regional hospital in Alabama on Aug. 23. The next morning — around 12 hours after he was admitted — his daughter said her mother got a call saying that hospital workers were unable to find him a specialized cardiac ICU bed in the area. 

He was eventually transferred to a hospital in Mississippi about 200 miles away and died on Sept. 1, just three days before his birthday.

In DeMonia’s obituary, his family pleaded with people to get the vaccine.

“In honor of Ray, please get vaccinated if you have not, in an effort to free up resources for non COVID related emergencies,” they wrote. “He would not want any other family to go through what his did.”

Rising Hospitalizations

Officials and healthcare providers in Alabama have said DeMonia’s case is not a one-off incident. 

Jennifer Malone, a spokesperson for Cullman Regional, told The Washington Post that situations like this have been an “ongoing problem” reported by doctors at the hospital and others throughout the state.

“When patients are transported to other facilities to receive care that they need, that’s becoming increasingly more difficult because all hospitals are experiencing an increased lack of bed space,” she said.

On Friday, Scott Harris, the head of the Alabama Department of Public Health, said that the state’s spike in ICU patients has stabilized some. Still, he added there are not enough ICU beds for the number of patients that need intensive care, many of whom are unvaccinated.

Even with the spikes “stabilizing,” Alabama still has the second-highest COVID hospitalizations in the U.S., according to The Post tracker

The calls from DeMonia’s family for people to get vaccinated also come as Alabama struggles with the country’s fourth-lowest vaccination rate. Despite those figures, top officials in the state are doing little to address the issue.

Last week, after President Joe Biden rolled out a sweeping vaccine mandate for 100 million people and promised he would use his power to circumvent Republican leaders “undermining” relief efforts, Alabama Gov. Kay Ivey (R) told the president to “bring it on.”

Ivey then doubled down on her refusal to mandate vaccines in her state, where people are being refused emergency hospital care because so many unvaccinated people are in ICU beds.

“You bet I’m standing in the way. And if he thinks he’s going to move me out of the way, he’s got another thing coming,” she said, referring to the mandates as “outrageous” and “overreaching” policies that will “no doubt be challenged in the courts.”

See what others are saying: (The Washington Post) (NBC News) (NPR)

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