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Updated on June 23, 2022 12:28 am
All countries
Updated on June 23, 2022 12:28 am
All countries
Updated on June 23, 2022 12:28 am

Global Statistics

All countries
Updated on June 23, 2022 12:28 am
All countries
Updated on June 23, 2022 12:28 am
All countries
Updated on June 23, 2022 12:28 am
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Has The Fda Approved The Covid Vaccine

Q: Does Spraying People With Disinfectant Lower The Spread Of Covid

Pfizer COVID-19 vaccine has received FDA approval

A: Currently there are no data showing that spraying people with aerosolized disinfectants, or having people walk through tunnels or rooms where disinfectant is in the air, can treat, prevent, or lower the spread of COVID-19.

Surface disinfectants should not be used on people or animals. Disinfectant products, such as sprays, mists, wipes, or liquids are only to be used on hard, non-porous surfaces such as floors and countertops, or on soft surfaces such as mattresses, sofas, and beds. CDC provides information regarding disinfectant practices for surfaces in the Reopening Guidance for Cleaning and Disinfecting Public Spaces, Workplaces, Businesses, Schools, and Homes.

Human antiseptic drugs, such as hand sanitizers, are intended for use on human skin, but are not intended for aerosolization . Due to serious safety concerns, including the risk of inhalational toxicity and flammability, the FDAs temporary policies for alcohol-based hand sanitizers during the COVID-19 public health emergency specifically do not apply to aerosol sprays. In addition, hand sanitizers are intended for use on the hands, and should never be used over larger body surfaces, swallowed, or inhaled.

What About The Risk Of Myocarditis And Pericarditis

  • The FDA conducted a rigorous evaluation of the post-authorization safety surveillance data regarding cases of myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 vaccine. It has determined that the data demonstrate very rare but increased risks, particularly within the seven days following the second dose.
  • The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age.
  • Most patients with myocarditis or pericarditis who received care responded well to medicine and rest and felt better quickly.
  • Patients can usually return to their normal daily activities after their symptoms improve. Those who have been diagnosed with myocarditis should consult with their cardiologist about return to exercise or sports. More information will be shared as it becomes available.
  • The known risks of COVID-19 illness and its related, possibly severe complications, such as long-term health problems, hospitalization, and even death, far outweigh the potential risks of having a rare adverse reaction to vaccination, including the possible risk of myocarditis or pericarditis.
  • Information is not yet available about potential long-term health outcomes of those who developed myocarditis or pericarditis following vaccination.
  • The Comirnaty prescribing information includes a warning about these risks.

Q: Are Antibiotics Effective In Preventing Or Treating Covid

A: No. Antibiotics do not work against viruses they only work on bacterial infections. Antibiotics do not prevent or treat COVID-19, because COVID-19 is caused by a virus, not bacteria. Some patients with COVID-19 may also develop a bacterial infection, such as pneumonia. In that case, a health care professional may treat the bacterial infection with an antibiotic.

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Using Data To Approve Covid

As of August 2021, hundreds of millions of COVID-19 vaccine doses have been given to people in countries all over the world.

People who get the vaccines are encouraged to report any problems, including any severe side effects. A cooperative effort between the U.S. Centers for Disease Control and Prevention and the FDA, the Vaccine Adverse Event Reporting System collects and analyzes reports from people who received a vaccination and who experienced an adverse event, such as a severe side effect, after getting the shot.

As a result, we now have even more evidence that all three of the FDA-authorized COVID-19 vaccines are safe for most people who receive them, and that all three work well to prevent severe coronavirus disease.

Like other fully approved vaccines used to help prevent illnesses, the FDA-authorized COVID-19 vaccines can cause temporary aches, pains and fever in some people, but the risk of serious side effects is extremely low.

Pfizer Officially Asks The Fda To Authorize Its Covid Vaccine For Kids Aged 5


    A healthcare worker prepares doses of the Pfizer-BioNTech Covid-19 vaccine at a mobile vaccination clinic at a high school in Los Angeles in August.hide caption

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    A healthcare worker prepares doses of the Pfizer-BioNTech Covid-19 vaccine at a mobile vaccination clinic at a high school in Los Angeles in August.

    Pfizer and BioNTech are officially asking the Biden administration to authorize the use of their COVID-19 vaccine for children ages 5 to 11.

    Pfizer tweeted on Thursday that the companies had submitted their formal request for Emergency Use Authorization of the vaccine to the Food and Drug Administration.

    “With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” the pharmaceutical giant said.

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    Q: Can 3d Printing Be Used To Make Ppe

    A: Personal protective equipment includes protective clothing, gowns, gloves, face shields, goggles, face masks, and respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. While it is possible to use 3D printing to make certain PPE, there are technical challenges. 3D-printed PPE may provide a physical barrier, but 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators. The CDC has recommendations for how to optimize the supply of face masks. Find more information about 3D printing during the COVID-19 pandemic.

    Pfizer Requests Booster Authorization For People As Young As 16 Years Old

    Yesterday, Pfizers CEO announced that the company has submitted an authorization request for COVID-19 booster shots in people as young as 16 years old. Booster shots with Pfizers COVID-19 vaccine are currently recommended for all adults age 18 and older, depending on when they finished their initial vaccination series.

    Pfizers vaccine is the only one authorized for use in people under 18 years old. That means people as young as 16 years old could be eligible for a booster 6 months after their second shot.

    Its been reported that authorization for this age group could happen within a week. After the FDA issues a decision, the CDC will need to weigh in with recommendations, too.

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    Q: Am I Currently Eligible For A Third Dose Of Pfizer

    A: If you received the Pfizer-BioNTech COVID-19 Vaccine, and you are 12 years of age and older and have undergone solid organ transplantation, or have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise, then you are eligible for a third dose of a three-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine at least 28 days following the second dose of vaccine.

    The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide doses for primary vaccination or a booster dose.

    If you received the Moderna COVID-19 Vaccine and you are 18 years of age and older and have undergone solid organ transplantation, or have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise, then you are eligible for a third dose of a three-dose primary series of the Moderna COVID-19 Vaccine at least 28 days following the second dose of vaccine.

    Q: Is Olumiant Approved By The Fda To Treat Covid

    FDA approves Pfizer COVID-19 vaccine for emergency use in United States | ABC News

    A: No. Olumiant is not FDA-approved for the treatment of COVID-19. However, the FDA issued an emergency use authorization authorizing Olumiant for emergency use by healthcare providers for the treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation .

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    Q: Are The Monoclonal Antibodies Bamlanivimab And Etesevimab Fda

    A: No. Bamlanivimab and etesevimab are not FDA-approved to treat any diseases or conditions, including COVID-19. However, the FDA issued an emergency use authorization for bamlanivimab and etesevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients. Learn more about bamlanivimab and etesevimab for COVID-19.

    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 children 5 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.

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    Hundreds Of Millions Of People Have Safely Received A Covid

    More than 469 million doses of COVID-19 vaccine had been given in the United States from December 14, 2020, through December 20, 2021. To view the current total number of COVID-19 vaccinations that have been administered in the United States, please visit the CDC COVID Data Tracker.

    COVID-19 vaccines are safe and effective. COVID-19 vaccines were evaluated in tens of thousands of participants in clinical trials. The vaccines met the Food and Drug Administrations rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization . The technology behind mRNA vaccines has been in development for over 15 years. Scientists pivoted to apply existing technology to COVID-19 vaccines. Learn more about EUAs in this video.external icon

    The Pfizer-BioNTech, Moderna, and Johnson & Johnsons Janssen COVID-19 vaccines will continue to undergo the most intensive safety monitoring in U.S. history. This monitoring includes using both established and new safety monitoring systems to make sure that COVID-19 vaccines are safe.

    Q: What Do I Do If I Get A Rash Or Other Reaction To Hand Sanitizer

    Pfizer seeks full FDA approval for COVID

    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 .

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    Covid Vaccines For Kids: What To Know About Boosters And More

    The CDC recommends COVID-19 vaccine boosters for teens 16 and older, while Pfizer tests a new three-shot vaccine protocol for kids under 5.

    As the omicron variant surges around the world, US health officials are urging everyone eligible to receive a COVID-19 booster shot — including teens 16 and up. In early December, the US Centers for Disease Control and Prevention recommended Pfizer’s booster for 16- and 17-year-olds after it was authorized by the US Food and Drug Administration.

    For the 19th week in a row, COVID-19 cases in children were above 100,000, according to a Dec. 20 report by the American Academy of Pediatrics.

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    On Dec. 17, Pfizer announced it would be testing a new three-shot vaccine protocol on children aged 6 months to 5 years.

    Teens as young as 16 can get boosted as long as six months have passed since their second Pfizer shot. Kids younger than 16 can’t get a booster yet, but children ages 5 and up can be fully vaccinated against COVID-19. Pfizer’s vaccine for kids ages 5 to 11 is one-third of a regular dose, a slightly different formula and given with a smaller needle. It was and recommended by the US Centers for Disease Control and Prevention after data showing an encouraging safety profile and high effectiveness was reviewed by independent committees to the CDC and FDA.

    As the COVID-19 landscape continues to change, here’s what we know about COVID-19 vaccines for kids.

    Q: What Should People Do If They Have Been Exposed To Hand Sanitizer With Potential Methanol Or 1

    A: People who have been exposed to contaminated hand sanitizer and are experiencing symptoms should seek immediate medical treatment for potential reversal of toxic effects.

    FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to 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.

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    Q: Is There A Shortage Of Personal Protective Equipment Such As Gloves Masks And N95 Respirators Or Of Ventilators

    A: The FDA has been working closely with PPE and ventilator manufacturers to understand their supply capabilities during this pandemic. The agency is also aware of challenges throughout the supply chain that are presently impacting the availability of PPE products and is taking steps to mitigate shortages that health care facilities are already experiencing.

    The FDA issued new guidance to give ventilator manufacturers and non-medical device manufacturers more flexibility to start making new ventilators and parts. We adjusted our screening of PPE and medical devices at U.S. ports of entry to expedite imports of legitimate products into the U.S. With CDC we took action to make more respirators, including certain N95s, available to health care personnel for use in health care settings. Read more about PPE.

    The FDA encourages manufacturers and health care facilities to report any supply disruptions to the device shortages mailbox at .

    What Safety Information Is Available About Covid

    FDA approves Pfizer COVID-19 vaccine for adolescents 12-15

    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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    Q: What Animal Species Can Get Covid

    A: We currently dont fully understand how COVID-19 affects different animal species.

    We are aware of a small number of pets, including dogs, cats and a ferret reported to be infected with the virus that causes COVID-19 after close contact with people with COVID-19. Infected pets might get sick or they might not have any symptoms. Of the pets that have gotten sick, most only had mild illness and fully recovered.

    Several animals in zoos and sanctuaries have tested positive for SARS-CoV-2, including big cats in captivity ,and gorillas after showing signs of respiratory illness. It is suspected these animals became sick after being exposed to zoo employees with COVID-19. In many situations, this happened despite the staff wearing personal protective equipment and following COVID-19 precautions.

    The virus that causes COVID-19 has been reported in minks on farms in multiple countries, including the United States. Once the virus is introduced on a farm, spread can occur between mink as well as from mink to other animals on the farm . Because some workers on these farms had COVID-19, it is likely that infected farm workers were the initial source of mink infections.

    For any animal that tests positive for SARS-CoV-2 at a private or state laboratory, USDA’s National Veterinary Services Laboratories performs additional testing to confirm the infection and posts the results on this page: Cases of SARS-CoV-2 in Animals in the United States.

    Fda Schedules Advisory Committee Meeting To Review Pfizers Covid

    Last week, Pfizer announced they had started the supplemental Biologics License Application submission process for a booster vaccine dose in people at least 16 years old. They must submit the BLA to the FDA to get their booster dose approved for use.

    A booster dose is currently for certain immunocompromised people, but the supplemental BLA would mean the booster dose is fully approved for use for all people ages 16 and older. The company was expected to complete the submission process by the end of last week.

    Since then, the FDA has announced that its Vaccine and Related Biological Products Advisory Committee is scheduled to meet on September 17 to review Pfizers booster application. The booster shot may be approved shortly after that.

    The VRBPAC meeting is scheduled just a few days before September 20, the target date announced by the Biden administration for when booster doses would be offered to the general public. People would be eligible for a booster shot once they were at least 8 months out from completing their initial two-dose series. However, this date was dependent on getting final sign-off from the FDA and the CDC beforehand.

    Once the FDA approves the booster dose, the CDCs Advisory Committee on Immunization Practices still needs to weigh in on their recommendations for use. This is done to help create more specific recommendations on who should use the vaccine and when.

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