Has The Fda Approved Any Of The Vaccines
All available vaccines in the United States have been under an EUA. Rigorous clinical trials among thousands of people have proven that vaccines are safe and effective. Over 200 million Americans have been safely fully vaccinated against COVID-19. The U.S. Food and Drug Administration approved the Pfizer-BioNTech COVID-19 vaccine, which Pfizer is calling Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. This is the only fully FDA approved COVID-19 vaccine at this time. The Pfizer adult vaccine will continue to be available under EUA for teens 12 to 15, for the administration of a third dose in certain immunocompromised individuals, and for a booster dose in 16 and 17 year olds. The FDA also issued an EUA for a lower dose of the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11, and the Centers for Disease Control and Prevention recommended all children in this age group get the vaccine to protect against serious illness and help keep them healthy. FDA approval of Pfizer for these younger populations will require additional time as the vaccine was not authorized for such use until more recently.
Is The Pediatric Vaccination Safe And Effective
Yes. There were no safety concerns or serious side effects noted in the clinical trials, which began in March 2021. The first phase of the trial initially enrolled 4,500 children ages six months to 11 years in more than 90 clinical trial sites. This is comparable to the number included in many similar clinical trials with children. Trials included volunteers from different races and ethnicities, including Black and Hispanic/Latinx volunteers around the world. 77% percent of clinical trial participants were white, 6% were Black, 8% Asian, 17% Hispanic/Latino and 7% multiracial. Additionally, the vaccine was found to be effective in this age group: it produced similar immune responses in children 5-11 as in older kids and adults ages 16 to 25. As always, keep in mind that the Food and Drug Administration reviews trials to determine if vaccines are safean independent, scientific committee checks the work. Vaccines are authorized and the Centers for Disease Control and Prevention recommends their use.
Is It Safe For My Teen To Get The Covid
Cases of myocarditis, or inflammation of the heart, have been reported in a small number of teens after receipt of the COVID-19 mRNA vaccine. The condition is continuing to be investigated. Here is what we know to date:
The CDC will continue to monitor the situation related to myocarditis, but for now, there is not a reason to stop vaccinating kids. The American Heart Association has also released a statement encouraging continued vaccination.
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How Long Before A Coronavirus Vaccine Takes Effect
The mRNA vaccines require two doses. While people will have some immunity after the first dose, protection will be most likely about one week after receipt of the second dose and the individual will be considered fully vaccinated two weeks after the second dose.
The adenovirus vaccine requires one dose. While people will have some immunity about two weeks after being vaccinated , protection will be more robust about one month after receipt of the vaccine. Likewise, individuals are recommended to get a second dose at least 8 weeks after the first dose to further bolster their immunity.
Should My Child Or Teen Get A Covid
An increasing number of vaccines are now being approved for use in children, so its important to stay informed of guidance by your local and national health authorities.
Both the Moderna and Pfizer vaccines have been approved by WHO for use in children 12 years and older. Studies are ongoing into vaccine efficacy and safety in children under 12 years of age and we will update when more information is available.
At this time WHO recommends that countries should vaccinate children only when high vaccine coverage with two doses has been achieved in higher priority-use groups. Children and adolescents tend to have milder disease compared to adults, so unless they are part of a group at higher risk of severe COVID-19, it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers.
Remind your children of the importance of us all taking precautions to protect each other, such as avoiding crowded spaces, physical distancing, hand washing and wearing a mask.
It is critical that children continue to receive the recommended childhood vaccines.
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If I Have An Autoimmune Or Immune
People with immune-compromising conditions may get the COVID-19 vaccine as long as they are not in one of the following categories:
- Severe allergy to a vaccine component
- History of severe allergy to any vaccine or injectable medication
However, it is recommended that individuals with compromised immune systems discuss their personal risks and benefits with a healthcare provider to determine whether to receive the vaccine or if they may need an additional dose.
Knowing the potential for a lower immune response, if someone with an immune-compromising condition decides to get vaccinated, it will be important to get both doses and possibly a third dose, depending on their condition . They may also choose to practice other public health measures until more is known about their protection against SARS-CoV-2, the virus that causes COVID-19.
Vaccine Mandates In The Past
In the mid-19th century, the British government made vaccination against smallpox compulsory. Local Anti-Vaccination Leagues were formed in response, brandishing the same hesitancy and uneven understanding of science that recur among anti-vaccination activists today. In many ways, not much is new.
Yet, some things about vaccine mandates do seem to have changed in recent decades.
When a successful polio vaccine candidate was announced in 1953, it made its developer a minor celebrity parents quickly sought it out for their children without needing coercion. Seven years later, Time magazines Man of the Year was awarded to US Scientists.
But then science became intertwined with the Cold War and government secrecy. Laboratories were bombed, a superfluous and flawed swine flu vaccination effort left dozens of people with a rare neurological disorder, and Soviet disinformation about the origin of AIDS an epidemic that claimed hundreds of thousands of lives last year spread around the world. Seeds of doubt were sown everywhere.
So, COVID-19 vaccine mandates may certainly seem like an attractive option to help stem the spread of the disease, as long as everyone affected has equal access .
But perhaps a more foundational effort is necessary to rebuild trust in science potentially making mandates unnecessary.
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How Are Vaccines Developed
This article is part of a series of explainers on vaccine development and distribution. Learn more about vaccines from how they work and how theyre made to ensuring safety and equitable access in WHOs Vaccines Explained series.
What are the ingredients in a vaccine?
Vaccines contain tiny fragments of the disease-causing organism or the blueprints for making the tiny fragments. They also contain other ingredients to keep the vaccine safe and effective. These latter ingredients are included in most vaccines and have been used for decades in billions of doses of vaccine.
Each vaccine component serves a specific purpose, and each ingredient is tested in the manufacturing process. All ingredients are tested for safety.
All vaccines contain an active component which generates an immune response, or the blueprint for making the active component. The antigen may be a small part of the disease-causing organism, like a protein or sugar, or it may be the whole organism in a weakened or inactive form.
Stabilizers prevent chemical reactions from occurring within the vaccine and keep the vaccine components from sticking to the vaccine vial.
Stabilizers can be sugars , amino acids , gelatin, and proteins .
Surfactants keep all the ingredients in the vaccine blended together. They prevent settling and clumping of elements that are in the liquid form of the vaccine. They are also often used in foods like ice cream.
Serum Institute Stops Making Covid Vaccines With 20 Crore Doses Spare
2 min read.
- Poonawalla noted that his company had stopped production from December 31, 2021, just to avoid waste
|Listen to this article|
The world’s largest vaccine maker, the Serum Institute of India, has stopped making fresh batches of shots after its stockpile grew to 20 crore doses amid a global supply glut, its chief executive Adar Poonawalla said on Friday.
There is now a global glut of coronavirus vaccines.
Warning against the return to the business-as-usual approach, Poonawalla said we “can’t afford to put a price tag on the life of a citizen” as the pandemic is not behind us yet.
Poonawalla noted that his company had stopped production from December 31, 2021, just to avoid waste.
He pointed out that there is rising vaccine fatigue among the public as the main reason for the low off-take of the vaccines even after the firm has massively slashed the price from 600 to 225 a dose.
We have got 200 million doses of stock. We had to shut down production in December,” the SII CEO said at a conclave today, saying he was worried about wastage if the shots expired. I have even offered to give free donations to whoever wanted to take it.”
Serums predicament underscores the vaccine oversupply that has crept up across a world once desperate for immunization against the coronavirus.
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What Is The Difference Between The Adult Version And The Pediatric Version Of The Pfizer
The main difference between the adult and pediatric version of the Pfizer BioNTech COVID-19 vaccine is that the vaccine for children 5-11 is one-third the amount given to people 12 and older. The pediatric vaccine still requires two doses. At this time, the 5-11 version of the vaccine is not offered as an additional or booster dose, as it has not been authorized by the FDA or CDC for these uses.
Did They Skip Any Steps
They did not skip any steps. The studies followed the same steps as studies for any other vaccine. The reason the vaccines were given Emergency Use Authorization instead of FDA approval has to do with the ability to get the vaccines to the public quickly. Like all vaccines, the COVID-19 vaccines were first tested in smaller studies to establish that there were no immediate safety concerns, and that they were likely to protect against COVID-19. Then, large studies were organized with tens of thousands of people to confirm the vaccines worked and to look further for safety concerns. The studies had to meet criteria showing that the vaccines worked. There also had to be at least two months of follow-up safety data before the FDA would consider authorization. Even after a vaccine is authorized, safety monitoring continues.
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Is It Safe For My Adolescent Or Teen To Get The Covid
The Pfizer COVID-19 mRNA vaccine is approved for those 5 years of age and older. Other COVID-19 vaccines are still being tested in those younger than 18 years of age.
When the Pfizer vaccine was tested in 5- to 11-year-olds, it was found to be safe:
- More than 15 million teens between 12 and 18 years of age had received one dose of COVID-19 vaccine, and more than 12.5 million had received both doses by Nov. 9, 2021.
- The clinical trial in 5- to 11-year-olds evaluated about 1,300 children who received the vaccine and compared them with about 660 children who got placebo . Three vaccinated individuals got infected with COVID-19 compared with 16 in the placebo group . Side effects were similar to those in older children and adults, including pain, swelling and redness at injection site fever tiredness headache muscle aches chills and occasionally, swelling of the under arm on the side the vaccine was given. However, children tended to experience side effects less often and those with previous infection were less likely to experience side effects.
No cases of myocarditis were identified in the clinical trial however, because the trials were small, it will be important to monitor for this rare, but serious side effect when more children are immunized.
Is A Coronavirus Vaccine Necessary
SARS-CoV-2 infections can be a minor hindrance or lead to severe disease or even death. While hygiene measures such as social distancing, handwashing, and wearing masks offer some help, the best way to stop this virus is to generate SARS-CoV-2-specific immunity. No virus has ever eliminated itself by inducing natural immunity in a large percentage of the population. Only herd immunity induced by vaccination can eliminate viruses, as has now been shown for smallpox and two of the three different types of poliovirus.
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Can I Get The Second Dose Of Covid
Yes. It is okay to get the second dose in the other arm as the immunity generated by the first dose will be circulating in your body watching for a potential exposure.
Indeed, individuals who experience a delayed reaction at the injection site are recommended to get the second dose in the opposite arm.
Does A Vaccinated Person Present A Risk To Unvaccinated Family Members In The Same House
Vaccinated people do not shed virus as a result of vaccination. Neither the mRNA nor the adenovirus vaccines are composed of live viruses, so there is no infectious virus to spread from a vaccinated person to someone else.
But a vaccinated person who encounters the virus can still experience what is referred to as asymptomatic infection. An asymptomatic infection occurs when a person is exposed to the virus in the community and the virus can still replicate in their body, but they dont have symptoms because their immune system stifles the infection as a result of vaccination. In this scenario, the person could potentially spread the virus without even knowing they are infected. While it is not anticipated that vaccinated individuals would be a source of significant spread of the virus, they may still spread the virus in a limited manner. Therefore, we need to practice caution.
Given that young children and possibly family members and friends will not all be vaccinated, vaccinated individuals should continue to follow public health guidance when they are out in the community to decrease spread of the virus. Even when a whole family is vaccinated, continuing to practice these measures will be important for two reasons:
Read more in the January 2021 Parents PACK newsletter article, When the Whole Family Has Not Yet Been Vaccinated Against COVID-19.
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What About The Safety Of Covid
The FDA and other reviewers closely consider diverse populations and include them in the trials. The clinical trials for the first two COVID-19 vaccines included members of underrepresented minorities and older age groups, and people with conditions such as obesity, diabetes, and heart and respiratory conditions.
A Guide To Global Covid
- Governments, multilateral organizations, and private firms have spent billions of dollars to develop effective vaccines for COVID-19.
- More than two dozen vaccinesincluding ones by Pfizer and BioNTech, Moderna, and Sinopharmare already being distributed, and about half of the global population is fully vaccinated.
- Vaccines go through rigorous testing for safety and effectiveness before they are approved for public use.
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General Tips For Leading A Covid
Will I Need To Get A Booster Shot
Data has shown boosters can provide continued protection, especially as the Omicron variant sweeps through the United States. The Food and Drug Administration as well as the Centers for Disease Control and Prevention have authorized use of COVID-19 booster shots available for all individuals ages 16 and over.
You should get a booster shot if you are ages 16 years and older. At this time, only the Pfizer-BioNTech COVID-19 vaccine is authorized for the use of a single booster dose for administration to individuals 16 and 17 years of age.
When to get a booster:
- At least 6 months after completing a Moderna or Pfizer primary mRNA COVID-19 vaccination series
- Two months after completion of a primary vaccination series of the Janssen vaccine
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