It takes a lot of people to develop a COVID-19 vaccine. Volunteers may be one of the most important. Wochit
As the United States gears up for a massive immunization effort tobegin as soon as a coronavirus vaccine is available, health officials are planning the details of the rollout.
While all new vaccines are closely followed once they enter the market, because a COVID-19 vaccine is likely to be released under an Emergency Use Authorization, safety considerations are front and center.
To track reactions in real time,the first people to be vaccinated against COVID-19 will get daily email and text messages the first week after their shot asking how they're feeling. After that first week, they'll continue to getweekly messages for the next month and a half.
Thefirst wave of immunizations are expected to go to up to 20 million Americans classified as essential workers. These include frontline health care workers, police, firefighters and paramedics, critical food and industry workers and potentially teachers. At least one of several candidate vaccines may be available by the end of the year.
The emails and texts will come from the Centers for Disease Control and Prevention, said Dr. Tom Shimabukuro of the CDC's COVID-19 Vaccine Planning Unit. He spoke at ameeting Tuesdayof the CDC's Advisory Committee on Immunization Practices.
The first texts willask four questions:
Anyone who says they couldn't work, do their daily activities or needed to goto the doctorwill automatically be considered to have had a "clinically important adverse event" and would get a call from the CDC's vaccine call center, Shimabukuro said.
That information willbe shared with the Food and Drug Administration to track any problems the vaccine might be causing.
Because vaccine is expected to be in short supply in the first phase of distribution,thelimited group of essential workerswill have to sign up in advance to get their shot or shots. All but one of the current COVID-19 vaccine candidates requires two shots, so reminders forthesecond shot will be needed.
More: Feds: COVID-19 vaccine will begin moving 24 hours after the first one is approved
More: Data, data and more data will make a coronavirus vaccine safe, USA TODAY's vaccine panel says
More: 'Mind-bogglingly complex': Here's what we know about how COVID-19 vaccine will be distributed when it's approved
Anyone who gets the COVID-19 vaccine will have to sign agreements with their health care provider so they can get updates on follow-up vaccinations and other information. That will include their email address or cellphone number, which will be used to contact them for the adverse event reporting system.
"We're basically borrowing part of the information being collected as part of the registration process and that's to identify these essential workers for scheduling and reminder recalls (for their second shot)," Shimabukuro said.
Patients will be informed that their contact information will be used for doing outreach from the CDC for the health checks, he said. They'll also have the option to opt out of getting the follow-up health checks.
"We'll also give them the opportunity to opt back in even if they've opted out," he added.
(Photo: Getty Images)
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