Q: How Long Does It Take To Approve Covid
A: On August 23, 2021, the FDA approved the first COVID-19 vaccine, known as the Pfizer-BioNTech COVID-19 Vaccine, now known as Comirnaty , for the prevention of the disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization , including for people 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. More information on the approval can be found here.
Each review of a COVID-19 vaccine for approval is unique and the amount of time it takes may be different. Having safe and effective approved COVID-19 vaccines is a top priority for the FDA. The process involves incredible expertise and attention to detail, which is critical to ensuring that the FDAs rigorous standards are met.
Our team is reviewing tremendous amounts of data. Vaccine applications have the equivalent of hundreds of thousands of pages of data and other information more than what is submitted as part of an EUA. When a BLA comes in, we have to make sure there is accurate safety and effectiveness information and manufacturing data. We also conduct inspections and develop testing protocols to make sure that every lot of vaccine that is released meets rigorous quality standards.
How Is The Moderna Covid19 Vaccine Given
The Moderna COVID19 Vaccine will be given to you as an injection into the muscle, typically in the upper arm.
The Moderna COVID19 Vaccine vaccination series includes two doses given one month apart. It is important to note that if you receive one dose of the Moderna COVID19 Vaccine, you should receive a second dose of the same vaccine one month later to complete the series.
If you are immunocompromised, you may receive a third dose of the Moderna COVID19 Vaccine at least 1 month after the second dose. Please consult your healthcare provider.
- A bad rash all over your body
- Dizziness and weakness
Side effects that have been reported with the Moderna COVID19 Vaccine include:
- Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling , and redness
- General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever
Side effects that have been reported during post-authorization use of the Moderna COVID19 Vaccine include:
- Severe allergic reactions
These may not be all the possible side effects of the Moderna COVID19 Vaccine. Serious and unexpected side effects may occur. The Moderna COVID19 Vaccine is still being studied in clinical trials.
What About Getting The Covid
In May 2021, the Centers for Disease Control and Prevention updated their recommendations regarding getting other vaccinations around the time youre getting your COVID-19 vaccine. You can safely get other vaccines at the same time as the COVID-19 vaccine.
However, if you do receive multiple vaccinations at once, you should receive them in different limbs, so if you have an injection reaction, you know which vaccine is the cause.
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How Might These Drugs Reduce Vaccine Efficacy
Vaccines work by teaching your immune system to recognize a specific threat so that it can respond appropriately if it ever sees that threat again, said Wallace.
However, according to Wallace, immunosuppressive drugs work by reducing the ability of your immune system to recognize and fight off threats.
This suppression is useful in treating autoimmune conditions like rheumatoid arthritis, where an undesirable immune reaction is occurring.
But immunosuppression also reduces the immune systems ability to mount a response to things you want it to respond to, like infections and vaccines, she said.
Were starting to realize that people taking immunosuppressive drugs may have a slower, weaker response to COVID vaccination.
Interactions With Drugs Used To Treat Travelers Diarrhea
Close monitoring for side effects of azithromycin is recommended when azithromycin is used with nelfinavir. Increased anticoagulant effects have been noted when azithromycin is used with warfarin monitoring prothrombin time is recommended for people taking these drugs concomitantly. Additive QTc prolongation may occur when azithromycin is used with the antimalarial artemether, and concomitant therapy should be avoided. Drug interactions have been reported with macrolides and antiretroviral protease inhibitors, as well as efavirenz and nevirapine, and can increase risk of QTc prolongation, though a short treatment course is not contraindicated for those without an underlying cardiac abnormality. Concurrent use with macrolides may lead to increased levels of calcineurin inhibitors.
Rifaximin is not absorbed in appreciable amounts by intact bowel, and no clinically significant drug interactions have been reported to date with rifaximin except for minor changes in INR when used concurrently with warfarin.
No clinical drug interactions have been studied. Because of minimal systemic rifamycin concentrations observed after the recommended dose, clinically relevant drug interactions are not expected.
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Talk To Your Doctor Before Altering Your Treatment Plan
All experts stress that before altering any treatment you’re receiving, steroid injections included, ahead of your COVID vaccine, you must speak to your doctor. “Talk to your provider about when it would be safe to get the COVID-19 vaccine because there are always exceptions to every rule,” Vyas says. “Cancer therapies, immune suppression or if you have a rheumatologic disease and you need certain shots or injections every month, don’t put those off.”
In addition, the Food and Drug Administration also advises that you should make your vaccine provider aware if you have any of the following conditions: allergies fever a bleeding disorder or you’re on blood thinners are immunocompromised are pregnant or planning to become pregnant are breastfeeding have received another COVID-19 vaccine. This will ensure that your vaccination goes according to plan.
But in general, Vyas says, people with preexisting conditions shouldn’t worry. “If you have hypertension or another common medical condition, you can have a little more peace of mind knowing that they did studies and trials on the COVID-19 vaccines which included people with the same conditions. The good news is that they responded well to the vaccines. So, don’t change any of your regular medications,” she says. And for more on how long the vaccine keeps you safe, check out Dr. Fauci Says Your COVID Vaccine Protects You For This Long.
Should You Take Otc Medications Before Getting The Vaccine
Taking OTC pain medications ahead of your shot to try and decrease symptoms is not recommended by the CDC, because it’s not clear how that could affect the vaccine’s effectiveness.
The concern is that pre-treating with pain medications that reduce fevers and inflammation could dampen your immune system’s response to the vaccine.
That’s because your immune system responds to vaccines through a process called “controlled inflammation,” Dr. Colleen Kelley, an associate professor of medicine at Emory University School of Medicine, told USA Today in January.
Covid messenger RNA vaccines work by giving cells genetic material that tells them how to make a non-infectious piece of the virus. The immune system then creates antibodies against it which is controlled inflammation and can remember how to trigger an immune response if exposed to the virus in the future.
But OTC pain-relieving medications “reduce the production of inflammatory mediators,” Kelley said. That’s why it’s important to wait until after you’ve gotten the vaccine to take pain medication.
Research on children has shown that those who take acetaminophen before getting vaccines have a lower immune response than those who didn’t. And a recent study out of Yale found that giving mice nonsteroidal anti-inflammatory drugs before being exposed to SARS-CoV-2 led to fewer protective antibodies from the virus.
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Log Your Vaccination With The New Cdc Tool
Get set up with V-safe, the CDC’s “after vaccination health checker” tool. Sign up online and log the day and time of your vaccine, as well as the type of vaccine you got. The tool will also ask for your name, age, biological sex and some other basic information.
Once you’re set up, you can report any side effects you experience after getting the vaccine. Someone from the CDC may contact you if they think your report requires follow-up .
V-safe asks how you’re feeling after vaccination.
If You Become Ill After Vaccination
If you experience mild symptoms such as fatigue, headache or elevated temperature within one or two days of vaccination, this could be a side-effect of the vaccination. The side-effects will pass within a few days.
In addition to these mild symptoms, do you also have other symptoms that could indicate COVID-19 ? Or have you had contact with someone who has COVID-19? Get tested. Stay home and follow the protection rules until you get the test results.
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Surgery And Vaccination Timing
General principles for timing administration of vaccines, including for COVID-19, around surgeries are in the Australian Immunisation Handbook.
Recent or imminent surgery is not a contraindication to vaccination, and vice versa.
Schedule COVID-19 vaccination at least one week before or after surgeries. This will reduce the chance that adverse events following the vaccination are attributed as surgical complications .
If you suspect possible TTS in the 42 days after vaccination , you should perform investigations for TTS. You should defer surgery until either:
- TTS is ruled out, or
- the patient recovers fully from confirmed TTS.
Some Medicines May Dampen Vaccine Effectiveness
As with most rules of medical science, there are some exceptions. If you happen to be taking prescription drugs that do affect your immune system, the vaccine might not be as effective as it would be if you weren’t.
So if you have had an organ transplant and are taking immunosuppressant drugs or taking those drugs to treat an autoimmune disease, or if you’re taking certain cancer chemotherapies, the immunosuppressive drug could decrease the efficacy of the vaccine, says William Moss, M.D., executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. Same goes for people who are HIV positive and take one or more medications that affect their immune systems.
Even so, Schaffner emphasizes, such medications will continue to work on the conditions you’re taking them for and so will the COVID-19 vaccine.
“Should you still get the vaccines? asks Schaffner, referring to the currently available COVID-19 vaccines from Pfizer-BioNTech and Moderna. Absolutely. Now, can we guarantee that you will have 95 percent protection? No, but you will get some degree of protection. And some is better than nothing.”
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Feature Article: Medications And Covid
Many people take regular medications, so as they prepare to get the COVID-19 vaccine, they wonder whether their medications will interfere with the vaccine or vice versa. In this article, we will discuss why some medications may be expected to alter the response to the vaccine and others would not. However, given the almost 40 different categories of medications and the thousands of medicinal products distributed, this article will not exhaustively address the topic. With this in mind, individuals should always consider three important points:
Four types of medications have been commonly discussed related to COVID-19 vaccinations, so we will start by addressing these:
Q: How Does Fda Ensure The Quality Of Covid
A: The FDA takes its responsibility for helping to ensure the quality of manufacturing of vaccines and other medical products for use during this pandemic very seriously. The agency is using a variety of inspectional tools to help ensure that products being produced in different facilities meet the high-quality standards that Americans have come to expect. It is important to note that even when companies use contract manufacturing organizations, it is ultimately the responsibility of the company that holds the emergency use authorization to ensure that the quality standards of the FDA are met. No product can be distributed by manufacturers until the FDA authorizes its distribution from the facility that is manufacturing it. The FDA will continue to work with companies to ensure that the quality standards that it expects for products distributed under an emergency use authorization are met, and will continue to work diligently to help bring needed medical products in a timely manner to Americans during this public health emergency.
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Q: What Is The Fdas Role In Regulating Potential Treatments During A Public Health Emergency
A: The FDA carries out many activities to protect and promote public health during a public health emergency, including helping to accelerate the development and availability of potential treatments, protecting the security of drug supply chains, providing guidance to food and medical device manufacturers, advising developers on clinical trial issues, and keeping the public informed with authoritative health information.
The FDA is committed to supporting the development of new drugs, and the potential repurposing of existing drugs, to address COVID-19 by working with potential drug makers and sponsors to rapidly move products into clinical trials, helping to ensure that trials are properly designed and safe, and protecting the public from potentially unsafe products.
A: Yes, the FDA has approved Veklury for certain COVID-19 patients. Read more about the approval here.
Additionally, during public health emergencies, the FDA may in certain circumstances authorize use of unapproved drugs or unapproved uses of approved drugs for life-threatening conditions when there are no adequate, approved, and available options and other conditions are met. This is called an Emergency Use Authorization .
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 Are The Most Important Things I Need To Know To Keep Myself And Others Safe When I Go To The Grocery Store During The Pandemic
A: There are steps you can take to help protect yourself, grocery store workers and other shoppers, such as wearing a face covering, practicing social distancing, and using wipes on the handles of the shopping cart or basket. Read more tips in Shopping for Food During the COVID-19 Pandemic – Information for Consumers.
Medical Experts Explain Why There’s Little Reason To Worry About Your Medications
by Dena Bunis, AARP, Updated February 25, 2021
En español | Every morning, you take a pill for your blood pressure or diabetes, and then maybe at night, you take a statin for your cholesterol. Now, because of the pandemic, you’re being asked to throw a coronavirus vaccination into the mix. While you should consult your doctor if you have concerns, medical experts say the vast majority of prescription drugs will work just as well after you get a COVID-19 vaccine, and they won’t diminish the effectiveness of the shot you’re getting to ward off the coronavirus.
How can doctors be so sure? It comes down to the fact that most of the maintenance medications we take go nowhere near the system in your body that the COVID-19 vaccines affect: your immune system.
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Q: What Do I Do If I Get A Rash Or Other Reaction To Hand Sanitizer
A: Call your doctor if you experience a serious reaction to hand sanitizer. The FDA encourages consumers and health care professionals to report adverse events experienced with the use of hand sanitizers to the 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.
- Include as much information as you can about the product that caused the reaction, including the product name, the manufacturer, and the lot number .
Doctors Are Advising That You Don’t Do Any Steroid Shots Close To Your Covid Vaccine
The Spine Intervention Society’s interim advice is currently to keep a period of two weeks between your COVID vaccine and your regular steroid shots. “It may be prudent, based on indirect evidence, to schedule elective corticosteroid injection approximately two weeks before vaccine administration and no later than one week before vaccine administration to avoid potential decrease in immunogenicity of the mRNA vaccines,” they advise.
While some other experts’ timelines vary slightly, the general consensus is the same. Michaela Schneiderbauer, MD, of Southern Vermont Health Care recently wrote: “While conclusive evidence is not yet available to recommend for or against using steroids around COVID-19 vaccinations, the providers at SVMC Orthopedics are recommending that our patients hold steroid injections in the two weeks before and one week after administration of COVID-19 vaccine.” And for more COVID news sent right to your inbox, .
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