Global Statistics

All countries
554,058,479
Confirmed
Updated on July 3, 2022 5:21 am
All countries
526,121,184
Recovered
Updated on July 3, 2022 5:21 am
All countries
6,360,834
Deaths
Updated on July 3, 2022 5:21 am

Global Statistics

All countries
554,058,479
Confirmed
Updated on July 3, 2022 5:21 am
All countries
526,121,184
Recovered
Updated on July 3, 2022 5:21 am
All countries
6,360,834
Deaths
Updated on July 3, 2022 5:21 am
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Has The Covid Vaccine Been Approved

Drug And Vaccine Authorizations For Covid

Moderna COVID-19 vaccine approved for use in Australia | 7NEWS

Date published: 2021-11-23

Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here.

In the list below, the entry for each authorized drug and vaccine includes the:

  • brand name, proper name or common name, linked to the rationale for authorizing the product for use against COVID-19
  • medicinal ingredient, strength, dosage form and route of administration
  • drug identification number , linked to the entry for the product in the Drug Product Database, which includes the product monograph

Streamlining The Approval Process

Were moving quickly to make sure New Zealand gets the best protection against COVID-19, but this doesnt mean cutting any corners.

Medsafe has made changes to its vaccine assessment and approval process so its more efficient. Medsafe has been:

  • assessing large volumes of in-depth data from pharmaceutical companies as it becomes available. Usually pharmaceutical companies send all the data once all the studies have been completed
  • talking to and getting responses from pharmaceutical companies as soon as it can. For example, Medsafe asked Pfizer to respond to its questions within a week usually companies have up to four months to respond.

First Phase Initial Approvals Launch Of Vaccination Programme

In September 2020, India’s Health minister Harsh Vardhan stated that the country planned to approve and begin distribution of a vaccine by the first quarter of 2021. The first recipients were to be 30 million health workers directly dealing with COVID patients.

On 1 January 2021, the Drug Controller General of India approved emergency use of the OxfordAstraZeneca vaccine . On 2 January, the DCGI also granted an interim emergency use authorisation to BBV152 , a domestic vaccine developed by Bharat Biotech in association with the Indian Council of Medical Research and National Institute of Virology. This approval was met with some concern, as the vaccine had not then completed phase 3 clinical trials. Due to this status, those receiving Covaxin were required to sign a consent form, while some states chose to relegate Covaxin to a “buffer stock” and primarily distribute Covishield.

The first phase of the rollout involved health workers and frontline workers, including police, paramilitary forces, sanitation workers, and disaster management volunteers. By 1 March, only 14 million healthcare and frontline workers had been vaccinated, falling short of the original goal of 30 million.

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Pfizer Submits Authorization Request To Expand Booster Eligibility To All Adults

Yesterday, Pfizer submitted an to the FDA to expand its COVID-19 vaccine booster eligibility to all adults at least 18 years old. Currently, Pfizer booster shots are only authorized for certain groups, including older adults and people at high risk for severe illness.

Pfizer is now requesting broader authorization based on clinical trial results that studied the effects of booster shots. The trial enrolled more than 10,000 participants.

Everyone in this study received two doses of the Pfizer vaccine, but some people also received a booster shot. During the study, more people who didnt get a booster shot developed COVID-19 compared to those who got one.

As of today, theres no FDA vaccine expert panel meetings scheduled to review Pfizers request. But it has been reported that the FDA could make the call without the panel before Thanksgiving.

Reports Of Death Are Rare

COVID

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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When Can I Get A Covid

On Monday, the FDA cut the waiting period between the second dose of an mRNA vaccine, like Moderna’s shot, and a booster from six months to five.

The CDC and other health authorities are now urging people to get boosters as soon as they’re eligible, to keep the immune response against omicron, delta and other coronavirus variants of concern as strong as possible. Moderna’s mRNA vaccine booster has been approved for healthy Americans ages 18 and up. The FDA on Monday approved giving a booster of Pfizer-BioNTech’s vaccine, Comirnaty, to kids as young as 12 and to those 5 and up with compromised immune systems or certain other health conditions.

Last month, President Joe Biden outlined a plan to contact the 64 million people on Medicare and AARP’s 38 million members about getting a booster. Nationwide pharmacy chains like Walgreens, CVS and Rite Aid are also contacting customers who got a vaccine at their stores when it’s time to schedule a booster.

Coronavirus Vaccinations Are Currently Available And Have Been Shown To Be Safe For People Of All Ages Here’s A List Of Covid Vaccines Approved By Who

IMAGE:Shutterstock

Coronavirus vaccinations are currently available and have been shown to be safe for individuals of all ages, including those with chronic health issues. There are many vaccines that have been developed by several countries, two of which are Covishield and Covaxin. So is Covishield approved by WHO? Is Covaxin approved by WHO? Here’s a list of COVID vaccines approved by WHO.

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Does Approval Have Anything To Do With Brexit

Though some MPs have suggested that this approval process has been made possible only because the UK is leaving the European Union, Salisbury said that is not true. The MHRA acted in line with EU regulations, and any other EU country could have done the same, he said.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, has said that still being in the transition period may have helped speed up the approval because UK staff have not had to assess new vaccines or drugs intended for the whole EU for the past 18 months, allowing them to focus on the UK authorisation.

However, this will change from 1 January 2021 when the MHRA will become responsible for handling all applications for new drugs and vaccines to be authorised in the UK.

Who Is Exempt From Arrival Testing

Moderna COVID-19 vaccine approved for booster shots in Australia | Coronavirus | 9 News Australia
  • Already recovered: Travellers who provide a positive COVID-19 molecular pre-entry test result, conducted at least 14 and no more than 180 days before their scheduled flight or arrival at the land border crossing, are exempt from arrival testing
  • Travellers arriving by boat
  • Children under the age of 5
  • Crew and essential service providers already exempt from arrival testing continue to be exempt

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Will We Need An Annual Covid Booster Shot

With vaccines appearing to offer waning protection and the continuing evolution of variants, Hoge said we will most likely need seasonal COVID boosters, much like we do with the flu, at least to protect those at high risk of infection.

The CDC updated its guidance to indicate that, starting in 2022, some immunocompromised people will be able to get a fourth COVID-19 booster shot. Israel, Germany and other nations are researching the efficacy of a fourth shot and Dr. Anthony Fauci, chief medical adviser to the president, said a fourth jab was “conceivable” in the US, too.

Do People Who Have Had Covid

Yes, says Salisbury. We do not know the length of immunity of the natural infection and therefore having a vaccine will not do them harm and has the probability of doing the benefit . . . I cant think of reasons why you should not be vaccinated, he said. And we do know that people whove had covid can be reinfected. My judgment would be, if youre offered the vaccine, to have it. But there are many questions to which as yet we dont have evidence based answers.

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Is Covaxin Better Than The Other Vaccines

The Indian Council for Medical Research, which helped develop Covaxin, says the vaccines approach is like a Bruce Lee assault because it targets three potentially fatal areas at the same time.

It was created with an adjuvant developed by the NIH, technology that has been lauded by Fauci.

I am pleased that a novel vaccine adjuvant developed in the United States with NIAID support is part of an efficacious COVID-19 vaccine available to people in India, Fauci said.

But theres little data to support that its better than the Pfizer and Moderna vaccines. COVID-19 infections are decreasing in India. However, the country has reported a swift rise in omicron cases.

Covaxin does have one advantage: It doesnt require the ultra-cold storage of the American vaccines, which is expensive. That makes Covaxin more attractive to poorer, developing countries.

Health expert Jammi N Rao told Quartz India in early December that to date, there is no reliable evidence that they necessarily offer wide-ranging protection against new variants that result from multiple points of genetic mutation.

Million Mark Johnson & Johnson Covid

COVID Vaccine Stocks Long Call or Put? The mumps vaccine ...

On 6 August 2021, India crossed the 500 million doses milestone within 6 months from the onset of the vaccination program.

On 7 August 2021, the Drug Controller General of India approved emergency use of the Johnson and Johnson single-dose vaccine. On 16 Aug 2021, India administered around 8.81 million doses of COVID-19 vaccines, achieving the highest single-day record and overtaking its own previous record of 8.61 million doses, by 16 August the cumulative doses had surpassed the 55 millon mark.

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Fda And Cdc Sign Off On Pfizer And Moderna Boosters For All Adults

Last week, the FDA the expansion of single-dose Pfizer and Moderna booster shots for all adults. The CDC has also issued the same recommendation.

This latest announcement means that the following people are eligible for booster shots with the Pfizer or Moderna COVID-19 vaccine:

  • Adults who completed their initial Moderna vaccine series at least 6 months ago

  • Adults who completed their initial Pfizer vaccine series at least 6 months ago

  • Adults who initially got the single-dose J& J vaccine at least 2 months ago

COVID-19 vaccine booster recommendations allow for mixing and matching vaccines. This means that if you initially got Pfizer, you can get Moderna. Or you can stick with Pfizer again for your booster. The same applies to people who initially got the Moderna vaccine. Keep in mind that the Moderna booster is a half-dose shot compared to the initial doses.

Mhra Chief Executive Dr June Raine Said:

We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The publics safety has always been at the forefront of our minds safety is our watchword.

Im really pleased to say that the UK is now one step closer to providing a safe and effective vaccine to help in the fight against COVID-19 a virus that has affected each and every one of us in some way – and in helping to save lives.

We are globally recognised for requiring high standards of safety, quality and effectiveness for any vaccine. Our expert scientists and clinicians worked tirelessly, around the clock, carefully, scientifically, robustly and rigorously poring over hundreds of pages and tables of data, methodically reviewing the data.

Vaccines are the most effective way to prevent infectious diseases. They save millions of lives worldwide.

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Fdas Vaccine Advisory Committee Votes On Recommending A Lower

This week, the FDAs vaccine advisory committee met to discuss Pfizers vaccine data for children ages 5 to 11. The committee voted in favor of authorizing the vaccine in this age group. The final vote was 17 members in favor of recommending the vaccine and 1 member who abstained from voting.

Pfizers COVID-19 vaccine is given as 2 doses, 3 weeks apart. But children in this age group get a lower dose than whats given to people at least 12 years old.

Even though the advisory committee came to this vote, the FDA still needs to weigh in with its decision to authorize the vaccine. A CDC expert panel is also scheduled to meet next week to give their recommendations. As soon as both agencies sign off on the vaccine, the Biden administration has announced plans to help distribute shots quickly across the country.

Summaries Of Monitoring Efforts

COVID-19 Vaccines for Kids Ages 5-11 | Duke Health

FDA is conducting intensive monitoring of COVID-19 vaccine safety in the U.S. using a variety of approaches. Based on available information, FDA strongly believes that the known and potential benefits of COVID-19 vaccination greatly outweigh the known and potential risks of COVID-19. As part of our efforts to be transparent about our COVID-19 vaccine safety monitoring activities, FDA is posting summaries of the key safety monitoring findings on this page.

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    What Is Covaxin The Covid Vaccine Not Approved In The Us

    Dr. Anthony Fauci this week addressed Covaxin, a COVID-19 vaccine made in India that has not been approved in the U.S. but is finding its way into the social media feeds of the American public.

    We have enough vaccines, the best vaccines available, in the United States, Fauci, the chief medical advisor to President Joe Biden, said in response to a question about Covaxin during his Thursday interview with Adrienne Bankert on NewsNations Morning in America.

    Im puzzled by that question, he said about Covaxin. We have more vaccines than we need right now. We just need the people to get vaccinated with the vaccines that we have. The mRNA vaccines are vaccines that are desired by everyone else in the world. So we have what we need we need to use it.

    So why the interest in Covaxin? How does it compare to the vaccines currently available in the United States?

    What makes Covaxin different?

    Covaxin is different from the Pfizer-BioNTech and Moderna vaccines in how they are made. Pfizer and Moderna are mRNA vaccines, a relatively new approach that teaches our cells how to make a protein that triggers an immune response inside our bodies, according to the CDC.

    Covaxin takes a more traditional approach. Its made by using a disabled form of the COVID-19 virus to stimulate the immune system. This is similar to Johnson & Johnsons approach to the vaccine.

    Why the interest IN Covaxin?

    What Share Of The Population Has Been Partly Or Fully Vaccinated Against Covid

    The following charts show the breakdown of vaccinations by those that have been partly or fully vaccinated. A person is considered partly vaccinated if they have received only one dose of a 2-dose vaccine protocol. A person is considered fully vaccinated if they have received a single-dose vaccine or both doses of a two-dose vaccine.

    This data is only available for countries which report the breakdown of doses administered by first and second doses.

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    Booking Your 2nd Dose

    People aged 16 or over are eligible for a 2nd dose.

    People aged 18 or over should have their 2nd dose from 8 weeks after their 1st dose.

    Most people aged 16 or 17 should have their 2nd dose from 12 weeks after their 1st dose.

    Does The Fda Monitor Covid

    India gets another good news, indigenous Covid

    Yes. The FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety. These systems, called passive surveillance and active surveillance systems, rapidly detect and investigate potential safety problems. Systems such as the Vaccine Adverse Event Reporting System and CDCs text-based v-safe system, which receive reports of adverse events following vaccination, are examples of passive surveillance systems. The FDAs BEST Initiative is an example of an active surveillance system, which analyzes information occurring in millions of individuals recorded in large data systems to investigate any safety signals that are identified by VAERS or v-safe.

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    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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