It takes a lot of people to develop a COVID-19 vaccine. Volunteers may be one of the most important.
As the United States gears up for a massive immunization effort to begin 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 get weekly messages for the next month and a half.
The first wave of immunizations are expected to go to up to 20 million Americans classified as essential workers. These include front line 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 a meeting Tuesday of the CDC’s Advisory Committee on Immunization Practices.
The first week texts will ask four questions:
- Any pain, redness, swelling or itching at the injection site?
- Any chills, headaches, joint pains, muscle or body aches, fatigue or tiredness, nausea, vomiting, diarrhea, abdominal pain or rash?
- Any other symptoms or health conditions to report?
- Did any of the symptoms cause them to:
- Miss work?
- Be unable to do their normal daily activities?
- Get care from a doctor or other healthcare professional?
Anyone who says they couldn’t work, do their daily activities or needed to go to the doctor will 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 will be 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, the limited group of essential workers will 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 for the second shot will be needed.
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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 cell phone 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.
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