Q: Does The Fda Foresee Any Instance In Which A Vaccine Might Receive An Eua And Not Meet The Criteria For A Biologics License Application If A Product Doesnt Meet The Bla Standard Does The Eua Get Revoked
A: If safety or effectiveness concerns arise with a vaccine under EUA, the FDA has the authority to revoke the EUA. However, it is expected that the data supporting the EUA, together with those that will be collected during use of vaccine under EUA, and additional data collected from ongoing trials will be sufficient to support licensure of a vaccine authorized under EUA.
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What We Don’t Know
There’s so much scientists are still learning about the SARS-CoV-2 virus, how to treat it and why it seems to cause severe symptoms in some people but not in others.;
Because the virus is mutating, every new strain of the virus brings with it new questions and concerns. Some variants, like the delta strain,;are more transmissible than others. Scientists worry;that as the virus continues to spread,;new variants will emerge that could evade the current tests or render the vaccines and treatments ineffective.;Such a;strain;could be deadlier as well.
That’s one of several reasons why doctors and health officials urge as many people as possible to get vaccinated. Immunizing more people will reduce the rate of infection;and thereby cut the chances the;virus has to mutate.;
Because the coronavirus vaccines have been on the market for less than a year,;some people who’ve yet to get vaccinated say they are concerned about potential long-term effects.
While there aren’t;studies yet showing their safety over a long period of time, the CDC says serious;side effects that could cause long-term health problems are extremely unlikely for the COVID-19 vaccines, as they are for any vaccine.
That’s because side;effects from any vaccination are most likely to occur within six weeks after getting a shot, the CDC reports.
Are You Safe After Second Dose Of Vaccine
Both the Pfizer-BioNTech and Moderna COVID-19 vaccines introduce a part of the new coronavirus called the spike protein to your immunity system. The protein which is found on the virus surface is the one that helps the virus to bind and enter the host cells in the human body. The immune system has its own memory which uses the vaccine to understand and store the information about the spike protein. This helps your immunity system to protect you from the COVID-19 virus attack in the future.
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When Can Children Get The Vaccine
The Pfizer vaccine received authorization in May for;adolescents age 12 to 15 after clinical trial results showed it is safe and effective in that age group. That has allowed many students to get vaccinated against COVID-19 before the start of the school year.;
But younger kids will have to wait a while longer.;Vaccine makers;have begun;including younger children in clinical trials, with results expected in the coming months. Many experts expect vaccines to be available for younger age groups;by early this winter.
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The Complete Guide To Staying Safe After Your Covid Vaccine
This article was co-authored by David Nazarian, MD. Dr. David Nazarian is a board certified Internal Medicine Physician and the Owner of My Concierge MD, a medical practice in Beverly Hills California, specializing in concierge medicine, executive health and integrative medicine. Dr. Nazarian specializes in comprehensive physical examinations, IV Vitamin therapies, hormone replacement therapy, weight loss, platelet rich plasma therapies. He has over 16 years of medical training and facilitation and is a Diplomate of the American Board of Internal Medicine. He completed his B.S. in Psychology and Biology from the University of California, Los Angeles, his M.D. from the Sackler School of Medicine, and a residency at Huntington Memorial Hospital, an affiliate of the University of Southern California.There are 17 references cited in this article, which can be found at the bottom of the page.wikiHow marks an article as reader-approved once it receives enough positive feedback. In this case, 86% of readers who voted found the article helpful, earning it our reader-approved status. This article has been viewed 36,846 times.
What Are The Risks Of Getting The Third Shot
The safety profile is the same as for the first and second vaccine doses. Studies with immunocompromised people did not show severe adverse effects after a third dose. The effectiveness of additional COVID-19 vaccine doses in immunocompromised people is very good. After receiving the third shot, many people developed protective antibodies.
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Do Young People Have More Severe Vaccine Side Effects Than Adults
In some cases, children may experience more intense side effects than adults because their immune systems are more robust, but rest assured, it shows the vaccine is working. They cant contract COVID-19 from the vaccine. It just shows they are developing immunity from it.
Most young people who have side effects feel better after a day and seldom need to take time away from school or activities. If you are worried about side effects, schedule a day off for your child with no events or activities.
Should You Get The Second Dose If You Test Positive For Covid
If you get the first dose, only to test positive days later, Dr. Abunasser says this shouldnt keep you from getting the second dose. He says that you should just monitor your symptoms and quarantine accordingly. If your symptoms resolve before your next dose, which will be three or four weeks after the first, you can get the second injection.
The only cases where youd want to skip the second dose would be if you had an allergic reaction to the first dose or if you did get sick with COVID-19 and received an infusion of a monoclonal antibody drug due to being at high risk or having a chronic medical condition;. If you were put on an antibody regimen, Dr. Abunasser recommends postponing the second dose for about three months .
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Is It Possible To Get Covid
None of the new vaccines contain the live virus that causes COVID-19, so it is not possible to get the disease from the vaccine.
It typically takes a few weeks for the body to build immunity after vaccination. That means it is possible for an individual to be infected with the virus that causes COVID-19 just before or just after vaccination, as the vaccine has not had enough time to provide protection.
Common Questions About Covid
Getting a COVID-19 vaccine is an important tool; along with wearing a cloth mask, socially distancing and good hand hygiene; to help stop the ongoing pandemic. As wide-scale vaccination efforts continue, many people have questions about the vaccines. Mayo Clinic’s Vaccination and Distribution Workgroup has answered some of the most common questions about COVID-19 vaccines.
What are the benefits of getting a COVID-19 vaccine?
A COVID-19 vaccine might:
- Prevent you from getting COVID-19 or from becoming seriously ill or dying due to COVID-19
- Prevent you from spreading the virus that causes COVID-19 to others
- Add to the number of people in the community who are protected from getting COVID-19 making it harder for the disease to spread and contributing to herd immunity
- Prevent the virus that causes COVID-19 from spreading and replicating, which allows it to mutate and possibly become more resistant to vaccines
Should I get the COVID-19 vaccine even if I’ve already had COVID-19?
Getting COVID-19 might offer some natural protection or immunity from reinfection with the virus that causes COVID-19. But it’s not clear how long this protection lasts. Because reinfection is possible and COVID-19 can cause severe medical complications, its recommended that people who have already had COVID-19 get a COVID-19 vaccine. If you were treated for COVID-19 with monoclonal antibodies or convalescent plasma, wait 90 days before getting a COVID-19 vaccine.
Symptoms to watch for include:
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What You Can Do
If youve been fully vaccinated:
- You can resume activities that you did prior to the pandemic.
- To reduce the risk of being infected with the Delta variant and possibly spreading it to others, wear a mask indoors in public if you are in an area of substantial or high transmission.
- You might choose to wear a mask regardless of the level of transmission if you have a weakened immune system or if, because of your age or an underlying medical condition, you are at increased risk for severe disease, or if a member of your household has a weakened immune system, is at increased risk for severe disease, or is unvaccinated.
- If you travel in the United States, you do not need to get tested before or after travel or self-quarantine after travel.
- You need to pay close attention to the situation at your international destination;before traveling outside the United States.
- You do NOT need to get tested before leaving the United States unless your destination requires it.
- You still need to show a negative test result;or documentation of recovery from COVID-19 before boarding an international flight to the United States.
- You should still get tested 3-5 days after international travel.
- You do NOT need to self-quarantine after arriving in the United States.
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Is The Technology Used To Develop The Mrna Vaccines Brand New
No, it’s not new.
The technology has been studied and tested for decades, including in the development of vaccines for flu, Zika, rabies and;cytomegalovirus. It’s just that the COVID-19 mRNA vaccines created by Pfizer and Moderna were the first to complete the federal regulatory process and bring an mRNA vaccine to market.;
In addition to using mRNA in the production of;vaccines, the technology also has been used in cancer research to trigger;the immune system to attack;cancer cells.
Does Being Fully Vaccinated Protect Me From Coronavirus Variants
We need to maintain safeguards for a while as we watch what happens with the currently circulating coronavirus variants, Bumpus says. We need to take the time to get the facts and figure out each step at a time. A measured approach is essential.
So far, Bumpus explains, the COVID-19 vaccines offer at least some protection from the circulating coronavirus variants, including the highly contagious delta variant. If a vaccinated person catches a variant, the vaccine is likely to protect him or her from a serious case of COVID-19.
She adds that COVID-19 vaccines protect not only individuals but also the community. The more people who are vaccinated for , the fewer infections will happen, and fewer infections mean fewer chances for the coronavirus to mutate, Bumpus says.
I think the biggest issue right now in addressing the pandemic is the importance of vaccination in limiting the number and prevalence of infections and the emergence of new variants, she says. A great thing is that these vaccines are nimble we can modify them . Even though these variants are not fully understood, we have science on our side in addressing them.
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Why Isn’t Natural Immunity Just As Good As A Vaccine
While a person who contracts coronavirus is likely to develop antibodies that;should provide some protection from reinfection for at least a little while, it’s unclear how long that protection will last.
The CDC urges everyone, including people who’ve already had COVID-19, to get vaccinated. The federal agency in August that;analyzed coronavirus reinfections from May to June among hundreds of fully vaccinated people and unvaccinated people in Kentucky.;
It found that those who were unvaccinated were more than twice as likely to be reinfected with the virus than;fully vaccinated people were.;
If you have had COVID-19 before, please still get vaccinated, Walensky, the CDC director,;said in a statement. This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious delta variant spreads around the country.
If you had the virus and were treated with;monoclonal antibodies or convalescent plasma, the CDC recommends waiting 90 days before getting a coronavirus vaccine.;;
What Can Be Done To Relieve Side Effects Of Covid
Side effects are normal signs that the body is building immunity. These side effects usually go away in a few days. Over-the-counter medicines, such as aspirin, antihistamines, or acetaminophen, may help relieve fever, pain, or discomfort after getting vaccinatedbut should not be used before getting vaccinated.
To reduce pain and discomfort in the arm, apply a clean, cool, wet washcloth over the area, and use/exercise your arm gently. To reduce discomfort from fever, drink plenty of fluids and dress in layers that can be removed.
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How Do The Covid
Both Moderna’s and Pfizer’s COVID-19 vaccines;are made with;messenger RNA technology. They use;a protein that mimics the spike protein of the SARS-CoV-2 virus. It;tricks the body into mounting an immune response that will protect a person from the virus.
They do not use the live virus and cannot give a person COVID-19.
The mRNA used to make these vaccines does not affect or interact with a person’s DNA or genetic material. It is quickly broken down by the body and eliminated.;
The J&J vaccine is different. It is an adenovirus vector vaccine. It uses a modified cold virus that has been stripped of several of its genes. Those genes are replaced with genetic material from the SARS-CoV-2 virus, which then triggers;an immune response to protect a person from the virus.;
The Johnson & Johnson vaccine cannot multiply in the body, and it cannot give a person COVID-19.;It also does not alter a person’s DNA.
Should Children Get Vaccinated Even If Theyve Recovered From Covid
Yes. Children who are eligible based on their age should be vaccinated as soon as they are feeling well and no longer need to quarantine. Natural protection from COVID-19 peaks at about six weeks after recovering and begins to drop at three months after recovering.
Protection from COVID-19 after getting vaccinated lasts much longer: data shows protection remains high six months after vaccination, and researchers predict it will last much longer than that. The vaccines offer a very high level of protection against COVID-19, as well as protection against COVID-19 variants.
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Who Should Not Receive Covid
- Current vaccines are not authorized for children less than 12 years of age
- Individuals who have had severe allergic reactions to other vaccines or injectable therapies should not get vaccinated against COVID-19. Those with other allergies may be vaccinated but should remain at the vaccination site for 15-30 minutes for observation, following vaccination.
- There are no known safety issues for pregnant or breastfeeding women
- COVID-19 vaccination is recommended for those who have previously tested positive for COVID-19
Women younger than age 50 years should be aware of the rare risk of blood clots with low platelets after vaccination with the J&J/Janssen COVID-19 vaccine. Other COVID-19 vaccines are available where this risk has not been seen.
What Are The Health Risks Of Getting The Vaccine After An Infection
There have been some exceedingly rare adverse events, including blood clots and myocarditis. But for most of those cases, the patients recovered quickly and showed no evidence of long-term consequences.
Wherry said most of the people who had the rare blood clots and allergic reactions did not previously have COVID-19.
So the risk seems to be at least a little bit lower why that is, Im not sure. It may just be statistics, that we dont have as many previous COVID people getting vaccinated, he said.
If you get the vaccine too close to a COVID-19 infection, an inflammatory response might be provoked that would make you feel pretty sick again. Thats considered a side effect not an adverse event, Wherry said. Though people with no previous COVID infections typically get stronger side effects after the second dose of a vaccine, people who have had previous infections often get side effects after the first dose.
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