Covid-19 Vaccine Development

[margarita25]

 

[BetteDavisEyes]

FDA: Pfizer's Covid-19 vaccine safe and effective after one dose (nbcnews.com)

The new information comes ahead of a planned meeting at the FDA to consider emergency use of the vaccine.

Pfizer's Covid-19 vaccine candidate offers protection after the first dose, according to documents released Tuesday by the Food and Drug Administration.

The information was made public before a meeting Thursday of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC — an advisory group to the FDA that will vote on whether to advise the agency to grant emergency use authorization of the vaccine in the U.S. ...

 

[dixiegirl1035]

FDA: Pfizer's Covid-19 vaccine safe and effective after one dose (nbcnews.com)

The new information comes ahead of a planned meeting at the FDA to consider emergency use of the vaccine.

Pfizer's Covid-19 vaccine candidate offers protection after the first dose, according to documents released Tuesday by the Food and Drug Administration.

The information was made public before a meeting Thursday of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC — an advisory group to the FDA that will vote on whether to advise the agency to grant emergency use authorization of the vaccine in the U.S. ...

Interesting, yet not unexpected that the first dosage created above 50% (not said how high, we won't know how long it would have lasted as to humoral and Tcell immunity though long term... ) Putting this here for later for folks to compare vaccines... if they even have an option later when it gets to them due to supply and what plan they are on . iykwim. I'm on ACA/Obamacare next year as usual, but I'm moving to Kaiser from BCBS/Anthem due to premiums. They may cover differently as to such? dunno.

"So far, summary results disclosed in news releases indicate that Pfizer's vaccine, produced in partnership with BioNTech, has an overall efficacy rate of 95% and efficacy of 94% in people 65 and older. Moderna's overall efficacy is 94%, with 87% efficacy in preventing moderate disease in older adults, according to Moncef Slaoui, chief science adviser to Operation Warp Speed, the US government's Covid-19 vaccine development program."

What seniors can expect when Covid-19 vaccines become available - CNN

 

[margarita25]

Pfizer, Moderna officials not attending White House coronavirus vaccine summit

Rsbm

“Their lack of attendance at the event focused on vaccine distribution is notable, as both Pfizer and Moderna are set to distribute millions of doses by the end of 2020 in the U.S. following FDA clearance.

Trump has also publicly feuded with Pfizer, claiming the company and the FDA purposely withheld vaccine information until after the presidential election — though Pfizer didn’t learn of the interim results until Nov. 8. The FDA was not involved in Pfizer’s decision to announce its early results.“

[...]

“Trump also will sign an executive order to prioritize Americans for coronavirus vaccines procured by the federal government. A second official said the order would restrict the U.S. government from donating doses to other nations until there is excess supply to meet domestic demand.

Both officials spoke on condition of anonymity to discuss plans for the summit.

Officials from President-elect Joe Biden's transition team were not invited to the vaccine summit, even though they will oversee the continuation of the largest vaccination program in the nation's history once he takes office on Jan. 20.“

 

[margarita25]

(Link courtesy via @dixiegirl1035)

First 'mass air shipment' of Pfizer's Covid vaccine arrives as airlines prepare for more

“Pfizer didn’t respond to multiple requests for comment. Spokeswoman Kim Bencker has previously said the company won’t ship the vaccine until it wins approval from the FDA for emergency use. Pfizer submitted its application for emergency clearance on Nov. 20, and the FDA is expected to publicly discuss it when the agency’s Vaccines and Related Biological Products Advisory Committee next meets Dec. 10. Moderna said it plans to submit its application Monday.“

[...]

“Pfizer’s vaccine will initially be very limited. It’s previously said it can make 50 million doses of its two-dose regimen by the end of the year — enough to immunize 25 million of the nation’s roughly 331 million people. The company plans to ship frozen vials of the vaccine to vaccination points from its sites in Kalamazoo, Michigan, and Puurs, Belgium.“

—

In the video at the above link, Dr. Gottlieb says post market data will shed insight on if the vaccine will also affect viral shedding/contagiousness (paraphrasing).

 

[margarita25]

A new paper from Oxford on the AstraZeneca vaccine does little to answer the most pressing questions about its data.

 

[CSIDreamer]

Hurray!

Britain becomes first to roll out clinically approved BioNTech-Pfizer vaccine

 

[10ofRods]

A new paper from Oxford on the AstraZeneca vaccine does little to answer the most pressing questions about its data.

Quite sobering, really. Without an explanation of why they have their results, and an explanation for how they "mistakenly" gave a different dose than they thought they were giving, the whole thing looks gummed up.

 

[IceIce9]

Three indianapolis hospitals are supposed to receive the Pfizer vaccine within the week. My employer sent out emails to employees today stating they expect to begin vaccinations on December 14.

 

[CSIDreamer]

Three indianapolis hospitals are supposed to receive the Pfizer vaccine within the week. My employer sent out emails to employees today stating they expect to begin vaccinations on December 14.

Happy to hear this!

 

[margarita25]

“Two British people with severe allergies apparently had allergic reactions to Pfizer/BioNTech's COVID-19 vaccine, raising questions about whether it is safe for people with preexisting allergies.

In response, British regulators advised those with severe allergies to avoid the vaccine.

It was not immediately clear what triggered the allergic reactions. Unlike some vaccines, in the Pfizer/BioNTech vaccine there are no preservatives or egg products, which have been known to trigger reactions with other types of vaccines.“

[...]

“Slaoui said he assumes that the U.S. Food and Drug Administration committee meeting Thursday will discuss this issue and will suggest that people with severe allergies "should not take the vaccine until we know exactly what happened."

But a vaccine that triggers dangerous reactions in people with severe allergies poses a major challenge in the U.S., said Dr. Peter Hotez, a pediatrician and dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston.

"If you start issuing recommendations that anyone with an EpiPen doesn't get vaccinated, that could be a showstopper for Americans," he said. About 3 to 4 million Americans carry epinephrine with them at all times in case of allergic reactions, Hotez noted, and 50 million have less severe allergies.

Hotez was confused by the allergic reaction, which was not predicted by trials in tens of thousands of people.“

[...]

“Dr. Paul Offit told CNN early Wednesday that severe allergic reactions to vaccines occur in about one of every 1.4 million shots. That's why people are asked to stay in a doctor's office for a few minutes after a vaccination, said Offit, an infectious disease specialist and director of the Vaccine Education Center at Children's Hospital of Philadelphia.

Rather than a "blanket recommendation" for people with allergies, "the smarter thing to do would be to try and look at these two patients and see what specific component of the vaccine they were allergic to," he said.“

More at link
COVID vaccine allergic reaction: How Pfizer side effect may affect US

 

[margarita25]

Quite sobering, really. Without an explanation of why they have their results, and an explanation for how they "mistakenly" gave a different dose than they thought they were giving, the whole thing looks gummed up.

Hi, I realize I posted the link and forgot to read it lol. Thanks for reminding me.
Without reading the link yet, I assume you are referring to the dose error
(quick reference Oxford/AstraZeneca Covid vaccine 'dose error' explained
AstraZeneca Defends Dosing Error in Covid-19 Vaccine Trial )

Dr. O talked a little about this in a recent podcast, and said something about how this dosing error actually turned out to be good thing in hindsight/blessing in disguise bc it showed that the 50% dose reduction actually turned out to be more efficacious wrt it’s relationship to the boost and second shot (laywoman paraphrasing, IANAD, moo).


eta / qmfr: I think he talked about this in the second video, Ep 33

Dr. Osterholm is optimistic about the vaccines, “we just need to make it to the vaccines”:

In Dr. Osterholm’s latest podcast, he gives a rather in-depth explanation and comparison of the vaccines. Good broadcast, as usual:

—
eta2:
New article from CIDRAP / U Minn / (Dr. O’s Organization) / marking:
Phase 3 trials show AstraZeneca COVID vaccine has up to 90% efficacy

 

[10ofRods]

Hi, I realize I posted the link and forgot to read it lol. Thanks for reminding me.
Without reading the link yet, I assume you are referring to the dose error
(quick reference Oxford/AstraZeneca Covid vaccine 'dose error' explained
AstraZeneca Defends Dosing Error in Covid-19 Vaccine Trial )

Dr. O mentioned talked a little about this in a recent podcast, and said something about how this dosing error actually turned out to be good thing in hindsight/blessing in disguise bc it showed that the 50% dose reduction actually turned out to be more efficacious wrt it’s relationship to the boost and second shot (laywoman paraphrasing, IANAD, moo).


eta / qmfr: I think he talked about this in the second video, Ep 33




—
eta2:
New article from CIDRAP / U Minn / (Dr. O’s Organization) / marking:
Phase 3 trials show AstraZeneca COVID vaccine has up to 90% efficacy

It did turn out to be a good thing - although, it raises questions (I'm seeing it in the academic literature) about how this "mistake" happened. The vaccine is supposed to have a known amount of the active RNA in it. Not some other amount (in this case, a lesser amount). They do not test each vial, they test batches. So, apparently, they gave the dose not knowing that it was actual less and now we all want to know exactly how did that happen? Were the vials mismarked? Was it actually intentional (but not mentioned in the published data)? They keep making it sound like it was serendipity, but really, the people who got the half dose were originally slated to get the full dose - but didn't. That's not good technique.

Anyway, at some point (when?) they realized that about ⅓ of the people had better antibody responses and went back and figured out that they had had a different original dose (I'm sure they kept samples from all the batches and re-checked them).

But it is concerning if they actually shipped the vaccine thinking it was full dose...and it wasn't. They need to tell us how all of that happened!

 

[margarita25]

It did turn out to be a good thing - although, it raises questions (I'm seeing it in the academic literature) about how this "mistake" happened. The vaccine is supposed to have a known amount of the active RNA in it. Not some other amount (in this case, a lesser amount). They do not test each vial, they test batches. So, apparently, they gave the dose not knowing that it was actual less and now we all want to know exactly how did that happen? Were the vials mismarked? Was it actually intentional (but not mentioned in the published data)? They keep making it sound like it was serendipity, but really, the people who got the half dose were originally slated to get the full dose - but didn't. That's not good technique.

Anyway, at some point (when?) they realized that about ⅓ of the people had better antibody responses and went back and figured out that they had had a different original dose (I'm sure they kept samples from all the batches and re-checked them).

But it is concerning if they actually shipped the vaccine thinking it was full dose...and it wasn't. They need to tell us how all of that happened!

Yeah for sure...

 

[IceIce9]

Interesting

Should you still wear a mask after getting a COVID-19 vaccine | wthr.com

 

[margarita25]

 

[margarita25]

3 new videos on vaccine and allergies:

Dr. Fauci Warns Those With Underlying Allergic Tendencies Prone To Covid Vaccine Reactions

Note she says to wait, no matter what type of allergy “trigger“ you have

 

[margarita25]

Courtesy via @dixiegirl1035

Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020
FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine

 

[margarita25]

COVID news: Canada approves Pfizer vaccine; allergic reaction in UK
Dec. 9, 2020

U.K. Regulator Warns People With ‘Significant’ Allergies To Avoid Pfizer-BioNTech Vaccine
Dec. 9, 2020

Trump officials passed on 'multiple' offers to buy more Pfizer vaccine, Gottlieb says
Dec. 8

U.S. declined to buy more Pfizer Covid vaccine doses, even after interim data, board member Gottlieb says
Dec. 8

COVID news: Ex-FDA head Gottlieb; UK vaccine; NY schools; Giuliani
Dec. 8

COVID-19 vaccine: ‘Get as many shots in arms as possible, right away’
Dec. 8


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[margarita25]

“Tonight the new warning on Pfizer’s COVID vaccine with FDA approval potentially hours away...”