Efficacy In Young People
For children aged 5 to 11, clinical trial results showed the Pfizer vaccine was 90.7% effective against getting COVID-19 symptoms, and no participants developed severe COVID-19.
Pfizer has reported 100% efficacy against symptomatic COVID-19 infection in the 12- to 15-year-old age group with a higher antibody response than was seen in the 16- to 25-year-old age group.
What’s The Difference Between Fda Approval And Emergency Use Authorization
If a vaccine is fully approved by the FDA, it means that the information on the vaccine and its effects have been thoroughly reviewed, and the FDA has determined that the benefits outweigh the known and possible risks for the people it is meant to help.
In an EUA, the FDA allows the use of a vaccine or drug during a time of emergency, such as the current COVID-19 pandemic, when the available evidence shows the potential benefits outweigh the potential risks. Drugs and vaccines that have been given an EUA continue to be studied in clinical trials. An EUA is not the same as a full FDA approval, which requires a more thorough review of safety and effectiveness.
Even after a drug or vaccine has been given full approval, the FDA might continue to monitor it for unexpected side effects or for more information that might be helpful to know. For example, it is not yet clear how likely it is that someone who gets one of the vaccines could still spread the virus to others. This is still being studied, as are any possible long-term effects of the vaccines. Researchers are also still trying to determine how long the vaccines will provide protection against the virus.
When To Get A Booster Dose
You can book a booster dose if it has been four months or longer since your second dose of COVID-19 vaccine.
The date you had your second dose of vaccine is on your COVID-19 digital certificate.
As soon as practical, ATAGI further recommends providing boosters to all eligible adults from a minimum of three months following the second dose of the primary course. Read the ATAGI statement . More information will be provided on when this change will take effect as soon as possible.
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And Pfizers pediatric vaccine will be easier still to administer, which may make it more likely pediatricians will become involved in the vaccine rollout. The 10-dose pediatric vaccine vial can be stored for up to 10 weeks at refrigerator temperatures. The bounds of trust between pediatricians and parents will be key in getting people who are uncertain about whether they want to vaccinate their children to agree to do so.
Modernas vaccine must be shipped at -4 degrees Fahrenheit, which is within the range of a regular refrigerator freezer. The Moderna product is stable at fridge temperature for 30 days and at room temperature for 12 hours. J& Js vaccine can be stored at room temperature not to exceed 77 degrees Fahrenheit for 12 hours when the vial hasnt yet been punctured. After the first dose is withdrawn, the vial can be stored in a fridge for six hours or at room temperature for two hours.
Andrew Joseph contributed reporting.
An earlier version of this story mischaracterized the way in which viral vectored vaccines work and incorrectly stated that the single dose J& J vaccine contains more antigen than the doses in its two-dose regimen.
Booster Doses For Healthcare Workers
Healthcare workers on the frontline of the COVID-19 response are at higher risk of infection. The Australian Technical Advisory Group on Immunisation recommends people working in a healthcare settings consider receiving a booster dose. Healthcare workers were prioritised early in the vaccination rollout, so many are due for their booster dose.
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What Do We Know About Johnson & Johnson’s Adenovirus Covid
In December 2021, the CDC stated a preference for one of the mRNA COVID-19 vaccines over Johnson & Johnsonâs single-dose adenovirus COVID-19 vaccine. The CDC made the decision because of growing evidence that Johnson & Johnsonâs vaccine increases the risk of blood clots. Although very rare, this problem can be serious and even lead to death.
The blood clots in question involve blood vessels in the brain, lungs, abdomen, and legs, and are accompanied by low levels of blood platelets. This combination is referred to as thrombosis and thrombocytopenia syndrome, or TTS, an abbreviation of the medical terms for the two conditions.
Since the FDA granted emergency use authorization for the Johnson & Johnson vaccine in late February 2021, nearly 17 million doses of the one-dose vaccine have been given. A total of 54 cases of TTS, including nine deaths, were reported in people who received the Johnson & Johnson vaccine through August 31, 2021. TTS has been seen in men and women across age ranges, but the highest risk was seen in women ages 30 to 49 years.
The Johnson & Johnson COVID-19 vaccine will still be available in the US to people who cannot or do not want to get an mRNA vaccine. The vaccineâs label and fact sheet list symptoms of TTS, and urge anyone who experiences them after receiving the Johnson & Johnson vaccine to seek immediate medical attention.
The Johnson & Johnson vaccine can be safely refrigerated for months and frozen for even longer.
Could An Mrna Vaccine Change My Dna
An mRNA vaccine cannot change your DNA.
mRNA, or messenger RNA, is genetic material that contains instructions for making proteins. mRNA vaccines for COVID-19 contain man-made mRNA. Inside the body, the mRNA enters human cells and instructs them to produce the “spike” protein found on the surface of the COVID-19 virus. Soon after a cell makes the spike protein, the cell breaks down the mRNA into harmless pieces. At no point does the mRNA enter the cell’s nucleus, which is where our genetic material lives.
The immune system recognizes the spike protein as an invader and produces antibodies against it. If the antibodies later encounter the actual virus, they are ready to recognize and destroy it before it causes illness.
The two mRNA vaccines available in the US are made by Pfizer/BioNTech and Moderna. Both have been granted full approval by the FDA.
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There have been reports of severe allergic reactions to the mRNA vaccines. Both the Pfizer and Moderna vaccines appear, on rare occasions, to trigger anaphylaxis, a serious and potentially life-threatening reaction. People who develop anaphylaxis must be treated with epinephrine the drug in EpiPens and may need to be hospitalized to ensure their airways remain open. The CDC says people should be monitored for 15 minutes after getting a Covid-19 shot, and 30 minutes if they have a history of severe allergies. J& J recently revealed that a single case of anaphylaxis has been reported in someone who received its vaccine.
The most recent data from the CDC suggest that anaphylaxis occurs at a rate of between two to five cases per one million people vaccinated in the U.S. Many of the people who have developed anaphylaxis have a history of severe allergies and some have had previous episodes of anaphylaxis.
The mRNA vaccines carry a small risk of myocarditis and pericarditis, two types of heart inflammation that are most commonly seen soon after people receive their second shots, health officials have said. Males under 30 seem to be at highest risk, particularly those aged 12 to 17. Most cases reported have been mild and resolved.
TTS occurs most commonly in women between the ages of 30 and 49. The CDC says from March 2 to Aug. 31 there were 54 confirmed cases, nine of whom died.
Could The Vaccine Cause Issues If Im Getting A Mammogram
Getting a COVID-19 vaccine might result in swollen lymph nodes under the arm in which the injection was given.
Swollen lymph nodes under the arm might show up on a mammogram done to screen for breast cancer, which could cause concern and might lead to the need for further tests.
If youre scheduled for a mammogram soon after you get a COVID-19 vaccine, its important to tell your doctor when and in which arm you received the injection. Based on your situation, they can discuss with you if you should change your mammogram appointment. Do not delay your mammogram without speaking to your doctor first.
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Are The Vaccines Safe
Every vaccine that is approved in the United States, even if under emergency use authorization, undergoes stringent safety testing, and the CDC continues to collect data on any side effects or adverse outcomes that could be related to the vaccine over time.
People who receive vaccines may experience a number of side effects, such as a sore arm, fever, fatigue, chills, nausea, and body aches especially after the second dose of one of the two-dose regimens. This is a sign that the immune system is reacting and is not a cause for concern. The CDC recommends taking a painkiller after getting the shot and exercising the arm to avoid soreness.
The side effects are generally more intense after the second shot, as the immune system reacts to the known spike protein. The CDC also reports that 80% of those who reported experiencing side effects were women, which may be related to sex hormones role in the immune response, according to a New York Times article.
There are some rare serious side effects, such as anaphylaxis a life-threatening, but treatable, allergic reaction. In the United States, this reaction has occurred in about two to five people per million vaccinated and has not resulted in any deaths.
The CDC requires that vaccinated people stay at the vaccination site for observation for at least 15 minutes after getting the shot in case they do have a negative reaction.
How Can I Protect My Family Until We Are All Vaccinated
Safe and effective vaccines are a game changer, but even once vaccinated we need to continue taking precautions for the time being to protect ourselves and others. The most important thing you can do is reduce your risk of exposure to the virus. To protect yourself and your loved ones, make sure to:
- Wear a mask where physical distancing from others is not possible.
- Keep a physical distance from others in public places.
- Avoid poorly ventilated or crowded spaces.
- Open windows to improve ventilation indoors.
- Wash your hands regularly with soap and water or an alcohol-based hand rub.
If you or a family member has a fever, cough or difficulty breathing, seek medical care early.
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What Are Mrna Vaccines And How Do They Work To Help Prevent Covid
mRNA, or messenger RNA, is genetic material that contains instructions for making proteins. mRNA vaccines for COVID-19 contain synthetic mRNA. Inside the body, the mRNA enters human cells and instructs them to produce the “spike” protein found on the surface of SARS-CoV-2, the virus that causes COVID-19. The body recognizes the spike protein as an invader, and starts producing antibodies against it. Soon after, the cell breaks down the mRNA into harmless pieces If the antibodies later encounter the actual virus, they are ready to recognize and destroy it before it causes illness.
The two mRNA vaccines available in the US are made by Pfizer and BioNTech and Moderna.
How Do These Vaccines Work
The Pfizer-BioNTech and Moderna vaccines contain messenger RNA , which is a type of genetic material. After a person receives the vaccine, the mRNA enters cells in the body and tells them to make copies of the COVID-19 viruss spike protein . This doesnt cause disease, but it does help teach the immune system to act against the virus if the body is exposed to it in the future.
The Johnson & Johnson vaccine contains an adenovirus , which has been changed in the lab so that it contains the gene for the COVID-19 viruss spike protein. Once the adenovirus enters cells in the body, this gene tells the cells to make copies of the spike protein. This triggers the immune system to recognize and attack the COVID-19 virus if the body is exposed to it in the future. The adenovirus in this vaccine is not a live virus because it has been changed so that it can no longer reproduce in the body .
You cannot get COVID-19 from any of these vaccines, as they do not contain the virus that causes COVID-19.
Some vaccines for other diseases contain changed versions of the live viruses that cause the diseases. These live viruses dont cause problems in people with normal immune systems. But they might not be safe for people with weakened immune systems, so live virus vaccines typically are not recommended for cancer patients. However, the COVID-19 vaccines available in the US do not contain these types of live viruses.
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What Needed To Happen Before The Fda Authorized Or Approved A Vaccine For Covid
Approval of the Pfizer/BioNTech and Moderna vaccines and authorization of Johnson & Johnson’s vaccine required completion of the following steps:
- Pre-clinical testing: Animals are infected with the virus. Scientists study their immune response to see what aspects of the immune response might be critical for protection. Normally, a vaccine is first tested in animals. However, in the setting of a pandemic such as this one, the animal testing stage can be skipped.
- Phase 1 trials: A vaccine is tested in small groups of people to determine what dose safely and consistently stimulates the immune system. At this stage, scientists don’t yet know if the immune response triggered by the vaccine will protect against the virus.
- Phase 2 trials: The vaccine is given to hundreds or thousands of people. Scientists continue to focus on whether the vaccine is safe and produces a consistent immune response.
- Phase 3 trials: These trials typically enroll tens of thousands of people. This is the first phase that involves a placebo group. It compares the number of people who get sick in the vaccine group to the number of people who get sick in the placebo group. This is the only phase that can show whether or not the immune response triggered by the vaccine actually protects against infection in the real world.
Safety data continue to be collected and monitored even after the vaccines are approved or authorized.
Ingredients That Are Not Used In Covid
The above table lists ALL ingredients in the Pfizer-BioNTech COVID-19 vaccine. There are NO ingredients in this vaccine beyond what is listed in the table. The Pfizer-BioNTech COVID-19 vaccine has:
- No preservatives like thimerosal or mercury or any other preservatives.
- No antibiotics like sulfonamide or any other antibiotics.
- No medicines or therapeutics like ivermectin or any other medications.
- No tissues like aborted fetal cells, gelatin, or any materials from any animal.
- No food proteins like eggs or egg products, gluten, peanuts, tree nuts, nut products, or any nut byproducts .
- No metals like iron, nickel, cobalt, titanium, rare earth alloys, or any manufactured products like microelectronics, electrodes, carbon nanotubes or other nanostructures, or nanowire semiconductors.
- No latex. The vial stoppers used to hold the vaccine also do not contain latex.
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Why Are Some People Hesitant About Getting A Covid Vaccine
Itâs natural to want to make an informed decision about the COVID-19 vaccine. Fortunately, the safety of the vaccine seen in the clinical trials has been verified by the real-world results. The FDA has granted full approval to the Pfizer/BioNTech and Moderna COVID-19 mRNA vaccines. The transition from emergency use authorization status to full licensure was based on additional data and longer follow-up showing that the vaccines met certain safety, effectiveness, and manufacturing quality standards.
Warp speed? Yes, the speed with which the COVID-19 vaccines were developed was incredibly fast. But the science and technology to make it happen came after decades of research.
COVID-19 mRNA vaccines are new, but scientists have been studying mRNA for many years. They cannot change your DNA. The mRNA sends a message to the bodyâs cells to make only a specific protein, not a virus, that stimulates the immune system to give you protection. Experts predict that most vaccines in the future will use mRNA technology.
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Some communities, particularly communities of color, may have historical reasons to doubt the health care system. But these communities have also been among the hardest hit by this pandemic, and like all of us, have a lot to gain from vaccination.
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All three vaccines continue to offer solid protection against severe illness, though there is concern within the Biden administration that this too will weaken if boosters are not given.
A key question at this point is whether the booster shots will solidify protection in a way that is more sustained, or if these additional doses mark the start of a regular booster shot effort.
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Mrna Vaccines Are Newly Available To The Public But Have Been Studied For Decades
Researchers have been studying and working with mRNA vaccines for decades. Interest has grown in these vaccines because they can be developed in a laboratory using readily available materials. This means vaccines can be developed and produced in large quantities faster than with other methods for making vaccines.
mRNA vaccines have been studied before for flu, Zika, rabies, and cytomegalovirus . As soon as the necessary information about the virus that causes COVID-19 was available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine.
Future mRNA vaccine technology may allow for one vaccine to provide protection against multiple diseases, thus decreasing the number of shots needed for protection against common vaccine-preventable diseases.
Beyond vaccines, cancer research has used mRNA to trigger the immune system to target specific cancer cells.