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Updated on August 7, 2022 2:41 am
All countries
Updated on August 7, 2022 2:41 am
All countries
Updated on August 7, 2022 2:41 am

Global Statistics

All countries
Updated on August 7, 2022 2:41 am
All countries
Updated on August 7, 2022 2:41 am
All countries
Updated on August 7, 2022 2:41 am
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Are Covid Shots Fda Approved

How Effective Are The Covid Vaccines

FDA approves 4 Covid-19 vax brands as booster shots

Vaccine efficacy has been a main question as the delta variant continues to spread around the country.

Health experts have said that a majority of hospitalizations and deaths associated with the variant in recent months are almost entirely in unvaccinated individuals. The CDC has said the risk of infection is 8x higher in the unvaccinated than the vaccinated, and the risk of hospitalization or death is 25x higher.

But is one better than the other at protecting against breakthrough infections in vaccinated populations?

Researchers in Belgium directly compared the Pfizer and Moderna COVID-19 vaccines by testing the antibodies of 2,500 health care workers after two doses of both vaccines.

The study found the Moderna vaccine produced more than double the antibodies compared to Pfizer, but doctors urge caution.

Antibody level itself is interesting, but it doesnt necessarily lead to a significant difference in the way the vaccine is performing, said Dr. Allison Arwady, Commissioner of the Chicago Department of Public Health.

Another study to consider when comparing vaccines is one from the Mayo Clinic earlier this month, which is awaiting a full review.

That study found the risk of suffering a breakthrough COVID-19 infection with the delta variant after being fully vaccinated with the Moderna vaccine may be much lower than the risk for those who received the Pfizer vaccine.

Pfizer Asks Fda For Emergency Authorization For Its Covid Vaccine For Kids Ages 5

Pfizer and BioNTech announced Thursday that they had submitted an emergency request to the U.S. Food and Drug Administration for authorization of the companies’ two-dose Covid-19 vaccine in children ages 5 to 11.

“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,” Pfizer tweeted. “Were committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”

An FDA advisory committee plans to meet to discuss authorization on Oct. 26.

Pfizer and BioNTech’s Covid vaccine would be the first authorized for use in children under 12 in the United States.The companies said last month that the vaccine was safe in children 5 to 11 and showed a robust antibody response based on data collected in a trial that included more than 2,000 children.

Q: Is The Us Food Supply Safe

A: Currently there is no evidence of food or food packaging being associated with transmission of COVID-19.

Unlike foodborne gastrointestinal viruses like norovirus and hepatitis A that often make people ill through contaminated food, SARS-CoV-2, which causes COVID-19, is a virus that causes respiratory illness and not gastrointestinal illness, and foodborne exposure to this virus is not known to be a route of transmission.

It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes, but this is not thought to be the main way the virus spreads. Its always important to follow the 4 key steps of food safetyclean, separate, cook, and chill.

A: Currently there is no evidence of animal food or food packaging being associated with transmission of COVID-19.

Foodborne exposure to the virus that causes COVID-19 is not known to be a route of transmission.

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Fda Approval Of Pfizer Covid Shot Could Come Next Week

The Food and Drug Administration is on track to approve Pfizers coronavirus vaccine for adults as soon as next week, three people with knowledge of the matter told POLITICO.

The long-anticipated announcement would make Pfizer’s Covid-19 shot the first to receive full licensure from the federal government, a milestone in the nation’s year-and-a-half pandemic battle.

It would also come as the Biden administration grapples with a resurgence of infections fueled by the Delta variant a worsening situation that has prompted a redoubling of efforts to vaccinate the roughly 85 million Americans who have yet to get a shot.

The available Covid-19 shots have long been considered safe and highly effective. But Biden administration officials are hoping the full approval, which would apply to people 16 and older, will spur a wave of vaccinations among holdouts who have waited months for the FDA to put its formal stamp on the Pfizer vaccine.

Recent Kaiser Family Foundation polling shows that about 30 percent of those still unvaccinated say they would be more likely to get a fully approved vaccine than one authorized for emergency use.

Full approval could also convince more employers to mandate the shot, further increasing vaccination rates. And it is a key step toward implementing the administrations plan to offer booster shots, beginning in late September, to people who got their initial doses of the Pfizer and Moderna vaccines at least eight months ago.

Q: What Should I Do If I Think My Pet Has The Virus That Causes Covid

WDH prepares to administer COVID vaccines with FDA ...

Pets infected with this virus may or may not get ill. Of the pets that have gotten sick, most only had mild illness and fully recovered. Serious illness in pets appears to be extremely rare.

Pets that do have symptoms usually have mild illness that can be taken care of at home. If you think your pet is sick with the virus or if you have concerns about your pets health, talk to your veterinarian. Most pets that have gotten sick from the virus that causes COVID-19 were infected after close contact with a person with COVID-19.

If your pet is sick and you think it might be from the virus that causes COVID-19, talk to your veterinarian.

If you are sick with COVID-19 and your pet becomes sick, do not take your pet to the veterinary clinic yourself. Call your veterinarian and let them know you have been sick with COVID-19. Some veterinarians may offer telemedicine consultations or other plans for seeing sick pets. Your veterinarian can evaluate your pet and determine the next steps for your pets treatment and care.

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Q: How Can I Prevent Covid

A: The best way to prevent illness is to avoid being exposed to the virus. The CDC recommends everyday preventive actions to help prevent the spread of respiratory diseases. They include:

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.

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Big Costs Few Benefits

Think of it this way: In the highly unlikely event that the evidence were to change radically if, say, the vaccines began causing serious side effects about 18 months after people had received a shot Americans would not react by feeling confident in the F.D.A. and grateful for its caution. They would be outraged that Woodcock and other top officials had urged people to get vaccinated.

The combination means that the F.D.A.s lack of formal approval has few benefits and large costs: The agency has neither protected its reputation for extreme caution nor maximized the number of Americans who have been protected from Covid. In my mind, its the No. 1 issue in American public health, Topol told me. If we got F.D.A. approval, we could get another 20 million vaccinated, he estimated.

Rebecca Robbins, who covers the vaccines for The Times, says she is less sure about the size of the impact. But she agrees that full approval, whenever it happens, is probably going to be the catalyst for many new mandates.

My colleague Noah Weiland says: Right now, it appears a full approval for the Pfizer vaccine could come in September, with Moderna not far behind.

In the meantime, more Americans may get sick from Covid. About 34 percent of Americans who are eligible for the vaccines have not yet gotten a shot. The number of new cases has roughly tripled this month, largely because of the Delta variant. The number of deaths has almost doubled in the past two weeks.


Q: Is Hand Sanitizer Effective Against Covid

Connect the Dots: When will the COVID-19 vaccines get FDA approval?

A: The best way to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water, advises the CDC. Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom before eating and after coughing, sneezing, or blowing ones nose. If soap and water are not available, CDC recommends consumers use an alcohol-based hand sanitizer that contains at least 60% alcohol.

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Q: What Does It Mean To Be An Fda

A: FDA approval of a drug means that the agency has determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the products approved labeling. The drug approval process takes place within a structured framework that includes collecting clinical data and submitting an application to the FDA. Learn more about the FDAs Drug Review Process.

Q: Is The Monoclonal Antibody Actemra Approved For The Treatment Of Covid

A: No. Actemra is not approved as a treatment for COVID-19. However, the FDA issued an emergency use authorization for use of Actemra by healthcare providers for the treatment of COVID-19 in hospitalized adults and pediatric patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation .

Actemra is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor. In the case of COVID-19 infection, the immune system can become hyperactive, which may result in worsening of disease. Actemra does not directly target SARS-COV-2. Actemra is a prescription medication given by intravenous infusion that is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis.

Monoclonal antibody treatments for COVID-19 may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and have the ability to activate the emergency medical system , if necessary. Please speak with your doctor or contact your local or state public health department for more information.

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Q: What Is The Fdas Role In Regulating Potential Treatments During A Public Health Emergency

A: The FDA carries out many activities to protect and promote public health during a public health emergency, including helping to accelerate the development and availability of potential treatments, protecting the security of drug supply chains, providing guidance to food and medical device manufacturers, advising developers on clinical trial issues, and keeping the public informed with authoritative health information.

The FDA is committed to supporting the development of new drugs, and the potential repurposing of existing drugs, to address COVID-19 by working with potential drug makers and sponsors to rapidly move products into clinical trials, helping to ensure that trials are properly designed and safe, and protecting the public from potentially unsafe products.

A: Yes, the FDA has approved Veklury for certain COVID-19 patients. Read more about the approval here.

Additionally, during public health emergencies, the FDA may in certain circumstances authorize use of unapproved drugs or unapproved uses of approved drugs for life-threatening conditions when there are no adequate, approved, and available options and other conditions are met. This is called an Emergency Use Authorization .

Pfizer Files For Full Fda Approval Of Covid

FDA offers tips to avoid coronavirus vaccine scams

A vial labelled with the Pfizer-BioNTech coronavirus disease vaccine is seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/File Photo

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Dec 16 – Pfizer Inc and its German partner BioNTech SE said on Thursday they have filed for full approval of their COVID-19 vaccine with the U.S. Food and Drug Administration to include adolescents aged 12 to 15.

The vaccine received full approval for ages 16 and above in the United States in August. The shot also has an emergency use authorization for 5 to 15 year olds.

Pfizer is seeking for an approval based on long-term data from a late-stage study conducted among adolescents. The company said in November the two-dose series of the vaccine was 100% effective against COVID-19, measured seven days through over four months after the second dose.

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The company is seeking clearance for a 30 micrograms dose of the vaccine for those aged 12 and above. Pfizer/BioNTech’s vaccine is the only COVID-19 vaccine authorized for the given age group in the U.S.

Pfizer said it expects to file for approval with the European Medicines Agency and other regulatory authorities around the world in the coming weeks.

The FDA gave the two-dose vaccine emergency-use authorization for adolescents in May.

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What Do We Know About The Omicron Variant

The Omicron variant, also known as B.1.1.529, is now the most common SARS-CoV-2 variant in the US. This variant has about 50 mutations, including more than 30 mutations on the spike protein, the region of the virus that binds to and allows the virus to enter human cells. Heres what we know about it.

How transmissible is Omicron?

Dr. Anthony Fauci, Chief Medical Advisor to the President of the US, said in a White House press briefing, “we know now incontrovertibly that this is a highly, highly transmissible virus” A report from the United Kingdom found that someone infected with the Omicron variant is three times more likely to infect a member of their household than someone infected with the Delta variant. According to the CDC, most transmission occurs in the one to two days before symptoms begin and the two to three days after.

How well does Omicron evade protection from vaccines?

Several studies, including some presented at a WHO meeting in mid-December, have shown that two doses of an mRNA vaccine like Pfizer/BioNTech or Moderna do not protect as well against infection with Omicron as they did against previous SARS-CoV-2 variants.

One small laboratory study conducted by researchers in South Africa, for example, found a 41-fold decrease in neutralization with Omicron compared to the earlier coronavirus variant. Pfizer/BioNTech also released data from a laboratory study showing a significantly decreased antibody response to Omicron after two vaccine doses.

Hawaii Governor Urges Tourists To Stay Away As Coronavirus Surges

Gov. David Ige of Hawaii asked visitors not to travel to the islands unless it is for essential business purposes, as high numbers of coronavirus cases strain the states hospitals.

We are seeing more Covid patients in our hospitals and the I.C.U.s are filling up. We need to take action now in order to reduce the spread of Covid and ensure that our hospitals are not overrun. I did ask everyone, residents and visitors alike, to reduce travel to Hawaii to essential business activities only. We do know that it is not a good time to travel to the islands. Restaurant capacity has been restricted. There is limited access to rental cars and we know that the visitors who choose to come to the islands will not have the typical kind of holiday that they expect to get when they visit Hawaii. Our call to reduce travel to the islands to only essential businesses will have an impact on the numbers who have come here. But I also would like to point out that our hospitals are at capacity, our I.C.U.s are full. We are working on surge plans at every facility to expand capacity. Were transitioning acute care beds to be able to support those who are sick. And so I do know that thats a risk. But I believe that as a community, thats a risk we have to take to discourage travel to the islands until we can get to a better place with our health care facilities.

Facing a surge of Covid-19 cases that is straining hospitals, Gov. David Ige of Hawaii asked tourists to stay away.

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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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