Posted on 12/11/2020 3:46:35 AM PST by Oldeconomybuyer
LONDON - Drugmakers GlaxoSmithKline and Sanofi said Friday that their potential COVID-19 vaccine won’t be ready until late next year because they need to improve the shot’s effectiveness in older people.
The companies said early trials showed the vaccine produced an “insufficient” immune response in older adults, demonstrating the need to refine the product so it protects people of all ages. London-based GSK and Paris-based Sanofi, now expect the vaccine to be available in the fourth quarter of 2021.
“The results of the study are not as we hoped,” Roger Connor, president of GSK Vaccines, said in a statement.
While researchers around the world are racing to develop COVID-19 vaccines, the setback announced by Sanofi and GSK shows the challenges scientists face as they try to condense a process that usually takes years into a matter of months. Researchers in Australia said Friday they were abandoning their own vaccine candidate because it produced false positive results to HIV tests.
Public health experts say several vaccines will be needed to end the pandemic, which has killed more than 1.5 million people worldwide, because of the challenges in rapidly producing and distributing enough doses to vaccinate billions of people.
(Excerpt) Read more at apnews.com ...
Several vaccines needed to end Covid? Does this mean multiple doses?
The second stage of confusion and chaos is over vaccine.
Is there one? How fast can we get it? Is it safe? How many of these question will be settled?
How many have died due to shutdowns including delayed or denied health care for other conditions?
uhoh:
AUDIO: 2m38s: 11 Dec: 4BC Radio, Australia: Aussie COVID vaccine cancelled after false-positive HIV results
by Neil Breen
A deal for the federal government to purchase 50 million doses of the University of Queensland’s potential COVID-19 vaccine has been terminated after several trial participants returned false-positive HIV test results.
While the test results were false and no participants have contracted HIV, the government terminated the contract to maintain public confidence in the vaccine rollout in March.
“It’s very disappointing for all concerned,” immunisation expert from the University of Sydney Robert Booy told 4BC’s Neil Breen...
“We do have enough ordered from other companies to cover Australia beginning March next year,” Mr Booy assured.
“However, the University of Queensland … is going to continue working with CSL and a modified variant may well be able to be developed.”
The University of Queensland and CSL will hold a press conference at 8am.
https://www.4bc.com.au/aussie-covid-vaccine-cancelled-after-false-results/
AUDIO: 5m32s: 11 Dec: 4BC Radio, Australia: Vaccine trial participants knew of false-positive HIV results for weeks
Presenter: Neil Breen
Participants of the University of Queensland vaccine trial have revealed on the 4BC Breakfast Show they knew about the false-positive HIV test results more than a week.
“They did call me in … a few weeks ago and I could see the writing on the wall when they told us of these false-positive results,” said trial participant Mel Stott.
“I feel that we have been kept informed all the way along.
“The very first paperwork that we signed … explained the way they were targeting the virus would be through using some of the HIV proteins.
“I knew there would be HIV antibodies from the very beginning.”
Ms Stott was not concerned the vaccine trial had risked her health.
“I have absolutely no regrets,” she said.
“The vaccine was effective and I am still very grateful to have received it once or twice.
“But I do fully understand how it’s come to this.”
https://www.4bc.com.au/vaccine-trial-participants-knew-of-false-positive-hiv-results-for-weeks/
That’s why normally a vaccine needs years to validate, test and be sure.
Right now Pfizer, GSK etc. are making best guesses.
Essentially, clinical trials are now being done on millions actual patients.
No it means multiple companies making a vaccine in the context of this article.
I just want ALL federal and state politicians and department leaders, and their spouses, children and parents, to be the first to get the vaccine. Well documented.
Then wait 30 days, and publish their results, before going public with it.
Yeah... I've been wondering about that. Are we talking, a shot every year like flu, or maybe every five like the pneumonia.??
I like it, you’re asking some real questions.
“How many have died due to shutdowns including delayed or denied health care for other conditions?”
This one did: https://freerepublic.com/focus/f-chat/3914361/posts
I think it is better than completely from scratch. After all this is based on the previous vaccines they started for Covid1 - SARS
30 days is not enough time to track side-effects.
January 20
I agree that we have no choice.
“Essentially, clinical trials are now being done on millions actual patients.”
The public is being misinformed. It was all over the news last night about the FDA giving “approval’ for the Pfizer vaccine. It will still actually be an “unapproved drug”.
This is nothing more than a massive clinical trial and they have no idea about the longer term side effects.
Here it is in their own Report:
Below is some of the information found in the FDA Report:
https://www.fda.gov/media/144245/download
Vaccines and Related Biological Products Advisory Committee Meeting
December 10, 2020
FDA Briefing Document
Pfizer-BioNTech COVID-19 Vaccine
“In the event an EUA is issued for this product, it would still be considered unapproved and it
would be under further investigation (under an Investigational New Drug Application) until it is
licensed under a Biologics License Application (BLA).
Licensure of a COVID-19 vaccine will be
based on review of additional manufacturing, efficacy, and safety data, providing greater
assurance of the comparability of licensed product to product tested in the clinical trials, greater
assurance of safety based on larger numbers of vaccine recipients who have been followed for
a longer period of time,”
” Female study participants of childbearing potential were screened for pregnancy prior to each vaccination, with a positive test resulting in exclusion or discontinuation from study vaccination...Unsolicited AEs related to pregnancy include spontaneous abortion and retained products of conception, both in the placebo group. Pregnancy outcomes are otherwise unknown at this time.”
(FDA mandates three more 30 month studies- does not notify population that they will be guinea pigs)
“Sponsor studies will include completion of long-term follow-up from ongoing clinical trials as well
as the following three planned active surveillance studies. Of note, the Sponsor will submit plans
for a clinical study to assess safety and immunogenicity in pregnant women and has proposed
active surveillance studies designed to monitor vaccination during pregnancy within populations expected to receive the vaccine under EUA.
• Study Protocol Number C4591008. The Sponsor proposes to survey 20,000 U.S. health
care workers enrolled in the COVID-19 HERO registry as well as health care workers in
certain participating health care facilities about adverse events of special interest, and
other clinically significant events of interest after vaccination with the Pfizer-BioNTech
COVID-19 Vaccine. Incidence rates of these events in this cohort will be compared to
expected rates. The respondents would receive follow-up surveys for a 30-month period.
• Study Protocol Number C4591011. This study is an active safety surveillance evaluation
conducted within the Department of Defense Health System Databases using data
derived from electronic health records and medical service claims among covered U.S.
military and their families. Rates of safety events of interest in vaccinated participants
will be compared to unvaccinated comparators. The study will be conducted for 30
months.
• Study Protocol Number C4591012. This study is an active surveillance study for adverse
events of special interest and other clinically significant events associated with the
Pfizer-BioNTech COVID-19 Vaccine using the Veteran’s Health Administration electronic
medical record database. Vaccinated participants will be compared to unvaccinated
participants or to recipients of seasonal influenza vaccine. The study will be conducted
for 30 months.
Currently, the primary objective of all three proposed studies above is descriptive, and the list of
adverse events in the studies has not been finalized. FDA will provide feedback on these
studies after further review.
Following authorization of the vaccine, use in large numbers of individuals may reveal
additional, potentially less frequent and/or more serious adverse events not detected in the trial
safety population of nearly 44,000 participants over the period of follow up at this time. Active
and passive safety surveillance will continue during the post authorization period to detect new safety signals.
(The fact that this is an experimental vaccine should be disclosed to those who choose to take it and along with this admission of long term health risk.)
“...risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies...”
No
Essentially clinical trials are done and approved on two vaccines and clinical trials are demonstrating other scones to be failures or less efficacious. Exactly what is supposed to be done.
People who do not understand the process should claim no expert opinion in the meaning of the process.
Did they find a way to shorten time for clinical trials? Several months ago, they said it will take a few years to get vaccines out.
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