Vaccine delivery expected as early as next week
Tuolumne and Mariposa counties are expected to receive 975 doses of the pharmaceutically-produced COVID-19 vaccine in its first rollout, which may come as early as next week.
Dr. Eric Sergienko, the health officer for both counties, described the imminent distribution of the vaccine as a landmark moment in the ongoing COVID-19 pandemic, which has reached its apex in positive cases and deaths in recent weeks in Tuolumne County.
“It’s not the beginning of the end, it’s the end of the beginning,” said Sergienko, who noted he was quoting Winston Churchill. “I think that’s where we’re at when we see vaccines starting to be distributed, that is a turning point.”
The first round of vaccines will be given to the highest-risk populations, frontline health workers (who are most in contact with COVID patients), such as ICU medical staff, and the elderly in residential care facilities like assisted living homes. The vaccine will be split between counties at a “per-capita” rate depending on the number of frontline health care workers, the residential care population and other metrics.
The vaccine is not mandatory. Frontline care workers notify their administrative staff to opt-in to the first round of vaccinations, and that information is provided to public health officials.
Michelle Jachetta, public health director for Tuolumne County, said her office submitted a vaccination plan to the state, and she is working with healthcare stakeholders to identify the first recipients.
“It’s close to finalization, because we expect to receive vaccines soon,” she said.
The healthcare offices are identifying who will first receive the vaccine and will provide that information to public health, Jachetta said.
“We have to define how we store, receive, and distribute the vaccine,” she said, such as identifying locations where it will be administered, priority populations for receiving it and the county staffing plan to execute the program.
“It’s all the different parts of a mass vaccination plan which have been developed and in place with Public Health for many years,” Jachetta said.
The plan is based in part on the annual rollout of the flu vaccine.
The COVID vaccination plan consists of various elements, including:
The plan additionally
includes the other offices involved in the planning efforts, the organizational structure of the county public health office, how the vaccine will be stored and handled, public communication and vaccine safety monitoring, Jachetta said in an email.
On Dec. 5, the state released a tiered series of guidelines for the first recipients of the vaccine. Phase 1a, the first rollout of the vaccine, is currently the most “well-defined” as to who will actually receive the vaccine, Sergienko said.
The state describes the first group as “persons at risk of exposure to SARSCOV-2 through their work in any role in direct health care or long-term care settings,” which includes nonclinical roles like environmental services or patient transport, and “residents of skilled nursing facilities, assisted living facilities, and similar long-term care settings for older or medically vulnerable individuals.”
The county has had to sub-prioritize the rollout (as demand is expected to largely outpace supply) according to state guidelines, which factors the type of facility or role of the recipient, the location of the facility and the attributes of individuals.
The availability of a vac
cine to the general public is still largely unknown at this time. Sergienko said it could happen as early as March through June, but also later into the fall and winter.
Dore Bietz, coordinator of the Tuolumne County Office of Emergency Services, said her office is briefed daily by the state and county public health on the development of the distribution plan.
Bietz said her office’s role would likely be more of a support function, such as coordinating with the vaccine partners or educating stakeholders on the details involved.
“We will serve as a coordinator, and we work closely with public health and other partners in executing the plan for distribution,” she said.
The vaccine’s public availability will be dependent on the speed other vaccine candidates are approved, how fast it can be manufactured, and the mechanics of distribution around the country.
An advisory committee to the FDA, Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in a public meeting on Thursday and officially recommended approval of the vaccine.
A banner on the FDA site reads, as of Thursday, “Vaccine Status: Currently, there is no Fda-approved or authorized vaccine for the prevention of COVID-19.”
The vaccine is expected to be approved and sped
through an emergency process with instructions and known information.
The open session on Thursday involved the discussion of Emergency Use Authorization of the “Pfizer-biontech COVID-19 Vaccine” for the prevention of COVID-19 in individuals 16 and older, according to the FDA.
Sergienko said VRBPAC is an independent advisory committee to the FDA which provides a recommendation based on a study. The FDA can approve or disapprove the vaccine after the recommendation.
Following the committee recommendation, the FDA posted a 53-page review document covering the details of the vaccine and trial testing data.
California also has a vaccine advisory committee that reviews the process before it is administered.
“We can’t really tell people all that we know about this because it hasn’t been well defined,” Sergienko said. “We do know it’s a safe vaccine and it produces a good immune response.”
The Pfizer vaccine has a 94.5% success rate in fighting the virus, Sergienko said.
Another vaccine from the pharmaceutical company Moderna will go through an FDA approval process next week and is 95 percent effective, Sergienko said.
According to the CDC as of Nov. 24, large-scale clinical trials are in process or being planned for three other COVID-19 vaccines from pharmaceutical companies Astrazeneca, Janssen and Novavax.
Sergienko said the Pfizer and Moderna products are MRNA vaccines, which use the protein-making parts of the cell to make antigens (a toxin which promotes an immune response), which then prompts the body to make antibodies (which counteracts the antigen). He added that the vaccine was non-replicating and would not produce additional MRNA, messenger ribonucleic acid, which activated the protein production in the cells.
“It’s not going to get into your body or take over your cells,” he said. “It’s not designed to do that at all. It uses your own body to produce the antibodies.”
The vaccine is administered in two shots.
“Typically the first shot is well tolerated by the vast majority of people, despite some aches or pain in the arm where it’s administered,” Sergienko said.
On the second dose, approximately a third of people may experience aches, headaches or soreness, like a mild case of the flu, which are expected to dissipate after about a day.
“What it tells you is that the immune response is working. It’s the body trying to fight off this shot,” Sergienko said.
People would not be contagious with COVID-19 while experiencing these reactions, he said.
The vaccines are stored in sub-zero temperatures, at approximately - (negative) 80 degrees Fahrenheit.
They are shelf-stable in a fridge for four to five days and must be diluted before being administered. After dilution, they have six hours to be administered.
Sergienko said the receiving site for the vaccines can not be shared due to safety, but said it is in either Tuolumne or Mariposa counties.
The first round of vaccinations very likely will not be enough to cover the needs of the first tier, Sergienko said, and the counties will rely on additional rounds going forward.