COVID-19 Boosters Available Now, May Become Annual

New COVID-19 booster shots are available now (or within days), according to a Biden administration briefing on the latest developments with the virus’ vaccines. What’s more, the public should expect regular annual booster shots against the virus will be necessary. “It is becoming increasingly clear, that looking forward with the Covid-19 pandemic, in the absence…

FDA Approves First COVID-19 Vaccine

The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, the first COVID-19 vaccine to move enjoy a status beyond emergency use status in the United States.

The Pfizer vaccine 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.

William A. Dombi, President of the National Association for Home Care & Hospice (NAHC) hailed the approval, calling the coronavirus vaccines “safe and vitally important for us to move beyond the COVID pandemic.”

From the beginning of the public health emergency, NAHC has been at the forefront of COVID-19 education and advocacy. You can learn more about coronavirus and care in the home at the following pages:

About 85 million eligible Americans remain unvaccinated and the federal government hopes FDA approval will encourage many of them to now get vaccinated. Those who continue to reject vaccination may face considerable problems keeping or getting jobs, as well as gaining access to some public facilities and private businesses.

A June 2021 Kaiser Family Foundation poll found about 30 percent of unvaccinated Americans would be more likely to get vaccinated if a vaccine receives regulatory approval.

The Equal Employment Opportunity Commission approved some COVID vaccine requirements and incentives, as we reported in this space back in early June.

FDA approval of the Pfizer vaccine is likely to trigger a wave of vaccine requirements by cities, businesses, universities, health care systems and organizations, and more. The Veterans Administration became the first federal agency to require the COVID vaccine for employees, followed quickly by the Department of Defense, and the Department of Health & Human Services health care workers. The Pentagon vaccine requirement covers 1.3 million active duty troops and comes into effect after approval of the first vaccine, which has just occurred.

California has come close to a vaccine mandate for health care workers, while Oregon has created a vaccine mandate for schoolteachers and staff in public schools from kindergarten through 12th grade.

United Airlines recently announced it will require all employees to show proof of vaccination within five weeks of FDA approval of a vaccine.

“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.”

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.

“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.”

According to Pfizer, it showed the FDA data from 44,000 clinical trial participants in the United States, South America, European Union, Turkey, and South Africa, demonstrating the vaccine is 91 percent effective in preventing infection.

As NAHC Report reported on Wednesday, August 18, the Biden Administration has developed a plan to begin offering COVID-19 booster shots this fall, subject to an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines, and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence.

The National Association for Home Care & Hospice has strongly communicated to HHS how important it is that shipments of booster vaccines be sent directly to home care providers, so that safe and efficient booster vaccinations of the elderly and disabled – the most at-risk population – can take place in the home. NAHC will continue to make this case and we will keep our members up to date on this critically important topic.

“We look forward to working with the Administration to get vaccines to a very vulnerable group of individuals who, in many cases, are homebound and cannot otherwise secure the life-saving Covid vaccines and booster shots,” said NAHC President Bill Dombi, in response to the news.

FDA Approves First COVID-19 Vaccine

The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older, the first COVID-19 vaccine to move enjoy a status beyond emergency use status in the United States. The Pfizer vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16…

Administration Announces Plan for COVID-19 Booster Shots in Late September

The Department of Health & Human Services (HHS) announced today the Biden Administration has developed a plan to begin offering COVID-19 booster shots this fall, subject to an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines, and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence.

The National Association for Home Care & Hospice has strongly communicated to HHS how important it is that shipments of booster vaccines be sent directly to home care providers, so that safe and efficient booster vaccinations of the elderly and disabled – the most at-risk population – can take place in the home. NAHC will continue to make this case and we will keep our members up to date on this critically important topic.

“We look forward to working with the Administration to get vaccines to a very vulnerable group of individuals who, in many cases, are homebound and cannot otherwise secure the life-saving Covid vaccines and booster shots,” said NAHC President Bill Dombi, in response to the news.

The booster shots would begin to be offered to Americans in the week of September 20, in response to evidence that protection against the novel coronavirus COVID-19 could wane over time. The highly contagious delta variant of the virus continues to ravage parts of the country, particularly among unvaccinated persons.

“Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout,” read a joint statement by federal health officials on Wednesday, August 18. (You can read the entire statement at the end of this article.)

Persons will be eligible for a third dose of Pfizer-BioNTech or Moderna shots eight months after they received their second dose. Additional shots are already being administered to people with compromised immune systems.

It is likely the boosters will be offered first to health care workers, people over 65, and nursing home residents, similar to the original rollout of the vaccines.

“We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that Covid-19 poses to them,” read the joint statement.

While the plan announced today does not include the Johnson & Johnson vaccine, it is believed booster shots will also be needed for the group that received that vaccine. Health officials are waiting for more data on the effectiveness of the J&J vaccine, which should be coming within the next few days.

It is important to note that the current vaccines continue to offer excellent protection. The vaccines provided a 95 percent protection against hospitalization before the delta variant and 92 percent protection against hospitalization during the delta variant.

Only after a thorough review of the evidence will CDC’s independent advisory committee make recommendations on the use of boosters for the public.

The Advisory Committee on Immunization Practices (ACIP), composed of medical and public health experts, develops recommendations, and provides guidance to the CDC Director on the use of vaccines for the general public.

For more information, please check the NAHC COVID-19 Vaccine and Resources page and the Coronavirus Resources page.

The full statement from Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC); Dr. Janet Woodcock, Acting Commissioner, Food and Drug Administration (FDA); Dr. Vivek Murthy, U.S. Surgeon General; Dr. Francis Collins, Director of the National Institutes of Health (NIH); Dr. Anthony Fauci, Chief Medical Advisor to President Joe Biden and Director of the National Institute of Allergy and Infectious Diseases (NIAID); Dr. Rachel Levine, Assistant Secretary of Health; Dr. David Kessler, Chief Science Officer for the COVID-19 Response; and Dr. Marcella Nunez-Smith, Chair of the COVID-19 Health Equity Task Force, is below.

“The COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant. Recognizing that many vaccines are associated with a reduction in protection over time, and acknowledging that additional vaccine doses could be needed to provide long lasting protection, we have been analyzing the scientific data closely from the United States and around the world to understand how long this protection will last. The available data make very clear that protection against SARS-CoV-2 infection does begin to decrease over time following the initial vaccinations given, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease. Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and stay ahead of the virus.

“We have developed a plan to begin offering these booster shots this fall once FDA conducts an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issues booster dose recommendations based on a thorough review of the evidence. We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster. We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them.

“We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine. Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.

“Our top priority remains staying ahead of the virus and protecting the American people from COVID-19 with safe, effective, and long-lasting vaccines especially in the context of a constantly changing virus and epidemiologic landscape. We will continue to follow the science on a daily basis, and we are prepared to modify this plan should new data emerge that requires it.

“We also want to emphasize the ongoing urgency of vaccinating the unvaccinated in the U.S. and around the world. Nearly all the cases of severe disease, hospitalization, and death continue to occur among those not yet vaccinated at all. We will continue to ramp up efforts to increase vaccinations here at home and to ensure people have accurate information about vaccines from trusted sources. We will also continue to expand our efforts to increase the supply of vaccines for other countries, building on the more than 600 million doses we have already committed to donate globally.”

Administration Announces Plan for COVID-19 Booster Shots in Late September

NAHC: Providers of care in the home need access to COVID-19 booster vaccines Full information on the NAHC COVID-19 Vaccine and Resources page The Department of Health & Human Services (HHS) announced today the Biden Administration has developed a plan to begin offering COVID-19 booster shots this fall, subject to an independent evaluation and determination…