WORLD NEWS FLASH
UNITED STATES
NEW YORK & MAINZ, Germany – (BUSINESS WIRE) – Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced on Aug. 22 they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.
The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine to address the continued evolution of SARS-CoV-2. Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.
A conditional marketing authorization application has also been initiated with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed in the coming days.
“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges.”
“Given the ongoing evolution of SARS-CoV-2 and its variants, it’s of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our Omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the U.S. with the possibility to get a booster adapted to the currently most dominant strain of the virus.”
The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine, together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant. Pre-clinical data showed a booster dose of Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is expected to start this month.
The companies previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial of a 30-µg booster dose of their Omicron BA.1-adapted bivalent vaccine candidate, which combines the existing vaccine and a vaccine targeting the Omicron BA.1 variant spike protein. The Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 variant compared to the companies’ current COVID-19 vaccine. The Omicron BA.1-adapted bivalent vaccine was well-tolerated with a favorable safety profile.
Following guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA), Pfizer and BioNTech submitted an application for the Omicron BA.1-adapted bivalent COVID-19 vaccine in July.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (Comirnaty®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
EUROPE
ABORTION ACCESS EXPANDED
Women in England and Wales will be able to permanently access early medical abortions at home from August 30.
New legislation will allow women to access pills for early medical abortion via a teleconsultation, and for both pills to be taken at home for gestation of up to 9 weeks and 6 days.
The update comes as all independent sector abortion clinics in England have been reapproved ensuring abortion services continue to be available to women across the country. All current approvals are valid until July 31, 2026.
Minister for Public Health, Maggie Throup, said, “The wellbeing and safety of women requiring access to abortion services is paramount. With these measures women will have more choice in how and where they access abortion services, while ensuring robust data is collected to ensure their continued safety.”
To ensure the continued safety of children and young people, the Royal College of Pediatrics and Child Health will publish safeguarding guidance for under-18s accessing early medical abortion services.
The guidance, which will be published shortly, reinforces the principles that every young person should have access to early medical abortions in a timely manner and that their holistic and safeguarding needs must be addressed by providers.
To effectively monitor the impact and use of at home early medical abortions, doctors will be required to include information on place of termination, place of consultation as well as whether the consultation was fully remote on abortion notification forms. This data will allow for analysis of trends in abortion provision as well as monitoring pathways for home-use abortions.
Doctors will also be required to certify in ‘good faith’ that the gestation period is below 10 weeks for abortion pills prescribed from home and if one or both pills are taken at a woman’s home.
The amendments to the notification forms and certification requirement are set out in the Abortion (Amendment) Regulations 2022. These changes follow a free vote by Members of Parliament in March 2022.
CARIBBEAN
MAN SCAMS ELDERLY CITIZENS
A Jamaican man pleaded guilty Aug. 19 in Miami federal court to participating in a lottery fraud scheme targeting elderly victims in the United States.
According to court documents, Greg Warren Clarke, 29, of Montego Bay, Jamaica, pleaded guilty to one count of conspiracy to commit mail and wire fraud for his role in a Jamaica-based fraudulent lottery scheme that convinced American victims – many of whom were elderly – to pay money to collect fictitious lottery winnings. An indictment was filed against Clarke in the U.S. District Court for the Southern District of Florida in April 2019 and unsealed upon his extradition to the United States, which occurred in May 2022.
“This guilty plea demonstrates the Justice Department’s dedication to prosecuting those responsible for fraudulent lottery schemes, even when they commit their crimes from foreign countries,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “We will continue to aggressively combat scams that seek to prey on older Americans.”
“The U.S. Postal Inspection Service stands ready to stop overseas criminals from illegally enriching themselves by using the mail to defraud consumers in the United States,” said Acting Inspector in Charge Juan Vargas of the U.S. Postal Inspection Service Miami Division. “We will continue to work with foreign governments to track down these criminals and bring them to justice.”
As part of his guilty plea, Clarke admitted that, from in or around September 2013, through in or around August 2015, he worked with co-conspirators, including Claude Anthony Shaw, in a scheme to defraud in which victims were called and falsely told that they had won over a million dollars in a lottery and needed to pay fees or taxes to claim their winnings. Victims were instructed to send their money through wire transfers or the mail to Shaw and other individuals. Clarke further admitted that, as part of the conspiracy, he and Shaw discussed (over the phone and through cell phone text messages) plans to receive victims’ money.
At Clarke’s direction, Shaw received money from victims through wire transfers and the mail. Clarke further admitted that he and Shaw discussed arrangements for victims to send money to other individuals with whom Shaw worked. Clarke then instructed Shaw to send the victims’ money to Clarke in Jamaica, usually through wire transfers. Victims who sent money to Clarke and his co-conspirators never received any lottery winnings.
Shaw previously pleaded guilty to mail fraud in the U.S. District Court in Fort Lauderdale. In June 2017, he was sentenced to 36 months in prison. Clarke is scheduled to be sentenced on Oct. 28.
Senior Trial Attorney Arturo DeCastro of the Civil Division’s Consumer Protection Branch is prosecuting this case. The U.S. Postal Inspection Service investigated the case.
The department’s extensive and broad-based efforts to combat elder fraud seek to halt the widespread losses seniors suffer from fraud schemes. The best method for prevention, however, is by sharing information about the various types of elder fraud schemes with relatives, friends, neighbors and other seniors who can use that information to protect themselves.
If you or someone you know is age 60 or older and has been a victim of financial fraud, help is available at the National Elder Fraud Hotline: 1-833-FRAUD-11 (1-833-372-8311). This Department of Justice hotline, managed by the Office for Victims of Crime, is staffed by experienced professionals who provide personalized support to callers by assessing the needs of the victim and identifying relevant next steps.
Case managers will identify appropriate reporting agencies, provide information to callers to assist them in reporting, connect callers directly with appropriate agencies and provide resources and referrals, on a case-by-case basis.
Reporting is the first step. Reporting can help authorities identify those who commit fraud, and reporting certain financial losses due to fraud as soon as possible can increase the likelihood of recovering losses. The hotline is open Monday through Friday from 10:00 a.m. to 6:00 p.m. ET. English, Spanish and other languages are available.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch. Information about the Department of Justice’s Elder Fraud Initiative is available at www.justice.gov/elderjustice.
