CDPH Issues Statement on Western States’ Approval to Resume Use of Johnson & Johnson Vaccine
SACRAMENTO – Today the California Department of Public Health (CDPH) issued a statement from Dr. Erica Pan, state epidemiologist, regarding the Western States Scientific Safety Review Workgroup’s recommendation to support the lift of a temporary pause on administration of the Johnson & Johnson/Janssen COVID-19 vaccine.
“After a thorough review of very rare adverse events following the Johnson & Johnson vaccine, the Western States Scientific Safety Review Workgroup supports the recommendation of the FDA and CDC to lift the pause on the vaccine. Clinics in California may begin administering the Johnson & Johnson vaccine immediately as long as they provide appropriate educational materials to inform patients of the vaccine’s low risk of associated health effects and other available vaccine options.
More than half of Californians 16 and older have received one of the three vaccines available, and the one-shot Johnson & Johnson vaccine is also an important tool in our fight to stop the spread of COVID-19, especially as more aggressive variants of the virus spread throughout the country. We hope we continue to make progress in getting more Californians vaccinated so we can move beyond this pandemic.”
For more information about the rare adverse effects, and what to do if you are experiencing symptoms, please contact your healthcare provider.
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As a health department, it is our goal to ensure everyone in the county is safe and healthy. The care and safety of the public is always our top priority. As with any vaccine, San Benito County will not distribute a COVID-19 vaccine unless the U.S. Food and Drug Administration (FDA) has determined it is safe and effective. The governments’ high-tech, space-age name for the vaccine development program – Operation Warp Speed – may have inadvertently increased concerns about the safety of future vaccines. However, the FDA oversees and regulates vaccine quality, safety and effectiveness. The FDA says it is committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. It will not jeopardize the public’s trust in the science-based, independent review of any vaccine.
After the FDA determines a COVID-19 vaccine is safe, the Advisory Committee of Immunization Practices (ACIP) reviews the clinical trial data and provides advice and guidance to the Centers for Disease Control.
In addition to federal review, California has formed a panel of public health and immunization experts—the Scientific Safety Review Workgroup—to review the efficacy and safety data of COVID-19 vaccine candidates. Neighboring states Washington, Oregon and Nevada are joining California’s effort to conduct independent reviews to ensure the safety and efficacy of any vaccine approved by the FDA.
The vaccines will continue to be monitored even after the vaccines reach the general public. National vaccine safety monitoring systems watch for rare side effects (called adverse events) that may not have been seen in clinical trials. If the symptoms are true safety concerns, the guidelines for the vaccine will be changed. This monitoring ensures that the vaccine’s benefits continue to outweigh the risks.
Visit the CDC for more information on the Safety of COVID-19 Vaccines and to report unusual side effects following any vaccination (see links under “Existing Safety Monitoring Systems”). an
One might expect to have similar side effects as with other immunizations, such as fatigue, headache, body aches, soreness at the site of injection and even some fever. These are considered normal immune responses to the vaccine and are actually your body’s natural response in building immunity to this unwanted invader.
However, there’s a possibility that rare side effects (called adverse events) may emerge as millions of people are given the vaccine. Unusual side effects should be reported to one of the nation’s safety monitoring systems for the general public, military members, veterans and tribal nations. The CDC and FDA will continue to monitor safety concerns. This monitoring ensures that the vaccine’s benefits continue to outweigh the risks.
Learn about the difference between a vaccine side effect and an adverse event.
We will learn more about side effects associated with each individual vaccine as the clinical trial data is reviewed during the approval process. All agree that it’s important to be informed of the vaccine’s benefits and risks. The data will be of interest to California’s Scientific Safety Review Workgroup, as it will conduct an independent review to ensure the safety and efficacy of any vaccine approved by the FDA.
Yes. We all need to do our part to stay safe while we wait for vaccines to be widely available, and for a sufficient portion of the population to be vaccinated. Our county, like everyone else, has received a limited supply to start. More will come over time. It may take many months before everyone in the Bay Area who wants a vaccine has gotten one. This means we all need to work together to keep our risk of COVID-19 low. We can do that by protecting ourselves and others by wearing face masks, keeping our distance, and not gathering in groups.
Although our local skilled nursing facilities registered for the federal government program under which CVS and Walgreens are responsible for vaccinating residents and staff, San Benito County Public Health Services in partnership with Hazel Hawkins Memorial Hospital opted to vaccinate both staff and residents directly. This ensured prompt and expedited vaccinations of this high risk population.
At first, COVID-19 vaccines may not be recommended for children. In early clinical trials for various COVID-19 vaccines, only non-pregnant adults participated. However, clinical trials continue to expand those recruited to participate, including children. The groups recommended to receive the vaccines could change in the future.
The first vaccines made available to San Benito County (Pfizer and Moderna) will be the two-dose vaccines. The two-dose vaccines are spaced a few weeks apart, and the second shot is required to be effective.
There is a lag of a few weeks between the time of receiving the vaccine to the time the body produces a robust immune response. For some vaccines, minimal immunity may begin approximately 2 weeks after the first dose, but maximum immunity may not be achieved for 2 to 4 weeks after the second dose. Depending on the dosing regimen and schedule, it may take as long as 6 to 8 weeks to get the full benefits of the vaccine. Therefore, it is possible that a person could be infected by COVID-19 just before or just after vaccination and then get sick because the vaccine did not have enough time to provide full protection.
Yes. The CDC recommends that you get vaccinated even if you have already had COVID-19, because you can catch it more than once. While you may have some short-term antibody protection after recovering from COVID-19, we don’t know how long this protection will last. Since people who have had COVID-19 are assumed to have some level of immunity, they may be directed to wait for 90 days before getting the vaccine.
Public Health strongly recommends the COVID-19 vaccine to help protect yourself, your family and your community from COVID-19 infections. However, choosing to accept or decline the vaccine is a personal choice.
After a vaccine is authorized or approved for use, many vaccine safety monitoring systems watch for adverse events (possible side effects). This continued monitoring can pick up on adverse events that may not have been seen in clinical trials.
There’s a possibility that rare side effects may emerge as millions of people are given the vaccine. The Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance program, collects and analyzes adverse events associated with U.S. licensed vaccines. Anyone can submit a report to VAERS, including providers, patients and parents.
Providers: Under the Emergency Use Authorization, providers are required to report serious negative side effects to VAERS or to the vaccine’s manufacturer per its Fact Sheet.
Public: The public should report unusual side effects to one of the nation’s safety monitoring systems for the general public, military members, veterans and tribal nations. Or, call VAERS toll-free number at 1-800-822-7967.
For an additional layer of safety monitoring, the CDC has introduced the V-safe app. It is a smartphone-based health checker for people who receive COVID-19 vaccines. V-safe uses text messaging and web surveys to:
- Check in with vaccine recipients
- Send second vaccine dose reminders
- Call anyone who reports medically significant adverse events. Learn about the difference between a vaccine side effect and a medically significant adverse event.
Vaccinations benefit both the person being vaccinated and the community at large. A community is sufficiently vaccinated when it reaches herd immunity. Herd immunity is a term used to describe when enough people have protection—either from previous infection or vaccination—that it is unlikely a virus or bacteria can spread within the community even if some people don’t have any protection themselves.
The percentage of people who need to have protection to achieve herd immunity varies by disease. Experts don’t yet know what percentage of people would need to get vaccinated to achieve herd immunity to COVID-19. However, the World Health Organization and Johns Hopkins Center have suggested at least a 70% vaccine coverage rate to reach population immunity through vaccination.
The federal and state government have established phases for when different populations are eligible to receive vaccine. Currently, the CDC and California Department of Public Health has instructed all counties in California to vaccinate only persons in “Phase 1A” which includes healthcare personnel and residents of long-term care facilities (e.g. nursing homes). The State of California further divided this group into three tiers, and has now authorized counties to vaccinate individuals in all three tiers of Phase 1A. As soon as people eligible to be vaccinated in Phase 1A have been offered the vaccine, the state will allow counties to begin vaccinating people in Phase 1B, which includes people 75 years of age or older, and “frontline essential workers.” The charts below outline the order in which individuals will become eligible under the phases established by the federal and state government. The California Department of Public Health is in the process of developing additional guidance for prioritization of people within Phase 1B below, and we expect that additional direction to counties will be released shortly.
We expect it to be: some provider offices, clinics (including HHMH clinics and SBHF), the pharmacies, and Public Health through some larger clinics.
Our healthcare workers are being vaccinated by appointment/scheduled times through HHMH, Public Health and also SBHF.
Yes. All healthcare personnel included in Phase 1A are now eligible for COVID-19 vaccination.
Yes. The California Department of Public Health has notified counties that mortuary or funeral home staff are included within Phase 1A (Tier 3). All individuals in Phase 1A are now eligible for COVID-19 vaccination.
Non-medical first responders are not yet eligible for vaccination. However, we expect law enforcement officers and correctional staff to become eligible very early in the next phase of vaccination (Phase 1B), which should begin in the coming weeks.