Today, the U.S. Food and Drug Administration 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.

A retired detective captain with the Massachusetts State Police has been arrested and arraigned in connection with allegedly possessing child pornography, Attorney General Maura Healey announced today.

Francis Hart, 60, of Amherst, was arraigned today in Eastern Hampshire District Court on the charge of Possession of Child Pornography (2 counts). Hart pleaded not guilty to the charge and was released after posting a $2,500 cash bail with the conditions that he have no contact with any child under the age of 18 and have no internet access other than on public devices that prohibit access to illegal sites or illegal content.

Hart will be back in Eastern Hampshire District Court on October 22 for a pretrial conference.

State Police assigned to the Cyber Crimes Unit and the AG’s Office began an investigation in January after receiving information from the National Center for Missing and Exploited Children that an email address registered to Hart had uploaded a file containing numerous images of suspected child pornography.

Hart was arrested Thursday at his Amherst residence. During the execution of a search warrant, police seized various digital devices. Subsequent investigation of the devices revealed alleged images of child pornography.

This investigation is ongoing. These charges are allegations and the defendant is presumed innocent until proven guilty.

This case is being prosecuted by Assistant Attorneys General Colleen Monroe and Stephanie Jimenez, both of AG Healey’s Criminal Bureau, with assistance from Massachusetts State Police assigned to the AG’s Office, Massachusetts State Police Cyber Crimes and Internet Crimes Against Children Task Force, Amherst Police, and the AG’s Digital Evidence Laboratory.

“On August 19th at approximately 19:30 hrs., north end units responded to 206 Ashley Blvd., #3S on reports of someone breaking into an apartment.

Upon arrival, the suspect was still on scene next to a kicked-in door and the apartment was in disarray. Arrested was Mr. EDDIE CAMACHO, 44 of 14 Allen St., #2. The arresting officer was Ofc. Kory Kubik.”-New Bedford Police Department.

New Bedford police detectives have arrested a New Bedford man on firearm and drug distribution-related charges.

On August 18th, gang and narcotics detectives assigned to the Organized Crime Intelligence Bureau executed a search warrant at 53 Ruth St., #3. The target of the investigation was DAMARION WOODLEY,18.

As a result of the search, a 9 mm firearm, 8 rounds of 9mm ammunition, and 45 rounds of 45 caliber ammunition was located. Also discovered was 17.6 grams of crack cocaine,1 Percocet and 42.7 grams of marijuana along with scales and packaging materials. $838.00 was also seized as a result of drug proceeds.

The arresting officer was Det. Nathaniel Almeida.

New Bedford police officers remain committed in their efforts to take illegal guns off of the street before they can be used in tragedy. If you have any information on criminal activity in your neighborhood, the New Bedford Police Dept. wants to hear from you. You can leave an anonymous tip on our voicemail at (508) 991-6300 Ext. 1.

Mayor Jon Mitchell announced Saturday a series of precautions New Bedford is taking in anticipation of Hurricane Henri. Hurricane Henri is expected to hit New Bedford as a tropical storm late Saturday evening and could bring a potential for tropical storm force winds, heavy rain, and high storm surges.

Beaches, CoveWalk, HarborWalk, and Fort Taber Closed to Public Effective Saturday, August 21 at 8:00pm

City beaches, CoveWalk, HarborWalk, and Fort Taber will be closed to the public effective Saturday, August 21, 2021 at 8:00p.m. Police will be making regular patrols of the South End beaches, HarborWalk, CoveWalk, and Fort Taber, and will remove people from those areas. The storm is expected to cause surges anywhere from 3-5 feet high.

Anticipated Closure of the New Bedford Hurricane Barrier

The Army Corps of Engineers may make a determination on the closure the New Bedford Hurricane Barrier based on the storm surge. Mayor Mitchell has urged all vessel owners to plan to be inside the harbor with all deliberate speed. The City may decide to close the barrier street gates at Padanaram Avenue, West Rodney French Boulevard or East Rodney French Boulevard, based on the severity of any storm surge.

Vaccine and Testing Clinics Cancelled for Sunday, August 22

Previously scheduled vaccine clinics on Sunday, August 22, 2021 at the Fisherman’s Memorial and YMCA will be canceled.

Covid testing at the New Bedford Regional Airport is also canceled on Sunday, August 22, 2021 and Monday, August 23, 2021.

Buttonwood Park Zoo Closed on Sunday, August 22, 2021

Buttonwood Park Zoo will be closed to the public on Sunday, August 22, 2021.

New Bedford Regional Airport Remains Open As Long as Safe

The New Bedford Regional Airport will remain in operation for as long as it remains safe. Passengers should contact their air carriers, including Cape Air, directly to confirm their flight status.

Trash Collection Schedule Delayed By One Day

The normal trash collection schedule will be delayed by one day. If your trash is normally collected on Monday, it will be collected on Tuesday this week. If your trash is normally collected on Tuesday, it will be collected on Wednesday this week, and so on. Residents whose trash is normally collected on Monday are urged not to put their trash out Sunday night.

City Office Closures on Monday, August 23, 2021

Mayor Mitchell will decide on the closure of city offices for Monday, August 23, 2021, on Sunday, August 22, 2021.

Hurricane Preparedness Tips for Residents and Business Owners

Mayor Mitchell advises residents and business owners to review the “Hurricane Preparedness Checklist” available on the city webpage (www.newbedford-ma.gov) and to take proactive steps to protect their property from potential heavy rain and wind damage.

Important Emergency Contact Numbers

· To report a downed power line, medical, fire or other emergencies please dial 911.

· Eversource is prepared to address any damage and outages resulting from the storm and encourages customers whose electric service is affected to call 1-800-592-2000. Eversource strongly urges people to stay away from all down wires and to report them immediately.

· New Bedford Police Department can also be reached on its non-emergency line at (508) 991-6350.

· Please visit the City’s website at www.newbedford-ma.gov for more information and updates regarding Hurricane Henri.

The Mayor will continue to update the public throughout the storm as necessary.

Update from the National Weather Service Boston: a slight shift west from the last update, but Massachusetts will still be impacted. Henri will make landfall near eastern LI ~ 2pm Sunday. A Flood Watch, Hurricane Warning, Tropical Storm Warning, and Storm Surge warning are all in effect.

Storm timing will be Sunday into early Monday, with heavy rain possibly lingering into Monday as Henri weakens rapidly over land.

Threats include: Heavy rain leading to flash flooding, storm surge (though arrival near low tide may help mitigate), and damaging winds leading to power outages.

Make final preparations before the storm’s arrival visit the Massachusetts Emergency Management Agency’s dedicated page of hurricane safety tips.

From the Massachusetts State Police: “We will adjust deployment of assets as necessary per the storm’s track and timing, a process that has already begun. We have moved additional Marine Unit assets into southeastern Massachusetts and will be prepared to move additional personnel or equipment to the islands if necessary.

Additionally, our Field Troops that cover coastal communities from the South Shore north to the New Hampshire line will be prepared to assist DCR and local communities with flooding response. Additional MSP sections and units will have personnel ready to deploy into affected areas to boost staffing, and Troop commanders will determine whether to hold over shifts or call in upcoming shifts early based on storm projections.

The MSP Air Wing will be standing by for any post-storm damage assessments that may be necessary. Please follow guidance from MEMA and the National Weather Service to ensure safety.”

National Weather Service photo.

National Weather Service photo.

National Weather Service photo.

Governor Charlie Baker today is urging the people of the Commonwealth to prepare for Hurricane Henri, which is expected to affect much of the Commonwealth beginning Saturday night into Monday, including the potential for strong winds, heavy rain, flooding and power outages.

The Baker-Polito Administration is advising everyone to avoid unnecessary travel and for those planning to visit the Cape or Islands this weekend to delay trips. For those that have already traveled to the Cape or Islands for the weekend, they are advised to consider leaving on Saturday or extend their travel plans through early next week.

Governor Baker also today activated the Massachusetts National Guard under state active duty to fulfill highwater rescue, debris clearing and public safety support from impacted communities. The activation order allows for up to 1,000 guardsmen and will remain in place until support is no longer needed.

Tropical Storm Henri is projected to become a hurricane and significantly impact much of Central and Eastern Massachusetts, including Cape Cod and the Islands, and the South Coast. Hurricane force winds and substantial storm surges in coastal communities are expected. Additionally, the majority of Massachusetts is projected to receive a significant amount of rain, particularly from Greater Boston to Worcester County. All residents are advised to begin storm preparations today, and to pay close attention to local weather reports to monitor the track of the storm.

Residents can call 2-1-1 to obtain disaster information and call local public safety non-emergency phone numbers or town halls for local questions. Property owners are encouraged to take photos or videos to document any damages to property and to contact their insurance company.

This storm could cause power outages impacting at least 100,000 residents, and possibly as many as 300,000, and utility crews are being staged to assist in restoring power. For power outage updates and specific restoration times by town, check the Eversource outage map at outagemap.eversource.com or call Eversource at 800-592-2000. Residents should use generators and grills outside because their fumes contain carbon monoxide and make sure their carbon monoxide detectors are working. People are also reminded to stay away from any downed utility wires.

The Baker-Polito Administration remains in close contact with the Massachusetts Emergency Management Agency (MEMA), National Weather Service, Massachusetts Department of Transportation (MassDOT) and State Police (MSP) to monitor the forecast and will work to alert the public with important updates or notifications.

MBTA: The MBTA is currently operating normal scheduled service on all modes, but anticipates delays or service disruptions, particularly in low-lying areas and sections of the rapid transit system where trains are powered by overhead wires. Keolis and the MBTA will closely monitor weather forecasts to assess expected and real-time conditions related to scheduled service and operations. The MBTA is encouraging its customers to get service information by signing up for T-Alerts, following @MBTA and @MBTA_CR on Twitter, and using the MBTA commuter rail app.

Highway Safety: Traveling during the storm is expected to be hazardous, and residents are advised to plan ahead and stay home if possible. Do not drive in flooded areas. Currently, it is projected that the Route 128/95 and Interstate 495 corridors will be heavily impacted Sunday through Monday.

Public Safety: In addition to 1,000 National Guard personnel available to assist local and state agencies, Massachusetts State Police have moved additional Marine Unit assets into southeastern Massachusetts and will be prepared to move additional personnel or equipment to the islands if necessary. Additional MSP sections and units will have personnel ready to deploy into affected areas to boost staffing, and Troop commanders will determine whether to hold over shifts or call in upcoming shifts early based on storm projections. The Department of Fire Services likewise remains in contact with fire departments on Cape Cod and elsewhere to provide support before, during, and after the storm.

DCR Closures: The Department of Conservation and Recreation (DCR) will close state campgrounds beginning Saturday at 11:00 a.m. through Monday evening. DCR anticipates reopening campgrounds Tuesday morning. Campers with reservations are being notified by DCR and will be provided with a full refund. All campers on DCR campgrounds must check out and exit the property by 11:00 a.m. on Saturday. Beginning Saturday at the close of guarded hours, DCR will close all state pools and coastal beaches through Sunday. Additionally, all DCR-managed inland waterfronts will be unguarded on Sunday. DCR strongly encourages residents to avoid visiting state parks throughout the duration of the storm due to high winds rain, and potential flooding, and will implement closures of certain access roads, parking areas and parkways as necessary to protect public safety.

The State Emergency Operations Center at MEMA Headquarters in Framingham is activated and closely monitoring the storm and forecast to provide situational awareness. Please visit www.mass.gov/MEMA to learn what you should do before, during and after a hurricane or tropical storm.

“A few minutes ago a Barnstable Superior Court jury ensured justice for the family of slain Yarmouth Police Department Sgt. Sean Gannon and his wounded K9 partner Nero, returning a guilty verdict on a charge of second-degree murder and six other indictments against Thomas Latanowich.

Jurors followed the facts and evidence outlined during an excellent trial presentation by the office of Cape and Islands District Attorney Michael O’Keefe. We commend and thank the investigative and prosecution team that secured justice for Sgt. Gannon and Nero.

We are proud of the strong and tireless work done by local police and Troopers, including Yarmouth Officers and our MSP homicide detectives, our Crime Scene Services Section, and our Ballistics Unit.

No verdict can return Sgt. Gannon to his family and his Department. But we hope those who knew Sean, and whose love for him will always endure, take what comfort they can find in knowing that the violent criminal who killed him and wounded his dog has been held accountable for his despicable and cowardly act.
#justice
#SeanGannon
#K9Nero”-Massachusetts State Police.

“The Massachusetts State Police Special Tactical Operations Team last night took a barricaded suspect into custody following negotiations with the man at a West Brookfield residence.

At approximately 7:25 p.m., at the request of West Brookfield Police, the MSP STOP Team and Crisis Negotiation Unit responded to the home, where an adult male with a reported history of weapons possession was threatening to shoot anyone who came to the door. Troopers from the State Police Bomb Squad also responded to assist with one of the unit’s robotic platforms.

Lengthy negotiation was conducted with the man in an attempt to persuade him to surrender peacefully. Eventually with assistance from an MSP negotiator, conditions for a STOP Team entry were optimized; Troopers made entry and secured the man without incident. The man was transferred to the custody of local police and was expected to be subject to a medical commitment.

The close coordination between State and local police and among various units allowed for the peaceful resolution to the situation.”-Massachusetts State Police.

“As sometimes good deeds go unnoticed, I wanted to make sure that this one did not.

Today, a young mother and her infant child broke down in Dartmouth. Upon informing Sergeant DaCosta that she could not afford to pay for the tow, he told her that he would pay for it.

After Adam Simmons of West End Towing arrived on scene, Sergeant DaCosta advised him of the situation, and, without hesitation, Adam advised Sergeant DaCosta that he was going to tow the vehicle free of charge.

Kudos to both Sergeant DaCosta and Adam Simmons for the compassion and generosity that they displayed to this woman ?”-Dartmouth Police Department.