Screengrab from FDA video on vaccine development.
Federal regulators released a detailed look Tuesday at the first coronavirus vaccine being considered for distribution in the United States, confirming the vaccination is highly effective and safe.
The analysis by the Food and Drug Administration comes ahead of a Thursday meeting when an advisory committee is set to meet and review Pfizer’s request for emergency use authorization of its COVID-19 vaccine, before making its recommendation to FDA regulators.
Findings for the clinical trial of some 44,000 volunteers confirmed the vaccine is about 95 percent effective after two doses and has shown no serious adverse effects.
With possible approval of the Pfizer vaccine for emergency use as early as this weekend, Nevada is preparing to receive its first doses shortly thereafter.
In Nevada those first doses of the vaccine will be given to hospital staff in every acute care hospital as well as skilled nursing facility staff.
Hospitals are still waiting for Pfizer and Moderna to receive approval for emergency use before receiving a portion of the vaccines from the Southern Nevada Health District. HCA Healthcare, which operates Mountain View Hospital, Southern Hills Hospital and Sunrise Hospital in Southern Nevada, said clinical and emergency operations teams have developed a plan that includes storage and a vaccination administration process, and are working closely with the state on distribution timing.
For physicians like Angie Honsberg who has been caring for critically ill COVID patients admitted to the University Medical Center of Southern Nevada the vaccine is “a look towards the light at the end of the tunnel.”
“It just takes one more concern out of the way. Getting infected is always at the back of your mind,” said Honsberg, who is the Medical ICU director at University Medical Center and the division chief for the UNLV School of Medicine Pulmonary and Critical Care Medicine.
She will be signing up for the vaccine once it’s available to hospitals. Frontline staff in UMC’s COVID Units will be the first to receive the vaccine on a volunteer basis, followed by other frontline and ancillary healthcare staff.
The state is set to receive 25,350 doses in the first week of distribution, however, those doses will not cover all hospital staff in Nevada.
A second dose is then expected to be delivered to the state three to four weeks after the initial distribution, with more than 164,0000 doses to be received throughout December, made up of 91,650 doses of Pfizer vaccine and 75,500 doses from Moderna.
A portion of those vaccines will go to pharmacies, including CVS and Walgreens, who will vaccinate employees and residents in skilled nursing facilities.
“We have had some physicians who have been out with COVID or quarantined, especially nursing staff and some respiratory therapists,” Honsberg said. “Taking care of very sick COVID patients requires so much staff, and right now with our current patient load everyone is so stretched that even one person out really affects staffing and potentially the hospital’s ability to take care of patients.”
The number of people hospitalized in Nevada with COVID has more than doubled over the last month, according to the Nevada Hospital Association, as COVID cases continue to surge in the state and the positivity rate hit a record high of 21.8 percent Tuesday.
With a vaccine in sight, however, medical staff are hopeful another line of defense will reduce infection.
“Hopefully seeing healthcare workers get vaccinated will make other people less reluctant to get the vaccine and more people will be protected from infection. That’s certainly what the hope is,” said Honsberg.
However she suspects education will be key.
“Just to be very realistic, in my experience even with getting the flu vaccine, there’s a lot of hesitancy. Hopefully that’s not the case here,” Honsberg said.
‘No corners have been cut’
While COVID vaccines, including the Pfizer vaccine, are rolling out in record time, they are proving safe and effective, said Trudy Larson, an infectious disease physician and professor at the University of Nevada, Reno who is also serves on Gov. Steve Sisolak’s Medical Advisory Team.
“Everyone needs to understand that these vaccines are not being proposed for use on a fast track in the sense that they’ve cut any corners. No corners have been cut with this vaccine. This is a technology that has already been developed and adapted for COVID,” said Larson.
Unlike flu shots, the COVID-19 vaccines do not contain a dead or live sample of the virus. The vaccine instead uses mRNA or messenger RNA, a technology that has been used in the past for gene therapy in cancer treatment.
This process uses a part of the viral DNA that is responsible for spike protein, a critical component needed to infect a healthy cell. An altered version of that protein is then injected into the muscle where it joins a human cell before being destroyed as a foreign protein by the immune system’s protective and creating future immunity.
FDA documents posted in advance of an advisory committee consideration of emergency use authorization revealed promising new findings on safety and efficacy, including similar levels of protection among groups at risk for disease complications, like the elderly or obese.
“We really have to let our vulnerable folks know that this is a good vaccine for them because it’s been tested on people like them,” said Larson.
The Pfizer vaccine is injected in the muscle as a series of two doses 21 days apart. Without both doses the vaccine will not be as effective and there is no guarantee immunity will last.
“That’s why it’s really important to get both doses. There are no guarantees if you only get one. It’s like rolling a dice,” Larson said.
Thousands of Nevada’s have already been infected with coronavirus and recovered, likely forming some level of antibodies to the disease. However, the recommendation is that everyone get the vaccine regardless of whether they had symptoms consistent with COVID.
“The vaccine will not harm you and it will make sure you have longer lasting immunity than what you might have with a natural infection,” Larson said.
As with most vaccines, there are temporary side effects which typically develop within a couple of days of inoculation and last for about a day or two on average, according to FDA analysis.
Data shows that among people ages 16 to 55, more than half had fatigue and headaches, and roughly one-third had chills and muscle pain. The effects were slightly less pronounced in people older than age 55.
The most common side effects were pain at the injection site (84.1 percent), fatigue (62.9 percent), headache (55.1 percent), muscle pain (38.3 percent), chills (31.9 percent), joint pain (23.6 percent), and fever (14.2 percent).
“That’s not uncommon for a vaccine that is that effective. It means it’s working and that our bodies are manufacturing immunity. When you get those kinds of side effects you know it’s working,” said Larson.
“People are going to need to know that there are going to be side effects because it’s effective and they’ll need to plan for that, but when it’s their turn I would not hesitate to recommend it.”
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