Covid-19 vaccine from Pfizer and BioNTech is strongly effective, early data from large trial indicate - Key information about the vaccine is not yet a

[Gert van der Hoek]

Pfizer and partner BioNTech said Monday that their vaccine against Covid-19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement — and relief — in the face of the global pandemic.

The vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective.

The Phase 3 study is ongoing and additional data could affect results.

In keeping with guidance from the Food and Drug Administration, the companies will not file for an emergency use authorization to distribute the vaccine until they reach another milestone: when half of the patients in their study have been observed for any safety issues for at least two months following their second dose. Pfizer expects to cross that threshold in the third week of November.

Although it is a bright spot in the battle against the pandemic and a triumph for Pfizer and BioNTech, a German company, key information about the vaccine is not yet available. There is no information yet on whether the vaccine prevents severe cases, the type that can cause hospitalization and death.

 

[Gert van der Hoek]

Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study

• Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
• Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
• Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; safety and additional efficacy data continue to be collected
• Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
• Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints

 

[Gert van der Hoek]

No expert here. This is what Wikipedia says about RNA vaccines:


"Currently, there are no RNA vaccines approved for human use"

Adverse effects and risks

• The mRNA strand in the vaccine may elicit an unintended immune reaction. To minimise this, the mRNA vaccine sequences are designed to mimic those produced by mammalian cells (for example monkey cells).[SUP][13][/SUP]
• A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity. Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken.[SUP][14][/SUP]

 

[sharon sanders]

This announcement has apparently caused a huge surge in the DOW. At this minute it is up 1,359,52 at 29,682.92.

Please do not expect a safe and effective vaccine for your personal use for months even if the Pfizer claims of 90% effectiveness are correct.

Please keep up your personal protection against COVID-19. General distribution for a successful vaccine developed at this time will not be available to most people before the end of winter.

I have seen many, many vaccine development stories over the years. Even at this stage some fail in a follow-up wider test. So while this news is hopeful, do not depend on it.

 

[Gert van der Hoek]

Bob Wachter

@Bob_Wachter
While being appropriately excited re: vaccine, it's worth remembering that it probably won't make a material difference in everybody's life/schools/economy until next summer. If so, that means the time from now to then is equal to the time from the 1st Covid cases in U.S. to now.

 

[Gert van der Hoek]

German biotech BioNTech says it has submitted COVID-19 vaccine for EMA approval


BioNTech confirmed it has submitted its COVID-19 vaccine for review by the European Medicines Agency, the UK Medicines and Healthcare products Agency, and the Canadian regulator Health Canada. The company also confirmed it expects to file for emergency use authorisation in the US before the end of November. This follows announcement of interim results from the phase III trial showing the vaccine is 90 per cent effective in preventing people getting infected with the virus.

BioNTech and its partner Pfizer currently have firm orders for 570 million doses in 2020 and 2021, with the EU having ordered 200 million doses with an option for an additional 100 million doses

 

[Mary Wilson]

Fauci says he will take new Pfizer vaccine if FDA approves it

NOVEMBER 10, 202011:31 AM UPDATED 14 MINUTES AGO
By Reuters Staff

WASHINGTON (Reuters) - U.S. infectious disease expert Anthony Fauci said he will take Pfizer Inc’s new coronavirus vaccine if the Food and Drug Administration approves it and that he has confidence in the company and the government agency.

Asked on MSNBC if he would take the vaccine, Fauci said: “I’m going to look at the data, but I trust Pfizer. I trust the FDA. These are colleagues of mine for decades, the career scientists.

https://uk.reuters.com/article/us-h...izer-vaccine-if-fda-approves-it-idUKKBN27Q2SU

 

[sharon sanders]

a small wrinkle.....

snip

The main issue is that the vaccine, which is based on a novel technology that uses synthetic mRNA to activate the immune system against the virus, needs to be kept at minus 70 degrees Celsius (-94 F) or below.

“The cold chain is going to be one of the most challenging aspects of delivery of this vaccination,” said Amesh Adalja, senior scholar at Johns Hopkins Center for Health Security.

“This will be a challenge in all settings because hospitals even in big cities do not have storage facilities for a vaccine at that ultra-low temperature.”

https://www.reuters.com/article/hea...he-local-pharmacy-any-time-soon-idUSKBN27P2VP

 

[Mary Wilson]

‘We’re being left behind’: Rural hospitals can’t afford ultra-cold freezers to store the leading Covid-19 vaccine

By OLIVIA GOLDHILL
NOVEMBER 11, 2020

Large urban hospitals across the U.S. are rushing to buy expensive ultra-cold freezers to store what’s likely to be the first approved Covid-19 vaccine. But most rural hospitals can’t afford these high-end units, meaning health workers and residents in those communities may have difficulty getting the shots.

The vaccine, developed by Pfizer and the German firm BioNTech, seems to provide 90% immunity according to early data released on Monday. But there’s a catch: The vaccine has to be stored at -70 degrees Celsius. Typical freezers don’t get that cold, making distribution of this vaccine a logistical nightmare.

The Centers for Disease Control and Prevention has advised state health departments against purchasing ultra-cold freezers — which cost $10,000 to $15,000 each — saying other vaccines with less demanding storage requirements will be available soon.

https://www.statnews.com/2020/11/11...ord-freezers-to-store-pfizer-covid19-vaccine/

 

[Mary Wilson]

Why Poorer Countries Aren't Likely To Get The Pfizer Vaccine Any Time Soon

November 11, 20205:53 PM ET
MICHAELEEN DOUCLEFF

... For starters, Pfizer can manufacture only a limited quantity of the vaccine next year – about 1.3 billion doses. "That sounds like a lot," Silverman says, "but quite a lot of that supply is already spoken for."

The U.S., U.K., E.U., Canada and Japan have already claimed, through advanced purchase agreement, about 1.1 billion doses, or more than 80% of the supply.

https://www.npr.org/sections/goatsa...dium=social&utm_term=nprnews&utm_campaign=npr
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[Emily]

10 to 15K seems a small expenditure for even smaller hospitals. Look at what cat scan machines cost:
https://www.meridianleasing.com/blog/medical-equipment-blog/ct-scanner-buyers-guide (US)
https://lbnmedical.com/how-much-does-a-ct-scanner-cost/ (EU)

Lots of small hospitals have them in the US. I think some of our senators store their gourmet ice cream in consumer fridges that cost more than the those super-cold hospital fridges.

Pfizer will be doing it's own distribution so their product won't be compromised before delivery, at least.

https://www.bloomberg.com/news/arti...ine-s-funding-came-from-berlin-not-washington
'While most vaccine front-runners that have been tapped by Warp Speed will distribute their doses through a government partnership with McKesson Corp., Pfizer is handling its own delivery of its products. The company has designed reusable containers that can keep the doses at ultracold temperatures, and is organizing trucks and flights to move them."

 

[sharon sanders]

bump this

 

[Emily]

No expert here. This is what Wikipedia says about RNA vaccines:


"Currently, there are no RNA vaccines approved for human use"

Adverse effects and risks

• The mRNA strand in the vaccine may elicit an unintended immune reaction. To minimise this, the mRNA vaccine sequences are designed to mimic those produced by mammalian cells (for example monkey cells).[SUP][13][/SUP]
• A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity. Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken.[SUP][14][/SUP]

The impression I get is that to get around the time constraints and contamination issues of traditional cell culture cultivation of vaccine antigens, mRNA vaccines will use the cells of the living human vaccine recipient to manufacture the antigen.

https://www.sec.gov/Archives/edgar/d...d577473ds1.htm

Gene therapies and mRNA based medicines may activate one or more immune responses against any and all components of the drug product (e.g., the mRNA or the delivery vehicle, such as a lipid nanoparticle) as well as against the encoded protein, giving rise to potential immune reaction related adverse events.

It seems with few exceptions that all the cells in the human vaccine recipient will be transfected.

All nucleated cells in the body are capable of translating mRNA, resulting in pharmacologic activity in any cell in which mRNA is delivered and translated. To minimize or prevent potential off-target effects, our platform employs technologies that regulate mRNA translation in select cell types.