Global Statistics

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Updated on June 23, 2022 8:27 pm
All countries
Updated on June 23, 2022 8:27 pm
All countries
Updated on June 23, 2022 8:27 pm

Global Statistics

All countries
Updated on June 23, 2022 8:27 pm
All countries
Updated on June 23, 2022 8:27 pm
All countries
Updated on June 23, 2022 8:27 pm
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Are The Covid Vaccine Fda Approved

Can My Child Get The Covid

FDA Approval of COVID Vaccine for Children Expected in Mid-October

According to the CDC, your child may get other vaccines when they go in for their COVID shot without waiting 14 days between appointments. Flu shots can be given to children ages 6 months and older.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

Fda And The Vaccine Review Process

  • Clinical trials. The FDA requires rigorous testing of vaccines through a series of clinical trials to make sure they work and are safe before authorizing or approving them for the public. The laboratories that conduct the trials are independent from the vaccine companies and the government, so the information they convey to the FDA for its approval process is not biased.
  • Risks and benefits. FDA approval of a vaccine involves careful assessment of risks and benefits. Before approval can happen, the clinical trials and other data used by the agency must demonstrate that the benefits of a vaccine are greater than its risks for those who will be vaccinated.
  • Continual monitoring. After authorization or approval, monitoring continues: The FDA continues to examine data for adverse effects among the people receiving the vaccine. If any problems are linked to a vaccine, the FDA may pause the administration of that vaccine to do more studies and ensure that the problem does not outweigh the vaccines benefit.
  • Manufacturing guidelines. The FDA also sets strict guidelines for vaccine manufacturers and requires that they test the vaccine doses in batches to ensure the quality and effectiveness of the vaccines remain consistent and reliable.

Reports Of Death Are Rare

Reports of death after COVID-19 vaccination are rare. FDA requires healthcare providers to report any death after COVID-19 vaccination to the Vaccine Adverse Event Reporting System external icon, even if its unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem.

More than 469 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through December 20, 2021. During this time, VAERS received 10,483 reports of death among people who received a COVID-19 vaccine. CDC clinicians review reports of death to VAERS including death certificates, autopsy, and medical records.

A review of reports indicates a causal relationship between Johnson & Johnsons Janssen COVID-19 vaccine and TTS. On December 16, 2021, CDC scientists released a comprehensive reviewpdf icon of reported U.S. cases through December 2, 2021. Continued monitoring has identified additional deaths for a total of nine deaths causally associated with Johnson & Johnson Janssen COVID-19 vaccination. CDC and FDA continue to review reports of death following COVID-19 vaccination and update information as it becomes available.

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How Is Pfizer’s Child Vaccine For Young Kids Different

Pfizer and BioNTech’s vaccine for children 6 months through 4 years comes in two doses that are one-tenth the volume of the vaccine for people age 12 and up. A third 3-microgram dose is being researched right now is expected to complete the series.

The vaccine for kids 5 to 11 is one-third the dose given to everyone 12 and up, and it’s delivered in two doses. Pfizer’s vaccine for kids can also be stored for up to 10 weeks in a fridge, making it easier to administer, and the cap on the vial is orange instead of purple and gray to avoid mix-ups.

And if it helps to put your kids at ease, the needle used to administer the child’s dose of vaccine is also smaller.

For more information about Pfizer’s vaccine for children ages 5 to 11, check out this fact sheet from the FDA.

Trial Trial Trial Again

FDA Grants Full Approval to Pfizer

Pfizer and BioNTech expedited this process by basing their trial decisions on preliminary results from previous ones and even, occasionally, from trials that were still underway. In other words, trials overlapped and evolved almost seamlessly from Phase 1 to Phase 2 to Phase 3 . This adaptive trial design, while efficient, required a great deal of advanced planning and involved a lot of risk: If a vaccine performed poorly and had to be withdrawn, it would have involved shutting down multiple trials as opposed to just one.

In Phase 1/2, over 360 healthy volunteers between the ages of 18 and 85 received one of four potential vaccine candidates. The trial was designed to study both safety and the relationship between dosages and immune response simultaneously. During this trial, the FDA granted fast track designation to two candidates based on preliminary data one of which, BNT162b2, was later selected as the lead candidate and moved on to Phase 2/3. The designation meant that the agency continuously looked at clinical trial data as it came in, rather than beginning after the submission of a BLA, shortening the amount of time it took to review that data this summer.

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Spikevax Fda Approval Information

The FDA said Spikevax meets the FDAs rigorous standards for safety, effectiveness and manufacturing quality required for approval.

Acting FDA Commissioner, Janet Woodcock, MD, stated that:

The FDAs approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDAs high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States. While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.

Here are some key points regarding the FDA approval of Spikevax:

  • Spikevax will have the same exact formulation as the Moderna mRNA-1273 vaccine that was approved for the EUA. There are no differences at all.
  • Spikevax and remaining stocks of mRNA-1273 can be used interchangeably. There are no differences .
  • It still requires two doses about one month apart.
  • It is approved for individuals 18 years and older.
  • It is approved as third dose for individuals 18 years of age and older who have certain conditions that can compromise the immune system.
  • Other age groups and booster recommendations that were approved under EUAs still remain in force.
  • The Road To Fda Approval

  • Pre-clinical trials: Long before a vaccine is tested in humans, it must show promise in the lab specifically, in tissue samples and animal models. Researchers conduct pre-clinical trials to learn more about how a vaccine works and assess whether its likely to be safe and effective in further clinical trials.

  • Investigational New Drug application: To begin testing its vaccine in people, a company must submit the results of any existing research and pre-clinical testing to the FDA. This submission is called an Investigational New Drug application and is used by the agency to determine the quality of the vaccine and the technology used to manufacture it, as well as whether the research was done according to good laboratory practices.

  • Phase 1 clinical trial: In a Phase 1 clinical trial, safety is the name of the game. Generally, the vaccine candidate is given to 20 to 100 volunteers who have yet to be exposed to the disease and are otherwise healthy. Researchers study these volunteers to determine whether the vaccine rears any unexpected adverse reactions.

  • Phase 3 clinical trial: If all goes well in the first two phases, the vaccine or placebo is generally given to thousands of volunteers to gather even more information on its safety and efficacy.

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    Cdc Recommends Pfizer Booster Shots For Certain People But Moderna And Johnson & Johnson Booster Shots Not Yet Recommended

    Today, the CDC announced that Pfizer booster shots are recommended for certain populations.

    This recommendation follows a meeting from yesterday by a CDC expert panel. This panel discussed and voted on the potential risks and benefits of a booster shot. Today, CDC Director, Dr. Rochelle Walensky, formally announced the agencys endorsement of the Pfizer COVID-19 vaccine booster shot.

    A few groups of people now qualify for a Pfizer booster shot at least 6 months after their second dose. This includes:

    • People 65 or older

    • People between 50 and 64 who have certain medical conditions, such as asthma, kidney disease, or diabetes

    • People living in long-term care facilities

    Other people may qualify for a booster shot depending on the situation. If a healthcare provider decides that the benefits of a booster shot outweigh its risks, they can give a booster shot to certain people at least 6 months after their second dose. This group includes:

    • People between 18 and 49 who have certain medical conditions, such as asthma, kidney disease, or diabetes

    • People between 18 and 64 who work in a setting where theyre frequently exposed to COVID-19

    This information only applies to the Pfizer vaccine not the Moderna or Johnson & Johnson vaccines. A Pfizer booster shot can help improve protection against COVID-19 for certain people. If you have questions, please reach out to your healthcare provider for additional guidance.

    No Newcomer To Criticism

    Some in US getting COVID-19 boosters without FDA approval

    The FDA has concluded that the trials conducted by Pfizer and BioNTech delivered the answers needed to approve the vaccine, but the fact that trials will continue well into 2022 is one reason some have argued against its approval.

    A group of scientists led by Linda Wastila, a professor of pharmaceutical health services research at the University of Maryland, recently called for the agency to slow down citing remaining unknowns about safety and effectiveness. If the FDA listens to us, they wont give serious consideration to approving a COVID-19 vaccine until 2022, the group said.

    To be sure, the road to FDA approval often includes rough terrain and the agency is no newcomer to criticism. Earlier this year, the FDA again made headlines when it ignored disparaging clinical trial data and the advice of an independent panel of experts, instead opting to green-light the first new drug for Alzheimers disease in 18 years: Aducanumab, developed by the company Biogen. Three members of the FDAs advisory panel resigned in protest.

    And in the late 1980s, HIV activist organizations accused the agency of unnecessarily delaying the approval of medications to fight HIV. Louis Lasagna, then chairman of a presidential advisory panel, estimated in 1990 that thousands of lives were lost each year because of delays in approval and marketing of the drugs.

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    What Safety And Effectiveness Data Are Required To Be Submitted To Fda For An Eua Request For A Vaccine Intended To Prevent Covid

    COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information submitted by a vaccine manufacturer.

    For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the studys primary efficacy endpoint.

    Part of FDAs evaluation of an EUA request for a COVID-19 vaccine includes evaluation of the chemistry, manufacturing, and controls information for the vaccine. Sufficient data should be submitted to ensure the quality and consistency of the vaccine product. FDA will use all available tools and information, including records reviews, site visits, and previous compliance history, to assess compliance with current good manufacturing practices.

    People Ages 16 And Older Now Eligible For A Pfizer Booster 6 Months After Their Initial Shots

    This week, the FDA Pfizers COVID-19 vaccine for booster shots in teens ages 16 and 17. The CDC followed the FDAs authorization with a similar recommendation.

    According to the CDC, this age group can get a Pfizer booster shot 6 months after completing the initial Pfizer vaccine series. By comparison, adults ages 18 and older should get a booster shot.

    The Moderna and J& J vaccines arent authorized in people under 18, so they arent booster options in this age group.

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    Fda May Not Review Modernas Authorization Request For Adolescents Until January 2022

    In June, Moderna requested authorization for its COVID-19 vaccine to be used in adolescents ages 12 to 17. But the FDA needs additional time to review recent international data to make sure its safe in this younger age group. This is due to the vaccine being linked to rare cases of myocarditis and pericarditis in younger males.

    The FDA recently notified Moderna that their review may not be complete until January 2022. However, adolescents still have at least one COVID-19 vaccine option in the interim. Earlier this year, Pfizers vaccine was authorized for use in adolescents ages 12 to 15 years old.

    What Safety Information Is Available About Covid

    FDA Fully Approves Pfizerâs COVID Vaccine

    The FDA evaluated data from clinical studies that included tens of thousands of people for Comirnaty, the FDA-approved COVID-19 vaccine, and for each of the COVID-19 vaccines authorized for emergency use.

    The FDA has authorized three vaccines for emergency use because the data from clinical studies clearly showed that the known and potential benefits of the FDA-authorized COVID-19 vaccines outweighed the known and potential risks.

    Approved COVID-19 Vaccine

    The data to support the decision to approve Comirnaty builds on extensive data and information that supported the Pfizer-BioNTech COVID-19 Vaccine EUA , including information about the vaccines safety and effectiveness. The safety of Comirnaty was evaluated in individuals 16 years of age and older, approximately 22,000 of whom received the vaccine and 22,000 of whom received placebo. More than half of the clinical trial participants were followed for safety follow-up for at least four months after the second dose. After issuance of the EUA, clinical trial participants were unblinded in a phased manner over a period of months to offer placebo recipients the Pfizer-BioNTech COVID-19 Vaccine. Overall, in blinded and unblinded follow-up, approximately 12,000 vaccine recipients have been followed for at least 6 months.

    Allergic Reactions

    Myocarditis and Pericarditis Following Vaccination with Comirnaty, Moderna and Pfizer-BioNTech COVID-19 Vaccines

    Guillain Barré Syndrome Following Vaccination with Janssen COVID-19 Vaccine

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    When Will The Fda Give Full Approval For Covid

    • Two vaccine manufacturers have submitted applications for full approval of their COVID-19 vaccines, but the FDA hasnt yet indicated when a decision will come.
    • COVID-19 vaccines have been given emergency use authorization in the United States but have not yet been granted full approval.
    • So far, the FDA has shown no indication of when it will grant full approval for these vaccines.
    • Experts say full approval may help increase vaccination rates.

    All data and statistics are based on publicly available data at the time of publication. Some information may be out of date. Visit our coronavirus hub and follow our live updates page for the most recent information on the COVID-19 pandemic.

    Its been almost 7 months since the Food and Drug Administration issued the first emergency authorization of a COVID-19 vaccine: Pfizer-BioNTechs mRNA vaccine.

    In the following months, two other COVID-19 vaccines, Modernas mRNA vaccine and Johnson & Johnsons adenovirus vector vaccine, were given emergency use authorization.

    Since that first authorization, more than 182.7 million U.S. people 55 percent of the total population have received at least one dose, according to the Centers for Disease Control and Prevention .

    During the vaccination campaign, most people have received an mRNA vaccine either because it was more available or they preferred an mRNA vaccine.

    Yet, so far the FDA has shown no indication of when it will grant full approval.

    Why Should I Get A Covid

    When you get a COVID-19 vaccine, you are choosing to protect yourself and make a difference for your children, parents, grandparents, and other loved ones. Millions of people in the U.S. have already received a COVID-19 vaccine. For a community to be fully protected, most community members need to get the vaccine. Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you.

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    What Are The Plans For Continued Monitoring Of Covid

    FDA expects vaccine manufacturers to include in their EUA requests a plan for active follow-up for safety, including deaths, hospitalizations, and other serious or clinically significant adverse events, among individuals who receive the vaccine under an EUA, to inform ongoing benefit-risk determinations to support continuation of the EUA.

    FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure .

    How Do I Get A Covid

    FDA approves Pfizer’s COVID-19 vaccine

    Search, text your ZIP code to 438829, or call 1-800-232-0233 to find COVID-19 vaccine locations near you in the U.S. In some states, information may be limited while vaccination providers and pharmacies are being added. Contact your state health department to find additional vaccination locations in your area.

    FDA-authorized or approved COVID-19 vaccines are distributed for free by states and local communities. You cannot buy COVID-19 vaccines online. You do not need to pay any out-of-pocket costs to get a COVID-19 vaccine not before, during, or after your appointment. If someone asks you to pay for your vaccine, it is either a scam or a mistake.

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