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California to review FDA-approved COVID-19 vaccines before releasing them to public

-Editorial

Governor Gavin Newsom today named a group of nationally acclaimed California physician-scientists with expertise in immunization and public health to the state’s COVID-19 Scientific Safety Review Workgroup that will independently review the safety and efficacy of any vaccine that receives FDA approval for distribution. While there is no proven vaccine for COVID-19 yet, these top health experts – guided by the principles of safety, equity, and transparency – will review any vaccine that receives federal approval and verify its safety, before California makes a COVID-19 vaccine available to those most at risk.

The Scientific Safety Review Workgroup is a key piece of the state’s initial COVID-19 vaccine distribution plan, which was submitted to the Centers for Disease Control and Prevention on Friday. Many vaccine candidates are in clinical trials currently, and California is putting a system in place for the distribution and administration of vaccines as supply becomes available.

“Our response to COVID-19 has and will continue to lead with data and science including when it comes to COVID-19 vaccines,” said Governor Newsom. “California leads in science and by bringing together our state’s brightest scientific minds, we can ensure that any vaccine distributed here meets safety requirements. Recognizing that supplies will be limited initially and the first doses of vaccines must go to health care workers, first responders, and others who are especially vulnerable to this disease, we are working to ensure that administration and distribution of an approved vaccine are equitable.”

California’s planning process for the eventual distribution and administration of the COVID-19 vaccine is guided by the overarching principles of ensuring the COVID-19 vaccine meets safety requirements; ensuring that the vaccine is distributed and administered equitably, at first to those with the highest risk of becoming infected and spreading COVID-19; and transparency, by bringing in community stakeholders from the outset.

“While a small number of doses of an FDA-approved vaccine could be deployed before year’s end, the reality is that the COVID-19 pandemic will be with us well into 2021 – and widespread vaccine distribution likely won’t occur for many more months,” said Dr. Erica Pan, Acting State Public Health Officer. “Across the country, states are seeing increases in COVID-19 transmission, but thanks to Californians’ adherence to our public health guidance and our slow and stringent reopening, that hasn’t happened yet here in California. Let’s keep it up – wear a mask, keep physical distance, limit contact outside your household, and wash your hands.”

The California Department of Public Health also encourages all persons six months of age or older to get vaccinated to protect from the flu this season to help keep us all healthier this winter.

In addition to the Scientific Safety Review Workgroup, which includes many current and prior members of the Advisory Committee on Immunization Practices for the Centers for Disease Control and Prevention, a Drafting Guidelines Workgroup comprised of immunization, public health, ethicists, health care and academic experts will develop California-specific guidance for the prioritization and allocation of vaccines when supplies are limited.

A Community Advisory Vaccine Committee will provide input and feedback to the planning efforts and solve barriers to equitable vaccine implementation and decision-making.

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