From escaping the Taliban to Kiwi academic excellence

https://www.rnz.co.nz/national/programmes/sunday/audio/2018809228/from-escaping-the-taliban-to-kiwi-academic-excellence

Abbas Nazari’s memoir couldn’t have come at a more poignant time as he watches his country fall to the same forces his family escaped from 20 years ago.

In After the Tampa: From Afghanistan to New Zealand, Nazari recounts a harrowing journey to leave Afghanistan at the age of 7 and being rescued by the MV Tampa, which resulted in an international diplomatic rift.

Graduating from the University of Canterbury, pictured with his mother and father.

Ali (left), his father (middle) and Abbas helping a Sungjoy family with their apricot harvest in 2017.

First day of school in Pakistan.

Talking to NZ with Mike McRoberts one week after 15th March.

The Nazari clan one year into their lives in Christchurch.

Ali and Abbas learnt about birthdays at school and convinced their mum to throw a joint party.

Listen to the full interview with Abbas Nazari here duration27′ :01″Add to playlistDownload

Listen to the full interview with Abbas Nazari here

Nazari’s story echoes the agonising decisions some in Afghanistan are having to make at every turn.

“The war is coming in and it’s getting more dangerous by the day and so [my parents] had a choice, do we stay and face persecution or potential killing by the Taliban? Or do we pack up our things and seek security elsewhere? And for my parents back then, that was across the border in Pakistan,” Nazari tells Jim Mora.

“There’s so many points along the way where they had to make a decision, to stay or to go into the unknown.”

With the persecution of the Hazaras ethnic minority in Afghanistan, his family became fearful. Having Central Asian genes, speaking a different language, and with most belonging to the Shia’a sect of Islam, they were a visible target, Nazari says.

“Over centuries, that has meant we are an ‘other’, a minority group that is unwanted in the land of the majority.

“In the book, I detail countless instances of massacres, of genocidal acts, culminating with the Taliban takeover and the many massacres and atrocities they committed against the Hazaras Afghans. That is a genuine fear, that now with the Taliban back in power, that they’ll continue what they started in the ’90s.

“Right now when viewers and readers are tuning in to the harrowing images of what’s happening in Afghanistan … we see statistics and crowds of people, but each person there is an individual story, where they’ve either had to say goodbye to their families, where they’ve had their families killed, or whether they’ve had absolute fear of staying because they might be an ethnic minority, a translator, or a woman.

“All that is lost when we talk about what’s happening in Afghanistan.”

The Taliban have claimed that their rule will be different to last time, while Nazari hopes that will be true, he says “their actions speak louder than words”.

“Keep in mind, they’re incredibly tech-savvy now. They have biometric data from all the technology they’ve seized, so they know exactly who has worked with the foreign troops, they know exactly who the journalists are, who the critical thinkers are, and they know exactly where people live.”

Now there’s a sea of people surrounding Kabul Airport, and Nazari says even though they probably have tickets to get out, militants are controlling the checkpoints and have been firing bullets over the crowds to make them withdraw.

His own journey to cross the border was troublesome, he says, when “every second feels like an eternity.”

Barely getting through there to Pakistan and finally Indonesia, they get on a rickety fishing boat with more than 400 asylum seekers, heading to Australia.

“That chapter describes the rollercoaster of emotions we went through. We were in the belly in the hull of the ship that was being torn apart by the wave, I remember the decking falling apart, holes in the sides, the beams are splitting and people are sliding across those decks … and it was the most horrendous experience I’ve ever been through … that particular night is installed in high definition in my memory.

“I remember one of the parents next to me, gripping on to his child, and his prayer he uttered was something along the lines of ‘oh God, if we were to die tonight then let our bodies wash ashore so we can be buried on land’. What more do you need to show how desperate and fearful people were about their circumstances.”

They were rescued by cargo ship Tampa, which was refused entry by Australia and spent 35 days at sea before New Zealand struck a deal to take in 150 people, among them Nazari’s family.

“That was one of the happiest times of my life … I learned my ABCs at Mangere, I remember eating all the mounds of food we were given.

“And how starkly different my life was to the 300-odd men and single dads and elder sons who had ventured alone, who were sent to Nauru, some who would spend three years there before they were given resettlement elsewhere.”

While the story of escaping the violence can be quite grim and dark, Nazari also hopes to show through his book that Afghanistan has known peace before and believes it can be accomplished again.

Nazari is now a Fulbright scholar, and recently came back to Aotearoa from his studies in the United States at Georgetown University. He was due to appear alongside former prime minister Helen Clark at a WORD event – which has now been cancelled due to the Covid-19 outbreak.

Novavex Delay

The vaccine cannot cause you to get COVID-19.

The Novavax vaccine uses a version of the spike protein made in the lab. The spike proteins are assembled into tiny particles called “nanoparticles” which aim to resemble the structure of the coronavirus, however they cannot replicate once injected and the vaccine cannot cause you to get COVID-19.

In order for these subunit vaccines to generate strong protective responses, they need to include molecules that boost your immune system, called “adjuvants”. The goal of these adjuvants is to mimic the way the real virus would activate the immune system, to generate maximum protective immunity.

COVID Vaccine Rollout: Anthony Albanese has slammed Prime Minister Scott Morrison for the delay in Australia’s Novavax vaccines. 51 million doses expected to arrive later this year will now only be available from 2022, which the Opposition Leader says is a “further setback” on Australia’s road to recovery from COVID-19.

“Scott Morrison had two big jobs this year – the rollout of the vaccine and effective national quarantine – and unfortunately, both of them have been botched.”
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How does the Novavax vaccine work?

The Novavax vaccine is given as two doses, similar to the Pfizer and AstraZeneca shots already being used in Australia.

It can be stored for up to three months at fridge temperature, which differs from the Pfizer mRNA vaccine which needs to be kept at ultra-low temperatures. In saying that, the TGA said last week the Pfizer vaccine can be stored at normal freezer temperatures for two weeks during transport, and at fridge temperatures for five days — though must still be kept ultra-cold after transport and in the long-term.

A graphic comparing Australia's three vaccine options
Comparing Australia’s three COVID-19 vaccine options. Jamie Triccas, made with BioRender, CC BY-ND

The vaccine also uses a different technology to the Pfizer and AstraZeneca vaccines. It’s a “protein subunit” vaccine; these are vaccines that introduce a part of the virus to the immune system, but don’t contain any live components of the virus.

The protein part of the vaccine is the coronavirus’ “spike protein”. This is part of the other COVID-19 vaccines in use but in a different form.


Read more: New coronavirus variant: what is the spike protein and why are mutations on it important?

The Novavax vaccine uses a version of the spike protein made in the lab. The spike proteins are assembled into tiny particles called “nanoparticles” which aim to resemble the structure of the coronavirus, however they cannot replicate once injected and the vaccine cannot cause you to get COVID-19.

In order for these subunit vaccines to generate strong protective responses, they need to include molecules that boost your immune system, called “adjuvants”. The goal of these adjuvants is to mimic the way the real virus would activate the immune system, to generate maximum protective immunity.

Novavax includes an adjuvant based on a natural product known as saponin, an extract from the bark of the Chilean soapbark tree.

How effective is the vaccine compared to those already in use in Australia?

The interim data from phase 3 testing, released in March, was very encouraging. When tested in the UK in a clinical trial including more that 15,000 people, the vaccine was 96% effective at preventing COVID-19 disease for those infected with the original strain of the coronavirus.

This compares well to the Pfizer vaccine, with an efficacy of 95%, and recent data from AstraZeneca demonstrating 76% efficacy against COVID-19.

The Novavax vaccine is also safe. In early clinical testing the vaccine caused mainly mild adverse events such as pain and tenderness at the injection site, and no serious adverse reactions were recorded. In the larger trials, adverse events occurred at low levels and were similar between the vaccine and placebo groups.

https://www.smh.com.au/business/companies/novavax-plans-to-trial-combined-flu-and-covid-super-jab-in-australia-20210806-p58gfk.html

Novavax plans to trial combined flu and COVID super jab in Australia

Emma Koehn
By Emma Koehn

August 6, 2021

In a statement on Friday morning, the company said it expects “to initiate [a] Phase 1 clinical trial in Australia later this year”.

Australia has already been key to Novavax’s development of its standalone COVID-19 vaccine, with an ongoing US-Australian study applying the initial two doses to local volunteers and then giving certain participants boosters

A special Birthday in 2014

auntyutaDiaryLife in AustraliaOld Age  September 23, 2014 1 Minute

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Related

Uta’s DiaryMay 13, 2016In “Diary”

Uta’s Diary June 2019June 17, 2019In “Diary”

My ParentsSeptember 7, 2013In “Childhood Memories”

Edit”On Sunday I turned 80″

Post navigation

Previous Post An Artist’s Eternal Message Of Peace.Next PostBurqas Under the Bed – Fabricated Fear for the New Millennium

13 thoughts on “On Sunday I turned 80”

  1. catterel EditMany happy returns of the day, Uta. Thatlooks like a really lovely celebration. May you be abundantly blessed xxReply
  2. stacylynngittleman Edithave a happy birthday and many more in good health!Reply
  3. cardamone5 EditHappy birthday!Reply
  4. Pocket Perspectives EditHappy, Happy Birthday, Uta!!!! Reply
  5. gerard oosterman EditHappy Birthday Uta from us at Bowral.
    Gerard & Helvi.“Lang zal ze leven” Hiep Hiep Hoera!Reply
  6. berlioz1935 EditI think you had a really great day. Here is a little musical treat from Indiahttps://www.youtube.com/embed/FWbRuUE5E9M?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en&autohide=2&wmode=transparentReply
    1. auntyuta EditI love this musical treat from India. Thank you for this, Peter. Yes, I had a really great day and I thank everyone for their good wishes to my 80th birthday. Thank you very much for all your comments!Reply
  7. Team Oyeniyi EditHappy Birthday!!Reply
    1. auntyuta EditThank you, Robyn! Reply
  8. The Emu EditMy apologies for a very late acknowledgement of a great milestone in your life
    May your birthday year bring you much happiness, and beautiful recollections of the love of your family, and all those who have been privileged to be a part of your life.
    Kindest regards
    Ian and AnaReply
    1. auntyuta EditThank you so much, Ian and Ana, for your lovely wishes . Yes, I regard this birthday as a great milestone! 
      Have a great week!
      Love, UtaReply
  9. Holistic Wayfarer EditPhotos are simply beautiful. I trust it was a special day with loved ones. I am so happy to see more comments on your blog.Love,
    DianaReply
    1. auntyuta EditIt was for me a very special day indeed, Diana. Thank you so much for commenting.
      Love,
      Uta

Burqas Under the Bed – Fabricated Fear for the New Millennium

auntyutaUncategorized  September 23, 2014 

I think Jenni’s blog is well written with good links. Well worth reading to get a picture where we are at in Australia.

Unload and Unwind

reds-under-the-beds-omg-commies-mommy-politics-1354105987

Well it seems as if the new boogeyman of the 21st century is fully established.  Instead of drumming up fear and paranoia at the idea of Reds Under the Bed as was done in the past our governments have now determined that all our fear focused hate should be turned in the direction of those who follow the Muslim faith.  In short we should all fear the ‘Burqa Under the Bed‘ [courtesy of Yvette Scholtmeyer].

Regardless of the political tap dancing our world leaders use to present the idea that they are only interested in those who are extremist in their faith to the point of violence against others the facts are that they have stirred up a mighty brew of xenophobic fear and hatred.  How easy it is to cast stones at those whose beliefs differ to ours especially when we do little…

View original post 740 more words

Related

Monika’s BirthdayDecember 5, 2013In “Diary”

HAPPY BIRTHDAY, LUCASJuly 21, 2013In “Diary”

Blue Lotus Water GardenJanuary 2, 2015In “Diary”Edit”Burqas Under the Bed – Fabricated Fear for the New Millennium”

Previous Post On Sunday I turned 80Next PostWednesday, 24th of September 2014

15 thoughts on “Burqas Under the Bed – Fabricated Fear for the New Millennium”

auntyutaUncategorized  September 23, 2014 

I think Jenni’s blog is well written with good links. Well worth reading to get a picture where we are at in Australia.

Unload and Unwind

reds-under-the-beds-omg-commies-mommy-politics-1354105987

Well it seems as if the new boogeyman of the 21st century is fully established.  Instead of drumming up fear and paranoia at the idea of Reds Under the Bed as was done in the past our governments have now determined that all our fear focused hate should be turned in the direction of those who follow the Muslim faith.  In short we should all fear the ‘Burqa Under the Bed‘ [courtesy of Yvette Scholtmeyer].

Regardless of the political tap dancing our world leaders use to present the idea that they are only interested in those who are extremist in their faith to the point of violence against others the facts are that they have stirred up a mighty brew of xenophobic fear and hatred.  How easy it is to cast stones at those whose beliefs differ to ours especially when we do little…

View original post 740 more words

Previous Post On Sunday I turned 80 Wednesday, 24th of September 2014

15 thoughts on “Burqas Under the Bed – Fabricated Fear for the New Millennium”

  1. Jenni Thanks for the re-blog – it’s good to see that people understand how badly we are being manipulated.Reply
    1. auntyuta Since I just turned 80. Jenni, I can remember what it was like in Germany under the Nazi regime. How relieved we were when there was peace and freedom after World War Two!Reply
      1. Jenni EditIt’s too easy to forget just how much things can go wrong when people don’t speak out and just let things go until it reaches a point when it is no longer possible to speak out. History paints a very clear picture of what such actions bring but humanity just can’t seem to learn from the past. Frustrating is too mild a word for it but fortunately due to the internet those who want to speak out have a voice those in the past didn’t have access to. Although I’m pretty sure the Abbott government is taking steps to tighten control over social media.
      2. auntyuta EditMy goodness, Jenni, you seem to think on much the same wave length. – Yes, luckily the internet can be used to make our views known – Well, so far it is possible. Thanks for that. 
  2. likeitiz EditThis is very sad to read about, Aunty Uta.By the way, my nephew, who went to live in Sydney for a year of training for his company, is back here on vacation. He says he’s enjoying his life in Sydney.Reply
    1. auntyuta EditSydney has become very expensive but we love to go there for a visit. You can find some very enjoyable places in Sydney. 
      Thanks for commenting, dear Mary-Ann. Who knows where we are going in future?Reply
      1. likeitiz EditBTW, my daughter just got engaged. Her boyfriend of 7 years has proposed. I feel that they are still young, but what the heck! It’s not my life. Guess what! He was born in Washington D.C. but when he was barely 2 years old, his parents moved to Sydney. He came back to study at Stanford University for college and that’s where he met my daughter! Small world, Aunty!And yes, he has an Australian accent.
      2. auntyuta EditAmazing, Mary-Ann. Such a small world! 
  3. gerard oosterman Australia would be better of looking at our rate of youth unemployment which is almost 15%. They are spending 500.000.000.- a year on exercising their pyrotechnical toys bombing far away sandy countries.
    On top of that billions on keeping a few boat people away by the Australian defence Force and keeping them locked up in detention/jails.
    With that money they could have kept our manufacturing motor industry and other large employers of people.
    It is no wonder the young are disillusioned and seek adventure and excitement elsewhere.Reply
    1. auntyuta I totally agree, Gerard, the money is not spent the way it should be spent. I say, this is very sad state of affairs. It shows that our so called democracy is not working very well. So far it does not effect me personally. I have a good life and nothing to complain about. Still, this does not make me happy go lucky. It is so terrible to think about how more and more people in our own society have no prospects, absolutely none. What causes are the young ones going to fight for? I don’t like it.I am officially old now for I am 80; but all this makes me frightened for future generations. Even for well off people there is eventually going to be less and less security in this kind of a world. As Jenni says: ” . . . . humanity just can’t seem to learn from the past.”The years when government did not seem to do too much wrong, are long gone. Now they are making more and more mistakes, the same mistakes that had been done by other generations in other countries. Do they learn from the mistakes of the past? Of course not. All their actions are being rationalised to make people believe they do the right thing. And so it goes. . . . .Reply
  4. stuartbramhall  Great find. Thanks for sharing. I see Abbott is copying Obama’s and Bush’s old trick of scaring people to death to keep them from seeing how incompetent he is.Reply
  5. Team OyeniyiThank you for the introduction to Jenni! Love her work!Reply
    1. auntyuta EditI love it too, Robyn. Yes, she does good work.I am glad that you love it.

This is a Reblog! I did turn 80 on Sunday, 21 September 2014

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This picture is from yesterday (Tuesday) morning. Marion, one of my neighbours, came along to ask for our gardener’s phone number. Peter gave her the number. I showed Marion in the computer the photos that we had taken on Monday morning at the lake.

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Here is another photo that I tried to shoot with my camera from the computer screen. It shows part of that beautiful playground near the lake.

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Marion asked me whether I still felt to be in a celebratory mood. “Very much so,” was my reply. Tuesday morning was a lovely morning: Wonderful sunshine, the air felt balmy. When Marion arrived we had already finished our morning tea outside in front of the house.

A little bit of Sunday's ice-ream cake was still left. Peter and I  enjoyed this before we had our cup of tea.
A little bit of  ice-ream cake had still been left from Sunday. Peter and I enjoyed this before we had our cup of morning tea.
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Sitting outside in the sun I decided I would wear this hat.
 I wore this hat sitting outside in the sun.
I had tried the hat on in the bathroom to see what it looked like.
I had tried the hat on in the bathroom to see what it looked like.
Before I got dressed I had taken another picture in the bathroom. My aim was to take a picture of the flowers when I noticed I could also be seen in the mirror!
Before I got dressed I had taken another picture in the bathroom. My aim was to take a picture of the flowers when I noticed I could also be seen in the mirror!
So I stepped back - but surprise, surprise: the mirror did still catch me!
Later I took a picture stepping back a bit – but surprise, surprise: the mirror did still catch me!
Looking through my birthday cards again I felt like I wanted to take a picture of them.
Looking through my birthday cards again and again I felt I wanted to take a picture of them.
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These are the names of the ladies who gave me these beautiful flowers. Joan came a bit later after work. Her name is missing on the card. Anyhow these are the flowers I received from the ladies on Monday. Aren’t they beautiful?

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So Tuesday morning I went around enjoying all the flowers. I kept shifting them to different places and took  pictures of them from different angles. I just love taking pictures of beautiful things!

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Here you can see Peter in the kitchen busily fixing the curtain rod.

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Breakfast Time
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Sparkling Apple Juice for Lunch
Sparkling Apple Juice for Lunch
Salad for Lunch
Salad for Lunch
This in Lunch
This in Lunch
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Here is this week’s TIME magazine. On page 14 it says:

ON A HUMID MID-SEPTEMBER NIGHT,
SECRETARY OF STATE JOHN KERRY
ARRIVED AT THE ROYAL PALACE ON SAUDI
ARABIA’S RED SEA COAST TO BEG
THE FAVOR OF A KING

The writer of this article says that Abdula bin Abdulazis is perhaps the most powerful man in the Middle East.

It is said in this article that the U.S. has built a fragile web of alliances to fight ISIS.
The question is being asked: WILL THIS SHAKY GROUP OF PARTNERS HOLD?

I, Uta, ask myself, how can we as ordinary citizens possibly grasp all the complications? It’s of no use working myself up, right? But I still want to know as much as possible where we are at at present.

Back to my flowers. Here is another glance at them:

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Under the above picture it says: Diplomatic dance Kerry leaves a photo op with leaders of the Gulf Cooperaton Council in Jidda, Saudi Arabia, on Sept. 11
Under the above picture it says: Diplomatic dance
Kerry leaves a photo op with leaders of the Gulf Cooperation Council in Jidda, Saudi Arabia, on Sept.11 

  1. berlioz1935 EditYou have been busy Aunty Uta.Reply
    1. auntyuta EditYea, busily taking pictures, Berlioz. As you know, I love doing this! Reply
  2. giselzitrone EditEinen glücklichen Mittwoch liebe Ute so schöne Bilder und viele Blumen meinen Glückwunsch noch nachträglich und viel Gesundheit und Glück war sicher viel Arbeit für dich.Ja vom Fernsehen hatte ich auch mal versucht Bilder zu machen wahren aber nicht so schön.Ich wünsche dir noch einen glücklichen schönen Tag und alles liebe und Glück von mir.Gruß und Freundschaft.GislindeReply
    1. auntyuta EditNein, Gislinde, war nicht viel Arbeit für mich. Die Gäste kamen nur zum Nachmittags Kaffee. Caroline und Peter sahen nach der Küche und besorgten das Einschenken während ich wie die Königing mit meinen Gästen am Tisch sass! Wie du siehst, bin ich ordentlich verwöhnt worden und die vielen Blumengeschenke machten mich sehr glücklich. Es war ein ganz besonderer Geburtstag der sich über mehrere Tage erstreckte. Nun bin ich offiziel im fortgeschrittenen Alter. Hat aber auch seine guten Seiten, finde ich. Hab vielen Dank für deine lieben Glückwünsche, liebe Gislinde. Herzliche Grüsse, Uta. Reply
  3. catterel EditLovely pictures of what sounds like a lovely birthday. Btw only vampires don’t have a reflection in the mirror Reply
    1. auntyuta Well, Cat, now there is proof that I am not a vampire! He, he Reply
  4. rangewriter EditHappy belated birthday. You are as lovely as your flowers.Reply
    1. auntyuta Oh, thanks for this, Linda, thank you very much! 

Mutations?

Here is one answer to me that I received 2 days ago:

Aunty, it’s typical of all coronaviruses (the main viruses that cause colds) and flu viruses to continually mutate. As they mutate, the illnesses they cause become less severe. This usually means they become more contagious – mainly because people are less sick and are more likely to be active and mingle among other people.

All the evidence suggests this is true of Delta variant. Although it’s more contagious, the illness it causes is much milder. A year’s worth of data shows the the Wuhan virus itself tends to cause very mild illness in people under 65 without underlying health conditions. It also shows that people over 65 or those with underlying health conditions can be successfully treated as outpatients with early treatments. The mainstream media is trying very hard to conceal these facts because the goal is to scare the wits out of people to get them to take these dangerous experimental vaccines..

To Gaby: 28 August 1957 – 2012

You were a rare and beautiful flower !

Dear Gaby,


today 55 years ago you were born. When I heard the good news in the early hours of that day in 1957 I cried with happiness for you and your Mum. I wish you were still here so I could congratulate you for the good life that you lived, despite fate having given you a massive hurdle to overcome. But you did it !!! You put us all to shame with your zest for life. This zest for life you shared with the great German writer Johann Wolfgang von Goethe whose birthday you shared too. Here is what he wrote and you will understand, because you felt the same:

“I have come to the frightening conclusion that I am the decisive element. It is my personal approach that creates the climate. It is my daily mood that makes the weather. I possess tremendous power to make life miserable or joyous. I can be a tool of torture or an instrument of inspiration; I can humiliate or humor, hurt or heal. In all situations, it is my response that decides whether a crisis is escalated or de-escalated, and a person humanized or de-humanized. If we treat people as they are, we make them worse. If we treat people as they ought to be, we help them become what they are capable of becoming.”

Wasn’t that you? You spread the “good climate” and shared your attitude to life with the rest of us. Your birth and your life was a gift to us from the creator as the meaning of your name is “God gives Strength”. When we chose your name we must have subconsciously foreseen what would become of you.Your life was a gift to us. Thank you for having been Gabriele, our Gaby. We love and remember you for the rest of our lives.

A beautiful life

This is a blog that Peter wrote in 2012 and I copied it in memory of Gaby and Peter.

FDA Approves First COVID-19 Vaccine

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

FDA NEWS RELEASE

Approval Signifies Key Achievement for Public Health

Immediate Release:August 23, 2021

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval. 

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. 

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older

The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals. 

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population. 

Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. 

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.

Ongoing Safety Monitoring

The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

Related Information

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.