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Pfizer-BioNTech vaccine deliveries could start 'before Christmas'

Published 11/18/2020, 06:49 AM
Updated 11/18/2020, 04:31 PM
© Reuters. FILE PHOTO: Pfizer's logo is reflected in a drop on a syringe needle in this illustration

© Reuters. FILE PHOTO: Pfizer's logo is reflected in a drop on a syringe needle in this illustration

By Michael Erman and Ludwig Burger

(Reuters) - Pfizer Inc (N:PFE) and BioNTech (DE:22UAy) could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.

The vaccine's efficacy was found to be consistent across different ages and ethnicities - a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people.

The U.S. Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added.

"If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively," he said.

The success rate of the vaccine developed by the U.S. drugmaker and German partner BioNTech was far higher than what regulators had said would have been acceptable. Experts said it was a significant achievement in the race to end the pandemic.

Of the 170 volunteers who contracted COVID-19 in Pfizer's trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95% effective. Of the 10 people who had severe COVID-19, one had received the vaccine.

"A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique," said Enrico Bucci, a biologist at Temple University in Philadelphia. "Today is a special day."

BioNTech's Sahin said U.S. emergency use authorization (EUA) would be applied for on Friday.

An FDA advisory committee tentatively plans to meet on Dec. 8-10 to discuss the vaccine, a source familiar with the situation said, though the dates could change. The FDA did not respond to requests for comment.

COVID-19 RUNS RAMPANT

The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc (O:MRNA) on Monday released preliminary data for its vaccine showing 94.5% effectiveness.

"We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administration and ready to distribute within weeks," U.S. Health and Human Services Secretary Alex Azar said.

The Moderna vaccine is likely to be authorized within seven to 10 days of Pfizer receiving its EUA, U.S. officials said, with states ready to begin distribution within 24 hours.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.

The news was especially welcome with the virus again running rampant around the world, setting records for new infections and hospitalizations almost daily.

The Pfizer-BioNTech shot was found to have 94% efficacy in people over age 65, a particularly high-risk group.

"This is the evidence we needed to ensure that the most vulnerable people are protected," said Andrew Hill, senior visiting research fellow at the University of Liverpool's department of pharmacology.

Global shares rose as the trial results countered concerns around the soaring infection rate. Pfizer shares were up 1.6% while BioNTech jumped 3.8% in the United States. Moderna shares fell 3.6%. [MKTS/GLOB]

Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future.

DISTRIBUTING SHOTS

Pfizer said it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

While some groups such as healthcare workers will be prioritized in the United States and Britain for vaccinations, it will be months before large-scale rollouts begin in either country.

On Wednesday, Pfizer said it had offered to provide Brazil with millions of doses in the first half of 2021. It also has agreements with the European Union, Germany and Japan where distribution could begin next year.

Mike Ryan, the World Health Organization's top emergency expert, said it would be at least 4-6 months before significant levels of vaccination were taking place around the world.

Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultra-cold temperatures of -70 degrees Celsius. It can, however, be kept in normal refrigeration for up to five days, or up to 15 days in a thermal shipping box.

Moderna's vaccine can be stored for up to six months at -20C though it is expected to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius (36°-46°F).

FATIGUE AND HEADACHES

Pfizer said vaccine was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly. The only severe adverse events experienced by volunteers were fatigue (3.8%) and headaches (2%) after the second dose. Older adults tended to report fewer and milder adverse events.

"These are extraordinary results, and the safety data look good," said David Spiegelhalter, a professor and expert in risk and evidence communication at the University of Cambridge.

Of the dozens of drugmakers and research groups racing to develop COVID-19 vaccines, the next late-stage data will likely be from AstraZeneca Plc (L:AZN) with the University of Oxford in November or December. Johnson & Johnson (N:JNJ) said it is on track to deliver data this year.

Authorization of vaccines for children will take longer. Only Pfizer has started vaccinating volunteers under age 18 and as young as 12. Moderna and J&J have said they hope to start testing the vaccine in younger people soon.

© Reuters. FILE PHOTO: Vials and medical syringe are seen in front of Pfizer logo in this illustration

GRAPHIC-Tracking the vaccine race: https://tmsnrt.rs/3nEc4Gz

Latest comments

Maybe I already had Covid and my body successfully fought against it. Why would I get a rushed vaccine from a company who's primary goal is to make as much money as possible. Before I take the vaccine I want to know if I haven't had the virus yet
Wait until Inovio comes out with a 95.5% efficacy.
it is not 95% effective. if you put millions to mars with adequate living equipment, you can claim mars is the vaccine. the fact is these participants are given dose of covid droplet on purpose to test its effectiveness of a vaccine. most ppl are quarantine, and possibly the "vaccine" is helping. it is not 95% effective unless under 5 out of every 100 get infected while purposely exposed to covid.
looks like you have done your PHD in clinical research
That’s a marketing hype wrapped as a Christmas gift. No wonder investors sell on the trumpets.
A vaccine with 95% success or my own bodys vaccine that is 99.997% effective... excuse me if i prefer to take this one on my own...
Just snother success of the Teump Administration...
Eddie Glass will be the first in line right after medical personnel. He’s in the “vulnerable” group of elderly....demented, obese, and 98 years old.....at least he comes across that way on this board.
Stop hiding Thom!
Let’s see what side effects the vaccine users got (or not) in next couple of years. Then maybe I use this remedy too.
Vow! now that should pump up the markets if not anything else.. so people don't die during X'mas.
BioNTech went public December 2019? Same time it started in China 🤔
Vaccine 46 percent effective. Half of the people won't take it especially when they know they made feel fatigue or get a headache. Same percent that won't wear a mask.
How do we know the numbers are not fudge?
Last week when I posted that 90% was low for an important vaccine of this type, everyone said I was mistaken. But look at me now........I’m a “stable genius!”
pfizeer was 90%, then Moderna came out at 94.5% and easier to handle/distribute - suddenly pfizers is 95% - lol such B S !!!
Moderna says 94.5%Pfizer says 95%Covid says 99.97%Nature wins again
Recovery rate is already 95%+ why would you take a vaccine that has no better odds than your own immune system and who knows what side effects? pump and dump imo as he already unloaded a lot of shares on news day.
Because with the vaccine 95% of those who die will now survive.
Even those who die of cancer who happened to be covid positive?
"90% success!" "Well done but my vaccine is 94.5%!" "Eh... OK in fact is not 90% is 95%".
Nanochip inside the vaccine
is it also with guarantee without side effect?
fool people, qucik money. more than 1500 people die every day in US. and people are celebrating the end of Covi in the stock market because of this useless vaccine
CEO unloading shares on the good news
so if you take the vaccine your odds are just as good as if you don't take the vaccine, lol they're going to make us all take it or we won't be able to leave our house...
The flu strain pandemic is busy going the way of all flu strains. There has never been an effective flu vaccine. The next strain is already here. The vaccines are a money flow issue not some essential protector. The 'cases' are 99.95% no symptom full recovery. The distortions of truth have become an industry in themselves. https://www.globalresearch.ca/covid-19-rt-pcr-how-to-mislead-all-humanity-using-a-test-to-lock-down-society/5728483
In India  recoveries surged to 81,15,580, pushing the national recovery rate to 92.97 per cent, according to the Union Health Ministry. so... a vaccine of 95% is not that great, considering we have to pay for it
Yes 40 dollar is extremely expensive for not dying or having a lot of missory 🙄
 taking the vaccine dose not mean 100% you will not dye or have side defects
If i was in the hospital dying of covid i would f it
So who is taking the warp speed vaccine first?
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