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CDC and FDA Clear Janssen Biotech, Inc (Johnson & Johnson) for COVID-19 Vaccine for Use

On Friday, April 23 the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA), following the conclusion of the Advisory Committee on Immunization Practices’ (ACIP) review, announced that use of the Janssen Biotech, Inc. (Johnson & Johnson) COVID-19 vaccine should be resumed in the US. This decision was based on the assessment by FDA and ACIP that available data show the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older. The Western States Scientific Safety Review Workgroup (WSSSRW), after a thorough review of the evidence concerning the safety of the Johnson & Johnson COVID-19 vaccine, recommended resumption of its use once culturally and linguistically appropriate patient and provider educational materials in plain language that support informed decision-making are available. The WSSSRW further stated that resumption of its use will support COVID-19 vaccine uptake and help reduce severe COVID-19 illnesses and control the pandemic in California. Monterey County Health Department will align itself with the California Department of Public Health and will plan to resume the use of the Johnson & Johnson vaccine. Monterey County Health Department applauds the thorough and transparent assessment of the safety and effectiveness of the Johnson & Johnson vaccine by the ACIP, CDC, FDA, and the WSSSRW, including their assessment of the risk of thrombosis – thrombocytopenia syndrome (TTS). According to the CDC, to date there have been only 15 confirmed cases of the rare clotting event among nearly 8 million doses administered in the US, all in females ages 18 to 59 years. This translates to a risk of about 2 cases per 1,000,000 doses overall and 7 cases per 1,000,000 among women between 18 and 49 years of age. For those who have a confirmed COVID-19 diagnosis, the risk of dying from COVID-19 is 1 in 56 in the US and 1 in 114 in Monterey County. The public is encouraged to get vaccinated as soon as possible. All vaccines are proven to be highly effective at preventing hospitalization and death from COVID-19. The longer you wait to get vaccinated, the greater the risk of contracting COVID-19. Currently, the Monterey County Health Department’s Public Health Bureau has 3,000 doses of the Johnson & Johnson vaccine, which will be integrated back into vaccine clinics pending development of appropriate educational materials. The Monterey County Health Department will make it clear on the department’s COVID-19 vaccine appointment website (www.mcvaccinate.com) and in other forms which vaccines are available at Public Health Bureau-run vaccine sites. The Public Health Bureau has 1,440 doses of Pfizer and 500 doses of Moderna vaccine on hand. To date, local vaccine service providers have administered more than 9,000 doses of the Johnson & Johnson vaccine to Monterey County residents. It has been used for all populations generally and also for targeted populations such as homeless and homebound, where the benefits of needing to administer only one dose are significant. People who have received the Johnson & Johnson vaccine should contact their primary healthcare provider if they have concerns or if they develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination. COVID-19 vaccine safety is a top priority for the Monterey County Health Department. We will continue to monitor the situation and look to the CDC and California Department of Public Health (CDPH) for any additional future guidance. For more information: Joint FDA and CDC Statement: https://www.cdc.gov/media/releases/2021/fda-cdc-lift-vaccine-use.html WSSSRW Statement: https://www.gov.ca.gov/wp-content/uploads/2021/04/4.24.21-Western-States-Scientific-Safety-Review-Workgroup-report.pdf

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