Newsom: Potential COVID Vaccines To Be Reviewed By State Panel; 'We Will Not Take Someone's Word For It'
SACRAMENTO (CBS SF) -- Preparing for the next step in the battle with COVID-19, Governor Gavin Newson Monday unveiled the framework for a massive statewide vaccine distribution network, driven by a group of immunization and public health experts which will green-light any vaccine approved by the federal government.
Newsom said the state's COVID-19 Scientific Safety Review Workgroup will independently review the safety and efficacy of any vaccine that receives approval by the U.S. Food and Drug Administration before the state makes the vaccine available.
Last month, California Health and Human Services Secretary Dr. Mark Ghaly indicated the state would review any potential COVID-19 vaccines, underlining the distrust of the Trump administration's "Operation Warp Speed" initiative on developing a vaccine.
"Of course, we will not take someone's word for it [on vaccine safety], we will do our own independently-reviewed process with our world-class experts," said Newsom. The governor also noted the review process would be used even if Joe Biden wins the presidential election.
California is one of five jurisdictions within the United States to already be working with the U.S. Centers for Disease Control and Prevention and the Department of Defense on a distribution plan, Newsom said.
"This has been underway for a number of months here in the state of California -- this formal partnership," said Newsom. "We have long been on the vaccination business. Our experience in mass vaccinations make us a unique partner for the CDC ... based on the scale and scope of the vaccinations that occur on an annual basis here in the state of California. Just consider 19 million annual flu shots typically distributed here in the state of California."
While there are no current vaccines against COVID-19, there are a number of vaccine candidates currently in clinical trials, and Newsom said the earliest a vaccine could be available would be by November or December, only for health care workers, first responders, and high-risk groups.
Newsom said the best-case scenario is that some 45 million vaccine doses would be available by end of year, but in very limited availability. Large-scale vaccine distribution was not expected to be ready until well into 2021.
"You won't be able to go down to your pharmacy and get a shot this calendar year," said Newsom.
In addition to the coronavirus' medical novelty, the pace of vaccine development is likely to be hampered because most treatments
currently consist of two shots over 21 days.
Those doses must also be kept in either cold storage or ultra-cold storage at temperatures as low as below 70 degrees Celsius. That necessary cold storage could further affect the availability of commodities like dry ice that would be used to prevent the vaccine doses
from spoiling.
Acting State Public Health Officer Dr. Erica Pan reiterated that it will be some time before any vaccine would be available for the general public.
"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. Pan in a prepared statement. "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."
Newsom said the state's COVID-19 vaccine planning process and advisory workgroup would be guided by the overarching principle of vaccine safety, would ensure the vaccine is distributed equitably, and would strive to be transparent by bringing in community stakeholders at the start of the process.
"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," Newsom said in a statement. "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 is equitable."
The governor's office listed the following members of the Scientific Safety Review Workgroup:
- Chairman Dr. Arthur L. Reingold, the Division Head of Epidemiology and Biostatistics at the UC Berkeley, School of Public Health.
- Tomás Aragón, the Health Officer of City & County of San Francisco, and Director of the Population Health Division at the San Francisco Department of Public Health.
- Ambassador Eric Goosby is a Distinguished Professor of Medicine and Director of the Center for Global Health Delivery, Diplomacy and Economics, Institute for Global Health Sciences, at the University of California, San Francisco.
- Rodney Hood, the president and founder of the Multicultural Health Foundation and the past president of the National Medical Association and a Board Trustee of Alliance Healthcare Foundation.
- Nicola P. Klein, a senior research scientist at the Kaiser Permanente Northern California Division of Research, and director of the Kaiser Permanente Vaccine Study Center.
- Grace Lee, a professor of pediatrics specializing in infectious diseases at the Lucile Salter Packard Children's Hospital at Stanford.
- Yvonne (Bonnie) Maldonado, a professor and Chief of the Division of Infectious Diseases, Department of Pediatrics at Stanford Medicine.
- Mark Sawyer, an infectious disease specialist at Rady Children's Hospital and a professor of clinical pediatrics at UC San Diego and the medical director of the UC San Diego San Diego Immunization Partnership.
- Rob Schechter, Chief of California Department of Public Health's Immunization Branch.
- Peter Szilagyi, a pediatric health services and clinical researcher at UCLA with an overall mission to improve access to health care, quality of care, and health outcomes for children.
- Matt Zahn, the Medical Director of the Division of Epidemiology and Assessment for the Orange County Health Care Agency. He served as chair for the Immunization Advisory Workgroup for the National Association of County and City Health Officials from 2009 to 2012.
A separate Community Advisory Vaccine Committee has been formed to give input and feedback to the planning efforts taking into account the barriers of equitable vaccine implementation and decision-making.
