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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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2 years ago

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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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U.S.

Disney Renders DeSantis-Appointed Oversight Board Powerless

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11 hours ago

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March 30, 2023

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The board is looking into avenues for potential legal retaliation, but Disney maintains its actions were “appropriate and were discussed and approved in open, noticed public forums.”

The Fight For Disney’s Special District 

Disney has stripped powers from the board Florida Gov. Ron DeSantis (R) installed to oversee its theme parks, board members claimed. 

According to the Orlando Sentinel, board member Brian Aungst Jr. said Disney’s action “completely circumvents the authority of this board to govern.”

DeSantis has been waging a war against the House of Mouse ever since the company condemned his controversial “Don’t Say Gay” law, which heavily restricts the discussion of sexuality in classrooms. To retaliate against the company, he took control of Disney’s special status that allowed it to operate as a self-governing district with autonomy over the land encompassing and surrounding Walt Disney World. 

Disney operated under that special status for decades under the Reedy Creek Improvement District, but after DeSantis took over, it was changed to the Central Florida Tourism Oversight District. DeSantis appointed all members of the board, prompting concerns that it could be used to silence and sway Disney on social and cultural issues, including its content. 

The oversight board gets control over infrastructure, property taxes, issue bonds, road and fire services, and other regulations. When DeSantis seized it, it was considered a big loss for the entertainment giant, but now, board members say the company may have lost little to no power at all. 

As first reported by the Sentinel, Disney and the previous board signed an agreement allowing Disney to retain control over much of its land on Feb. 8, the day before Florida’s House signed the bill that gave DeSantis power to stack the board. Disney now holds veto powers over changes to the park, and any changes must be subject to the company’s “prior review and comment” to ensure thematic consistency. 

The agreement also bars the board from using Disney’s name or trademarked characters like Mickey Mouse.

The Board’s Plan to Fight Back

Board members reportedly did not become aware of this until recently and discussed the issue at a Wednesday meeting. 

“This essentially makes Disney the government,” board member Ron Peri said, via Click Orlando. “This board loses, for practical purposes, the majority of its ability to do anything beyond maintain the roads and maintain basic infrastructure.”

The subject of the agreement that has perhaps caught the most public attention is its staying power. The declaration says it will remain “in effect until 21 years after the death of the last survivor of the descendants of King Charles III, King of England living as of the date of this Declaration.” That means that so long as direct members of the royal family are alive, so is this deal. 

According to BBC News, this is known as a “royal lives” clause and its use dates back to the 17th century, though it is rarely used in the U.S.

The board, however, already has plans to push back against Disney and has voted to hire outside legal counsel to evaluate their options.

“We’re going to have to deal with it and correct it,” Aungst said. “It’s a subversion of the will of the voters and the Legislature and the governor. It completely circumvents the authority of this board to govern.”

A spokesperson for DeSantis released a statement claiming that “these agreements may have significant legal infirmities that would render the contracts void as a matter of law.”

Disney maintains everything was above board. 

“All agreements signed between Disney and the district were appropriate and were discussed and approved in open, noticed public forums in compliance with Florida’s Government in the Sunshine law,” the company said. 

See what others are saying: (Orlando Sentinel) (Click Orlando) (The Washington Post)

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White Supremacist Propaganda Reached Record High in 2022, ADL Finds

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3 weeks ago

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March 9, 2023

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 “We cannot sit idly by as these extremists pollute our communities with their hateful trash,” ADL CEO Jonathan Greenblatt said.

White supremacist propaganda in the U.S. reached record levels in 2022, according to a report published Wednesday by the Anti-Defamation League’s Center of Extremism.

The ADL found over 6,700 cases of white supremacist propaganda in 2022, which marks a 38% jump from the nearly 4,900 cases the group found in 2021. It also represents the highest number of incidents ever recorded by the ADL. 

The propaganda tallied by the anti-hate organization includes the distribution of racist, antisemitic, and homophobic flyers, banners, graffiti, and more. This propaganda has spread substantially since 2018, when the ADL found just over 1,200 incidents. 

“There’s no question that white supremacists and antisemites are trying to terrorize and harass Americans with their propaganda,” ADL CEO Jonathan Greenblatt said in a statement. “We cannot sit idly by as these extremists pollute our communities with their hateful trash.” 

The report found that there were at least 50 white supremacist groups behind the spread of propaganda in 2022, but 93% of it came from just three groups. One of those groups was also responsible for 43% of the white supremacist events that took place last year. 

White supremacist events saw a startling uptick of their own, with the ADL documenting at least 167, a 55% jump from 2021. 

Propaganda was found in every U.S. state except for Hawaii, and events were documented in 33 states, most heavily in Massachusetts, California, Ohio, and Florida.

“The sheer volume of white supremacist propaganda distributions we are documenting around the country is alarming and dangerous,” Oren Segal, Vice President of the ADL’s Center on Extremism said in a statement. “Hardly a day goes by without communities being targeted by these coordinated, hateful actions, which are designed to sow anxiety and create fear.”

“We need a whole-of-society approach to combat this activity, including elected officials, community leaders, and people of good faith coming together and condemning this activity forcefully,” Segal continued. 

See what others are saying: (Axios) (The Hill) (The New York Times)

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Business

Adidas Financial Woes Continue, Company on Track for First Annual Loss in Decades

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3 weeks ago

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March 8, 2023

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Adidas has labeled 2023 a “transition year” for the company. 

Yeezy Surplus 

Adidas’ split with musician Kanye West has left the company with financial problems due to surplus Yeezy products, putting the sportswear giant in the position to potentially suffer its first annual loss in over 30 years. 

Adidas dropped West last year after he made a series of antisemitic remarks on social media and other broadcasts. His Yeezy line was a staple for Adidas, and the surplus product is due, in part, to the brand’s own decision to continue production during the split.

According to CEO Bjorn Gulden, Adidas continued production of only the items already in the pipeline to prevent thousands of people from losing their jobs. However, that has led to the unfortunate overabundance of Yeezy sneakers and clothes. 

On Wednesday, Gulden said that selling the shoes and donating the proceeds makes more sense than giving them away due to the Yeezy resale market — which has reportedly shot up 30% since October.

“If we sell it, I promise that the people who have been hurt by this will also get something good out of this,” Gulden said in a statement to the press. 

However, Gulden also said that West is entitled to a portion of the proceeds of the sale of Yeezys per his royalty agreement.

The Numbers 

Adidas announced in February that, following its divergence from West, it is facing potential sales losses totaling around $1.2 billion and profit losses of around $500 million. 

If it decides to not sell any more Yeezy products, Adidas is facing a projected annual loss of over $700 million.

Outside of West, Adidas has taken several heavy profit blows recently. Its operating profit reportedly fell by 66% last year, a total of more than $700 million. It also pulled out of Russia after the country’s invasion of Ukraine last year, which cost Adidas nearly $60 million dollars. Additionally, China’s “Zero Covid” lockdowns last year caused in part a 36% drop in revenue for Adidas compared to years prior.

As a step towards a solution, Gulden announced that the company is slashing its dividends from 3.30 euros to 0.70 euro cents per share pending shareholder approval. 

Adidas has labeled 2023 a “transition year” for the company. 

“Adidas has all the ingredients to be successful. But we need to put our focus back on our core: product, consumers, retail partners, and athletes,” Gulden said. “I am convinced that over time we will make Adidas shine again. But we need some time.”

See what others are saying: (The Washington Post) (The New York Times) (CNN)

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