FDA clears the way for first COVID-19 vaccine
Health District: virus surge continues, prevention tactics still needed
Last updated 12/14/2020 at 10:13am
The FDA authorized emergency use of a new COVID-19 vaccine Dec. 11 on the same day the health district reminded the public that the virus is still surging.
Two-thirds of infections in the county from close contacts and community interactions, which includes homes and workplaces.
Cases in Snohomish County continue to be a concern, with the two-week rate at 428 per 100,000 residents through Dec. 5, the health district states. A health district update on Dec. 11 said hospitalization rates are high and the number of deaths continue to increase.
The FDA approval on Dec. 11 allows for emergency use of the mRNA vaccine by Pfizer-BioNTech COVID-19 that is in-use in both Canada and the United Kingdom. The vaccine is cleared for a distribution plan throughout the US, with the general public gaining access sometime late in 2021.
The Snohomish County Health District was contacted for detail on when the vaccine would be delivered to health care facilities.
"We're still waiting to hear," wrote government affairs manager Heather Thomas in an email Saturday morning.
Details on who will be vaccinated first is still in flux, but officials have mentioned priority for health care workers, first responders, and groups at high risk for severe illness. Distribution is expected to continue in phases as more vaccines become available.
If all goes as planned, officials estimate the process will complete in late 2021.
The county has been poised to begin and already conducted a mock delivery, to work out any problems in advance. The usual locations for other vaccines are intended to be the providers for the vaccine. Those sites will include medical clinics and other health care agencies, said Dr. Chris Spitters early last week, in the Dec. 8 Joint Information Commission briefing.
In the same event, county executive Dave Somers estimated it would take time before widespread vaccination is achieved and urged the public to commit holiday spending to local businesses, as all prepare for another hard year.
"It's clear we're six to eight months out" before the vaccine is fully distributed, he said. "I think next year is going to be very difficult."
Doctors in past interviews have said a full end to the pandemic will come with a comprehensive approach of prevention and therapy. Prevention available now includes masking, social distancing and cleanliness. The vaccine is another prevention-tool. Therapies such as remdesivir and monoclonal antibodies are used in the hospital setting for severe illness, and data is collected to judge their benefits.
The vaccine is not expected to help those who already have the virus. Until herd immunity is achieved through vaccination, health officials repeat the mantra of prevention: masks, hand-washing and social distancing.
Naturally occurring herd immunity through purposeful spread has been mentioned by critics of COVID-related restrictions, but it is an idea strongly discouraged by doctors and health officials who generally say it could lead to severe illness for the vulnerable, while overtaking medical resources.
Most people recover from the virus but hospital capacity is still a concern.
During viral surges, too many people flow into urgent care settings alongside other patients needing care for car wrecks, heart attacks, strokes, and other emergency room scenarios. "Important" care is also affected in a surge, Spitters has said in past JIC updates. Important but non-urgent care can include cancer treatment and kidney dialysis.
Spitters was asked by the Beacon during the most recent JIC update if the data for the current vaccine showed any therapeutic benefit. Some vaccines provide both prevention and therapy. He said data shows that the first vaccine by Pfitzer and BioNTech is not expected to help people who are already sick.
"The vaccine has not been studied as a therapeutic vaccine to treat COVID disease. Its design, intent and the evidence base for it is to prevent COVID disease," Spitters said. "What they found is about 90% efficacy in preventing COVID, that is people who got the vaccine had only about 10% of the incidence of COVID-19 than the group that got the placebo injection."
A data-review was completed by a committee advising the FDA endorsed the vaccine before the weekend, when it was released for use. It cleared use for pregnant and lactating women as well as 16 and 17 year olds. Officials at the FDA said in a statement that they have been reviewing the data for weeks prior to the emergency use decision. The vaccine is not yet "approved" by the FDA, but is OK'd for emergency use, in the pandemic.
The mRNA vaccine is showing a promising safety profile in clinical trials, and it is a medical innovation with the potential to end the pandemic sometime in 2021. Other vaccines are being developed as well, including one by Moderna.
The health district rehearsed delivery. Vaccines enroute need to be kept well below zero, with some reports saying 80 below and others 70 below. That level of chill and the correct equipment and handling to assure the vaccines are kept viable.
"We're cautiously confident and optimistic that things will go well. I'm certain that somewhere there will be a glitch or two here or there, and we'll learn from that and try to adjust," Spitters said.
In all medical innovation and treatment, the risk-benefit analysis is applied: data for the risk of the illness that is treated is weighed against the risk of the treatment.
All treatments come with risks.
While mRNA vaccines are new science, the data so far is promising. Pfizer's fact sheet says "approximately 20,000 individuals 16 years of age and older have received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine," and a second dose is needed within three weeks.
"There certainly are common mild side effects, pain, swelling, redness at the injection site, sometimes tiredness, fever, achiness, especially after the second dose four weeks later," Spitters said. "But no serious adverse effects. So that's what the trials were measuring."
The mRNA vaccine is new science.
Vaccines often use a weakened germ to trigger immune response. Flu vaccines work that way – training the body to fight a germ by introducing a less damaging version of the illness. The mRNA vaccines show the cells how to make a protein that triggers immune response, without introducing the germ itself, according to the CDC.
"That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies," the CDC states.
Check back for updates on the vaccine and other news.
Posted Dec. 12, earlier in the a.m .:
The FDA authorized emergency use of a new COVID-19 vaccine on Dec. 11, and on the same day health officials in the county reminded the public that the virus is still surging -- through family friends and community contacts.
Story in process. Check back for updates.