Odisha News, Odisha Latest news, Odisha Daily - OrissaPOST
  • Home
  • State
  • Metro
  • National
  • International
  • Business
  • Opinion
  • Feature
  • Timeout
  • Entertainment
  • Sports
  • IPL 2022
  • Sci-Tech
  • Others
    • COVID-19
    • Today’s Pic
  • Home
  • State
  • Metro
  • National
  • International
  • Business
  • Opinion
  • Feature
  • Timeout
  • Entertainment
  • Sports
  • IPL 2022
  • Sci-Tech
  • Others
    • COVID-19
    • Today’s Pic
No Result
View All Result
OrissaPOST - Odisha Latest news, English Daily -
No Result
View All Result

Pfizer, BioNTech seek emergency use of COVID-19 shots in US

AP
Updated: November 21st, 2020, 09:23 IST
in Coronavirus, International
0
Vaccine

Photo courtesy: news.cgtn.com

Share on FacebookShare on TwitterShare on WhatsAppShare on Linkedin

Washington:  Pfizer formally asked U.S. Regulators Friday to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic — but not until after a long, hard winter.

The action comes days after Pfizer Inc. And its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.

The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to the FDA submission, they have already started “rolling” applications in Europe and the U.K. And intend to submit similar information soon.

With the coronavirus surging around the U.S. And the world, the pressure is on for regulators to make a speedy decision.

“Help is on the way,” Dr. Anthony Fauci, the top U.S. Infectious disease expert said on the eve of Pfizer’s announcement, adding that it’s too early to abandon masks and other protective measures. “We need to actually double down on the public health measures as we’re waiting for that help to come.”

Friday’s filing sets off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, still another government group will have to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.

How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed. Globally, Pfizer has estimated it could have 50 million doses available by year’s end.

About 25 million may become available for U.S. Use in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week. Recipients will need two doses, three weeks apart. The U.S. Government has a contract to buy millions of Pfizer-BioNTech doses, as well as other candidates than pan out, and has promised shots will be free.

Not far behind is competitor Moderna Inc.’s COVID-19 vaccine. Its early data suggests the shots are as strong as Pfizer’s, and that company expects to also seek emergency authorization within weeks.

Here’s what happens next:

MAKING THE DATA PUBLIC

The public’s first chance to see how strong the evidence really is will come Dec. 10 at a public meeting of the FDA’s scientific advisers.

So far, what’s known is based only on statements from Pfizer and BioNTech.     Of 170 infections detected to date, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot. On the safety side, the companies cite results from 38,000 study participants who’ve been tracked for two months after their second dose. That’s a milestone FDA set because historically, vaccine side effects don’t crop up later than that.

“We’ll drill down on these data,” said FDA adviser Dr. Paul Offit of the Children’s Hospital of Philadelphia.

Think of it like science on trial. A few days before the meeting, the FDA will release its own internal analysis. That sets the stage for the advisers’ daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict.

They’ll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom. For example, is there enough proof the vaccine works as well for older, sicker adults as for younger, healthier people?   There’s still no guarantee. “We don’t know what that vote’s going to be,” said former FDA vaccine chief Norman Baylor.

EMERGENCY USE ISN’T THE SAME AS FULL APPROVAL

If there’s an emergency green light, “that vaccine is still deemed investigational. It’s not approved yet,” Dr. Marion Gruber, chief of FDA’s vaccine office, told the National Academy of Medicine this week.

That means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, she said.

There will be a lot of unknowns. For example, the 95% protection rate is based on people who developed symptoms and then were tested for the virus. Can the vaccinated get infected but have no symptoms, able to spread the virus? How long does protection last? That’s why the 44,000-person study needs to keep running — something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers.

“I’m curious,” said Barry Colvin, 52, of White Plains, New York, who is taking part in that study at NYU Langone Health.

But he’s not in a great hurry to find out which group he’s in. “You need to hang in there for a while to understand and answer a lot of the other questions that remain unknown.” Additionally at least for now, pregnant women won’t qualify because they weren’t studied. Pfizer only recently began testing the vaccine in children as young as 12.

A decision on Pfizer-BioNTech’s vaccine won’t affect other COVID-19 vaccine candidates in the pipeline, which will be judged separately.

MANUFACTURING

Brewing vaccine is more complex than typical drug manufacturing, yet the millionth dose to roll out of Pfizer’s Kalamazoo, Michigan, factory must be the same purity and potency as every dose before and after.

That means the FDA decision isn’t just based on study data, but on its determination that the vaccine is being made correctly.

The Pfizer-BioNTech vaccine — and Moderna’s shots — are made with brand-new technology. They don’t contain the actual coronavirus. Instead, they’re made with a piece of genetic code for the “spike” protein that studs the virus.

That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.

AP

Tags: BioNTechCoronaviruscovid19Pfizervaccine
ShareTweetSendShare
Suggest A Correction

Enter your email to get our daily news in your inbox.

Related Posts

Ministry

India slams OIC for ‘unwarranted’ comments on delimitation exercise in J&K

May 16, 2022
Magdalena Andersson

Sweden ends neutrality, goes the Finland way, seeks NATO berth

May 16, 2022
Modi-Deuba

India, Nepal sign 6 MoUs during Narendra Modi’s visit to Lumbini

May 16, 2022
Modi-International Centre

Narendra Modi lays foundation stone for India’s Buddhist centre in Lumbini

May 16, 2022

Musk prefers to visit Indonesia as top Indian ministers fail to impress him

May 16, 2022
Nepal, India sign 6 MoUs during Modi's Lumbini visit

Nepal, India sign 6 MoUs during Modi’s Lumbini visit

May 16, 2022

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

OrissaPOST epaper Sunday POST OrissaPOST epaper

Click Here: Plastic Free Odisha

Plastic Free Odisha

Puri SCS College Students

Puri SCS College Students support a plastic free odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) ...

August 30, 2018
Plastic Free Odisha

Naveen Jindal-Enterpreneur

Naveen Jindal support a Plastic Free Odisha. Do you?  *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) *Post your Photos/Selfie ...

August 30, 2018
Plastic Free Odisha

D.A.V Public School-Kalinga Nagar

D.A.V Public School Students, support Plastic free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) *Post ...

August 30, 2018
Plastic Free Odisha

Akash Dasnayak, Actor

Akash Dasnayak, Actor supports a Plastic Free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) *Post your ...

August 30, 2018
Plastic Free Odisha

Sudarsan Pattnaik,Sand Artist

Sudarsan Pattnaik support a Plastic Free Odisha. Do you?  *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) *Post your Photos/Selfie ...

August 30, 2018
Plastic Free Odisha

Korei college students

Korei college students support plastic free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) *Post your ...

October 2, 2018
Plastic Free Odisha

Padmashree Aruna Mohanty-Odissi Dancer

Padmashree Odissi Dancer Aruna Mohanty calls for a Plastic Free Odisha. Have You Joined the movement? *Visit our website orissapost.com. ...

August 30, 2018
Plastic Free Odisha

Deepak Kumar-Actor

Deepak Kumar support a Plastic Free Odisha. Do you support the movement? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page ...

August 30, 2018
Plastic Free Odisha

Odisha Rajya Rogi Adhikar Mancha & Mangalabagh International Club workers

Odisha Rajya Rogi Adhikar Mancha & Mangalabagh International Club Workers support a plastic free Odisha. Do you? *Visit our website ...

October 2, 2018
Plastic Free Odisha

Actress Bhoomika Dash

Actress Bhoomika Dash calls for a Plastic Free Odisha. Have You Joined the movement? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our ...

August 30, 2018
Plastic Free Odisha

Students of Tulasipur Saraswati Sishu Vidya Mandir, Cuttack

Students of Tulasipur Saraswati Sishu Vidya Mandir, Cuttack call for a Plastic Free Odisha. Do you support the movement? *Visit our ...

August 29, 2018
Plastic Free Odisha

Arindam Roy, Actor

Arindam Roy supports call for a Plastic Free Odisha. Do you support the movement? *Visit our website www.orissapost.com. Like,Share,Subscribe,Recommend our Facebook ...

August 29, 2018
Plastic Free Odisha

Bijay Mohanty, Actor

Actor Bijay Mohanty calls for a Plastic Free Odisha. Have You Joined the movement? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our ...

August 30, 2018
Plastic Free Odisha

Sabyasachi Mishra, Actor

Sabyasachi Mishra calls for a Plastic Free Odisha. Do you support the movement? *Visit our website www.orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page ...

August 29, 2018
Plastic Free Odisha

Miteish Khimji,Entrepreneur

Miteish Khimji supports a Plastic Free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) *Post your ...

August 30, 2018
Plastic Free Odisha

Unit III Bharat Scouts and Guide

Unit III Bharat Scouts and Guides team call for a Plastic Free Odisha. Do you support the movement? *Visit our website ...

August 29, 2018
Plastic Free Odisha

Govinda Poddar-Odisha Ranji Team Captain

Govinda Poddar, Odisha Ranji Team Captain  calls for a Plastic Free Odisha. Have You Joined the movement? *Visit our website ...

August 30, 2018
Plastic Free Odisha

Elina Samantray, Actress

Elina Samantray calls for a Plastic Free Odisha. Do you support the movement? *Visit our website www.orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page ...

August 29, 2018
Plastic Free Odisha

Hinjili Police

Hinjili Police support plastic free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) *Post your Photos/Selfie ...

October 2, 2018
Plastic Free Odisha

Actor Sritam Das

Actor Sritam Das supports a plastic free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) *Post ...

October 2, 2018
Plastic Free Odisha

Members of All Ride Bicycle

Members of All Ride Bicycle supports a plastic free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page ...

October 2, 2018
Plastic Free Odisha

Gandhi Science Higher Secondary School in Khandagiri, Bhubaneswar

Gandhi Science Higher Secondary School students of Khandagiri, Bhubaneswar support a plastic free Odisha. Do you?   *Visit our website ...

October 2, 2018
Plastic Free Odisha

Hockey Player Dilip Tirkey

Hockey Player Dilip Tirkey supports a Plastic Free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) ...

August 30, 2018
Plastic Free Odisha

Bridge school students

Bridge school students support plastic free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) *Post your ...

October 2, 2018
Covaxin
Christmas

Bharat Biotech rubbishes criticism, says its vaccine is safe    

New Delhi/Hyderabad: Hyderabad-based Bharat Biotech rejected Monday criticism over the grant of emergency use authorisation by India’s drug regulator to ...

January 5, 2021
Plastic Free Odisha

Cuttack College NCC students

Cuttack College NCC students support a plastic free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) ...

October 2, 2018
Plastic Free Odisha

Olympian Anuradha Biswal

Olympian Anuradha Biswal supports a Plastic Free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page Orissapost(@OrissaPOST.Here.Now) *Post ...

August 30, 2018
Plastic Free Odisha

Samanta Singhara Nodal High School students

Samanta Singhara Nodal High School students of Balia, Jajpur support plastic free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend ...

October 2, 2018
Plastic Free Odisha

Olympian Dutee Chand

Olympian Dutee Chand calls for a Plastic Free Odisha. Have You Joined the movement? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our ...

August 30, 2018
Plastic Free Odisha

Tanbhi Block School students and staff

Tanbhi Block School students and staff support plastic free Odisha. Do you? *Visit our website orissapost.com. Like,Share,Subscribe,Recommend our Facebook Page ...

October 2, 2018

Archives

Editorial

Putin’s Problems

May 16, 2022

The irony of Russian President Vladimir Putin’s decision to invade Ukraine in February is that the enemy he wanted to...

Read more

Outdated Laws

May 15, 2022

The Supreme Court has put a stay on the sedition law, and the Union government has also said the prime...

Read more

Tough Talk

May 14, 2022

‘Bad’ data is all around. Even as the Centre is vigorously questioning the WHO’s Covid death figures in India during...

Read more

West Got It Wrong

Russian President Vladimir Putin
May 13, 2022

The West responded to Russia’s invasion of Ukraine with sanctions of unprecedented severity and scope. By the standard of proportionality,...

Read more
  • Home
  • State
  • Metro
  • National
  • International
  • Business
  • Opinion
  • Feature
  • Sports
  • Sci-Tech
  • About Us
  • Advertise
  • Contact Us
  • Career
Developed By Ratna Technology

© 2020 All rights Reserved by OrissaPOST

  • Home
  • Metro
  • State
  • National
  • International
  • IPL
  • Sports
  • Business
  • Entertainment
  • Feature
  • Opinion
  • Sci-Tech
  • COVID-19
  • Today’s Pic
  • About Us
  • Contact Us
  • Career
  • Facebook
  • Twitter

© 2020 All rights Reserved by OrissaPOST