FDA voted in favor of Pfizer Vaccine
Developing story
Pfizer Vaccine gain approval during FDA meeting. The approval allows Emergency use authorization as early as Friday.
News Around the World
FACEBOOK SUED BY FTC AND SEVERAL STATES
CNBC-
The Federal Trade Commission and a coalition of attorneys general from 48 states and territories filed two separate antitrust lawsuits against Facebook on Wednesday. The lawsuits target two of Facebook’s major acquisitions: Instagram and WhatsApp.
Both are seeking remedies for the alleged anticompetitive conduct that could result in requiring Facebook to divest the two apps.
The company’s stock was down almost 4% following the news of the lawsuits.
“This is revisionist history,” Facebook General Counsel Jennifer Newstead said in a statement. “Antitrust laws exist to protect consumers and promote innovation, not to punish successful businesses. Instagram and WhatsApp became the incredible products they are today because Facebook invested billions of dollars, and years of innovation and expertise, to develop new features and better experiences for the millions who enjoy those products. The most important fact in this case, which the Commission does not mention in its 53-page complaint, is that it cleared these acquisitions years ago. The government now wants a do-over, sending a chilling warning to American business that no sale is ever final. People and small businesses don’t choose to use Facebook’s free services and advertising because they have to, they use them because our apps and services deliver the most value. We are going to vigorously defend people’s ability to continue making that choice.”
FTC lawsuit
The FTC alleges that Facebook engaged in a systematic strategy to eliminate threats to its monopoly, including the 2012 and 2014 acquisitions of Instagram and WhatsApp. It alleges Facebook holds monopoly power in the U.S. personal social networking market.
The FTC alleges that Facebook engaged in a systematic strategy to eliminate threats to its monopoly, including the 2012 and 2014 acquisitions of Instagram and WhatsApp, which the FTC previously cleared. Facebook acquired Instagram for $1 billion and WhatsApp for $19 billion.
As part of the lawsuit, the FTC will seek a permanent injunction that could result in the divestitures of Instagram and WhatsApp, the agency said. Additionally, the FTC will seek to prohibit Facebook from imposing anticompetitive conditions against third-party software developers.
“Since toppling early rival Myspace and achieving monopoly power, Facebook has turned to playing defense through anticompetitive means,” the FTC states in its lawsuit. “After identifying two significant competitive threats to its dominant position — Instagram and WhatsApp — Facebook moved to squelch those threats by buying the companies, reflecting CEO Mark Zuckerberg’s view, expressed in a 2008 email, that ‘it is better to buy than compete.’”
The FTC lawsuits also notes that Facebook tried and failed to buy up rivals Twitter and Snapchat.
“In lamenting that Twitter had ‘turned down [Facebook’s] offer’ to be acquired in November 2008, Mr. Zuckerberg wrote: ‘I was looking forward to the extra time that would have given us to get our product in order without having to worry about a competitor growing,’” the FTC lawsuit states.
A partially redacted portion of the FTC lawsuit states that Facebook’s main blue app has lost users and engagement to Instagram.
“Through its control of Instagram, Facebook has attempted to prevent Instagram from ‘cannibalizing’ Facebook Blue, confirming that an independent Instagram would constitute a significant threat to Facebook’s personal social networking monopoly,” the lawsuit reads.
“Facebook has kept WhatsApp cabined to providing mobile messaging services rather than allowing WhatsApp to become a competing personal social networking provider, and has limited promotion of WhatsApp in the United States,” the FTC states in another partially redacted portion of the lawsuit.
States complaint
While the states and FTC cooperated during the course of their investigation, the coalition of states led by New York Attorney General Letitia James chose to file a separate lawsuit.
James said at a press conference Wednesday that while the states are “aligned substantively with the FTC” there may be stylistic differences in the lawsuits. She made clear that the states are “independent enforcers of the law.”
The coalition of states suing Facebook is much broader than that which initially joined the Department of Justice in its suit against Google. Eleven Republican state attorneys general joined the DOJ in its suit. Other states are continuing to investigate Google and could file their own charges and potentially join them with the DOJ’s complaint.
The states suing Facebook include a wide swath of backgrounds, both Democratic and Republican, and include Facebook’s home state of California.
The states’ complaint also alleges Facebooks holds monopoly power in the U.S. personal social networking market, which it illegally maintains by “deploying a buy-or-bury strategy that thwarts competition and harms both users and advertisers.”
It suggests that Facebook was “driven, in part, by fear that the company has fallen behind in important new segments and that emerging firms were ‘building networks that were competitive with’ Facebook’s and could be ‘very disruptive to’ the company’s dominance.”
They claim Facebook kept Instagram and WhatsApp running as independent brands “to fill the void, so they would not be replaced by another app with the potential to erode Facebook’s dominance.”
The states allege Facebook used exclusionary tactics on top of its acquisition strategy to identify competitive threats in such a way that “has chilled innovation, deterred investment, and forestalled competition in the markets in which it operates, and it continues to do so.”
The complaint claims Facebook began making acquisitions with the goal of squashing competition and depriving competitors of valuable services far before its deals to buy Instagram and WhatsApp. In 2009 it bought FriendFeed after Facebook Chief Product Officer Chris Cox allegedly told CEO Mark Zuckerberg it “would be a bad scene” if the company went to Twitter instead. The next year, Facebook bought Octazen after a Facebook executive suggested such a move would deprive rivals of access to its contact importing service that could help social networks grow.
The lawsuit focuses attention on the role data collection by Facebook plays in maintaining its monopoly power. The complaint describes how Facebook’s alleged monopoly power gives it “wide latitude” in creating the terms on which it can collect and use information from its users. The states allege Facebook can do as it pleases with users’ data to serve its own business interests because users’ have no alternatives to turn to even if they would prefer other data practices.
Facebook’s data collection has also allowed it to create an experience that keeps users from switching to another service, the suit alleges. Because Facebook has such detailed data on users, it is able to build a highly-customized experience that other platforms would simply not be able to. On top of that, the complaint says, the sunk cost users put into creating their profiles in the first place and the huge networks effects Facebook has from its extensive userbase prevents users from looking for alternatives.
Facebook harms consumers, advertisers and competing firms through its practices, according to the complaint. Advertisers, for example, are allegedly harmed by being granted limited transparency into the value they receive from their ads as well as brand damage resulting from “offensive content on Facebook services.”
Facebook initially lured developers to its platform in the early days of its service by opening its application programming interfaces (APIs), only to later close it when those same developers became competitive threats, the complaint alleges. That action helped spread the message that access to those APIs was conditional on “staying away from Facebook’s turf in personal social networking services,” the states claim.
James said the state lawsuit sent a message that “any efforts to stifle competition, hurt small business, reduce innovation and creativity, cut privacy protections, will be met with the full force of our offices.”
17 states tell Supreme Court they support Texas bid to reverse Biden win
CNBC-Seventeen states whose elections were won by President Donald Trump told the Supreme Court on Wednesday that they support Texas Attorney General Ken Paxton’s effort to file a lawsuit that could effectively reverse President-elect Joe Biden’s projected Electoral College victory.
The filing backing Paxton by those the states came a day after he asked the Supreme Court for permission to sue Georgia, Michigan, Pennsylvania and Wisconsin, all of which Biden won, over their voting processes.
The states supporting Paxton Missouri, Alabama, Arkansas, Florida, Indiana, Kansas, Louisiana, Mississippi, Montana, Nebraska, North Dakota, Oklahoma, South Carolina, South Dakota, Tennessee, Utah, and West Virginia.
While Trump defeated Biden in the popular vote in those states, one of Nebraska’s electoral votes was awarded to Biden.
Representatives for the four battleground states being targeted in the lawsuit did not immediately respond to CNBC’s requests for comment.
Maryland Attorney General Brian Frosh, whose state overwhelmingly voted for Biden over Trump, said in a scornful tweet that Maryland would not join Paxton’s case after someone on Twitter suggested he do so.
“The suit is a cesspool of disproved charges, wild speculation, insupportable arguments and silly gibberish,” Frosh tweeted.
“Joe Biden is the President-Elect.”
Trump on Wednesday said he wanted to join Paxton’s legal effort at the Supreme Court, which the defendants have dismissed as a political stunt by the Republican attorney general. The Supreme Court has yet to rule on Paxton’s request.
Paxton, a Republican who remains under indictment for state felony securities fraud charges, is asking the hight court for permission to sue the four states to block their certification of Biden’s wins in them.
Paxton argues that a block is warranted because of supposedly improper changes to voting procedures there in the past year, purportedly different treatment of voters in Democratic-heavy areas, and voting “irregularities.”
The effort comes as all states have certified their individual presidential election results, which show that Biden easily won the national popular vote.
Biden is projected to win the Electoral College when it meets Monday with 36 more votes than the 270-vote minimum needed to clinch the White House.
Michigan Attorney General Dana Nessel on Tuesday said Paxton’s filing “is a publicity stunt, not a serious legal pleading.”
“The erosion of confidence in our democratic system isn’t attributable to the good people of Michigan, Wisconsin, Georgia or Pennsylvania but rather to partisan officials, like Mr. Paxton, who place loyalty to a person over loyalty to their country,” Nessel said in a statement.
“The Michigan issues raised in this complaint have already been thoroughly litigated and roundly rejected in both state and federal courts – by judges appointed from both political parties. Mr. Paxton’s actions are beneath the dignity of the office of Attorney General and the people of the great state of Texas.”
Trump has refused to concede the election to Biden, claiming without evidence that he was the victim of widespread ballot fraud.
Trump and his campaign, as well as their political allies, have repeatedly failed in legal efforts to invalidate votes for Biden.
The Supreme Court on Tuesday declined to hear a separate bid from Trump-allied Republicans challenging Biden’s win in Pennsylvania.
Election law experts saw that apparently unanimous rejection as a signal that the remaining efforts to overturn Biden’s win were all but doomed at the Supreme Court.
But the GOP plaintiffs in that case plan to petition the high court for a formal appeal, The Hill reported Wednesday.
The president and his lawyer, Rudy Giuliani, recently have pushed for legislatures in battleground states whose popular elections were won by Biden to overrule their citizens, and to appoint a slate of electors for Trump to the Electoral Colleges.
US House of Representatives Voted 228-164 to decriminalize marijuana
The US House of Representatives voted to pass a measure that would decriminalize marijuana use at the federal level.
The vote comes months after pulling the bill because of fear the controversial vote would cause trouble for lawmakers to lose tight races.
The vote passed 228-164. The Representatives from Florida who cosponsor H.R.3884 includes
Republican Matt Gaetz, Dem. Rep. Theodore Deutch, Dem. Rep. Darren Soto, Dem. Rep. Alcee Hastings, Dem. Rep. Frederica Wilson, Dem. Rep. Charlie Crist and Dem. Rep. Kathy Castor.
Unemployment Numbers -November
Total nonfarm payroll employment rose by 245,000 in November, and the unemployment rate edged down to 6.7 percent, the U.S. Bureau of Labor Statistics reported today. These improvements in the labor market reflect the continued resumption of economic activity that had been curtailed due to the coronavirus (COVID-19) pandemic and efforts to contain it. However, the pace of improvement in the labor market has moderated in recent months. In November, notable job gains occurred in transportation
and warehousing, professional and business services, and health care. Employment declined in government and retail trade.
Governor Ron DeSantis Announces an Additional $28 Million in Funding for Disaster Relief Employment for Eligible Floridians in Response to COVID-19
Tallahassee, Fla. -Today, Governor Ron DeSantis announced that Florida has been awarded an additional $28 million in federal funding through the U.S. Department of Labor Disaster Recovery Dislocated Worker Grant in response to COVID-19.
This federal Disaster Recovery Dislocated Worker Grant is administered by the Florida Department of Economic Opportunity and will provide disaster-relief employment in the form of temporary jobs, employment and training services, and supportive services to eligible Floridians.
“As our state and local communities continue to recover from the pandemic, I am proud to announce $28 million in additional funding for disaster-relief employment,” said Governor DeSantis. “I look forward to putting these dollars to use right away to give Floridians in need an opportunity to work.”
“I want to thank Governor Ron DeSantis for his leadership and for his steps to reopen the state, so more Floridians can find gainful employment,” said Dane Eagle, Executive Director of the Florida Department of Economic Opportunity. “We look forward to helping Floridians get back to work and receive the training and support they need as we rebuild our economy.”
Earlier this year, the Department was awarded $12 million for the Disaster Recovery Dislocated Worker Grant in response to COVID-19. Disaster relief employment includes humanitarian assistance and cleanup activities. These activities may involve:
Providing medicine, food, and other supplies to individuals in need.
Assisting with setting up quarantine areas and providing assistance to quarantined individuals.
Working at food distribution centers and other community-support organizations.
Cleaning schools or sanitizing quarantine or treatment areas; and
Other activities related to organizing and coordinating recovery and quarantine efforts.
Individuals who qualify for disaster-relief employment are dislocated workers, workers who have been temporarily or permanently laid off as a result of COVID-19, self-employed individuals who have lost work due to COVID-19, and individuals who have been unemployed long-term.
“We are grateful for Governor DeSantis’ dedication to helping Floridians recover from the economic impacts of the COVID-19 pandemic,” said CareerSource Florida President and CEO Michelle Dennard. “The Disaster Recovery Dislocated Worker Grant will help Floridians who have lost jobs by providing employment and training services. With our partners at DEO, the CareerSource Florida network is here to help our neighbors as they rebound and, ultimately, reimagine and rebuild Florida’s economy.”
No Evidence of Fraud-Attorney William Barr
In a statement made today (12/1) in an interview with the associated press; Attorney William Barr stated “To date, we have not seen fraud on a scale that could have affected a different outcome in the election,” Barr told the AP.
Last month, Attorney Barr issued a directive to U.S. attorneys across the country allowing them to pursue any substantive allegations of voting irregularities if they existed.
Moderna Request Emergency Use Authorization
Primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe Vaccine efficacy against COVID-19 was 94.1%; vaccine efficacy against severe COVID-19 was 100% mRNA-1273 continues to be generally well tolerated; no serious safety concerns identified to date Phase 3 COVE Study has exceeded 2 months of median follow-up post vaccination as required by the U.S. FDA for Emergency Use Authorization (EUA) Moderna plans today to request EUA from the U.S. FDA, to apply for a conditional marketing authorization with the European Medicines Agency (EMA) and to progress with the rolling reviews, which have already been initiated with international regulatory agencies FDA has told Company to expect VRBPAC meeting for mRNA-1273 likely on December 17, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 30, 2020– Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1%. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB). The Company also announced that today, Moderna plans to request an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA). The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. Vaccine efficacy has been demonstrated at the first interim analysis with a total of 95 cases based on the pre-specified success criterion on efficacy. Today’s primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.
Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).
The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.
The Company will submit data from the Phase 3 COVE study to a peer-reviewed publication.
PFIZER AND BIONTECH TO SUBMIT EMERGENCY USE AUTHORIZATION REQUEST TODAY TO THE U.S. FDA FOR COVID-19 VACCINE
In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world
Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization
BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date
-Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.
The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis was based on 170 confirmed cases of COVID-19. This submission also is supported by solicited safety data from a randomized subset of approximately 8,000 participants ≥18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. The submission also includes solicited safety data on approximately 100 children 12-15 years of age. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine.
“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”
“Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”
The companies have already initiated rolling submissions with several regulatory agencies around the world, including the EMA and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and intend to submit applications to other regulatory agencies worldwide in the coming days. In some cases, governments may have regulatory pathways similar to an EUA. The companies will be ready to distribute the vaccine candidate within hours after authorization.
Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic.
The BNT162b2 vaccine candidate is not currently approved for distribution anywhere in the world. Both collaborators are committed to developing this novel vaccine with preclinical and clinical data at the forefront of all their decision making.
While Pfizer and BioNTech await potential authorization or approval from regulatory agencies, the companies continue to work in collaboration with governments and Ministries of Health around the world that will distribute the vaccine, subject to authorization or approval, to help ensure it can reach those most in need as quickly as possible.
Pfizer is bringing its leading in-house manufacturing capabilities to this effort, with the ability and experience to quickly scale, manufacture and distribute large quantities of vaccine at high quality, leveraging multiple sites in the U.S. and Europe, and complementing the mRNA manufacturing expertise of BioNTech, gained over almost a decade. Pfizer and BioNTech’s combined manufacturing network has the potential to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021 (subject to clinical success, manufacturing capacity, and regulatory approval or authorization).
Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months. The company has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Once thawed, the vaccine vial can be stored for up to 5 days at refrigerated (2 – 8oC) conditions.
From the start of the research program earlier this year, Pfizer and BioNTech have successfully supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the U.S., as well as Europe, Latin America, and South Africa. Based on their collective experience, the companies believe in their capability to distribute the vaccine globally upon approval or authorization.