Global Statistics

All countries
546,725,764
Confirmed
Updated on June 23, 2022 11:08 am
All countries
519,235,746
Recovered
Updated on June 23, 2022 11:08 am
All countries
6,346,057
Deaths
Updated on June 23, 2022 11:08 am

Global Statistics

All countries
546,725,764
Confirmed
Updated on June 23, 2022 11:08 am
All countries
519,235,746
Recovered
Updated on June 23, 2022 11:08 am
All countries
6,346,057
Deaths
Updated on June 23, 2022 11:08 am
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Did The Fda Approve The Covid Vaccine

White House Mandates Pfizer Vaccines For Millions Of Citizens Before The Fda Clinical Or Safety Reviews Have Been Made Public

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

NOTE: Neither Perino nor Hemmer said that they themselves thought that the FDA approval was either rushed or took too long. A representative from FOX News has since emphasized that Perino was teeing up Giroir to answer skeptics on the vaccine, and that both Perino and Giroir are great supporters of the vaccine.

Giroirs experience on the Fox News segment may have mirrored to some degree what the FDA has been experiencing over the past eight months or so. The FDA has been in a rather tough situation since it granted emergency use authorizations to the three currently available Covid-19 vaccines, starting in December 2020 with the Pfizer/BioNTech vaccine. Anti-vaccination accounts on social media have been telling people that they shouldnt get the Covid-19 vaccines because the vaccines were not yet fully approved. They have claimed that lack of official approval meant that the vaccines were experimental. Of course, not approved hasnt stopped some people from trying livestock medications to prevent or treat Covid-19, as I described this past weekend for Forbes:

Or supplements that dont have to go through the same rigorous approval process that vaccines have to undergo:

Heck, even with the approval of Comirnaty, some are already questioning the approval process:

Calling an approval that was formally announced by the FDA fake? Seriously? As they say, you cant keep everyone happy.

Authorization Status Is A Red Herring When It Comes To Mandating Covid

More practically, a full authorization could give businesses, universities, and government agencies more confidence when it comes to imposing vaccine mandates for students or employees.

The Department of Defense, already, has said explicitly that its willing to impose a vaccine mandate for military servicemembers but only once the FDA issues full approval.

It is not FDA-approved, John Kirby, a Department of Defense spokesperson, said last week. Therefore, it is still a voluntary vaccine.

Regardless of how big an impact full FDA approval might have, its also not clear the agency is at fault for the perceived delay. Typically, even an accelerated approval for a vaccine can take as long as six months Pfizer announced it had begun its rolling application for full licensure in early May, and Moderna did so a month later.

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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How Long Have Euas Been Around

The FDA established its EUA program in 2004 in response to threats of bioterrorist attacks, including anthrax. Later, it was used for H1N1 , Ebola, avian flu, Middle Eastern Respiratory Syndrome , and other major public health threats. EUAs in these instances included tests, an anthrax vaccine, antiviral treatments, and personal protective equipment.

An EUA can be revised or revoked by the FDA at any point as the agency evaluates the most current needs and available data. For example, the FDA issued an EUA for hydroxychloroquine during the first phase of the COVID-19 pandemic. Later, when it became clear that the treatment posed a risk but did not offer significant benefit, the FDA retracted the EUA.

What Is Required To Get Full Fda Approval

Pfizer plans to file for full FDA approval of COVID

Standard vaccine reviews generally take several months to a year or more to determine whether they are safe and effective for use in the general public.

FDA approval of a drug, which requires a rigorous and structured process, means that data on the drugs effects have been reviewed by the Center for Drug Evaluation and Research, which rules on whether the drug’s provided benefits “outweigh its known and potential risks for the intended population,” according to the agency’s website.

Chicago’s top doctor said timing is one of the largest factors in getting full approval.

“The difference between authorization and approval, does not have anything to do with new studies or changes, it has to do with making sure that people have been followed for a long enough time,” Chicago Department of Public Health Commissioner Dr. Allison Arwady said last month.

Before granting full approval, FDA scientists must painstakingly look through the companies’ clinical trial data, including for any discrepancies or safety concerns, said Dr. Paul Offit, a voting member of the agency’s Vaccines and Related Biological Products Advisory Committee.

Arwady echoed those comment.

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How Long On Average Does Full Fda Approval Take Compared With Eua

According to one study, over the past decade, the FDA approved 21 vaccines, mostly for flu or meningococcus. The median clinical development period was just over 8 years, including a median FDA review period of about a year.

For comparison, the COVID-19 vaccine from Pfizer-BioNTech, which was the first to receive an EUA, was under clinical development for six months before it submitted its EUA. An EUA was granted in less than a month full approval was issued eight months later.

Approval Could Lead To More Vaccinations

A from the Kaiser Family Foundation found that 31% of unvaccinated people said they would be more likely to get a COVID-19 vaccine once one receives full approval from the FDA.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Woodcock said. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

The FDA’s full approval applies to people 16 and older. Those ages 12 through 15 can still receive the vaccine under the existing emergency use authorization.

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Pfizer Is Expected To Ask The Fda To Authorize Its Covid Vaccine For Children Under 5

Pfizer and its partner BioNTech are expected as soon as Tuesday to ask the Food and Drug Administration to authorize a coronavirus vaccine for children under 5 years old as a two-dose regimen while they continue to research how well three doses work.

Federal regulators are eager to review the data in hopes of authorizing shots for young children on an emergency basis as early as the end of February, according to multiple people familiar with the discussions, who were not authorized to speak publicly. If Pfizer waited for data on a three-dose regimen, the data would not be submitted until late March and the vaccine might not be authorized for that age group until late spring.

Federal officials and Pfizer executives had been suggesting for days that an application for emergency authorization of a vaccine for children as young as 6 months was in the works. Every age group above that is eligible for shots, and the highly contagious Omicron variant has led to a sharp rise in infections among all ages, including children. There are more than 19 million Americans under 5 years old.

Scott Gottlieb, a Pfizer board member and former commissioner of the Food and Drug Administration, told CBS News on Sunday that the vaccine might be authorized as soon as March for the youngest age group. The development was first reported by The Washington Post.

United StatesAvg. on Mar. 1214-day change

What You Need To Know

5- to 11-year-olds could become eligible to get COVID vaccines with CDC approval
  • COVID-19 vaccines are safe and effective.
  • Millions of people in the United States have received COVID-19 vaccines under the most intense safety monitoring in U.S. history.
  • CDC recommends you get a COVID-19 vaccine as soon as possible.
  • CDC recommends that people who are starting their vaccine series or getting a booster dose get either Pfizer-BioNTech or Moderna . The mRNA vaccines are preferred over Johnson & Johnsons Janssen COVID-19 vaccine in most circumstances.

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What Does Full Fda Approval Of A Covid

Review for full FDA approval is a normal step in the process of making a vaccine available for the public. One of the COVID-19 vaccines has full approval, and the FDA may grant full approval for others in the future.

Full FDA approval takes place when enough data demonstrate that the vaccines are safe and effective for most people who receive them, and when the FDA has had an opportunity to review and approve the whole vaccine manufacturing process and facilities. After many months of studies and more than 165 million people having received a COVID-19 vaccine, the FDA has a lot of information on how safe and effective the COVID-19 vaccines are in protecting people, how well they work to prevent severe coronavirus disease, and how the vaccines are safely and consistently manufactured.

Pfizer Booster Authorized For Older Adults People With High Exposure Risk And Those At Risk For Severe Covid

Yesterday, the FDA a single booster dose of Pfizers COVID-19 vaccine for special populations. This announcement follows their expert panels last week to authorize booster shots for certain groups without approving them for the general public.

The panel debated whether or not boosters are needed right now, considering data shows that the vaccines are still very effective at preventing hospitalization and death from COVID-19. Given the limited data on boosters, the FDA agreed that the known benefits outweigh the risks for higher-risk groups but not for the general public at this time.

Under the , the following groups would be eligible for Pfizer boosters at least 6 months after their initial shots:

  • Adults at least 65 years old

  • Adults at high risk for severe COVID-19

  • Adults with frequent exposure to COVID-19 through their jobs or other settings that puts them at high risk for serious COVID-19 complications

A CDC expert panel is meeting today to discuss their recommendations for who should receive a booster shot, which may include additional information about:

  • Who is considered to be at high risk for severe COVID-19

  • What is considered to be frequent COVID-19 exposure

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Has The Fda Approved Any Covid

The Food and Drug Administration approved the first Covid vaccine — from Pfizer-BioNTech — this summer. This means the vaccine received the standard Biologic License Application approval, which represents the FDAs highest standard and requires a longer period of evaluation.

The FDA had previously granted Emergency Use Authorization to the Pfizer-BioNTech vaccine, the Moderna vaccine, and the Johnson & Johnson vaccine. Additional vaccines are in Phase 3 of clinical trials and maybe submitting data for review with the FDA soon.

Emergency Use Authorization exists to allow the FDA more flexibility to review and authorize products for use during public health emergencies, like a pandemic. In order to grant an EUA, the FDA must determine that a vaccine can effectively prevent infection or disease and that its benefits outweigh potential risks . While the EUA allows people to start receiving the vaccine, vaccine developers will continue to submit data to the FDA to achieve full FDA approval through a BLA.

Supply Chain And Distribution

FDA Panel Endorses Pfizers COVID

The deployment model developed for the distribution and administration of the product by the NHS in each of the four countries of the United Kingdom and Crown Dependencies should comply with the above conditions in order to ensure the safety, quality and efficacy of the product is not compromised. Where appropriate, the above assurances must be reflected in the conditions imposed on NHS contractors by NHS commissioners.

In the United Kingdom, the vaccines will be delivered to designated NHS bodies or NHS contractors that have capacity to hold the vaccines at ultra low temperatures, expected to be, but not necessarily, Movianto and the Welsh Blood Service).

Thereafter, the NHS arrangements for the onward and final distribution of the products, and their final deployment, are still being developed, but the bodies responsible under NHS arrangements in each of the four countries for any aspect of the distribution or final deployment of the vaccine must comply, as conditions of this authorisation, with the conditions that are applicable to that aspect of the distribution or final deployment in this authorisation.

The bodies responsible for the transit of the product to the designated NHS bodies or NHS contractors in the UK from the manufacturer must also comply, as conditions of this authorisation, with the conditions of the authorisation that are applicable to them.

In addition:

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What Can Happen Once A Vaccine Is Approved

U.S. approval is likely to spur a new wave of vaccine mandates from corporate America. Major companies already told some or all of their employees that they must get fully vaccinated against COVID this fall. Still, some private businesses may have felt hesitant about requiring the shots, before full approval.

Full approval is also very beneficial to companies that submit an application, former FDA Commissioner Dr. Robert Califf said in a phone interview in May.

With it, Pfizer and BioNTech are now able to market the shots directly to U.S. consumers. Companies can’t promote their products under an EUA.

It also allows the shot to stay on the market once the pandemic is over and the U.S. is no longer considered in an “emergency.”

Pfizer and BioNTech have said they expect to generate billions from the vaccine. Under full approval, the companies could also decide to charge more for the vaccines, health experts say.

This article tagged under:

Learn More About Covid

Learn about the evidence supporting FDA-approval of Comirnaty and FDA emergency use authorization of COVID-19 vaccines

    FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16- and 17-year-olds. FDA expands eligibility for COVID-19 vaccine boosters to vaccine recipients 18 and older after completion of primary vaccination. FDA expands emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 5 through 11 years of age.

    Emergency use authorization allows these vaccines to be distributed in the U.S. Learn more about EUAs for COVID-19 vaccines from the FDAs Center for Biologics Evaluation and Research .

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    Possible Mandates After Covid Vaccine Approval

    Earlier in August, Dr. Anthony Fauci predicted a fully approved vaccine would lead to the empowerment of local enterprises to institute vaccine mandates.

    Some businesses and venues across the state have already started screenings before allowing people in.

    Full approval could spur new vaccine mandates in private businesses, a move public health officials praise. Fauci warned that if COVID is not controlled another variant might emerge that is even more problematic than the delta variant now racing across the nation.

    USA Today contributed to this report.

    Full Approval May Help Ease Vaccine Hesitancy

    Report: FDA to Give Pfizer COVID Vaccine Full Approval Monday

    More than 200 million Americans have received at least one dose of COVID-19 vaccine.

    Still, others have remained hesitant.

    “We’re hopeful that full approval provides these people with the confidence needed to get vaccinated as soon as possible. COVID-19 has taken more than 900,000 lives in the U.S. alone and vaccination is the best tool we have to protect against more death,” says Dr. Sostman.

    The FDA’s message is clear: The Pfizer and Moderna COVID-19 vaccines meet the high standards for safety, effectiveness and manufacturing quality the agency requires of an approved product.

    “If you’re not yet vaccinated, now is the time. And if you have questions about the vaccines, I cannot stress enough how important it is to turn to a trusted health expert for guidance, rather than to social media that is full of myths and misinformation,” adds Dr. Sostman.

    For instance, your primary care doctor can help you understand how the vaccines work, the side effects that may occur and the benefits of vaccination. He or she can also provide tips on how to deal with vaccine anxiety and decision-making.

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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.

    Mixing And Matching Vaccines Also On The Agenda

    In addition to reviewing Moderna and J& J boosters, the committee will also discuss the available data on mixing and matching the COVID-19 vaccines. Mixing and matching means that you were initially vaccinated with one vaccine and you receive a different one as a booster dose.

    The data will be presented by the National Institute of Allergy and Infectious Diseases . NIAID began studying mixing and matching vaccines in June. Early results were expected in late summer.

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