Emergency authorization of COVID-19 vaccine lingers as providers answer community concerns via Facebook
Around the time the UK Wildcats were slammed by the Georgia Tech Yellow Jackets, Dr. J. Kyle Turnbo and his wife Nicole sat down in the comfort of their home for a ‘live’ Facebook chat with friends, family, colleagues, and the community. As the COVID-19 vaccine awaits emergency authorization from the FDA (Food and Drug Administration), the Turnbo’s offered their time and expertise based on drug manufacturers’ press releases and other findings.
Dr. Turnbo and Nicole Turnbo RN have been very accessible to the media by answering the community's questions and giving information via social media. On Saturday, December 5, Nicole sent out a Facebook post asking friends and family if they would be interested in a ‘live’ Facebook chat to answer questions about the Covid vaccines. And, if there’s interest, what are some of those questions. Everybody jumped online with a definitive ‘yes’ for the opportunity to learn more. Sunday morning, Nicole posted to tune in at 5 pm.
On Tuesday, December 8, information on the phase 3 trials will be released. The FDA vaccine advisory panel will meet on December 10 to discuss the emergency authorization of Pfizer's COVID-19 vaccine. If approved, distribution of the vaccine will begin immediately. On December 17, clinical data will be available for review of the Moderna COVID-19 vaccine pending emergency use by the panel as well.
The first question discussed was the approval process for the vaccine. Some are concerned that the drug companies may have rushed to market and the vaccine may not be ready to go. Dr. Turnbo called it “unprecedented warp speed”.
Dr. T shared an example of 'warp speed' use regarding the polio vaccine. In 1955, Jonas Salk revolutionized the meaning of warp speed. A test group of 1.8 million children were in the trial phase. Children in the US, Canada, and Finland were given the vaccine. One year later, the vaccine was deemed safe and effective and became part of the childhood diseases vaccination protocols.
The C-19 vaccine has been in the Phase 3 stage for two months. Typically, it’s a six month phase, however, the need for the vaccine is immediate. During this Phase 3 trial, over 100,000 people have been vaccinated. For traditional vaccines, the majority of side effects happen within the first six weeks. Therefore, the two month trial falls within this timeline.
Another reason for the “unprecedented warp speed” is the new technology used to create the vaccine. The technology that has been studied for over a decade is messenger RNA vaccines or mRNA vaccines. The mRNA vaccine takes advantage of proteins to trigger an immune response of immunity to CoV-2, the virus that causes COVID-19.
The benefits of the new technology includes the use of a non-infectious element, shorter manufacturing times, and the potential to target multiple diseases. “It’s revolutionary,” said Nicole.
According to Dr. Turnbo the safety data is “very impressive”. He’ll be able to take a look more closely when the trial information is released on December 8. In addition to side effect data, he said that the disease prevention looked ‘very good’ coming in at 95% effective. In addition, there were nearly 100% reductions in fatalities associated with the COVID-19 or serious symptoms. These findings are ‘significant.’
Another question was about how the vaccine is administered. Most have heard that there are two shots that need to be administered for the Pfizer and Moderna C-19 vaccine. Dr. Turnbo said the window of time for the second shot is 28-30 days. He also said that if you get your first shot from one of the drug companies, you need to stick with that brand for the second shot.
More Questions Answered
How long are you immunized? There’s no clear cut answer to this question since this is a new virus. Dr. Turnbo said, “Nobody knows but with 95% effectiveness one would assume six months to a year.”
Could someone get COVID-19 from the vaccine? Some said they got the flu after getting the flu vaccine. Dr. Turnbo said, “Nobody gets the flu from the flu vaccine. People get an immune response.” Possible side effects from the COVID-19 vaccine could be inflammation of the muscle at the injection site, flu-like symptoms, headache, low-grade fever. He said, “It sounds like coronavirus symptoms.” If you have some of these mild symptoms you know the vaccine is working. “Congratulations, you get immunity.” said Dr. Turnbo. Symptoms would only last a day or so.
What about ‘herd immunity’? Dr. T said, “No disease or virus has been completely eradicated naturally.”
Is there an advantage of getting the vaccine even if you’ve had COVID-19? The chances of having severe symptoms are lessened by getting vaccinated. We don’t know how long someone has the antibodies in their system to fight off the virus again.
Who will be the first to get vaccinated? More likely than not frontline healthcare workers that are in the Covid units will receive the first vaccine, as well as long-term care facilities. The Covid floors would include healthcare workers and those cleaning the patient rooms. For long-term care facilities, it would make sense for those taking care of residents to get the vaccine. It doesn’t necessarily have to be the residents.
Should the vaccine be mandatory? At this point, Dr. Turnbo doesn’t believe the vaccine should be mandatory. There’s still more to learn about the vaccine and time will make that determination.
Dr. T said, “If everything is approved by the advisory panel, I’ll be much more comfortable getting vaccinated myself and recommending it to my patients.” It’s risk and benefits.