Pennsylvania — Secretary of Health Dr. Rachel Levine on Friday said the process to approve vaccines for emergency use is an important step in the fight against Covid-19.
“The creation of a COVID-19 vaccine is a crucial development in the fight against COVID-19, both nationwide and in Pennsylvania,” Dr. Levine said. “I want to stress that in order for an Emergency Use Authorization to be issued for a vaccine, the FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine.
“With advanced technology available today, the FDA is able to expedite its review process of thoroughly analyzing the safety and efficacy results of clinical trials. We all want the pandemic to end, and a COVID-19 vaccine is the next tool in our COVID-19 toolkit to achieve that goal.”
On Friday, an Allegheny Health Network spokesperson told Channel 11 they don’t have details yet regarding supply but are prepared to follow the Pa. Department of Health’s phased approach to vaccinating -- first prioritizing frontline caregivers. Employees will not be required to receive the vaccine, but it will be highly encouraged, the spokesperson said.
Similarly, a spokesperson for UPMC said that the company is “committed to making vaccines available to our dedicated frontline health care workers as soon as responsibly and safely possible.” UPMC added that there are a lot of “unknowns” right now, including when the vaccine will arrive.
Channel 11 learned that doses will also be made available to the Pittsburgh VA Health Care System. It is among 37 VA medical centers receiving the vaccine, chosen for “their ability to vaccinate large numbers of people and store the vaccines at extremely cold temperatures.” After health care workers receive vaccinations there, veterans in long term care facilities will be the first patient group to be immunized.
An EUA is used by the U.S. Food & Drug Administration to approve the use of safe and effective medical products during a public health emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions. An EUA can be used to approve a number of medical products, including vaccines. All vaccines must undergo the EUA approval process before being fully licensed.
After being approved and licensed, the FDA continues to oversee its production to ensure continued safety. Monitoring of the vaccine and its production activities must continue as long as the manufacturer holds a license for the vaccine product.
Currently, U.S. drug manufacturers are working to create a safe and effective COVID-19 vaccine through clinical trials, including:
- Johnson & Johnson
During public health emergencies such as a pandemic, the development process may not follow routine timelines. However, Levine said these COVID-19 vaccines have been produced according to rigorous standards set by the FDA and are safe for people to get when available. The COVID-19 vaccine will help to prevent the virus or lessen the severity of the symptoms if someone does get it.
Allegheny County Executive Rich Fitzgerald told Channel 11 on Friday that the Pfizer vaccine is expected to be in Pittsburgh within a few days. It will first go to the area’s major hospital systems like UPMC and AHN.
Fitzgerald said by early next week, he is hopeful that our healthcare workers will start getting vaccinated.
The first phase of the vaccine rollout will also extend to nursing homes, including those most at-risk.
“The hospitals should be getting those I believe within the next couple of days so early next week there will be people inoculated or at least getting the first shot,” he said. “It’s a two-shot process with Phizer a few weeks apart. They’ll get their first shot within the next few days.”
The Moderna vaccine is one week behind Pfizer. As soon as it is authorized for emergency use, likely the end of next week, it will also be rolled out immediately.
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