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U.S. Supreme Court strikes down CDC's eviction moratorium as Black America remains at risk...Evictions filings are happening in the Black community at a disproportionate rate, a report by the Aspen Institute says...By Clevelandurbannews.com

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Clevelandurbannews.com and-Kathywraycolemanonlinenewsblog.com.Tel: (216) 659-0473 and Email: editor@clevelandurbannews.com.

By Kathy Wray Coleman, associate publisher, editor-in-chief

WASHINGTON, D.C.- I n a 6-3 decision, the U.S. Supreme court on Thursday struck down the Centers for Disease Control and Prevention's (CDC) eviction moratorium saying the federal agency lacked authority to issue such a mandate and paving the way for a flood of evictions nationwide as new variants of the coronavirus continue to emerge and Black America embraces itself to be among those hardest hit by the never-ending eviction crisis.

Led by the more conservative arm of the court, and with the court's three liberal justices dissenting, the court sided with a group of landlords and  ruled that the  CDC does not have statutory or any other authority to bring evictions to a standstill.

"It would be one thing if Congress had specifically authorized the action that the CDC has taken," the court's majority wrote in an unsigned opinion. "But that has not happened. Instead, the CDC has imposed a nationwide moratorium on evictions in reliance on a decades-old statute that authorizes it to implement measures like fumigation and pest extermination. It strains credulity to believe that this statute grants the CDC the sweeping authority that it asserts."

A report by the Aspen Institute that came out last year during the height of the pandemic says an estimated 30 million to 40 million people in the U.S, both renters and home dwellers alike,  are at risk of eviction due to the COVID-19 housing crisis. And Black neighborhoods should embrace themselves for the worst

According to Aspen, there were averages of 1,880,053 eviction filings and 665,668 evictions per year. Each year, an average of 666,396 of these eviction filings (35.4%) and 181,495 of these evictions (27.2%) took place in Black-majority neighborhoods, the report says.

Research continues to show that Blacks and Latinos are more likely to be suffering economically during the pandemic and remain at greater risk for evictions than their White counterparts. A  report dubbed "The State of the Nation's Housing 2020" found that over half of Black and Hispanic renter households were cost burdened going into the pandemic,compared to 42 percent of Asian and white households.

Issued earlier this month after Congress could not agree on evictions legislation and President Joe Biden would not sign another executive order banning such evictions, the CDC evictions ban had been applicable to areas of the country with high or substantial transmission of  COVID-19 and was set to expire Oct 3, CDC officials said in an announcement at the time.

Prior to the CDC taking its latest action on evictions, House Speaker Nancy Pelosi and Congressional Democrats  demanded that the Biden administration extend the national eviction moratorium put in place a year and a half ago to protect renters and keep people in their homes as the coronavirus pandemic continues to escalate.

Pelosi issued a written statement calling for immediate action by the Biden administration. It was also signed by Majority Leader Steny Hoyer, Assistant Speaker Katherine Clark, and Majority Whip James E. Clyburn, a South Carolina Democrat and the highest ranking Black in Congress.

Calling it a "moral imperative," House Democrats had called for the president to use his executive powers to extend his executive eviction moratorium that had been in place since March 2020 until  Oct 18.

Amid strong opposition from Congressional Republicans, who control the Senate, as well as a cadre of more moderate Congressional Democrats, Pelosi and House Financial Services Chair Maxine Waters led a failed effort to try to reach a legislative solution after Waters, a seasoned Democrat out of California, introduced a bill to renew the eviction moratorium.

But she and Pelosi were at odds over whether the Democratically-controlled House vote on the last minute extension bill should be made public with Waters wanting the latter.

The measure failed in the House after Stoyer stepped in and called for a unanimous consent, which does not require a vote. After that occurred the CDC, with Biden's support, stepped in and issued its moratorium, the one that was unceremoniously rejected by the Supreme via its ruling on Thursday that says the CDC acted in an arbitrary and capricious fashion.

Meanwhile, the delta variant, a more contagious strain of the coronavirus, continues to spread. It has quickly become the dominant SARS-COV-2 in more than a dozen countries worldwide.

Clevelandurbannews.com and-Kathywraycolemanonlinenewsblog.com, Ohio's most read Black digital newspaper and Black blog.Tel: (216) 659-0473 and Email: editor@clevelandurbannews.com. Kathy Wray Coleman, editor-in-chief, and who trained for 17 years at the Call and Post Newspaper in Cleveland, Ohio. We interviewed former president Barack Obama one-on-one when he was campaigning for president. As to the Obama interview, CLICK HERE TO READ THE ENTIRE ARTICLE AT CLEVELAND URBAN NEWS.COM, OHIO'S LEADER IN BLACK DIGITAL NEWS.

Last Updated on Wednesday, 08 September 2021 09:28

League of Women Voters of Ohio recognizes Women's Equality Day, which is today, August 26....LWVO says it will continue to defend the right to vote for women of color, women with disabilities, military voters, and so many others

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Clevelandurbannews.com and Kathywraycolemanonlinenewsblog.comthe most read Black digital newspaper in Ohio and in the Midwest. Tel: (216) 659-0473. Email: editor@clevelandurbannews.com

MESSAGE FROM LEAGUE OF WOMEN VOTERS

OF OHIO ON WOMEN'S EQUALITY DAY-

JEN MILLER, EXECUTIVE DIRECTOR (pictured)

Dear Supporter,

On August 26th each year, the United States recognizes Women's Equality Day. Chosen because it is the day Congress ratified the 19th amendment, this day signifies a major step towards women's right to vote nationally.  Since then, the League has worked tirelessly to defend the right to vote for women of color, women with disabilities, military voters, and so many others! It is hard to believe that 101 years later we are STILL fighting for the voting rights for ALL eligible voters.

Arguably, the current attack on voting rights is one of the worst in history. No community is immune to the voter suppression laws being proposed in 49 states - including Ohio.

Ohio lawmakers already sneaked a provision into the Ohio budget that could limit the League's ability to work with the Secretary of State and Boards of Elections on nonpartisan voter outreach and education. They are now considering drastically cutting early voting hours, requiring an excuse to vote absentee, prohibiting care (like water) for voters in long lines, and eliminating drop boxes completely. These blatant attacks on the rights of voters have made it clear that many legislators across the state and the nation believe it is more important to keep their seat than to ensure every eligible voter has the means and ability to cast their ballot. These same legislators are working hard to make sure Ohio, one of the worst gerrymandered states in the nation, does not have the time to draw fair maps that are driven by community input and with bi-partisan support.

The League of Women Voters of Ohio has spent over 100 years defending people's right to vote and we are NOT stopping now! LWVO NEEDS YOUR HELP to continue our fight.

We need your help to:

  • Hold map makers accountable by urging elected officials to listen to the over 70% of Ohio voters who voted to pass redistricting reform in 2015 and 2018
  • Educate Ohio voters about mapping, redistricting, voter suppression tactics and how they can be a part of the solution
  • Ensure all eligible Ohio voters have equitable and fair access to the ballot box through advocacy, partnerships and education.

Plain and simple: Our democracy is under attack, and we need your help. The League of Women Voters of Ohio relies on our three fundraising campaigns each year (WED, Trailblazer and End of Year) to cover operational expenses. Your donations ensure we have the resources to fight for voting rights across our great state. Donate today by visiting: https://bit.ly/LWVOWED2021

THANK YOU FOR SUPPORTING, LEAGUE OF WOMEN VOTERS OF OHIO!

Clevelandurbannews.com and Kathywraycolemanonlinenewsblog.comthe most read Black digital newspaper in Ohio and in the Midwest. Tel: (216) 659-0473. Email: editor@clevelandurbannews.com. We interviewed former president Barack Obama one-on-one when he was campaigning for president. As to the Obama interview. CLICK HERE TO READ THE ENTIRE ARTICLE AT CLEVELAND URBAN NEWS.COM, OHIO'S LEADER IN BLACK DIGITAL NEWS.

Last Updated on Thursday, 26 August 2021 23:32

Black Cleveland activists host Cleveland mayoral candidates forum that gets heated, a standing-room-only event....Moderated by activist Kathy Wray Coleman, six of the seven candidates appeared for the activists' event held on August 23

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Six of the seven mayoral candidates on the ballot for the Sept. 14 nonpartisan primary election participated in a community forum held by Black community activists on Mon., Aug 23 at Annie B & Earl's  Pancake House on the city's largely Black east side. From left: State Sen Sandra Williams (D-21), Ward 7 Councilman Bashear Jones, Justin Bibb, Zack Reed, Dennis Kucinich, and Attorney Ross DiBello (Click on the article on our latest news link on our website to see the full picture of the six participating candidates)
Clevelandurbannews.com and Kathywraycolemanonlinenewsblog.com Tel: (216) 659-0473. Email: editor@clevelandurbannews.com

CLEVELAND, OHIO – Black Cleveland activists, led by Imperial Women Coalition, Black on Black Crime Inc., and members of the Cleveland African-American Museum and the Black Women's PAC, hosted a community forum with Cleveland mayoral candidates on Monday at Annie B & Earl's Pancake House in Ward 10 on Saint Clair Avenue on the city's largely Black east side.

The standing-room-only event, which was free to activists and the public, got intense on issues ranging from excessive force to Mayor Frank Jackson's no chase policy.
The nonpartisan primary for mayor and the 17 city council seats is Sept 14 and the general election in which the top two vote-getters for mayor and from each of the city's wards will square off is Nov 2. A four term mayor and the city's third Black mayor, Jackson has opted not to seek an unprecedented fifth term.
Candidates in the seven-way primary race for mayor, all of them Democrats, and four of them Black, are state Sen. Sandra Williams (D-21), Cleveland City Council President Kevin Kelley, former congressman and one-time city mayor Dennis Kucinich, attorney Ross DiBello, non-profit executive Justin Bibb, Ward 7 Councilman Bashear Jones, and former Ward 2 Councilman Zack Reed.

Reed  lost a mayoral runoff to Jackson in 2017 and is making his second bid for mayor, and while he does not have big business behind him or a campaign war chest like Kelley, Bibb and Jones, he does have citywide name recognition, something Kucinich also has as a prior congressman and former city mayor.

Activist Kathy Wray Coleman, who leads Women's March Cleveland and the Imperial Women Coalition, a grassroots group founded behind the murders of 11 Black Women on Imperial Avenue on Cleveland's east side by the late serial killer Anthony Sowell, was the head organizer of the gathering and moderated the event, which was also organized by Cleveland African-American Museum Executive Director Frances Caldwell, Black on Black Crime President Alfred Porter Jr, Black Women's PAC president Elaine Gohlstin, and activist Donna Walker Brown.
All of the candidates were there on Monday but Kelley, who had Councilman Kevin Conwell stand in for him at the last minute, Conwell catching criticism from Jones for telling the Black audience that he has endorsed Kelley, a White west side councilman.

Jones said Conwell, a Black east side councilman who represents the Glenville neighborhood in Ward 9, was part of the problem at City Hall and would allegedly go in the back room to cut a deal to side with the establishment and Whites on key issues impacting the Black community. His comment drew chatter and chants, and a wealth of applause from the activists.

In turn, Conwell got upset and rose to his feet.

"I write policy," said Councilman Conwell in response to Councilman Jones' comment that he is a patsy for the establishment.

Activist Walker- Brown defended Conwell, her longtime community ally, and said he is an asset to the Black community and can be counted on when called upon on community issues.

In the heat of the moment Jones announced that he would pay the restaurant bill for Monday's activist event, after he learned that Kelley's campaign was chipping in on the bill.

"This is my community and I will pay the bill," said Jones,  adding that "Annie B has the best pancakes in town."

In the end candidates chipped in with Jones footing most of the bill, followed by Kelley.

On the question asked by Coleman on whether the candidates support masks in schools since the city mayor, per state law, controls Cleveland's public schools, all of them there said yes.They all nodded no to the question posed by Walker- Brown as to whether they support stop-and-frisk.
Asked by Coleman if the candidates support Mayor's Jackson no chase policy, a policy that precludes police from taking chase unless it is a suspected felony and one that the Cleveland police Patrolmen's Association and some White west side council persons, including Kelley, oppose as letting misdemeanors off easy, all of the candidates but Kucinich said yes.
As to more police, the candidates all said yes to that question, with Jones, Bibb, Williams, and Reed, the four Blacks in the race for mayor, adding a caveat and saying that they want more police in needed areas such more detectives on cold cases and to patrol the streets and neighborhoods.
A front-runner, Kucinich stressed that he would push for the city to hire more good cops if he is elected, and not racist cops or cops who will be "killing people with impunity."
And Williams, in her sixteenth year as a state lawmaker, said that while she supports an adequate number of police on the city's police force, she also supports getting rid of "qualified immunity," a legal doctrine that keeps police safe from lawsuits.
Candidates Reed, Bibb and DiBello said that improving police- community relations is a significant role as a mayor and that they are better equipped than the other candidates to minimize fallout between police and the Black community
All of the candidates agreed to a diversified cabinet and law enforcement leadership team if elected, as well as more Blacks at central office relative to the Cleveland Metropolitan School District. And that each said they would implement strategies to deal with the dearth of Black police officers, given that the city's police department is roughly 65 percent White
The candidates spoke at length on what they would do regarding excessive force and police killings of Blacks since 2012 such as 12-year-old Tamir Rice, Malissa Anderson, Timothy Russell, Brandon Jones, rapper Kenneth Ball and Tanisha Anderson, all of the them promising police reforms and agreeing that there needs to be a monitoring mechanism in place once the consent decree for police reforms between the city and the U.S. Department of Justice is dissolved.
During the question and answer session of the forum Latisha Powell, whose son was murdered and his killer is still on the loose, spoke on gun violence and Scott Hawkins, whose son, Arthur Keith, was shot and killed by a Cleveland Metropolitan Housing Authority (CMHA) cop, said he could not understand why the cop at issue was not indicted after shooting his son several times in the back.

Activists said County Prosecutor Mike O'Malley, whom some of them supported when he ousted then county prosecutor and fellow Democrat Tim McGinty from office in 2016, has, in their view, not been assertive enough in getting indictments against cops and other law enforcement personnel who erroneously kill Black people in the line of duty.
Sen. Wiliams, the only woman in the race for mayor this year, took on Bashear Jones, saying O'Malley is doing what he is doing because people like Jones and other Blacks put him in office.

Activist Michael Nelson questioned Kucinich on whether he agrees with the longstanding practice by city council that if the person elected mayor is White city council will choose a Black as council president, and if the person elected mayor is Black, a White will be chosen.

Kuncinich responded and said "I agree with having a Black council president, a facetious comment that suggests that he believes that he, a White candidate, might win for mayor.
Other speakers at the pancake brunch forum were Cleveland Ward 1 Councilman Joe Jones, Republican congressional nominee for the 11th district Lavern Jones Gore, and activists Brenda Adrine, Alfred Porter Jr, the Rev. Pamela Pinkney Butts, Genevieve Mitchell and Elaine Gohlstin of the Black Women's PAC. Ward 10 Councilman Anthony Hairston, who represents the Saint Clair-Superior neighborhood where the mayoral candidates forum was held, was also in attendance but did not speak.

Other affiliated activist groups at the forum include Black Lives Matter Cuyahoga County, Brickhouse Wellness Center, Carl Stokes Brigade, and the Black Man's Army.

Cleveland is a largely Black city of some 372,000 residents, and geographically it is the second most segregated city in the nation behind Boston with most Whites residing on the city's west side and Blacks living primarily on the east side, the two sides separated by the Cuyahoga River. Both Cleveland and Cuyahoga County, which includes Cleveland, are Democratic strongholds run primarily by Democrats.
Clevelandurbannews.com and Kathywraycolemanonlinenewsblog.comthe most read Black digital newspaper in Ohio and in the Midwest. Tel: (216) 659-0473. Email: editor@clevelandurbannews.com. We interviewed former president Barack Obama one-on-one when he was campaigning for president. As to the Obama interview. CLICK HERE TO READ THE ENTIRE ARTICLE AT CLEVELAND URBAN NEWS.COM, OHIO'S LEADER IN BLACK DIGITAL NEWS.

Last Updated on Saturday, 28 August 2021 03:48

U.S. House passes the John Lewis Voting Rights Advancement Act, proposed legislation that would restore a provision of the Civil Rights Act of 1965 that required federal oversight in voting venues across the country that have a history of discrimination

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Pictured is the late George congressman and Civil Rights icon John Lewis
Clevelandurbannews.com and Kathywraycolemanonlinenewsblog.comTel: (216) 659-0473. Email: editor@clevelandurbannews.com.
Kathy Wray Coleman, associate publisher, editor-in-chief
WASHINGTON, D.C.- The Democratically-dominated U.S. House of Representatives on Tuesday passed the John Lewis Voting Rights Advancement Act, proposed legislation that would restore a provision of the landmark Civil Rights Act of 1965 that required federal oversight in voting venues across the country that have a history of discrimination, a provision stripped away some eight years ago by a U.S. Supreme Court that ruled that the formula for determining such is outdated an antiquated.

If it ultimately passes the U.S. Senate, which is unlikely, the measure, introduced by Democratic Rep. of Alabama Terri Sewell and named for the late Civil Rights icon and the late congressman out of Georgia John Lewis, would update the formula that the nation's high court deemed null and void in Shelby County vs. Holder, a decision that Civil Rights groups, Black leaders and other voting rights advocates say opened the floodgates for discrimination against Black voters.

The measure passed the House 219-212 on Tuesday, and along party lines as Democrats admit that they face a hurdle in the Republican-dominated Senate where it now sits, though they are in no way deterred.

The House passed a similar bill in 2019 but it subsequently failed in the Senate.

A 17-term congressman, Lewis died some two years ago after a valiant struggle with pancreatic cancer. He was 80-years-old
.

As a federal lawmaker he fought against the reversal of decades of Civil Rights gains and spoke out against the Supreme Court's 2013 decision in Shelby County vs Holder, saying it lessened  government over watch of state voting rules and made it easier for state officials to make it harder for Black and other racio- ethic minority voters to vote.


Led by House Speaker Nancy Pelosi, Congressional Democrats remain concerned about voting access to Blacks and other vulnerable groups as they continue to demand sweeping voter rights changes while Republican-dominated state legislatures across the country, including in Georgia in April, adopt voting laws that Democrats say severely limits voting for Black people.

 

The son of sharecroppers who was beaten and brutalized along with some 600 other protesters as a 25-year-old voting rights activist as they crossed the Edmond Pettus Bridge from Montgomery, Alabama to Selma, Georgia on Sun, March 7, 1965 to demand passage of the Voting Rights Act 1965, Lewis was one of the most respected members of Congress.


The celebrated bridge crossing, led by the late and iconic Civil Rights leader the Rev Dr. Martin Luther King Jr., and affiliated violence by police against protesters, would come to be known as "Bloody Sunday."


Lewis nearly died that day, history says. But instead he survived and went on to fight for Civil and Human rights for decades to come, and until cancer slowed him down.


A celebrated death that his colleagues in Congress, Civil Rights leaders and mourners nationwide called a a tremendous loss to the Black community and the fight for democracy and equal opportunity, Lewis died on July 17, 2020. As part of a procession held nine days after his death, a carriage carried his body across the Edmund Pettus Bridge, a symbolic measure that was a part of the week-long funeral activities for the Congressman, the first Black federal lawmaker to lie in state at the U.S. Capitol.

 

"It is with inconsolable grief and enduring sadness that we announce the passing of U.S. Rep. John Lewis," the Lewis family said in a statement after his death. "He was honored and respected as the conscience of the U.S. Congress and an icon of American history, but we knew him as a loving father and brother."

 

A former Georgia state legislator out of Atlanta who represented Georgia's 5th congressional district in Congress, Lewis was a native of Troy Alabama.

 

His great grandfather was born into slavery.

 

He lost his first bid for Congress and later won the seat in 1986 against his Republican challenger, but only after winning a contentious and now infamous Democratic primary over Julian Bond, a  prominent Black Georgia state senator at the time.

 

One of 10 siblings, he was 16-years-old when he fought to desegregate public libraries in Troy and against Jim Crow Laws.

 

While in college in Nashville studying theology on a  scholarship he was a member of the activist  student group the Freedom Riders that fought against racial segregation and to desegregate lunch counters in the city and became a symbol of the student movement for racial equality.

 

The congressman once said that that his true activism was  inspired by  the Montgomery Bus Boycotts that took place when he was 18-years-old, and the sermons of Dr King on the radio.

 

He fought with King and the Southern Christian Leadership Conference that King led during the height of the Civil Rights Movement of the 1960s and spoke at the March on Washington in 1963 in spite of fears by then president John F. Kennedy that his speech might be too radical.

 

At 23-years-old he was the youngest speaker at the event in Washington, and gave a dynamic speech, pundits said, a speech  overshadowed by Dr. King's historic "I Have a A Dream Speech."

 

He was arrested for civil disobedience more that 44 times, 40 of those arrests occurring before he was elected to Congress.

 

He returned to Selma each year for anniversary festivities and to remember "Bloody Sunday."

 

A recipient of the Presidential Medal of Freedom in 2011 from former president Barack Obama, the nation's first Black president, Lewis never stopped fighting for justice for the underprivileged and the disenfranchised.

 

He endorsed Obama for president in 2008 and for reelection in 2012, and he boycotted the inauguration of former president Donald Trump in 2016, whom President Joe Biden defeated last November in a contentious election. Lewis was also a strong ally Biden, a former U.S. senator turned vice president whom he served with in Congress.

 

One of his last public appearances was a town hall with Obama.

 

A husband and father, Lewis loved Black people, unequivocally.

He was married to his wife Lillian for nearly 50 years, and until her death in 2012.

 

Whether fighting for public policy changes for his constituents in particular, or for the country as a whole, overtime he drew the love and respect of his fellow lawmakers. He was a biblical figure on a mission, and in spite of his stubbornness at times he had friends and enemies across partisan lines.


Considered a hard- core liberal in Congress by some accounts, Lewis opposed the U.S  waging of the 1991 Gulf War, and the Clinton Administration on NAFTA and welfare reform. During his 30-plus years in Congress  representing  a district in the seep South Lewis opposed the Iraq War and also fought in Congress for public policies in support  of voting rights, reproductive rights for women, affirmative action, gun control, human and Civil Rights, universal healthcare and the gamete of issues embraced by the liberal wing of the Democratic Party. He backed same sex marriage, which became legal under federal law across all 50 states and the District of Columbia in 2015.

His legacy, however, transcends the Democratic Party that he had no problem challenging on matters he deemed necessary to address.The National Museum of African American History opened on the National Mall in Washington D.C. in 2016 during Obama's tenure, Lewis the impetus for the congressional bill that led to funding for the historical monument.


Obama praised the congressman when he was on his deathbed.


If there’s one thing I love about @RepJohnLewis, it’s his incomparable will to fight," Obama tweeted after learning that Lewis had terminal cancer. "I know he’s got a lot more of that left in him. Praying for you, my friend."
Clevelandurbannews.com and Kathywraycolemanonlinenewsblog.comTel: (216) 659-0473. Email: editor@clevelandurbannews.com.

Last Updated on Wednesday, 25 August 2021 21:32

FDA approves Pfizer vaccine for regular use, the U.S. Food and Drug Administration reports....It is no longer an experimental vaccine, FDA says

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REPORT FROM THE US FOOD AND DRUG ADMINISTRATION (FDA)

WASHINGTON-D.C.-The U.S. Food and Drug Administration on Tuesday approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older

The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

Ongoing Safety Monitoring

The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

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Last Updated on Wednesday, 25 August 2021 21:15

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