vaccine

Will more or less time save or cost lives? Shortcuts On Regulations For The Coronavirus/Covid-19 Vaccine Research

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Will more or less time save or cost lives?

 Shortcuts On Regulations For The Coronavirus/Covid-19 Vaccine Research

According to Dr. Steven Goldstein, founder of the Houston Healthcare Initiative, it usually takes years for any vaccine to be developed, tested on humans and finally introduced to the public. What of the Shortcuts On Regulations For The Coronavirus/Covid-19 Vaccine Research? The much-anticipated vaccine for the Coronavirus/Covid-19 pandemic is progressing at unprecedented speed. But why is this the case and should the public be concerned? On his regular podcast Dr. Goldstein provides explanations. The listen to the Houston Healthcare Initiative podcast visit: Soundcloud, Libsyn, iHeartRadio, Apple Podcasts, Spotify, Stitcher, and Radio.com,

Timing

Will more or less time save or cost lives?
Will more or less time save or cost lives? Shortcuts On Regulations For The Coronavirus/Covid-19 Vaccine Research.

Dr. Goldstein described to his audience some of the reasons these vaccine trials were progressing so quickly. “Given the urgent need for a vaccine to help end this global pandemic, some vaccine developers are compressing the clinical process by running trial phases simultaneously,” Dr. Goldstein said. “Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said that independent Data and Safety Monitoring Boards can end trials early if their interim results are overwhelmingly positive or negative, so that is another time saver.”

Caution Takes Time

The Food and Drug Administration (FDA) promised to fast track the approval process for a Covid-19 vaccine. But they have also said that there are far more rigorous standards in place than is typical for the Emergency Use Authorization (EUA) process for this vaccine. So while the NIAID made a way for the work on the vaccine to proceed more quickly than normal, the FDA says that its work will be ‘a careful evaluation with no rushing.’

The FDA Speaks

In an article published in the October 27, 2020 issue of USA Today, Dr. Peter Marks states that “this process will not be rushed. There will be no shortcuts in developing the relevant phase 3 efficacy results.” Dr. Marks also said that the public’s trust is important for the Covid-19 vaccine so it gets taken by the public. “Trust means everything. Trust in vaccines facilitated the incredible positive impact that vaccination had on public health in reducing illness and death over the past century.”

Not Predicting The Future But

Dr. Goldstein admitted that he was not very good at predicting the future, but he believed that the Coronavirus/Covid-19 vaccine could be available as early as January 2021. “There are currently dozens of vaccines under development and in the advanced stages of approval,” Dr. Goldstein said. “That the government has streamlined some of the requirements without compromising safety to help advance development is remarkable. But nothing in the world of medicine is without risk and the ultimate introduction of the Coronavirus vaccine is no exception. The laws and regulations, at least for now, seem to strike a balance that protects the public and aids in the fast delivery of a vaccine.”

About The Houston Healthcare Initiative

Dr. Steven Goldstein is a Houston based neurologist. He founded the Houston Healthcare Initiative and is an advocate for common sense solutions to the healthcare crisis that confronts the citizens and residents of the United States of America.

 

Child COVID-19 vaccine trials to begin in Florida this week.

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NOTE: Child COVID-19 vaccine trials to begin in Florida this week. Watch how Dr. Steven Goldstein, founder of the Houston Healthcare Initiative, contributed to a major television feature on vaccine trials in the state of Florida. You can see him and the full story here:

WFTV ABC in Orlando, Florida news on Covid-19 vaccine trials.

By: Megan Cruz, WFTV.com and Adam Poulisse, WFTV.com
Updated: October 14, 2020 – 11:45 PM

Child COVID-19 vaccine trials to begin in Florida this week. Starting this week, researchers will begin testing one of the experimental COVID-19 vaccines on children, marking the first trial in the country to do so.

It’s one of several big developments in the race to approve a vaccine.

Screen Shot 2020-10-27 at 4.23.06 PM Child COVID-19 vaccine trials to begin in Florida this week.
In this story Dr. Steven Goldstein discusses liability waivers for vaccine trials starting in the state of Florida.

So far, more than 600 Central Floridians have walked into a DeLand lab, willing to test the Moderna vaccine.

Moderna and Pfizer are in the final phases of testing their vaccines. For Pfizer, that includes testing children 12 and over.

On Tuesday, Johnson & Johnson paused its study after one person got “an unexplained illness.” And it’s been over a month since AstraZeneca’s trial had been put on hold in the U.S. after two British participants experienced neurological issues.

READ: Florida reports 70 new coronavirus-related deaths; almost 3K new cases

When a vaccine is approved and available by, at the earliest, the end of the year, companies cannot be held liable for any unexpected complications. A good place to start with answers is here as Child COVID-19 vaccine trials to begin in Florida this week.

“Now, if there are expected complications, and the company hid that information, like they knew about something that it would happen, and they don’t tell people about it, you can still sue for that,” said Dr. Steven Goldstein of the Houston Healthcare Initiative.

A recent Gallup Poll found people are split right down the middle when asked if they’d take a vaccine, down from the 66% of people who were willing to take it three months ago. People in Florida will help the entire country find answers.

What Will Vaccine Liability Waivers Mean For The Covid-19 Inoculation

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What Will Vaccine Liability Waivers Mean For The Covid-19 Inoculation. There will be issues with the new Coronavirus/Covid-19 vaccine because there were issues with every single vaccine introduced before. There are currently numerous studies and trials devoted to finding a shot that will give immunity to the recipient against the deadly and contagious Coronavirus/Covid-19 pandemic. The company that is first to introduce a successful shot for immunity will reap big rewards in the form of profits and scientific prestige. But when there are problems with it, as there certainly will be, what recourse does the public have?

Vaccine Liability Photo
Vaccine waivers protect manufacturers from lawsuits and liability other drugs have.

On his regular podcast, respected neurologist Dr. Steven Goldstein describes the risks and benefits of vaccines and a regulation known as the ‘vaccine liability waiver.’ The Houston Healthcare Initiative Podcast can be heard on SoundCloud, LibSyn, Google Play, iHeartRadio, iTunes, Stitcher, Radio.com and many other places where podcasts are heard.

What Is The Vaccine Liability Waiver?

According to Dr. Goldstein, vaccine liability waivers are really what the name implies which is that vaccine makers are not generally held responsible for injuries their vaccines may cause. “This is notable because it is the only part of the healthcare industry where such protection exists,” Dr. Goldstein told his listeners. “The companies that make these vaccines cannot be sued for monetary damages unless a person who died or was seriously injured can demonstrate that the company engaged in “willful misconduct” which is a very high legal standard to achieve.”

The Vaccine Waiver Makes Vaccines Possible

What Will Vaccine Liability Waivers Mean For The Covid-19 Inoculation? It is very likely that were it not for the ‘waiver’ there would be few if any vaccine makers in the U.S. Starting with the Salk vaccine in the 1950’s through the 1970’s and ‘80’s, lawsuits against vaccine makers increased to the point that there was only one Diphtheria Pertussis Tetanus (DPT) vaccine maker in the U.S.

In 1986 the U.S. Congress responded to the situation in the vaccine market by passing the ‘National Childhood Vaccine Injury Act’ or NCVIA. The act included a number of regulations related to informed consent and adverse event reporting but also removed many of the monetary recovery options that were putting the industry out of business.

Complexity Comes With Safeguards

Vaccines are developed, tested, and regulated the same as other drugs but more so. Vaccine development is a complex process that takes usually takes years. That is because the number of people in vaccine clinical trials are usually greater, and, those who receive vaccines are more in number than those who receive or take other prescription drugs. In addition, post-license monitoring of vaccines is closely examined by the Centers for Disease Control (CDC) and the Food & Drug Administration (FDA).

So, while the liability waiver exists, all the other pharmaceutical safeguards are in place. Regardless of expectations, no medical treatment is completely risk free. “Vaccines are made to protect us from disease, but they can have negative side effects,” Dr. Goldstein said. “Most of these effects are pretty mild like soreness in the arm from the injection. Others can be more serious. But without these rules it is unlikely anyone in the U.S. would be researching a Covid-19 vaccine.”

What Will Vaccine Liability Waivers Mean For The Covid-19 Inoculation? Nothing in the world of medicine is without risk and the ultimate introduction of the Coronavirus vaccine is no exception. The laws and regulations strike a balance that protects the public and aids in the delivery of a vaccine sooner than later.

The Effectiveness Standard for Covid-19

The minimum requirement by the Food and Drug Administration (FDA) for any COVID-19 vaccine is that it should at least prove 50% effective when compared with a placebo — that is, a neutral saline solution. The annual flu vaccine is a success when it is 40% – 60% effective. Fifty percent is right in the same range as the flu vaccine.

About The Houston Healthcare Initiative

Dr. Steven Goldstein is a Houston based neurologist. He founded the Houston Healthcare Initiative and is an advocate for common sense solutions to the healthcare crisis that confronts the citizens and residents of the United States of America.