Covid-19 Vaccine Development

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I’m a bit late getting back to this thread. I think the 6 questions asked in this blog are solid and would give us good info. I’m curious if high risk people can tolerate this vaccine. I know my oncologist has me on a “no live vaccine” order. I can have a dead vaccine tho.

Pfizer/BioNTech COVID-19 vaccine efficacy: Six key questions

This is encouraging news today by press release. Six key data questions are still pending in details. They will very likely be addressed when the request for FDA EUA is submitted later this month:

  1. What is the detailed safety profile and specific adverse event profile?
  2. What was the spectrum of clinical disease in the placebo group infected by the virus?
  3. How many severe cases of COVID-19 were in the placebo group? (The FDA has stated at least 5 cases of severe disease are needed to help evaluate for Enhanced Respiratory Disease (ERD) in vaccine recipients).
  4. What was the spectrum of clinical disease in the vaccine group infected by the virus?
  5. Were there any severe cases (or any evidence of vaccine-associated enhanced respiratory disease (ERD) in the small number of persons infected after receiving the vaccine?
  6. What impact did the vaccine have on transmission of the virus?
 
margarita25 said:
(Courtesy via @sds71 )

AstraZenaca vaccine trial shows 90% efficacy when given as a half dose, followed by a full dose one month later. 62% efficacy in a separate trial with two full doses one month apart. Combined efficacy estimate is 70%.

AstraZeneca - Research-Based BioPharmaceutical Company

COVID-19: Oxford vaccine is up to 90% effective in preventing coronavirus, tests show
Click to expand...

I'm interested to know how they're defining efficacy. They mention reducing hospitalizations, etc. I think this may be a vaccine that doesn't fully prevent COVID 19, but makes the symptoms less worse, which isn't the same thing.

For all of these vaccines, we need to see their data.

From the link above:

When two full doses were given at least a month apart, the Oxford inoculation had an efficacy of 62%.

A total of 2,741 people were on the course that proved 90% effective, while 8,895 were given two full doses.

When all the results are tabulated, the average efficacy of the vaccine works out to 70%.
Click to expand...

Also, they say they only didn't count hospitalizations

"He added: "It's critical to understand what everyone is measuring. What counts as COVID disease varies between different protocols.

"If you are only counting hospitalisations then we would have bigger efficacy. We count mild disease and that is much harder to protect against."

BBM

Some of his remarks makes me think the other vaccines have been including people with mild disease, at least. Too late to require the protocols be the same but at least they should be publicly evaluated in a way that helps us make good choices.
 
Last edited:
Betty P said:
I'm interested to know how they're defining efficacy. They mention reducing hospitalizations, etc. I think this may be a vaccine that doesn't fully prevent COVID 19, but makes the symptoms less worse, which isn't the same thing.

For all of these vaccines, we need to see their data.

From the link above:



Also, they say they only didn't count hospitalizations

"He added: "It's critical to understand what everyone is measuring. What counts as COVID disease varies between different protocols.

"If you are only counting hospitalisations then we would have bigger efficacy. We count mild disease and that is much harder to protect against."

BBM

Some of his remarks makes me think the other vaccines have been including people with mild disease, at least. Too late to require the protocols be the same but at least they should be publicly evaluated in a way that helps us make good choices.
Click to expand...

Those are complex questions and there's no way to answer without writing an awful lot.

But basically, each protocol establishes its rubrics. COVID is COVID, it doesn't change. I believe all protocols used PCR swab tests (2-3 of them, that's where they vary). Each protocol chose a different time window (to try and eliminate white noise from COVID infections that would have happened anyway, before the vaccine took effect). Moderna chose 14 days, Pfizer chose 7 days.

They compared the two groups (vaccinated and non-vaccinated) in large numbers. They used data from places where large numbers of people in the control group got COVID (matched for age, sex, pre-existing conditions to the other group).

The vaccinated people still got COVID (for Moderna, at a rate of 5 per 100 vaccinated; for Pfizer at a rate of 8 per 100 vaccinated; for AstraZeneca 2 dose model - 10 per 100 people).

Modern is the one I know the best. They had no hospitalizations in their vaccinated group. So they couldn't have used hospitalizations as the criterion (and I don't know if the others did).

All of the vaccines prevented COVID entirely in large numbers of people. None of them prevented all COVID, but in the small numbers who got it, it was mild. Win-win.

To summarize: the vast majority of the vaccinated did not get COVID, already had antibodies to it and did not have live virions to pass on. They did not get COVID.

The rest had a mild case.

Efficacy means preventing the disease entirely. COVID was not able to enter through ACE-2, it could not attack the immune system, it could not reproduce in the bodies of the vaccinated. They were immune.
 
CSIDreamer said:
https://twitter.com/SkyNews/status/1330771354141020160?s=19

BREAKING: Trials of Oxford's AstraZeneca #COVID19 vaccine shows it is up to 90% effective in preventing the virus. More on this story: COVID-19: Oxford vaccine is up to 90% effective in preventing coronavirus, tests show https://t.co/yu7PyUAUqS

Good news! This vaccine can be refrigerated, no Arctic temperatures required.
Click to expand...

It is good news. As with the other vaccines, some still got COVID (with this one - 10% still got it and were likely still contagious - which is why Fauci keeps saying vaccines alone are not enough).

But as with other vaccines, that 10% had mild cases. The storage and temperature issues are huge. It will be interesting to see how this rolls out.
 
(Courtesy via @Legally Bland)

The Oxford/AstraZeneca half dose trials were a mistake:

“The reason we had the half dose is serendipity,” said Mene Pangalos, executive vice-president of biopharmaceuticals research and development at AstraZeneca.

When university researchers were distributing the vaccine at the end of April, around the start of Oxford and AstraZeneca’s partnership, they noticed expected side effects such as fatigue, headaches or arm aches were milder than expected.

“So we went back and checked … and we found out that they had underpredicted the dose of the vaccine by half,” said Pangalos.

Instead of restarting the trial, he said researchers decided to continue with the half dose and administer the full dose booster shot at the scheduled time.

Oxford Covid vaccine hit 90% success rate thanks to dosing error
 
I just got an email from Rite Aid that they are an approved Vaccination Provider through the CDC. I know Walgreens bought out Rite Aid so I don't know where Rite Aid actually exists nowadays. JMO
 
Tara C. Smith: A Covid vaccine can save America — but not if we can't convince Americans it's safe (nbcnews.com)

As vaccines from Moderna, Pfizer and AstraZeneca/Oxford University head into the final stretch, a number of questions remain, including how the public will respond to their release..

We are in a dark place right now. Watching surges of Covid-19 in the spring and summer was like following a bouncing ball across the country: from San Francisco Bay to New York to Washington state, Michigan, Florida and Arizona. Case numbers oscillated in many areas, ticking up after holidays and then slowing down for a bit. More states instituted mask mandates; in states lacking them, many cities made their own. Health care workers from other states where cases were low were brought in to help in hard-hit locales.

And then came November...
 
AstraZeneca manufacturing error clouds vaccine study results | 11alive.com

"In a statement Wednesday, Oxford University said some of the vials used in the trial didn’t have the right concentration of vaccine so some volunteers got a half dose. The university said that it discussed the problem with regulators, and agreed to complete the late stage trial with two groups. The manufacturing problem has been corrected, according to the statement.

WHAT ABOUT THE RESULTS THEMSELVES?

Experts say the relatively small number of people in the low dose group makes it difficult to know if the effectiveness seen in the group is real or a statistical quirk. Some 2,741 people received a half dose of the vaccine followed by a full dose, AstraZeneca said. A total of 8,895 people received two full doses.


Another factor: none of the people in the low-dose group were over 55 years old. Younger people tend to mount a stronger immune response than older people, so it could be that the youth of the participants in the low-dose group is why it looked more effective, not the size of the dose."

(courtesy via @dixiegirl1035)
 
United Airlines Holdings Inc. on Friday began operating charter flights to position doses of Pfizer Inc.’s Covid-19 vaccine for quick distribution if the shots are approved by regulators, according to people familiar with the matter.

United Begins Flying Pfizer’s Covid-19 Vaccine

Whoop!

***

City firefighters, emergency medical technicians and paramedics will be among the first to receive the emergency COVID-19 vaccine once the feds approve it, FDNY officials said Saturday.

“Vaccination will potentially begin in mid-to late-December of this year,” Fire Commissioner Daniel Nigro Nigro wrote in a memo acquired by the Daily News.

FDNY first responders among first to receive emergency COVID vaccine
 
(Courtesy via @SouthAussie)

The UK govt has just submitted the Oxford vaccine to the regulator .. first step in approval.

They say that the Oxford vaccine will be a most useful vaccine as it will target "hundreds of millions of doses to low and middle income countries and to deliver the vaccine on a not-for-profit basis to those nations in perpetuity. The vaccine developed at England's Oxford University is significantly cheaper than the others and, crucially, it would be far easier to transport and distribute in developing countries than its rivals since it does not need to be stored at freezing temperatures."

Oxford's Covid-19 vaccine could do more for the world than other shots - CNN
 
margarita25 said:
CDC Covid-19 vaccine advisers call emergency meeting - CNN

(Courtesy via @dmac55)
Click to expand...

(courtesy via @SouthAussie)

21 million healthcare personnel
87 million essential workers
100 million adults with high-risk medical conditions
53 million others 65 and older

The federal government has said 40 million coronavirus vaccine doses could be available by the end of December.

"It is important for the public to understand that we are dealing with select groups of individuals -- not the general public."
 
margarita25 said:
A shot. A wait. Another shot: Two-dose coronavirus vaccine regimens will make it harder to inoculate America

(Courtesy via @ilovewings)
Click to expand...

Post courtesy via @anneg:

“Thanks. From the link, regarding a three-shot vaccine schedule:

It’s not unusual for a vaccine to require re-upping in order to provoke the immune system to respond more effectively. The classic schedule for vaccines that target proteins like the spike protein on the surface of this coronavirus, Moore said, is three shots — “prime, prime, boost” — with the second and third shots coming one and six months after the first injection. Each of the first two shots primes the immune system and is typically followed by a modest drop-off in antibodies. The third shot, usually at least six months after the first one, can give long-term protection by boosting the immune system’s memory cells, which by that point have matured and are ready to respond.

It’s not yet clear whether any of the new coronavirus vaccines in the pipeline will ultimately work best with a third shot capable of boosting long-term protection.

[snip]

It’s also possible that fewer doses may prove sufficient.

“For all we know, all these two-dose vaccines may work in one dose,” Duchin said.

IMO, there is still much to be learned about the Covid vaccines.“

—

(Pssst, how are you all liking my ninja vaccine thread tagteaming :D@dixiegirl1035 , @ilovewings , @SouthAussie, @dmac55 , @Legally Bland, @sds71, @BUF )
 
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