U.S. FDA authorizes Pfizer COVID-19 vaccine for emergency use

[rooster59]

U.S. FDA authorizes Pfizer COVID-19 vaccine for emergency use

By Michael Erman

 

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Pfizer logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/File Photo

 

(Reuters) - The United States said it authorized the use of Pfizer Inc's COVID-19 vaccine on Friday, with the first inoculations expected within days, marking a turning point in a country where the pandemic has killed more than 295,000 people.

 

The U.S. Food and Drug Administration granted an emergency use authorization for the vaccine, developed with German partner BioNTech, which was shown to be 95% effective in preventing the disease in a late-stage trial. It said the vaccine can be given to people aged 16 and older.

 

Healthcare workers and elderly people in long-term care facilities are expected to be the main recipients of a first round of 2.9 million doses this month.

 

BioNTech Chief Executive Ugur Sahin said the vaccine "will help to save lives across the United States and could accelerate a return to normality."

 

U.S. health authorities, shipping services, hospitals and pharmacies have been readying a nationwide inoculation campaign. Pfizer said it would start shipping immediately and state public health systems have been planning to begin shots as early as Monday.

 

The government plans to accelerate vaccinations in the coming weeks and months, especially if a second vaccine from Moderna Inc is quickly approved. An advisory group to the U.S. Centers for Disease Control and Prevention will meet on Saturday to make crucial recommendations about whether some groups such as pregnant women and 16-year-olds should be immunized.

 

The authorization comes as cases are surging in the United States, with thousands of death per day, while hospital intensive care units across the country are nearing capacity, threatening to overwhelm healthcare systems.

 

"It is one step in a sequence of steps that will bring this pandemic to an end," said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

 

He added: "A lot of people will be infected, a lot will be hospitalized and a lot will die before the vaccine is able to have a meaningful impact on spread."

 

The Pfizer/BioNTech vaccine was first approved in Britain earlier this month, and UK residents began receiving the shots on Tuesday. Canada also authorized the vaccine and expects to start inoculations next week.

 

Mexico, Bahrain and Saudi Arabia have also approved the Pfizer vaccine.

 

U.S. President Donald Trump, in a video posted on Twitter, trumpeted the achievement and blamed China for the pandemic.

 

Critics have said his focus on China was aimed at deflecting attention from his missteps in combating the pandemic.

 

"The United States is the first nation in the world to produce a verifiably safe and effective vaccine. Today's achievement is a reminder of America's unlimited potential," Trump said.

 

COMPLEX CHALLENGES

 

Others with vaccines in advanced development include Moderna, which could win emergency U.S. authorization as soon as next week, AstraZeneca Plc with Oxford University, and Johnson & Johnson.

 

BioNTech began developing the vaccine in January, using a technology called synthetic messenger RNA (mRNA) that had yet to produce an approved product. The technology uses a chemical messenger to instruct cells to make proteins that mimic part of the new coronavirus, which the immune system learns to recognize as an invader. BioNTech struck a development deal with Pfizer in March.

 

The vaccine comes with complex distribution challenges as it must be shipped and stored at -70 Celsius (-94 F), requiring specialized ultra-cold freezers or supplies of dry ice.

 

Moderna's vaccine employs the same technology but does not need to be stored at sub-Arctic temperatures.

 

Pfizer has developed a special shipping container that will be filled with dry ice to keep the vaccine from spoiling. Many states are concerned about whether there is enough dry ice for shipments to rural areas that lack the specialized freezers, but Pfizer believes there should be sufficient supply.

 

U.S. health officials have said they will have enough to supply all of the 330 million U.S. residents who wish to be vaccinated by the middle of 2021.

 

'HERD IMMUNITY'

 

The government has ordered 100 million doses of the Pfizer vaccine - enough to inoculate 50 million people - through its Operation Warp Speed virus development program and could negotiate for more. The status of those talks are unclear.

 

Pfizer board member and former FDA commissioner Scott Gottlieb said in an interview with CNBC earlier this week that the company had offered to sell the United States more doses as recently as last month but had been turned down.

 

The United States has agreed to buy 200 million doses of Moderna's two-dose vaccine. The government also has supply deals with J&J and AstraZeneca, but authorization of those vaccines are not imminent.

 

Top U.S. infectious diseases expert Dr. Anthony Fauci said if distribution goes well and enough Americans agree to get vaccinated, relief for a pandemic weary nation may be on the horizon, with enough immunizations providing safety for the 'herd' of collective society.

 

"By the end of summer or end of third quarter, we may actually have enough herd immunity protecting our society," he said.

 

(Additional reporting by Ann Maria Shibu in Bengaluru, Tim Ahmann and Eric Beech in Washington and Carl O'Donnell in New York; Editing by Caroline Humer, Bill Berkrot, Leslie Adler, Daniel Wallis, Peter Henderson, Sonya Hepinstall and Raju Gopalakrishnan)

 

-- © Copyright Reuters 2020-12-12

 

- Whatever you're going through, the Samaritans are here for you

- Follow Thaivisa on LINE for breaking COVID-19 updates

[Jack Mountain]

More info about the brains in the development of this vaccin. Well done German Turkish immigrants!

 

https://www.channelnewsasia.com/news/world/biontech-pfizer-covid-19-vaccine-husband-wife-sahin-tureci-13500724

Edited December 13, 2020 by onthedarkside
link cleanup

[placeholder]

Trump reportedly threatened to fire Hahn , the head of the FDA, if he authorized its use on Saturday instead of on Friday.

[Emdog]

1 hour ago, placeholder said:

Trump reportedly threatened to fire Hahn , the head of the FDA, if he authorized its use on Saturday instead of on Friday.

Another attempt to undermine public confidence in the vaccine and screw up Biden's presidency by undermining confidence in FDA procedures. Gives the nut cases some ammunition to say "Hahn didn't want to authorize, but Trump forced him to" although it was going to authorized anyway. Trump always pushing his way into the limelight regardless of the damage

[ourmanflint]

The US approach to who gets vaccine first seems very odd when compared to UK. Essential workers coming before old and infirm seems like a strange decision

[Scott]

6 hours ago, ourmanflint said:

The US approach to who gets vaccine first seems very odd when compared to UK. Essential workers coming before old and infirm seems like a strange decision

I would guess that a number of things are at play in deciding who gets it and when.   First, States have a say in who is first in line, for example, Arizona will have teachers at the front of the line after health care workers. 

 

The elderly are next on the list after the high priority workers.  

 

A big problem with getting it to the elderly is that many of them are in care facilities and the vaccine can't easily be transported to the facilities to give them shots.  I believe they have plans for doing it, but once it is thawed out, it has a short shelf-life and of course, you don't want to waste even one dose.  

 

A final thing that needs to be looked at is how effective it is in the elderly.   At 95% general effectiveness, it is likely to be slightly less effective in the elderly.  Elderly people have immune systems that don't function as well as younger people, so the effectiveness may be less, although it will still be high I would suspect.  

 

[Pedrogaz]

I'd like to see the number of patients treated who have 6 months of safety data available. I'd also like to see NNT and the cost of saving one life. How does the NNT and cost of saving a life compare to other therapeutic interventions?

[Jack Mountain]

26 minutes ago, Pedrogaz said:

I'd like to see the number of patients treated who have 6 months of safety data available. I'd also like to see NNT and the cost of saving one life. How does the NNT and cost of saving a life compare to other therapeutic interventions?

I want to see the costs of life years saved. 

[2530Ubon]

22 hours ago, rooster59 said:

The Pfizer/BioNTech vaccine was first approved in Britain earlier this month, and UK residents began receiving the shots on Tuesday. Canada also authorized the vaccine and expects to start inoculations next week.

Funny how Dr Fauci was criticising the speed that the UK approved this vaccine. All countries are set to endorse this one, and Fauci was complaining that the UK 'rushed' their work? Perhaps they were just more efficient.

 

Personally, I'm a little too cautious to take this one, as it's method of innocultaing is totally new and has never been used before.

I would be more comfortable taking the Astrazeneca & Oxford University viral vector vaccine. Viral vector vaccines are a well established method of protecting populations, and have been successfully used as a vaccine against Ebola.

 

The cost is also substantially cheaper. 3 USD to innoculate 1 person and can be stored in the fridge at 8 degrees celcius.

The Pfizer/BioNTech vaccine costs 39 USD to innoculate 1 person and has to be stored at -70 degrees celcius.

Edited December 13, 2020 by 2530Ubon

[Jeffr2]

11 minutes ago, 2530Ubon said:

Funny how Dr Fauci was criticising the speed that the UK approved this vaccine. All countries are set to endorse this one, and Fauci was complaining that the UK 'rushed' their work? Perhaps they were just more efficient.

 

Personally, I'm a little too cautious to take this one, as it's method of innocultaing is totally new and has never been used before.

I would be more comfortable taking the Astrazeneca & Oxford University viral vector vaccine. Viral vector vaccines are a well established method of protecting populations, and have been successfully used as a vaccine against Ebola.

Perhaps Fauci was right:

https://www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html

After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine

Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures have eroded confidence.

[2530Ubon]

1 hour ago, Jeffr2 said:

Perhaps Fauci was right:

https://www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html

After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine

Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures have eroded confidence.

Fauci was not commenting on that vaccine, he was commenting on the UK's speedy approval of the Pfizer/BioNTech vaccine.

 

It is important to note that the story you have quoted was factually incorrect. The NY times has written several exceptionally biased and negative articles about this vaccine, and one must wonder what it's aim is. Perhaps the family are shareholders of pfizer?

 

It faced no difficult questions as everything had been above board. The dosing error had been reported to the regulator as soon as it happened. The regulator instructed the research to team to continue with the study and these results were included in the official results. Difficult questions? I think not. I think some sub-par journalism with a motive is to blame.

https://www.cnbc.com/2020/11/26/astrazeneca-oxford-defend-vaccine-trials-after-questions-raised-in-us.html

 

Quote

Defenders of the trials have pointed out that the criticism seems to come primarily from within the U.S., home of the only other Western vaccine candidates to announce higher effectiveness in their vaccine test results: Pfizer-BioNTech and Moderna, who earlier this month announced their vaccines showed as much as 95% effectiveness. 

 

It's also important to note that this dosing error actually gave some great results to the research team, and was found to be more effective at more than 90%.  It turns out that giving half a dose first and then a full dose a few weeks later is much more effective. Scientists think this is due to memory cells having time to acclimate to the virus, whereas a full dose was being attacked by the auto immune system.

 

Plenty of discoveries and breakthroughs have occured by accident. Some of the most famous ones include penicillin, X-rays, the microwave, coca-cola, velcro, pacemakers etc.

 

Quote

Experts said the company’s spotty disclosures have eroded confidence.

I take particular issue with this statement. It wasn't mentioned in a press release, but whilst the study was going on, the regulators had all been informed. Both in the UK and in the EU.

 

https://www.bbc.com/news/health-55086927

AstraZeneca stressed that the data are preliminary, rather than full and final - which is true for the reported Pfizer and Moderna jab results too. It is science by press release.

When they can, all of the companies will publish full results in medical journals for public scrutiny.

https://www.wsj.com/articles/astrazeneca-defends-dosing-error-in-covid-19-vaccine-trial-11606358805

AstraZeneca on Monday said in interviews with news media that the half-dose regimen was the result of a manufacturing error, which neither the company nor Oxford initially mentioned in their press releases announcing the results.

The dosing error was identified after a trial investigator noticed that volunteers weren’t having as much of an inflammatory response to the shot, prompting the researchers to analyze their vaccine supply and find that they had miscalculated the dose, Dr. Pangalos said.

AstraZeneca and Oxford informed regulators in the U.K., U.S., and European Union and amended the study design to include the half-dose group in their analysis.

“The mistake is actually irrelevant,” said Dr. Pangalos. “Whichever way you cut the data—even if you only believe the full-dose, full-dose data….We still have efficacy that meets the thresholds for approval with a vaccine that’s over 60% effective.”

Edited December 13, 2020 by 2530Ubon

[Surelynot]

21 hours ago, ourmanflint said:

The US approach to who gets vaccine first seems very odd when compared to UK. Essential workers coming before old and infirm seems like a strange decision

The problem of cold storage meant that the virus had to go to hospitals rather than care homes.....so they switched to vaccinated frontline workers instead......that is my understanding

[TallGuyJohninBKK]

Part of the reason there have been questions about the AstraZenaca vaccine is that its most effective dosing method, the half dose first followed by the full dose second, which the company wandered into by error, wasn't fully vetted on elderly trial participants. Nor was the company exactly forthright about that at the outset.
 

Quote

 

The initial data from Astra and Oxford last month appeared positive but raised concern over how much protection the shot would offer after the trials produced two different results from two dosing regimens. The partners said their vaccine was 90% effective when a half-dose was given before a full-dose booster, and that two full doses showed an efficacy of 62%.

 

It later emerged the lower dose was the result of a manufacturing mistake and only tested in a younger group. Astra Chief Executive Officer Pascal Soriot said in an interview last month the company would set up an additional, probably global, trial to verify the 90% result.

 

https://www.bloomberg.com/news/articles/2020-12-08/astra-vaccine-is-effective-but-leaves-questions-in-older-ages

 

Can't speak for the UK regulators. But it's pretty clear that foul-up and resulting testing limitation for the elderly has at least delayed the AZ vaccine's likelihood of getting quick U.S. approval.
 

Quote

 

While the vaccine’s efficacy rate may be enough to get it approved, the variability in different subgroups and lack of data for older people should give regulators pause in rushing this through, according to Bloomberg Intelligence analyst Sam Fazeli.

 

 

Quote

The authors noted “limitations” with the results, including less than 4% of participants who were older than 70 years of age, as well as the finding that no participants older than 55 received the mixed-dose regimen.