By Dr. Henning Ansorg, M.D., FACP, Health Officer County of Santa Barbara, Department of Public Health Last week, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorizations (EUA) for Moderna and Johnson & Johnson COVID-19 booster doses. The Centers for Disease Control and Prevention (CDC) and the Western States Scientific Safety Review Workgroup followed suit…
By Dr. Henning Ansorg, M.D., FACP, Health Officer County of Santa Barbara, Department of Public Health
If you’ve been waiting for full federal approval for a COVID-19 vaccine, the wait is over!
The Pfizer-BioNTech COVID-19 vaccine received full approval on August 23, 2021, from the U.S. Food and Drug Administration (FDA) for persons 16+ years of age. The vaccine has been known as the Pfizer-BioNTech COVID-19 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 administration of a third dose in certain immunocompromised individuals.
According to Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research: “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. 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-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products.
Santa Barbara County, please get vaccinated today! Visit https://publichealthsbc.org/vaccine/ to find a clinic near you.
Dr. Henning Ansorg, M.D., FACP, Health Officer County of Santa Barbara, Department of Public Health and Van Do-Reynoso, MPH, PhD, Director, Public Health Department, Santa Barbara County
It would be wonderful if the worldwide coronavirus pandemic were truly over, but the fact is, June 15 marks the beginning of our return to normalcy in California, not the end of the Pandemic.
June 15, 2021, marks the State of California’s reopening, at which time the state will discontinue the use of the Blueprint colored tier structure that helped the state manage COVID-19 in our counties over the past year.
California is enjoying the lowest COVID-19 case rate of any US state, and hospitalizations are near record lows, but the virus can still infect persons without immunity and lead to severe illness.
The Santa Barbara County Public Health Department is encouraging all eligible residents to get vaccinated and to adhere to masking where it is still required. The California Department of Public Health (CDPH) issued a new masking guidance to go into effect on June 15 here.
The new guidelines align with recommendations by the U.S. Centers for Disease Control and Prevention (CDC) stating that fully vaccinated people do not have to wear face-coverings or distance in almost all situations.
Under the state’s updated guidelines, vaccinated residents can safely choose to shed their masks except in select circumstances which include public transportation, indoors at schools and child-care facilities, health care and long-term care facilities, correctional facilities and homeless shelters.
Those who are not yet vaccinated will need to continue wearing masks at indoor public settings, including retail stores, government offices, and movie theaters.
After June 15 in California:
- No more physical distancing requirements for attendees, customers, and guests at almost all businesses and other institutions (except public transportation, health care settings, correctional institutions, and homeless and emergency shelters).
- No more occupancy capacity limitations for indoor businesses.
- Restrictions at restaurants, open bars, and buffets will go away.
- Organizers of indoor events with more than 5,000 people, such as a basketball games etc., will be required to either verify that attendees are fully vaccinated or have tested negative within 72 hours of the event’s start time or they can choose to have everyone wear a mask.
- Organizers of large outdoor events with more than 10,000 attendees should follow the new masking guidance.
- The requirement/recommendation for testing and vaccine verification will remain in effect through Oct. 1, though state officials will assess conditions prior to that to determine how, or whether, to update or extend that guidance.
- California’s travel advisory will be retired. We urge everyone to follow CDC travel advisories.
The removal of the Blueprint tiers on June 15 will happen with the emergency proclamation still in place. The emergency proclamation will remain in place for the time being as it gives California the needed administrative flexibility to respond to the crisis and ensures counties will be supported in their response to the pandemic. It allows for facilitation with FEMA on programs like vaccinations and testing.
While we are ready to reopen safely, COVID remains a risk and leaving the emergency order in place allows us to move quickly if the situation changes.
We want to take this opportunity to thank our amazing community for their diligence throughout the pandemic. We will continue to provide information and monitor data relevant to the pandemic at: publichealthsbc.org. Please stay safe Santa Barbara County!