Revised to "Winter Storm Advisory"
Saturday Jan. 30 7 p.m. until Sunday Jan. 31 7 p.m. Eastern
My part of the city, state, nation, world, solar system, galaxy, universe
Revised to "Winter Storm Advisory"
Saturday Jan. 30 7 p.m. until Sunday Jan. 31 7 p.m. Eastern
According to Old Farmer's Almanac (www.almanac.com):
2:18 p.m. Eastern -- Thursday 1/28/2021
Another fitting name for this full Moon is the Center Moon. Used by the Assiniboine people, it refers to the idea that this Moon roughly marks the middle of the winter season.
Other traditional names for the January Moon emphasize the harsh coldness of the season: Cold Moon (Cree), Frost Exploding Moon (Cree), Freeze Up Moon (Algonquin), Severe Moon (Dakota), and Hard Moon (Dakota).
from PBS.org
After the House delivered the impeachment article, senators were sworn in Tuesday as members of an impeachment proceeding. An official summons for the trial will also be sent to Trump, the first former president to undergo an impeachment trial.
Sen. Patrick Leahy, D-Vt., the Senate’s president pro tempore, was sworn in Tuesday to preside over the trial. Chief Justice John Roberts presided over the last impeachment trial because Trump was a sitting president. But with Trump out of office, the task falls to Leahy, the longest-serving Senate Democrat, instead of Roberts or Harris.
Trump must respond to the charge by Feb. 2, the same day by which House impeachment managers are required to submit their pre-trial brief outlining their case. Trump’s defense team must submit its pre-trial brief by Feb. 8.
The opening arguments of the trial are set to start Tuesday, Feb. 9. However, before they begin, the Senate must approve rules for how the trial will be conducted.
Trump’s first impeachment trial, which took place early last year, offers some clues for how the upcoming trial could proceed.
In that case, Trump was charged by the House with abuse of power and obstruction of Congress for his efforts to pressure Ukraine’s president to investigate alleged corrupt business dealings by Biden and his son, Hunter Biden.
Republicans controlled the Senate, and approved rules on a party-line vote that gave each side 24 hours over three days to make their case. That portion of the trial lasted six days.
After hearing from both sides, senators spent three days debating the case. Then the Senate voted — also on a party-line GOP vote, without any support from Democrats — not to extend the trial by subpoenaing documents or witnesses.
Five days later, the Senate acquitted Trump on both impeachment charges. Sen. Mitt Romney, R-Utah, was the only senator who crossed party lines, casting a vote to convict Trump for abuse of power.
The coming trial will be different from the last in some important ways, due to the new balance of power in the Senate and the unprecedented nature of trying a former president. The first trial lasted roughly three weeks from start to finish. But Democrats have speculated the upcoming trial could be wrapped up much faster, since Trump’s criticism of the election and rally on Jan. 6 — and the attack itself — played out in public and will likely require less investigation to uncover misconduct than the previous trial.
There is reason “to expect that it would go faster,” Rep. Madeleine Dean, D-Pa., one of the House impeachment managers, said on NBC’s “Meet the Press” program Sunday.
This time, with Democrats in control of the Senate, Schumer will have final say on how the trial proceeds. But since the Senate is split 50-50, Schumer has less wiggle room than McConnell did last year, when Republicans held 53 seats and could afford to lose three votes during the course of the trial.
Schumer could push through a party-line vote when setting the trial rules if he can’t strike a deal with his Republican counterpart. But all 50 members of the Democratic caucus would need to approve of his terms in order to give Vice President Kamala Harris the tie-breaking vote.
Finding consensus among Democrats may prove difficult. At least one, Sen. Joe Manchin of West Virginia, has criticized the impeachment effort. Sen. Tim Kaine of Virginia and other Democrats have floated the idea of invoking the 14th Amendment as an alternative method to block Trump from running for federal office in the future.
If the Senate convicts Trump it could then vote separately to bar him from ever holding public office again. But a conviction requires 67 votes, and it’s considered unlikely that at least 17 Republicans will join every member of the Democratic caucus to vote to convict Trump.
from DHS dot-gov (Dept. of Homeland Security)
The Acting Secretary of Homeland Security has issued a National Terrorism Advisory System (NTAS) Bulletin due to a heightened threat environment across the United States, which DHS believes will persist in the weeks following the successful Presidential Inauguration. Information suggests that some ideologically-motivated violent extremists with objections to the exercise of governmental authority and the presidential transition, as well as other perceived grievances fueled by false narratives, could continue to mobilize to incite or commit violence.
Expires: April 30, 2021 01:00 pm
from www.stmargaretshouse.org/
Please join us this year in our 1st ever 100% VIRTUAL Winter Walk! Join us by taking a one-mile walk whereever you are during this week-long event. We walk in solidarity with the women and children of St. Margaret's House whose everyday means of transportation are their feet. Walk a mile in her shoes anytime between 2/14/21 and 2/21/21.
Be sure to register HERE and share your progress with us on social media with hashtag #SMHWinterWalk.
Brandywine Public Schools (Niles Twp., MI)
Niles (MI) Community Schools
St. Mary's of the Immaculate Conception School (Niles, MI)
Monday 1/25/2021 to Tuesday 1/26/2021
National Weather Service for SW Michigan (including Berrien and Cass counties)
Mixed precipitation expected. Total snow accumulations of 2 to 5 inches and ice accumulations of a light glaze. WHERE...Portions of northern Indiana, southwest Michigan and northwest Ohio. WHEN...From 5 PM EST Monday to 1 PM EST Tuesday. IMPACTS...Plan on slippery road conditions. The hazardous conditions will likely impact the Tuesday morning commute. ADDITIONAL DETAILS...Snow is expected to overspread the area Monday evening, with the greatest snowfall rates expected Monday mid to late evening. Periods of light snow will likely continue into Tuesday.
www.weather.com/
from CNN source (article)
It will remain closed for the future -- later announcements to follow
Saturday Jan. 23, 2021
https://www.cnn.com/2021/01/23/politics/washington-monument-closed-coronavirus/index.html
from NBC Affiliate (WNDU-TV) - South Bend / Notre Dame, IN
FIRST ALERT WEATHER DAY FOR MONDAY INTO TUESDAY.
There is an increasing chance of moderate to heavy snow
which will likely cause hazardous driving and road conditions through Monday
and into Tuesday morning.
We will keep you updated on the latest so keep checking back with your First Alert Weather Team.
Sign-up online https://runsignup.com/Race/MI/Hamtramck/PaczKiRun
The run before the big day (Fat Tuesday)! Due to COVID-19, we have decided to ensure everyone's safety and make the PaczKi Run virtual in 2021.
Feel better about eating those paczki, or run the route to scout out your favorite place to purchase them. This year you can don your PaczKi Run shirt, run your favorite 5K course with polka music in your ears and then celebrate with a paczek from one of Hamtramck's famous bakeries. Na Zdrowie!
The run before the big day (Fat Tuesday)! Feel better about eating those paczki, or run the route to scout out your favorite place to purchase them. The 5K route winds through Hamtramck, highlighting the city that boasts “the world in 2 square miles.” After the race, paczek and beer are served to each finisher. Na Zdrowie!
Jan. 21, 2021 -- day after the Inauguration from the Biden-Harris administration www.cnn.com article
The Trump administration will not have its own signature collection to display in the White House China Room -- another departure from protocol for the outgoing first family.
A representative for Melania Trump did not immediately respond to a request for comment.
Each administration has the opportunity to design and have made its own official china collection, both for entertaining purposes and for legacy and future administrations to use -- with the exception of few, every administration since George Washington has done so.
It Will Start
The week of February 8, 2021
The House has sent the single article for reading on Monday 1/25
The Senate will be sworn in as "jurors" (100) on Tuesday 1/26
from Politico dot-com
Vice President Kamala Harris and Second Gentleman Doug Emhoff will stay at Blair House while repairs at Naval Observatory are underway, Harris' adviser and spokesperson Symone Sanders told POLITICO Thursday.
Harris' office had announced their move to the official vice presidential residence would be delayed Wednesday, citing household maintenance and repairs to the chimney. The office had previously declined to say where she would be staying in the mean time due to security concerns. Harris had purchased a condo in a luxury high-rise just north of Washington Circle, but the heightened security led to added inconveniences for the residents there, The Wall Street Journal reported. Secret Service agents swept packages and cars entering the building, and concrete barricades were installed outside. Blair House, a 19th-century row house located just across Pennsylvania Avenue from the Eisenhower Executive Office Building and steps from the White House, serves as the president's guest house. President Joe Biden spent the night at Blair House before his inauguration. President Harry S. Truman also lived in Blair House while the White House underwent renovations after World War II.
from CBS affliate (S. Bend, IN) -- Jan. 19, 2021
NEW YORK (AP) — After leaving the White House, President Donald Trump may lose his
SAG card, too.
The Screen Actors Guild said Tuesday that the SAG-AFTRA board voted "overwhelmingly"
that there is probable cause that Trump violated its guidelines for membership. The charges, the guild said, are for Trump's role in the Capitol riot on January 6, "and in sustaining a reckless campaign of misinformation aimed at discrediting and ultimately threatening the safety of journalists, many of whom are SAG-AFTRA members."
If found guilty by a disciplinary committee, Trump faces expulsion.
Trump has been a SAG member since 1989. His credits include "The Apprentice," "Saturday Night Live" and many cameos in films and TV series including "Home Alone 2: Lost in New York," "The Fresh Prince of Bel-Air" and "Sex in and City."
The SAG board acted in response to a request from Gabrielle Carteris, the guild's president.
"Donald Trump attacked the values that this union holds most sacred — democracy, truth, respect for our fellow Americans of all races and faiths, and the sanctity of the free press," said Carteris in a statement. "There's a straight line from his wanton disregard for the truth to the attacks on journalists perpetrated by his followers."
posted at NBC affiliate (WNDU dot-com)
A WINTER WEATHER ADVISORY IS IN EFFECT FOR BERRIEN AND CASS COUNTIES, Michigan
DUE TO THE THREAT OF LAKE EFFECT SNOW
FROM 3 PM TUESDAY UNTIL 4 AM WEDNESDAY.
Low visibility likely along with hazardous road conditions developing overnight.
Low temperatures in the low 20s overnight. 1-3″ of lake effect snow accumulation.
Time: Jan 22, 2021 12:00 PM - 05:00 PM
How many web / internet visitors to this Google Blogger account - (since 2007) during Jan.2021?
This month of January -- 1192
Jan. 18, 2021 -- 210 page visits
Jan. 19 -- 24 page visits
Jan. 20 (Inauguration Day) -- 29 page visits
Jan. 23 - 29 page visits
Jan. 24 (Sunday) - 31 page visits
January 25 - 80 page visits
Jan. 26 = 21 page visits
Final section of Joanna Weiss' discussion of Trump as 'anti-hero' and what is in store for his post-presidency episodes of "The Trump Show":
But once Trump leaves office for good, the prizes that have fed his appetite and driven his presidency—adulation, importance, obsessive attention—will be gone. History will cement him as a one-term president who entered the political world in a dramatic escalator ride, and exited clinging to the tablecloth as the chinaware went crashing to the floor. An impeachment conviction in the Senate could prevent him from holding office again, defanging his political machine. His celebrity friends will have scurried from his brand. The major networks will have labeled him toxic. No one of consequence will call anymore.
You can imagine the coda: Trump living out his days, comfortable but grumpy, in a gilded prison on a golf course. He golfs, he dines, he broadcasts his version of the world on what amounts to an oversized ham radio. He scrapes up money to fund his defense from a long string of court dates from entities he’d never feared before—New York district court, various corners of the Justice Department. Maybe he has a Newsmax show, or a brisk ongoing business in MAGA hats, or he sells tickets to rallies to make money.
There’s no guarantee of any ending at this point; Trump is a master of rewriting his own script, even re-inventing the medium. But there are limits to how far his image rehabilitation can go. In his TV life, the ratings-hungry Apprentice franchise once rejected Trump’s most incendiary idea, a season pitting Black contestants against white ones. In real life, even some Republicans in Congress voted to impeach him, and all indications are that his final act did permanent damage to his brand. It’s hard to imagine a PGA tour on a Trump-branded golf course for a very long time. At this point, he wouldn’t even make it onto Dancing With The Stars. To a media-chaser, an attention-seeker, an egotist like Donald Trump, there’s nothing more painful than irrelevance. Roll the credits and change the channel.
Joanna Weiss, a POLITICO Magazine contributing editor, is editor of Experience magazine, published by Northeastern University.
www.cartercenter.org/ in 2021
FOR IMMEDIATE RELEASE
Rosalynn and I are troubled by the violence at the U.S. Capitol today. This is a national tragedy and is not who we are as a nation. Having observed elections in troubled democracies worldwide, I know that we the people can unite to walk back from this precipice to peacefully uphold the laws of our nation, and we must. We join our fellow citizens in praying for a peaceful resolution so our nation can heal and complete the transfer of power as we have for more than two centuries.
https://www.lakemichigancollege.edu/calendar?trumbaEmbed=eventid%3D150059147%26view%3Devent%26-childview%3D
Join us as we virtually kick off a week celebrating the life of Martin Luther King, Jr.
The event will include remarks and presentations from community leaders and elected officials who will help us frame our week around the theme, "Now is the time," interspersed with musical performances.
During the event we will announce the inaugural Spirit of MLK Spotlights, shining a light on an individual, organization, and student who embody MLK’s spirit of brotherhood/sisterhood and love in our own community through their direct action.
Invocation
Pastor R. Chester Gulley, president of the Southwest Michigan Ministerial Alliance
Keynote
Tekeidra Masters, Midwest Regional Youth of the Year - Boys and Girls Clubs of America
Following Ms. Masters’ remarks will be a Q&A moderated by Mackenzie Kastl, the new CEO of Boys & Girls Clubs of Benton Harbor.
This event is only the beginning of the MLK Community Celebration Week. We will share many other ways to keep the momentum going throughout the week and beyond. NOW is the time!
After you register for this event, you will receive an email confirmation with Zoom details for logging in to the event.
Location | Virtual |
---|---|
Cost | Free |
Event Type | Performance, Special Event |
more details at PBS dot-org
Westminster Abbey.
Throughout its history, Westminster has embodied stories of power struggles and tradition.
As one of the world’s most famous churches, it is steeped in Anglo-Saxon myths and legends dating back to the 11th century.
Viewers are privy to a behind-the-scenes tour to one of the most memorable vantage points of this architectural masterpiece, the site of the coronations of every English monarch since 1066.
https://www.abc57.com/news/hunter-ice-festival
from Meteorologist John Hammersmith (ABC 57):
The Hunter Ice Festival starts today (Friday 1/15) in Niles Michigan and will last through the weekend and into next week, as long as the ice sculptures stay frozen. The ice sculptures can be found near Riverfront Park in downtown Niles. This year will be more ice, and less festival. People are encouraged to come out to see the ice sculptures, but make sure to be masked up and keep distance between others.
from FACEBOOK page for Niles Downtown - Hunter Ice Festival sculpture competition
Yes, there will be ice.
No, it will not be a Hunter Ice Festival as we have had all previous years because of COVID restrictions.
This weekend (Friday 1/15, Saturday 1/16) the team will put out 28 large sculptures, strategically placed throughout town, visible for drive bys and apart enough for social distancing if folks want to walk and see them.
The weather forecast looks like it might be cold enough that they might stick around a couple of weeks
Sponsor is Harbor Country Hikers (Berrien County, Michigan)
Learn about the "greats" who influenced conservation, botany, exploration in
Online Presentation at 7 p.m. January 14, 2021
SPEAKER: Carol Line, executive director of Frednwood Botanical Gardens, rural Niles
Link via Zoom at http://harborcountryhikers.com/events
http://redcross.org/ Super Bowl contest - award mentioned in Article
January is National Blood Donor Month, a time to celebrate the lifesaving impact of blood and platelet donors. It has been celebrated each January for nearly 50 years and coincides with one of the most difficult times to maintain a sufficient blood supply for patients and this year is no exception.
For Robert Harris, donating blood and understanding the importance of blood donors is not something new. In fact, the blood donation process has been a part of his life for over 50 years.
“I have been a blood donor for over 50 years. I started as a sophomore at The Citadel and later as a student I helped at blood drives to man the snack tables and direct donors where to go.” said Harris.
Harris still vividly remembers the first time he gave blood and credits that experience with his commitment to donating blood moving forward. He was a student at The Citadel when he heard there was a need for blood donors at a drive that was happening on campus.
“A couple of friends who had given before asked if I wanted to join them,” said Harris. “We walked over to the Red Cross drive that was adjacent to the Children’s Hospital. After we gave, the nurse asked if we wanted to see someone that benefited from our blood donation.”
Harris and his friends were then able to meet the father of a 12-year-old girl that was in the Children’s Hospital that needed blood transfusions.
“The father came out, thanked us and asked us to look in and see his daughter. I remember seeing the fear in the father's face,” said Harris. “It was unforgettable.”
That experience left an impression on him and lead him to become a dedicated blood donor for the past five decades. Harris has also helped sponsor blood drives at local churches, given in support of family members, and is looking for more time to become a dedicated platelet donor.
“I have always had a great regard for the Red Cross,” said Harris. “I could not always give money like I would have liked to, but, the donation of blood cost me nothing except a little time and does so much for those who need.”
Every two seconds, someone in the U.S. needs blood. And those needs do not diminish during disasters or pandemics. That patient could be a grandparent battling COVID-19 in need of convalescent plasma, a child battling cancer, an accident victim being raced into the ER, or new mom with a complicated childbirth.
Through our national inventory system, the Red Cross has the ability to move blood around the country to wherever and whenever it is needed most. With the help of volunteer donors, the Red Cross stands ready to provide blood and blood products as needed in response to these ongoing emergencies both large and small.
The NFL and Red Cross Partnership: The American Red Cross and the NFL are partnering this January, during National Blood Donor Month, to urge individuals, especially those who have recovered from COVID-19, to give blood and to help tackle the national convalescent plasma shortage.
The Red Cross has teamed up with the NFL to offer those who come to give blood, platelets or plasma, Jan. 1-31, 2021, a chance to win a getaway to the 2022 Super Bowl LVI in Los Angeles. As an extra thank-you from the Red Cross, those who come to give Jan. 1-20, 2021, will also be automatically entered to win a Big Game at Home package, which includes a 65-inch television and $500 gift card toward food and fun so their household can enjoy an awesome viewing experience safely at home. Terms apply; visit RedCrossBlood.org/SuperBowl for more information.
from CNN dot-com
The Super Bowl will be played Feb. 7, 2021
6:30 p.m. at Tampa, FL
College National Championship (for season August - December 2020):
#1 seed meets #3 seed
1. Alabama (12 - 0) meets 3. The Ohio State University
Monday 1/11/2021 8 p.m. eastern (ESPN)
in Miami Gardens, FL
in previous meetings, Alabama leads OSU 3 - 1
from Michigan Live! website www.mlive.com/
The Critics Choice Super Awards air on The CW tonight, Jan. 10, at 8 p.m. ET/PT. You can also stream the show on FuboTV (free trial).
Hosted by Kevin Smith and Dani Fernandez, these awards reflect the most popular, fan-obsessed genres across both television and movies, including Superhero, Science Fiction/Fantasy, Horror, Action and Animation.
At tonight’s presentation, the Star Trek franchise will be honored with the Legacy Award for its longterm cultural impact while continuing to expand its loyal fanbase with new stories and characters. Patrick Stewart and Sonequa Martin-Green will be accepting the honor.
Jan. 8 - 6:35 p.m. Eastern
www.nbcnews.com
Twitter on Friday permanently suspended President Donald Trump,
citing his recent comments ahead of a mob
of his supporters that stormed the Capitol.
USA Today coverage of Thursday evening (Jan. 7) statement from White House pre-taped video:
President Donald Trump on Thursday acknowledged President-elect Joe Biden’s victory in his strongest words yet as he faces mounting criticism for his handling of the violence that erupted a day earlier at the U.S. Capitol.
"A new administration will be inaugurated on Jan. 20," Trump acknowledged in a video posted to social media, the closest he has come to conceding the Nov. 3 election. “My focus now turns to ensuring a smooth, orderly and seamless transition of power. This moment calls for healing and reconciliation.”
Trump did not mention Biden by name nor congratulate his rival, who has been introducing members of his Cabinet and preparing to assume the presidency even as Trump has for weeks leveled evidence-free claims of voter fraud to argue that the election was stolen. Trump did not abandon those baseless claims in the video, but did acknowledge that the nation had "just been through an intense election" and that emotions were high.
"Tempers must be cooled and calm restored,” he said.
Trump did not address his own role in flaring those emotions and he did not discuss his effort to whip up a large rally outside the White House minutes before a pro-Trump mob rushed the Capitol. During those remarks, the president urged his supporters to march on the Capitol and encouraged them to not be "weak."
The video, one of several Trump has posted from the White House in recent weeks, was the latest effort to get ahold of the fallout from the chaos that unfolded Wednesday afternoon when a mob attacked the Capitol and disrupted the counting of Electoral College votes. Members of both parties have criticized the president's rally remarks.
While Trump appeared to relent in his effort to overturn the election he hinted, at the end of the video, that he continued to see a future in politics. Addressing all of his "wonderful supporters," Trump promised that "our incredible journey is only just beginning."
from Washington Post dot-com
Greek churches held services Wednesday to mark the Feast of the Epiphany, flouting government restrictions to halt the spread of the coronavirus on one of the most important Orthodox Christian holidays.
Greece entered a hard lockdown Sunday amid a new rise in cases and ahead of a planned reopening of schools on Jan. 11. The lockdown included a ban on religious ceremonies, a move that angered the Greek Orthodox Church.
Earlier this week, church leaders wrote to the government and vowed to defy the ban. The Orthodox Church is highly influential in Greece, where the majority of the population is Orthodox Christian.
On Wednesday, congregants attended services in the capital, Athens, and other cities. Attendance was limited to between 25 and 50 people, depending on the size of the church, Greek media reported.
Police patrolled outside churches but did not prevent people from entering, Reuters reported.
The Feast of the Epiphany commemorates the baptism of Jesus. In some places, believers mark the holiday with a ritual that includes a priest throwing a cross into a body of water. Swimmers race to retrieve the cross and the diver who carries it back is believed to be blessed with good luck.
Greece has escaped some of the widespread covid surges in the rest of Europe, but suffered a peak in infections in November. About 133,000 people in Greece have contracted the virus, while some 4,400 people have died.
from CNN dot-com
President-elect Joe Biden's inaugural committee will promote the national day of service on Martin Luther King Jr. Day as part of festivities ahead of the inauguration on January 20.
The committee plans to post service events and urge Americans to sign up for volunteer opportunities through its inaugural website.
We're extracting the DNA from the cells in your
saliva sample. This step usually takes 1-2 weeks.
It’s time to free your DNA from the cheek, gum, and white blood cells in your saliva. Once done, we copy your DNA millions of times, before cutting it up into many pieces, cleaning it, and measuring it.
SOUTH BEND, Ind. (WNDU) -You can check out some iconic rides of the 70′s at the Studebaker National Museum’s new Disco Decade Rides exhibit.
These cars came out after Studebakers stopped production, but mark a turning point in the way many North American cars are designed.
Folks are invited to check them out during the museum’s normal hours.
Location
201 Chapin Street
South Bend, IN 46601
(574) 235-9714
(888) 391-5600
Due to power outages - also Elkhart, IN Schools
SOUTH BEND, Ind. – All South Bend Community schools will be closed Monday, Jan. 4, 2021
due to power outages across the corporation.
All virtual and in-person learning is canceled on this day.
Starrville Methodist Church (Winona, TX) -- coverage from online article Longview, TX News-Journal
Smith County Sheriff Larry Smith said the pastor opened the bathroom door and was confronted by a person who was hiding. The pastor had a firearm, drew his firearm on the person and ordered him to stop. He came toward the front door, lunged and took the pastor's firearm and killed him.
Two other victims have gunshot wounds and are being treated.
A Harrison County Deputy caught the suspect who took the pastor's vehicle. The person had the church bank bag.
One person is dead and several others are injured after that church shooting.
from WHO World Health Organization information public internet announcement:
The World Health Organization (WHO) today Friday 31 December 2020 listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year ago (2019).
The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.
“This is a very positive step towards ensuring global access to COVID-19 vaccines. But I want to emphasize the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards. We encourage even more developers to come forward for review and assessment. It’s vitally important that we secure the critical supply needed to serve all countries around the world and stem the pandemic.”
Regulatory experts convened by WHO from around the world and WHO’s own teams reviewed the data on the Pfizer/BioNTech vaccine’s safety, efficacy and quality as part of a risk-versus-benefit analysis. The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO, and that the benefits of using the vaccine to address COVID-19 offset potential risks.
The vaccine is also under policy review. WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) will convene on 5 January, 2021, to formulate vaccine specific policies and recommendations for this product’s use in populations, drawing from the SAGE population prioritization recommendations for COVID-19 vaccines in general, issued in September 2020.
The Comirnaty vaccine requires storage using an ultra-cold chain; it needs to be stored at -60°C to -90°C degrees. This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible. For that reason, WHO is working to support countries in assessing their delivery plans and preparing for use where possible.
How the emergency use listing works
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.
Experts from individual national authorities are invited to participate in the EUL review. Once a vaccine has been listed for WHO emergency use, WHO engages its regional regulatory networks and partners to inform national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date.
In addition to the global, regional, and country regulatory procedures for emergency use, each country undertakes a policy process to decide whether and in whom to use the vaccine, with prioritization specified for the earliest use. Countries also undertake a vaccine readiness assessment which informs the vaccine deployment and introduction plan for the implementation of the vaccine under the EUL.
As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.