Pfizer and BioNTech announced today (Tuesday 25th January 2022) that they have started testing an Omicron-specific COVID-19 vaccine in healthy adults between the ages of eighteen (18) and fifty-five (55).

The clinical study will evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate. The study will have three (3) cohorts examining different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine. The study will draw upon some participants from the companies’ Phase 3 COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.

“While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection, and we believe developing and investigating variant-based vaccines, like this one, are essential in our efforts towards this goal.”

“Vaccines continue to offer strong protection against severe disease caused by Omicron. Yet, emerging data indicate vaccine-induced protection against infection and mild to moderate disease wanes more rapidly than was observed with prior strains,” said Prof. Ugur Sahin, CEO and Co-Founder of BioNTech. “This study is part of our science-based approach to develop a variant-based vaccine that achieves a similar level of protection against Omicron as it did with earlier variants but with longer duration of protection.”

The study will evaluate up to 1,420 participants across the three (3) cohorts, as follows:

• Cohort #1 (n = 615): Received two (2) doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one (1) or two (2) doses of the Omicron-based vaccine.
• Cohort #2 (n = 600): Received three (3) doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one (1) dose of the current Pfizer-BioNTech COVID-19 vaccine or the Omicron-based vaccine.
• Cohort #3 (n=205): Vaccine-naïve participants will receive three (3) doses of the Omicron-based vaccine.

Clinical and real-world data continue to find people who are vaccinated, particularly those that have received a booster, maintain a high level of protection against Omicron, particularly against severe disease and hospitalization. The companies have previously announced that they expect to produce four (4) billion doses of the Pfizer-BioNTech COVID-19 vaccine in 2022, and this capacity is not expected to change if an adapted vaccine is required.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.

[Source: Pfizer]

The Queen giveth and the Queen taketh away.

The second son of Queen Elizabeth II, Prince Andrew, 61, has been forced to relinquish his military titles and Royal charities, following a Federal Judge’s decision in New York to allow a sexual abuse case against him to move forward.

Prince Andrew's roles have been returned to the Queen with immediate effect, and will be redistributed to other members of the Royal Family, a Royal Source said. He will stop using the title “His Royal Highness” in any official capacity, they added.

Buckingham Palace issued a brief, but stinging statement on Thursday (13th January 2022) — a day after the Judge’s decision — saying, “With The Queen's approval and agreement, The Duke of York's military affiliations and Royal patronages have been returned to The Queen. The Duke of York will continue not to undertake any public duties and is defending this case as a private citizen.”

Prince Andrew has been accused by Virginia Giuffre of raping her when she was a teenager at age seventeen (17) — a charge he denies — during a period in which he was friendly with the late financier and convicted sexual predator, Jeffrey Epstein.

Prior to Thursday, Prince Andrew had already been largely banished from public life due to the raging scandal.

[Source: The New York Times]

UPDATE 3: In a statement to The Hollywood Reporter, the Saget family said, “We are devastated to confirm that our beloved Bob passed away today. He was everything to us and we want you to know how much he loved his fans, performing live and bringing people from all walks of life together with laughter. Though we ask for privacy at this time, we invite you to join us in remembering the love and laughter that Bob brought to the world.”

UPDATE 2: Tributes for Bob Saget have started coming in from celebrities, including several from his “Full House” co-stars.

UPDATE: The Orange County Sheriff's Office says Saget’s death appears to be a mystery to them as so far, there are no signs of any red flags at the scene. "On arrival, [Deputies] located a man who was unresponsive in a hotel room. The man, identified as Robert Lane Saget, (DOB: 5/17/1956), was pronounced deceased on scene. We have no information on cause of death, and Detectives have found no signs of foul play or drug use in this case. This is all the information we have for release at this time and we do not anticipate further updates."

The Medical Examiner’s Office will make the final call on the cause and manner of death.

Bob Saget, most famous for his starring role as Danny Tanner on “Full House,” has died at the age of sixty-five (65). He passed away on Sunday (9th January 2022) at the Ritz-Carlton in Orlando, Florida.

According to TMZ, the Sheriff's Department and the Fire Department responded to the Hotel around 4pm ET after Hotel Security found Saget unresponsive in his room. He was pronounced dead on the scene, but the circumstances of his death are still unclear.

Saget played the patriarch on the hit ABC sitcom for almost ten (10) years, landing the lead star role in 1987 and finishing out its first iteration in 1995 — opposite stars John Stamos, Dave Coulier and his TV daughters, Candace Cameron, Jodie Sweetin as well as Mary-Kate and Ashley Olsen, who swapped the duties of portraying Michelle. He later reprised his role in 2016 for Netflix's reboot of the franchise, “Fuller House,” which ran for four (4) years and ended in 2020.

In addition to performing stand-up comedy and his “Full House” fame, Saget will also be remembered for hosting “America's Funniest Home Videos,” from 1989 to 1997, running concurrently with his time/tone on “Full House.”

Saget’s other notable acting credits include a recurring role on “Entourage,” in which he played a zany version of himself, the narrator's voice of “How I Met Your Mother,” another sitcom he starred in called “Raising Dad,” one of the penguins in “Farce of the Penguins,” the lead in “Surviving Suburbia,” and a standout cameo in “Half Baked” as a recovering crack head, among many, many other appearances on film and television over the years.

Saget is survived by his wife, Kelly Rizzo, and three (3) children.

R.I.P.

[Source: TMZ]

As the Omicron variant continues to surge across the globe, becoming even more dominant than the Delta variant, there is news that France discovered another variant. This one has forty-six (46) mutations, which is reportedly more than the Omicron variant.

The variant, called B.1.640.2, was dubbed the "IHU variant" by researchers at the Méditerranée Infection University Hospital Institute (IHU) in Marseilles, France, who first identified the variant in November 2021.

According to a study in December 2021, that is not yet peer-reviewed, the researchers confirmed twelve (12) patients tested positive for the variant, which contained mutations that also appeared in other fast-spreading variants. While the new variant was discovered around the same time as Omicron, the B.1.640.2 variant has not been detected anywhere outside the Southern Alps region of France.

A virologist from the Imperial College in London noted on Twitter that the IHU variant predates the Omicron variant. The findings of the IHU researchers have not yet been peer-reviewed, which means other scientists have yet to look over the work that has been done.

The World Health Organization (WHO) has so far connected the positive cases back to the African country of Cameroon. The WHO has yet to name the new strain a variant of interest or concern but it is currently being investigated. WHO said the B.1.640.2 variant "has been on our radar." At a news briefing in Geneva on Tuesday (4th January 2022), Incident Manager for the WHO's COVID-19 Incident Management Support Team, Abdi Mahamud, said, “That virus had a lot of chances to pick up.”

Health experts are expecting more variants to appear as COVID-19 cases continue to rise globally, but doubt they will gain traction. Ultimately, experts do not believe the IHU variant is a significant enough threat to warrant panicking about at this time.

This is a developing story - refresh this page for updates.

[Source: Complex]

Beloved actress, comedian, legend and American icon, Betty White, has died at age ninety-nine (99), just weeks before her milestone 100th birthday on 17th January 2022. According to TMZ, Betty passed away at her home on Friday morning (31st December 2021).

She had the longest running career in TV as a female prior to her death — having starred in multiple shows over the past eight (8) decades, starting in 1939. Betty is perhaps most famous for her lead role as Rose Nylund in "The Golden Girls," which ran from 1985 to 1992 and is still beloved today by many across the globe. She was the last surviving main cast member of the iconic television series.

TMZ notes that she got her start in radio in the 1940’s, making appearances on "Blondie," "The Great Gildersleeve," and "This is Your FBI." She eventually got her own radio program. In 1949, Betty began working on a televised variety show with Al Jarvis called "Hollywood on Television" which she later co-hosted — before breaking out into more TV roles in the 1950’s and beyond.

With 115 acting credits to her name, Betty has been in productions such as "Life with Elizabeth," "Date with the Angels," "The Mary Tyler Moore Show," "The Betty White Show," "The Love Boat," "Mama's Family," "The Golden Palace," "Ladies Man," "That '70s Show," "Higglytown Heroes," "Boston Legal," "The Bold and the Beautiful," "Pound Puppies," "Hot in Cleveland," and many other shows and films.

She has received numerous accolades over the course of her career, including multiple Emmys, Screen Actors Guild Awards, American Comedy Awards and even a Grammy. She was nominated for several Golden Globes and has also been honored with numerous Lifetime Achievement Awards.

During the Pandemic, Betty had been extra cautious, mostly staying at home and passing the time by reading, watching TV and doing crossword puzzles.

Rest in peace with your cheesecakes, Betty.

[Source: TMZ]

Health authorities in the United States on Monday (27th December 2021) shortened the recommended time for isolation for asymptomatic Americans with COVID-19 to five (5) days from the previous guidance of ten (10) days.

The Centers for Disease Control and Prevention (CDC) also said that people who test positive after quarantining should follow five (5) days of wearing a mask when around others. The CDC noted last week that the Omicron variant already accounts for 73% of U.S. infections.

The CDC on Monday also gave guidance for people who are unvaccinated or are more than six (6) months out from their second mRNA dose or more than two (2) months after the Johnson & Johnson vaccine and not yet boosted. It recommended quarantine for those persons for five (5) days followed by strict mask use for an additional six (6) days.

Meanwhile, individuals who have received their booster shot do not need to quarantine following an exposure, but should wear a mask for ten (10) days, the CDC said.

Breakthrough infections are rising among the fully vaccinated U.S. population, including those who have had a third booster shot. However, Omicron appears to be causing milder symptoms in those people, some of whom have no symptoms at all.

White House Medical Adviser, Anthony Fauci, told CNN last week that reducing the CDC’s 10-day quarantine recommendation would help asymptomatic people return to work or school, with proper precautions.

[Source: Reuters]