WICHITA, Kan. (KSNW) — Almost as long as we have been in the coronavirus pandemic, there has been confusing, often misleading information. When viewers ask us questions, we do our best to provide clear, accurate answers.
KSN uses sources most people trust, including, but not limited to, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Kansas Department of Health and Environment (KDHE), the Sedgwick County Health Department (SCHD), the University of Kansas Health System, and other hospitals. We also get information from our trusted partners, including our Nexstar sister stations and The Associated Press.
With that in mind, here are some of the questions viewers are sending us and the answers we found.
What does full FDA approval of a vaccine or other drug mean?
It means that the Center for Drug Evaluation and Research (CDER), a consumer watchdog, has reviewed data on a drug’s effects and has determined the benefits of the drug outweigh any risks for people who will take the drug.
What is the efficacy of the Pfizer-BioNTech vaccine, also known as Comirnaty, that won FDA approval?
The FDA says the Pfizer-BioNTech vaccine, Comirnaty, was 91% effective in preventing COVID-19 disease, with 77 cases of COVID-19 occurring in the vaccine group and 833 COVID-19 cases in the placebo group.
What are the risks of taking the Pfizer-BioN-Tech vaccine, Comirnaty?
The FDA says it continues to monitor the vaccine, but this is the information it has after following approximately 12,000 recipients for at least six months:
“The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.”
The FDA goes on to say:
“Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.”
Did the FDA rush its approval of the Pfizer-BioNTech vaccine?
Most medical professionals would say no to this question. Some even believe the FDA was slow.
Let’s look at the timeline:
- July 2020 – The FDA grants Pfizer and BioNTech fast track designation for two of the companies’ four vaccine candidates. The decision was based on preliminary data from Phase 1/2 studies of the vaccines.
- Dec. 11, 2020 – After getting results from a Phase 3 clinical study, the FDA authorizes the Pfizer-BioNTech mRNA vaccine for emergency use in people 16 and older.
- May 7, 2021 – Pfizer and BioNTech submit a rolling submission for FDA approval of the vaccine for ages 16 and older. A rolling submission means the companies will submit data as it comes in, instead of waiting until the end as in a standard review.
- May 10, 2021 – After getting more results from the Phase 3 trial, the FDA expands the emergency use authorization for the vaccine to include children ages 12 through 15.
- July 16, 2021 – The FDA designates the vaccine for priority review. The FDA has two options for review. A “priority review” means the FDA’s goal is to take action on an application within six months. A “standard review” can take 10 months.
- Aug. 23, 2021 – The FDA gives the Pfizer-BioNTech vaccine full approval after getting longer-term follow-up data from the Phase 3 trial. The companies also submitted manufacturing and facilities data which is required by the FDA for licensure.
Dr. Angela Myers, the infectious diseases division director at Children’s Mercy, understands that some people think there is not enough data yet for the FDA to approve the vaccine. But she says the fact is these vaccines have more data available than any other vaccine in history. Furthermore, she stresses that after billions of doses given worldwide, the data shows the vaccine is safe.
The FDA provides information on its website explaining why some drugs are fast-tracked and how the process works. The FDA says, “Efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety.”
When will kids under age 12 be eligible to get vaccinated against COVID-19?
We don’t know. Clinical trials for children ages 11 and younger are currently underway with both the Moderna vaccine and the Pfizer-BioNTech vaccine.
“We need to see the data from those studies before we give this vaccine to younger children,” said Dr. Lee Savio Beers, president of the American Academy of Pediatrics (AAP).
The FDA approval of the Pfizer-BioNTech vaccine is only for people ages 16 and older. Children ages 12 through 15 can continue to get the Pfizer-BioNTech vaccine because of the emergency use authorization in May.
The AAP says the dose for adults is much higher than the dose being tested on children.
Is there any urgency to move it through for kids?
Yes. The AAP sent a letter to the FDA earlier this month asking the FDA to work aggressively toward authorizing a safe and effective vaccine for younger children.
“The hope is high that it will be very, very soon,” said Dr. Angela Myers, the infectious diseases division director at Children’s Mercy. “We are so close, so close.”
How soon do you predict companies will require proof of vaccination?
It is already happening, and other companies may join in. Dr. Dana Hawkinson, the medical director of infection prevention and control at the University of Kansas Health System, says the FDA approval will probably be one more step toward event organizers and other private entities requiring some proof of vaccination.
“I think this will help other companies that haven’t done so, so far, be able to mandate that for their employees,” Hawkinson said.
The Associated Press says employers that require vaccines are on solid legal ground. Private companies and government employers can generally require workers to be inoculated as a condition of working there, though they must offer exemptions or accommodations in some cases.
What is the status of other vaccines that are in the works?
The Regulatory Affairs Professionals Society (RAPS) says there are 21 COVID-19 vaccines that have been authorized around the world. It also lists 92 others that are in various stages of development. RAPS updates its charts every two weeks. They will not all make it to the FDA approval stage.
“FDA finds, gets all of that data and all of the people that have been vaccinated and looks at it and says, ‘OK, so we grant you full FDA approval,'” said Christine Steward, deputy health director Sedgwick County Health Department.
She said the process includes safety studies, emergency use authorization, more data, and then full FDA approval.
Now that the Pfizer-BioNTech vaccine, Comirnaty, has full FDA approval, how will the FDA know if there are problems with it?
“They will always monitor, always be monitoring,” Steward said. “That’s what the Vaccine Adverse Events Reporting System is for all vaccines, even after full FDA approval.”
The FDA says monitoring vaccine safety after approval is a federal government responsibility, shared primarily by the FDA and the CDC, but including other healthcare agencies.
In addition to the Vaccine Adverse Events Reporting System, other tools include the Vaccine Safety Datalink, the Biologics Effectiveness and Safety Initiative, and Medicare claims data.
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