J&J Seeks US Clearance for COVID-19 Vaccine Booster Doses

J&J seeks US clearance for COVID-19 vaccine booster doses
By MATTHEW PERRONE AP Health Writer
WASHINGTON (AP) — Johnson & Johnson has asked U.S. regulators to allow booster shots of its COVID-19 vaccine as the U.S. government moves toward shoring up protection in more vaccinated Americans. J&J said Tuesday it filed data with the Food and Drug Administration on giving a booster dose between two to six months after vaccination. The U.S. government last month authorized booster doses of Pfizer’s vaccine in vulnerable groups. A panel of FDA advisers meets next week to consider boosters for both J&J and Moderna vaccines. It’s part of a sweeping effort by the Biden administration to boost protection amid the delta variant and potential waning of vaccine strength.

Merck says experimental pill cuts worst effects of COVID-19

Merck says experimental pill cuts worst effects of COVID-19
By MATTHEW PERRONE AP Health Writer
WASHINGTON (AP) — Pharmaceutical company Merck says its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus. The company said it would soon ask health officials in the U.S. and around the world to authorize its use. Merck’s drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic. The study results were released by the company and have not been peer reviewed. An independent group of medical advisers monitoring the trial recommended stopping it early because the interim results were so strong.

Allegheny County Government Workers Face Vaccine Mandate

Allegheny County government workers face vaccine mandate
PITTSBURGH (AP) — Allegheny County government employees will be required to submit proof of COVID-19 vaccination by Dec. 1 or face termination. County Executive Rich Fitzgerald announced the policy on Wednesday. About 5,000 employees are subject to the mandate, of whom more than 75% are already vaccinated.  Officials say the rest will need to get the single-shot Johnson & Johnson vaccine or their second dose of the Moderna or Pfizer vaccines on or before Dec. 1 to be considered in compliance. County officials cite the rise of the highly contagious delta variant, which has led to increased caseloads, hospitalizations and deaths.

PA Lawmakers keep COVID-19 regulatory waivers for 6 more months

Lawmakers keep COVID-19 regulatory waivers for 6 more months
By MARC LEVY Associated Press
HARRISBURG, Pa. (AP) — Pennsylvania’s Republican-controlled Legislature is again extending hundreds of regulatory waivers that Gov. Tom Wolf’s administration had approved under its pandemic-related disaster emergency authority. Lawmakers voted unanimously Wednesday to add another six months to a prior extension they granted, as the delta variant of the coronavirus is causing a statewide surge in COVID-19 cases, hospitalizations and deaths. Lawmakers in June voted to end Wolf’s pandemic-related disaster emergency declaration, under new authority handed to them by voters. At the same time, lawmakers extended the hundreds of regulatory waivers through September. The power to suspend regulations are the key component of a governor’s authority under a disaster declaration.

Department of Health Releases Vaccination Dashboard by Legislative Districts

(Harrisburg, Pa.) The creation of the legislative district vaccine dashboard is the latest information provided to the General Assembly following their request seeking data on COVID-19 from the Department of Health (DOH) as stated in a September 10 letter from Gov. Wolf. Additionally, last week, DOH shared a breakthrough case data report showing since January 2021, 97 percent of COVID-19-related deaths and 95 percent of reported hospitalizations due to COVID-19 were in unvaccinated or not fully vaccinated people.

“The overwhelming majority of the COVID-19 related cases, hospitalizations and deaths in Pennsylvania occurred in people who were not vaccinated,” said Gov. Wolf. “In fact, the data shows that compared to unvaccinated people, fully vaccinated folks are seven times less likely to get COVID-19, and eight times less likely to die from COVID-19. We urge all Pennsylvanians who are not yet vaccinated to get their shot today.”

To keep all Pennsylvanians informed, the Department of Health provides daily and weekly updates to the COVID-19 Dashboard, the Early Warning Monitoring Dashboard  and the COVID-19 Vaccine Dashboard. These resources include significant statewide and county level case, death, hospitalization and vaccination information.

Allegheny Health Network Advances COVID-19 Booster Vaccine Campaign to Expanded Eligible Groups

Following CDC and FDA Emergency Use Authorization of Pfizer Third Dose Vaccinations, AHN Will Begin to Administer Booster Shots to Those Older than 65 Years and High-Risk Populations

PITTSBURGH (September 27, 2021)– Following emergency use authorization (EUA) by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) of the third dose of the Pfizer-BioNTech vaccination series on Friday, Allegheny Health Network (AHN) clinicians will begin to provide boosters today to expanded eligible groups including those over 65-years-old, individuals from 18 to 64 years with underlying health conditions and those who are at increased risk of COVID-19 transmission from their occupation, such as frontline healthcare workers.

AHN will host a series of employee-only vaccination clinics across its hospitals while also offering scheduling online and via phone to newly eligible groups for booster shots. Eligible patients can schedule by calling their primary care physician’s office, visiting the Network’s online scheduling portal at ahn.org/coronavirus/vaccine/schedule or accessing their MyChart accounts. COVID-19 boosters will primarily be administered across primary care and hospital-based vaccine clinics. 

Only individuals who initially received the Pfizer COVID-19 vaccination series will be eligible for their booster shot as part of this latest EUA; patients must wait at least six months from their second vaccine dose to also be eligible. 

“As one of the most prominent COVID-19 vaccines administers in the region, AHN is uniquely positioned to provide booster shots swiftly and efficiently to this newly expanded eligible group. We’ve been preparing for months to transition vaccine supply into the primary care and outpatient offices as well as our hospital-based clinics to help ensure seniors, essential workers and those at highest risk have timely and convenient access to booster shots during yet another critical time of this pandemic,” said Amy Crawford-Faucher, MD, family care physician and vice chair of the AHN Primary Care Institute.

To date, more than 680,000 Americans have died from COVID-19 while more than 4.5 million people have died from the disease worldwide. However, since the emergency use authorization of the Pfizer-BioNTech, Moderna and Johnson & Johnson COVID-19 vaccinations, just 55.5 percent of Americans are fully vaccinated according to Johns Hopkins data. Amid the Delta variant, these numbers have resulted in the latest COVID-19 surge across the country, with hospitalizations occurring predominately in unvaccinated populations.

Data released from the CDC in August noted a 30 percent decrease in vaccine effectiveness against the COVID-19 Delta variant among its studied cohort of approximately 4,000 frontline healthcare workers who received their initial vaccinations in December 2020. Another CDC study found 25% of new infections between May and July of this year were among fully vaccinated people signaling the potential need for an added layer of protection against the Delta variant as well as forthcoming strains. However, it’s important to note that receiving the COVID-19 series, both first and second doses, remains the most effective way to prevent transmission, severe illness, hospitalization and death even against forthcoming strains. 

“We strongly encourage everyone who is eligible to receive their booster shot to protect themselves and help to minimize the risk of wide-spread community transmission, hospitalizations and severe illness. As the holiday season quickly approaches, receiving the full series of the COVID-19 vaccine is the best thing someone can do to save lives, decompress hospital systems and help bring the pandemic to an end,” said Imran Qadeer, MD, chief medical officer of AHN’s Allegheny General Hospital.

In August, Pfizer and Moderna COVID-19 vaccines received EUA as booster shots for immunocompromised individuals. Pfizer’s clinical trials in particular documented that  a third dose in its vaccination series spurred a more than threefold increase in antibodies against COVID-19. AHN began has administered nearly 700 booster shots to immunocompromised patients to date.

Those receiving their third dose may experience mostly mild to moderate symptoms which will often mimic the side effects originally felt during the first and second doses i.e. soreness at the injection site, feeling of general malaise for one to two days, etc. Doctors say these side effects once again signal the expected immune reaction.

For more information on AHN and the Network’s coronavirus resources, please visit https://www.ahn.org/coronavirus.html.

Gov. Wolf: 85 Percent of Pennsylvanians have Received First COVID-19 Vacccine

(Harrisburg, Pa.) Governor Tom Wolf announced on Friday, Friday September 24, 2021 , that 85 percent of Pennsylvanians aged 18 and older have received their first COVID-19 vaccination.

Gov. Wolf said via release “I would like to thank all Pennsylvanians who have done their part to stop the spread of the virus and strongly encourage all eligible Pennsylvanians who have not yet gotten vaccinated to do so as soon as possible.”

As of Friday Pennsylvania vaccine providers have administered 12,645,207 COVID-19 vaccines. The commonwealth ranks 9th nationally in first doses administered.

Last week, the Pennsylvania Department of Health announced that, since January 2021, 97 percent of COVID-19-related deaths and 95 percent of reported hospitalizations due to COVID-19 were in unvaccinated or not fully vaccinated people.

To find a vaccine provider near you, visit vaccines.gov.

Pa Attorney General Shapiro Says Health Secretary Does Have Power to Order Making Mandate.

(Harrisburg, Pa.) Pennsylvania’s Attorney General Josh Shapiro is weighing in on the legality of Acting Secretary of Health Alison Beam’s masking order in schools. Shapiro’s office has filed a brief in Harrisburg that says Beam does have the power to mandate masks.
The letter is in response to a lawsuit that claims she does not have the power to order a mask mandate. The lead plaintiff is State Senate President Pro Tempore Jake Corman said Beam needs to follow regulatory laws on school masks, but Shapiro said she already has that power.

A judge in Commonwealth Courts will ultimately decide soon who is right in the case.

President Biden Doubling Vaccine Purchase, Calls for More Global Shots

By ZEKE MILLER Associated Press
President Joe Biden is set to announce that the U.S. is doubling, to 1 billion doses, its purchase of Pfizer’s COVID-19 shots to share with the world. Biden is also set to embrace a goal of vaccinating 70% of the global population within the next year. The stepped-up U.S. commitment will be the cornerstone of a global vaccination summit the president is convening virtually Wednesday on the sidelines of the U.N. General Assembly. Biden will push well-off nations to do more to get the coronavirus under control around the world. Word of Biden’s plan comes from two senior Biden administration officials who spoke on the condition of anonymity to preview the president’s remarks.

Pennsylvania Ready to Provide COVID-19 Booster Shots Upon CDC Authorization

(Photo Courtesy of Pa Media Services)

Hershey, PA – Acting Secretary of Health Alison Beam today signed an order to ensure that vaccine providers are prepared to start COVID-19 booster shots as soon as the Centers for Disease Control and Prevention (CDC) issues the necessary federal guidance.

“Pennsylvania is well prepared to start providing vaccine booster shots just as soon as the CDC provides the approval and guidelines on who can get it,” Beam said during a news conference at the Hershey Pharmacy. “Vaccine providers — especially pharmacies — have already done a tremendous job administering more than 12 million vaccines across the state. Now they are ready to get booster shots to people as quickly and efficiently as possible.”

The CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to discuss boosters on Sept. 22 and 23 and is expected to make recommendations and provide guidance to vaccine providers following the meeting.

The Department of Health’s order requires vaccine providers, as possible, to:

  • provide online scheduling for vaccination appointments,
  • provide a telephone number, with prompts to a live agent during normal business hours, to assist in scheduling appointments,
  • offer walk-in appointments, and
  • work with local Area Agencies on Aging (AAA) and Medical Assistance Managed Care Organizations (MCO) to help schedule eligible adults and people who cannot leave their homes.

“COVID-19 vaccines do work,” Hershey Pharmacy Owner and Pharmacist Chuck Kray said. “They are safe and highly effective at preventing serious illness. We are seeing the highly contagious Delta variant and it is sending case numbers soaring throughout our area. Getting the vaccines and the booster shot will protect not only you, but your loved ones during this spike.”

“Our team is still administering about 100 shots per week in Hershey Pharmacy and at area nursing facilities, clinics and schools,” Kray said. “We are ready to begin administering the boosters as soon as the federal government gives us the go ahead and guidelines. Please, do your part and get vaccinated in this fight to end the pandemic.”

There are currently more than 2,000 vaccine providers across the state with COVID-19 vaccine inventory. To date, vaccine providers have administered 12.6 million total vaccine doses. More than 6.1 million Pennsylvanians are fully vaccinated; with a seven-day moving average of more than 15,600 people per day receiving vaccinations.

“The data is abundantly clear that COVID-19 vaccines are safe and effective at preventing hospitalization and death,” said Acting Physician General Dr. Denise Johnson. “We continue to urge every eligible person to get the vaccine, not only for themselves, but to protect their family and loved ones, especially kids under 12 who are too young to get the vaccine, which is in plentiful supply across the state.”

Last week, the Pennsylvania Department of Health announced that, since January 2021, 97 percent of COVID-19-related deaths and 95 percent of reported hospitalizations due to COVID-19 were in unvaccinated or not fully vaccinated people.

To find a vaccine provider near you, visit vaccines.gov.