FDA Approves First Covid Vaccine
The FDA had 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.
Below is a letter sent to Healthcare Providers on Friday, 8/20/2021 from Larry Madoff, MD, Medical Director, Bureau of Infectious Disease and Laboratory Sciences and Catherine M. Brown, DVM MSc MPH, State Epidemiologist regarding COVID-19 Additional Dose Vaccination Guidance for Immunocompromised Individuals:
Information from the Massachusetts COVID-19 Vaccine Program COVID-19 Additional Dose Vaccination
Guidance for Immunocompromised Adults
Dear Healthcare Provider,
On Friday, August 13, 2021 the Centers for Disease Control and Prevention (CDC) recommendeda third dose of Moderna or Pfizer COVID-19 vaccine for certain individuals. People who are moderately or severely immunocompromised are more likely to have serious disease with COVID-19 and are less likely to develop adequate immunity in response to the two-dose series of Moderna or Pfizer vaccines. Recent data suggest that such individuals may get more protection from a 3rd dose. An additional dose is recommended for people who have already received a primary series with either of the Pfizer or Moderna COVID-19 vaccine and who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments. These conditions and treatments include but are not limited to:
- Active cancer treatment for tumors or cancers of the blood
- Organ transplant and are taking medicine to suppress the immune system
- Stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
- Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response
There is currently no recommendation for immune compromised individuals who received the Janssen (Johnson & Johnson) vaccine to receive an additional dose. There is ongoing investigation of this and will follow up with any additional information.
Also, please note that this recommendation for additional doses of COVID-19 vaccine for immune compromised individuals is distinct from booster doses that may soon be recommended for many individuals at a certain time after primary vaccination. Boosters are NOT currently available, and we are awaiting further guidance from federal authorities.
Because some of your patients may have compromised immune systems and be clinically appropriate for a third dose of Moderna and Pfizer, the Massachusetts Department of Public Health (MDPH) is sharing the following action steps you should take to ensure that all individuals are sufficiently vaccinated.
- Identify and contact such clinically appropriate individuals using your medical records or electronic health record systems.
- Offer an additional dose to these individuals at your practice location during routine care or through special vaccination clinics for these individuals.
- If the patient is unable to come to your practice location for vaccination, encourage additional dosing at a retail pharmacy or any other site for which the patient is eligible using http://vaxfinder.mass.gov or http://www.vaccines.gov.
- In-home vaccinations are available for anyone who is unable to get to a vaccine location. Patients or providers may call the In-Home Vaccination Central Intake Line at (833) 983-0485. Representatives are available Monday through Friday from 9 a.m. to 5 p.m.
As a reminder, any provider who would like to order COVID-19 vaccines must be registered with the MIIS and have a completed Massachusetts COVID-19 Vaccine Program (MCVP) agreement. If your practice is not MCVP enrolled, contact the MDPH Vaccine Unit at 617-983-6828 or DPH-Vaccine-Management@mass.gov.
All providers receiving COVID-19 vaccine will order vaccine directly from the MIIS and must comply with MCVP guidelines and the following requirements:
Registration for the 26th Annual MIAP Pediatric Immunization Skills Building Conference is now open!
Please see the letter below from Cynthia McReynolds of the Massachusetts Chapter of the American Academy of Pediatrics (MCAAP) Immunization Initiative regarding their upcoming conference. While this conference is focused on pediatrics, I know that many of our members would be interested in attending. If you have any questions, please contact Cynthia McReynolds: email@example.com.
Dear Immunization Colleague,
You are invited to attend the 26th Annual MIAP Pediatric Immunization Skills Building Conference on Thursday, October 28, 2021. This Conference is organized by the Massachusetts Immunization Action Partnership (MIAP) – The Massachusetts Chapter, American Academy of Pediatrics (MCAAP)
, the Massachusetts Department of Public Health (MDPH)
and individuals who share the mission to protect all citizens from vaccine-preventable diseases.
Visit our conference website
today Conference registration
is now open!
On October 28th, providers and advocates will meet for the annual MIAP Conference to support Massachusetts’ efforts to improve pediatric immunization rates. Due to the continuing COVID-19 pandemic, this year’s MIAP Conference will be held virtually using the Virtual Attendee Hub. This conference attracts physicians, nurses, nurse practitioners, physician assistants, medical assistants, community outreach and public health workers, immunization coalition members, and office staff who work in pediatric healthcare settings, healthcare and civic organizations.
Conference Plenary Speakers:
- Katherine Hsu, MD, MPH, FAAP
- Andrew Kroger, MD, MPH
- Paul Offit, MD
- Pejman Talebian, MA, MPH
- A. Patricia Wodi, MD
View our conference agenda
for more detailed schedule information.
Title: Important Information for Healthcare Providers about Moderna COVID-19 Vaccine
September 9, 2021, 12:00 PM ET, September 14, 2021 3:00 PM ET, September 15, 2021, 12:00 PM ET, September 16, 2021, 3:00 PM ET
Join Moderna for a webinar to learn about the investigational Moderna COVID-19 Vaccine, which hasbeen authorized for emergency use in the United States. There will be no continuing education offered for this webinar. Please register at the link below for one of our currently available dates/times.
Register Here: September 9
Register Here: September 14
Register Here: September 15
Register Here: September 16
Title: The Continued Threat of Influenza and How to Sustain Influenza Vaccination Efforts
September 9, 2021, 1:00 PM ET
The Immunization Action Coalition (IAC) will be holding two interactive webinars in September to emphasize vigilance in preventing influenza in the midst of the COVID-19 pandemic.
This first hour-long webinar will take place on Thursday, September 9 at 1 pm ET. The webinar will cover the following topics:
• influenza surveillance in US and worldwide;
• changes in circulation of other common respiratory pathogens, e.g., recent increases in RSV and other non-COVID-19 viruses;
• changes in vaccine strains and changes in influenza ACIP recommendations;
• the impact of influenza;
• communications issues providers may face with regards to perceptions of the need for influenza vaccination; and
• a public perspective on the importance of influenza vaccination and advocacy for vulnerable populations (chronic issues)
Title: Preventive Medicine Grand Rounds
September 1, 2021, 1:30 PM ET to 3:00 PM ET
Wyandotte County experienced the state of Kansas’ first death. Its residents, over half of whom are minorities, have been impacted by COVID-19 at disproportionally high rates. In response to these data, community members representing the diversity of the county’s neighborhoods partnered with the Unified Government of Wyandotte Health Department to launch a wide array of COVID-19 services despite a small budget and public health infrastructure.
Speakers will present their work, achievements, and next steps.
These Grand Rounds presentations are provided as a courtesy of CDC’s Preventive Medicine Residency and Fellowship (PMR/F) program with the goal of sharing systems-based approaches and leadership practices to address population health issues and public health emergencies.
Continuing education (CE) is available and there is no cost for this activity. For more details, go to https://www.cdc.gov/prevmed/pmgr/upcoming-lectures.html.
For More Information
Please contact the PMR/F program at firstname.lastname@example.org or visit the Preventive Medicine Grand Rounds web page.
Title: Partisan Divides and How to Improve Vaccination Rates
September 1, 2021, 3:00pm ET to 4:00pm ET
The Indiana Immunization Coalition
is offering a webinar titled How Political Partisanship Impacts Vaccination
on September 1 at 3:00 p.m. (ET). This webinar featuresBrian Castrucci, DrPH, MA, President and chief executive officer of the de Beaumont Foundation. He will discuss how partisan divides may be affecting herd immunity, and how to achieve the best public health outcomes.
Brian is an award-winning epidemiologist with ten years of experience working in state and local health departments. Brian brings a unique perspective to the philanthropic sector that allows him to implement visionary and practical initiatives and partnerships and bring together research and practice to improve public health.
Brian has published more than seventy articles in the areas of public health systems and services research, maternal and child health, health promotion, and chronic disease prevention. His recent work has focused on the public health needs of large cities, the need for better data systems, and public health system improvements.
CME, CNE, and Pharmacy Continuing Education will be offered.
Link to most recent Immunization MMWRs
August 18, 2021 (EARLY RELEASE)
to view all recent MMWRs!