Fda Evaluation Of Safety And Effectiveness Data For Approval For 16 Years Of Age And Older
The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDAs approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDAs review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
Why The Fda Still Has To ‘thoroughly Review’ Pfizer’s Data
The FDA has to look at Pfizer’s clinical data to “make sure that children responded to the vaccine the way we would expect, and that the safety profile is acceptable,” Woodcock said. “In other words, the benefits of the vaccine to children exceed the potential harms.”
Researchers are particularly looking into the potential risks of myocarditis, or inflammation of the heart, which tends to be more common on adolescents than adults. The condition is a rare side effect of the mRNA vaccines and fortunately, Woodcock said, most cases reported by recently vaccinated people are not severe. “But we want to make sure that the safety of the vaccine in the younger children is fully understood,” she said.
In that light, the timeline’s slow-moving nature makes sense: Pediatric vaccines are often approached with a particular amount of care, with agencies like the FDA ruling out any and all safety concerns before doling out vaccines to kids.
Of course, with high cases of Covid among children, the pressure is on to move as quickly as possible.
“But we have to get this right,” Woodcock said. “So, we’ll work on it.”
Q: What Is The Risk Of Using A Hand Sanitizer That Contains Methanol Or 1
A: Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although people using these products on their hands are at risk for methanol poisoning, young children who accidentally swallow these products and adolescents and adults who drink these products as an alcohol substitute are most at risk.
Swallowing or drinking a hand sanitizer with 1-propanol can result in decreased breathing and heart rate, among other serious symptoms, and can lead to death. Hand sanitizer with 1-propanol contamination can irritate your skin . Although it is rare, some people have reported allergic skin reactions. Learn more about methanol and 1-propanol toxicities.
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Q: What Should People Do If They Have Been Exposed To Hand Sanitizer With Potential Methanol Or 1
A: People who have been exposed to contaminated hand sanitizer and are experiencing symptoms should seek immediate medical treatment for potential reversal of toxic effects.
FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDAs MedWatch Adverse Event Reporting program :
- Complete and submit the report online or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Covid Vaccines: Emergency Use Authorization Vs Approval
Not every vaccine is granted an emergency use authorization before full approval. The FDA authorized three COVID-19 vaccines to answer an urgent need to protect people from the coronavirus pandemic, which was a public health emergency.
When it was clear in 2020 that COVID-19 was a rapidly spreading, dangerous disease, the FDA worked with vaccine manufacturers, independent laboratories, academic research centers and nonprofit organizations to quickly gather and interpret large amounts of data on the vaccines.
The data showed that the vaccines were very effective in preventing severe COVID-19 and the risks of serious side effects was extremely low. Based on these findings, the FDA granted the EUA so people could be vaccinated earlier in the approval process and be protected from serious effects of COVID-19.
Full approval is granted when, over time, the FDA has amassed even more scientific evidence to support use of the COVID-19 vaccines, showing that the benefits of the vaccine are greater than its risks, and that the vaccines can be manufactured reliably, safely and with consistent quality.
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How Is It That Covid
In public health emergencies, such as a pandemic, the development process may be atypical. For example, as demonstrated by the response to the COVID-19 pandemic, the U.S. government has coalesced government agencies, international counterparts, academia, nonprofit organizations and pharmaceutical companies to develop a coordinated strategy for prioritizing and speeding development of the most promising vaccines. In addition, the federal government has made investments in the necessary manufacturing capacity at its own risk, giving companies confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. However, 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.
Recognizing the urgent need for safe and effective vaccines, FDA is utilizing its various authorities and expertise to facilitate the expeditious development and availability of vaccines that have met the agencys rigorous and science-based standards for quality, safety, and effectiveness. Early in a public health crisis, FDA provides clear communication to the pharmaceutical industry pertaining to the scientific data and information needed to ensure development of vaccines and works quickly to provide advice on their proposed development plans and assessment of the data that are generated.
Q: Should I Purchase Personal Protective Equipment Such As Facemasks Or N95 Respirators For Me And My Family
A: No. Surgical masks and N95s need to be reserved for use by health care workers, first responders, and other frontline workers whose jobs put them at much greater risk of acquiring COVID-19. The cloth face coverings recommended by CDC are not surgical masks or N95 respirators. Surgical masks and N95s are critical supplies that must continue to be reserved for health care workers and other medical first responders, as recommended by CDC.
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Does The Fda Monitor Covid
Yes. The FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety. These systems, called passive surveillance and active surveillance systems, rapidly detect and investigate potential safety problems. Systems such as the Vaccine Adverse Event Reporting System and CDCs text-based v-safe system, which receive reports of adverse events following vaccination, are examples of passive surveillance systems. The FDAs BEST Initiative is an example of an active surveillance system, which analyzes information occurring in millions of individuals recorded in large data systems to investigate any safety signals that are identified by VAERS or v-safe.
What Does This Mean For School And Employer Vaccine Mandates
It’s likely we’ll see more vaccine requirements put in place now that there is one vaccine with full FDA approval.
The Defense Department, for example, has already announced that all service members will be required to get the vaccine now that the FDA has approved the Pfizer vaccine. Without the approval, it would have taken a presidential waiver to allow the secretary of defense to require service members to be vaccinated.
Even before the FDA’s full approval of the Pfizer vaccine, federal departments including the departments of Health and Human Services and Veterans Affairs had mandated that their employees who work with patients get the vaccine.
Misty Cunningham yells at a passing motorist outside Winchester Medical Center on Aug. 10 in Winchester, Va. Health care workers went on strike over a COVID-19 vaccine mandate by their employer Valley Health.hide caption
Misty Cunningham yells at a passing motorist outside Winchester Medical Center on Aug. 10 in Winchester, Va. Health care workers went on strike over a COVID-19 vaccine mandate by their employer Valley Health.
Outside of government entities, it’s possible that more universities will require vaccines for adults over age 18, something that many states have long required for meningitis, for example.
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Are There Any Side Effects
People in Merck’s trial reported a similar number of side effects regardless of whether they got the real drug or a placebo .
“We’re very comfortable that the drug will be safe if used as intended,” Daria Hazuda, Merck’s vice president of infectious diseases discovery, said in a press call earlier this month.
Read the original article on Business Insider
Why Do The Vaccines Even Need Full Approval
There are many reasons why its better for the companyand the publicto have full approval of a vaccine. For one, full approval bolsters the publics confidence, as it means that the vaccine has gone through an ultra-rigorous process to look at safety and effectiveness. The emergency use authorization process is rigorous as well, but full approval looks at more data over a longer period of time. There are benefits for the company as well: public health emergencies have time limits, meaning the vaccine would no longer be able to be sold once its over. Full FDA approval means the drug can be used at any time for as long as it is approved.
A lot of people are getting their news about the Covid-19 vaccine from cable news, so there may be an impact there, but in terms of trusted messengers, it’s always been doctors.
Ashley Kirzinger, Kaiser Family Foundation
What You Need To Know
- COVID-19 vaccines are safe and effective.
- Millions of people in the United States have received COVID-19 vaccines under the most intense safety monitoring in U.S. history.
- CDC recommends you get a COVID-19 vaccine as soon as possible.
- If you are fully vaccinated, you can resume activities that you did prior to the pandemic. Learn more about what you can do when you have been fully vaccinated.
Q: What Is Convalescent Plasma And Why Is It Being Investigated To Treat Covid
A: Convalescent refers to anyone recovering from a disease. Plasma is the yellow, liquid part of blood that contains antibodies. Antibodies are proteins made by the body in response to infections. Convalescent plasma from patients who have already recovered from coronavirus disease 2019 may contain antibodies against COVID-19. The FDA has issued an emergency use authorization for the use of convalescent plasma in hospitalized patients. It is being investigated for the treatment of COVID-19 patients. Based on scientific evidence available, the FDA concluded this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product for patients hospitalized with COVID-19. Learn more about donating from this video.
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Whats The Difference Between Emergency Authorization And Full Approval
Way back in January 2020, not knowing the full extent of the threat posed by Covid-19, the Health and Human Services Secretary declared a U.S. public health emergency. This action gave special power to the FDA to authorize medicines, vaccines and tests for use by the American public to fight the virus in an expedited fashion without going through the lengthy full approval process. The amount of data required for whats known as an emergency use authorization, or an EUA, is at the discretion of the FDA.
The main thing the FDA considers with emergency authorization is, based on the scientific evidence available, that its reasonable to believe that the product may be effective and that the known and potential benefit outweigh the known and potential risks, explains Nicholson Price, a professor of health law at the University of Michigan Law School in Ann Arbor. The medicine or vaccine also needs to be unique, there cant be an existing alternative thats already been approved. For vaccines, manufacturers were required to provide safety data that was much closer to what a company would need for full approval for the vaccine, he says. For emergency authorization, the FDA required two months of safety data versus six months for full approval, he explains.
Q: Are There Going To Be Any Animal Drug Shortages Due To The Covid
A: The FDA has been and is continuing to closely monitor how the COVID-19 outbreak may impact the animal medical product supply chain.
We have been reaching out to manufacturers as part of our approach to identifying potential disruptions or shortages. We will use all available tools to react swiftly to help mitigate the impact if a potential disruption or shortage is identified.
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Who Are The Fda Career Professionals Evaluating Euas For Vaccines
The FDA staff are career scientists and physicians who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines intended to prevent infectious diseases. These FDA professionals are committed to decision-making based on scientifically driven evaluation of data. FDA staff are like your family – they are fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are also directly impacted by the work that they do, and are exactly who you want making these important public health decisions for the United States.
Q: Am I At Risk For Serious Complications From Covid
A: Yes. Data shows that when compared to never smokers, cigarette smoking increases the risk of more severe illness from COVID-19, which could result in hospitalization, the need for intensive care, or even death. Smoking cigarettes can cause inflammation and cell damage throughout the body, and can weaken your immune system, making it less able to fight off disease.Theres never been a better time to quit smoking. If you need resources to help you quit smoking, the FDAs Every Try Counts campaign has supportive tips and tools to help you get closer to quitting for good.
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Full Approval: What Does Fda Approval For The Pfizer Covid
Dr. Chris Beyrer is the Desmond M. Tutu Professor in Public Health and Human Rights at the Johns Hopkins Bloomberg School of Public Health. An infectious diseases epidemiologist, he currently serves as Senior Scientific Liaison to the COVID-19 Vaccine Prevention Network, the Co-VPN, for Community Engagement. He is a Professor of Epidemiology and Medicine at Johns Hopkins.
- Pfizer-BioNTechâs mRNA COVID-19 vaccine has now received full FDA approval for those aged 16 and over it continues to have emergency use authorization for those aged 12 to 15.
- Full FDA approval has led some entities, including the U.S. Military, to mandate COVID-19 immunization.
- While the rate of immunization has increased following full FDA approval of Pfizerâs vaccine, we still need higher numbers of Americans to be immunized at a faster pace to get ahead of Delta and other emerging variants.
Since the full approval of the vaccine, and the start of vaccine mandates across multiple sectors, immunization rates are increasing again, but the science shows clearly that we need higher numbers of Americans to be immunized. And, we need a faster rate of immunization to get ahead of Delta and other emerging variants. Both pace and coverage matter.
Chris Beyrer, Desmond Tutu Professor in Public Health and Human Rights
Johns Hopkins experts in global public health, infectious disease, and emergency preparedness have been at the forefront of the international response to COVID-19.
Q: Is There A Shortage Of Personal Protective Equipment Such As Gloves Masks And N95 Respirators Or Of Ventilators
A: The FDA has been working closely with PPE and ventilator manufacturers to understand their supply capabilities during this pandemic. The agency is also aware of challenges throughout the supply chain that are presently impacting the availability of PPE products and is taking steps to mitigate shortages that health care facilities are already experiencing.
The FDA issued new guidance to give ventilator manufacturers and non-medical device manufacturers more flexibility to start making new ventilators and parts. We adjusted our screening of PPE and medical devices at U.S. ports of entry to expedite imports of legitimate products into the U.S. With CDC we took action to make more respirators, including certain N95s, available to health care personnel for use in health care settings. Read more about PPE.
The FDA encourages manufacturers and health care facilities to report any supply disruptions to the device shortages mailbox at .
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The Fda Pulled A Bait And Switch
Although the sources that led me to this particular conspiracy theory were articles posted by Tuesday, Ill begin with a Tweet from antivax thought leader Robert F. Kennedy, Jr.:
Here’s my latest with Buried in fine print of Monday’s approval by FDA of Pfizer Comirnaty COVID vaccine are 2 critical facts that affect whether vaccine can be mandated + whether Pfizer can be held liable for injuries.
The article linked to claims:
The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now requiredthe vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.
But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDAs regulatory capture, or the depths of the agencys cynicism.
First, the FDA acknowledges that while Pfizer has insufficient stocks of the newly licensed Comirnaty vaccine available, there is a significant amount of the Pfizer-BioNTech COVID vaccine produced under Emergency Use Authorization still available for use.
The FDA that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used interchangeably with the newly licensed Comirnaty product.
So what does that particular footnote in the FDA letter say? Lets quote it:
Reiss further notes: