Vaccine Testing Phases. COVID-19

Are we ready for a COVID-19 Vaccine

 Testing and Development of New Vaccines

The general stages of the development cycle of a vaccine are:

  • Exploratory stage
  • Pre-clinical stage
  • Clinical development
  • Regulatory review and approval
  • Manufacturing
  • Quality control

Vaccine Testing

Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and the vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.

Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.

New Vaccine Introduction Checklist, Activity List & Timeline

In order to ensure that all steps to guarantee a successful introduction of a new vaccine is planned and budgeted for, that roles and responsibilities are clear, and that a clear timeline is in place, countries are encouraged to use the New Vaccine Introduction Checklist to develop a New Vaccine Introduction Activity List and Timeline that reflects the country situation and to regularly monitor and review these planning tools at planning and review meetings to oversee the new vaccine introduction.

The Word document provides instructions on how to use the New Vaccine Introduction (NVI) Checklist worksheet of the Excel file and how to use the results of that worksheet to create a NVI Activity List and Timeline on the subsequent worksheet.

Personal Note: 

In regards to the vaccinations that are being produced to protect against the COVID-19 pandemic, they have NOT gone through this required timeline. This causes concern about the safety of these vaccinations.

This is a requirement by the WHO (World Health Organization)

Guidance on vaccine introduction

To assist national policy-makers with decisions on whether a vaccine should be added to a national immunization program and guidance on how to introduce a new vaccine, WHO has developed a general vaccine introduction document which includes information on planning and budgeting, monitoring implementation, evaluating impact, calculating vaccine supplies and managing the cold chain.

Using the detail provided in the main document “Principles and Considerations for Introducing a New Vaccine”, and building on the thinking that has taken place at the country level during the drafting of the New Vaccine Introduction Plan, the New Vaccine Introduction Checklist is ideally used to identify key activities to conduct starting 12-24 months before the introduction of the new vaccine, leading up to the actual date of the vaccine launch, and continuing into the post-introduction monitoring phase.

You may ask yourself if the new COVID-19 vaccine has met any of these requirements and would it be safe.

WHO, UNICEF, and their partners recommended that national program managers attempt to consolidate existing plans for immunization objectives into a single comprehensive multi-year plan (cMYP), including an evaluation of the costs and financing of that plan.

What is the implementation research?

Many definitions exist for operations and implementation research. These two terms are often used interchangeably or at least overlap in their scope. The term translational research is sometimes used to define the research required to inform policy decisions or introduce vaccines or other products. Here, implementation research is defined as that area of research devoted to understanding the bottlenecks around the introduction and scaling up implementation of proven public health intervention and finding practical solutions to overcome such barriers or constraints.

According to what the WHO has stated, the current vaccination DOES NOT meet their requirements.

Doctors warn against rushing a Covid-19 vaccine as Fauci says it’s critical to have a safe Labor Day (August 07/2020)

Just because states have been asked to have a vaccine distribution plan doesn’t mean the public should expect to get shots this fall, doctors say.

The Centers for Disease Control and Prevention told state and local public health officials to prepare to distribute a possible Covid-19 vaccine as soon as late October.

Many health experts say a safe and effective vaccine might not be publicly available until early 2021. But it’s possible the Food and Drug Administration could give an emergency use authorization for a vaccine to be distributed before its Phase 3 clinical trial is over if the data is very promising.

Some doctors say they’d rather see a vaccine go through all the rigors to get a full FDA approval.

“How can you justify a substandard or lesser review for something that would be injected in tens of millions, maybe hundreds of millions of Americans?” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.

Three Covid-19 vaccines in the US are now in Phase 3 trials, and officials have insisted no vaccine will be distributed to the public until it’s deemed effective and safe.

Yet these vaccinations are being administered.

And that’s not likely to happen by late October, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

“If you look at the projection, of the enrollment (of trial participants) and the kinds of things you’ll need to get a decision about whether the vaccine is safe and effective, most of us project that that’s going to be by November, December, by the end of the year,” Fauci told CNN on Thursday.

President Donald Trump has touted the idea that a vaccine could be out to the public by the November 3 election. But vaccine experts have said that’s not realistic.

But having a distribution plan doesn’t mean a vaccine is imminent, said Dr. Francis Collins, director of the National Institutes of Health.

“This is like the Boy Scout motto: ‘Be Prepared,’” he said.

“Even if it’s a very low likelihood if everything happened to come together really beautifully and we had an answer by then and we knew we had a vaccine that was safe and effective, wouldn’t you want people to be ready to figure out how to do the distribution? That’s all that CDC is saying.”

US coronavirus: Keep Covid-19 vaccines off the fast track, doctors warn

The Centers for Disease Control and Prevention told state and local public health officials to prepare to distribute a possible Covid-19 vaccine as soon as late October.

Many health experts say a safe and effective vaccine might not be publicly available until early 2021. But it’s possible the Food and Drug Administration could give an emergency use authorization for a vaccine to be distributed before its Phase 3 clinical trial is over if the data is very promising.

Some doctors say they’d rather see a vaccine go through all the rigors to get a full FDA approval.

Preliminary results of a survey conducted over the last three months in 19 countries showed that only about 70% of British and U.S. respondents would take a COVID-19 vaccine if available, Scott Ratzan, co-leader of ‘Business Partners to CONVINCE’, told Reuters.

Stats Canada survey suggests some Canadians worried about the safety of the COVID-19 vaccine

OTTAWA — A new Statistics Canada survey suggests that while the vast majority of Canadians would get a COVID-19 vaccine if and when it becomes available, more than one in 10 likely would not.

The survey comes as governments around the world are rushing to develop a vaccine for the illness that has infected more than 23 million people around the world, including 126,000 in Canada.

Among the reasons respondents gave for not wanting the vaccine were concerns about its safety and potential side effects, while some said they did not trust vaccines in general.

Canada’s chief public health officer Dr. Theresa Tam says authorities need more information about those who are worried about or opposed to a vaccine to ensure they have the proper information about how vaccines are approved.

She says while efforts are being made to accelerate the development of a vaccine, the federal government will not take shortcuts when it comes to ensuring the safety of a COVID-19 vaccine before it is approved and distributed.

Tam says she is concerned about misinformation spread online about vaccines, adding internet and social-media companies should have a responsibility to police their domains to make sure that doesn’t happen.

Making the Vaccine Decision: Addressing Common Concerns

The world greets newborn babies by bombarding them with everything from dust to disease-causing microbes. Babies can deftly parry exposures to certain harmful substances, thanks to antibodies passed onto them in the womb. But this kind of inherited immunity is short-lived, so a child must develop her own immune system response to combat life-threatening diseases. That’s where vaccines come into the picture.

By age two, most children will receive almost 30 shots designed to boost a child’s natural defenses against disease. Yet at the same time, parents who take their children for those recommended vaccinations might be inundated with the Web site and celebrity-espoused rumors making false claims that shots are not necessary or cause autism.

At best, navigating this landscape can be confusing. But when weighing the risks of encountering life-threatening disease against the benefits of receiving a vaccine there’s no contest. The vast majority of children do not experience anything worse than short-lived redness or itching at the spot of the injection. So why is there so much misinformation?

One reason is developmental timing. Children receive a bevy of vaccines before age two, roughly overlapping with when children with autism spectrum disorder may noticeably develop symptoms such as the inability to gain new skills. That coincidence has helped the autism-vaccine connection myth persist. And what may have once been passed around by neighborhood gossip is now amplified worldwide by Web sites and social media. But the science simply does not bear out such fears. In August 2011 the Institute of Medicine (IOM) released a report that examined eight childhood vaccines and potential side effects. It found that vaccines are largely safe and that side effects are usually very rare and minor.

There is a big difference between tested and un-tested vaccinations. The COVID-19 pandemic has put the world into a crisis mode. There are countries that are trying to rush the proper protocol to be the first to find a vaccination.

You have to ask yourself. Is it worth the risk?

Thank you for reading

Michael

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4 thoughts on “Vaccine Testing Phases. COVID-19”

  1. Thank you for your post. It is informative and educational. We are living in a unprecedented time. The corona has a huge impact on our daily life. We need a vaccine for the disease as soon as possible. 

    However, as mentioned in your article in order to create a vaccine fast we escape some critical step in vaccine development. We have limited animal test on the vaccine. We know that many side effects may take long time to appear. Without proper test on animals, the vaccines are tested on human, which cause concern about the safety of these vaccination.

    We need speed, but more importantly we need quality. I wish we don’t make mistakes on introducing the vaccine into human. Time will tell us what we did right and what we did wrong.  

    Reply
    • Hi Anthony,

      Thank you for your comments. You are quite right in saying we will not see any immediate side effects from an untested vaccine. We have made many mistakes with how we dealt with COVID-19. Let us not make any more mistakes by compromising speed versus quality.

      Best wishes,

      Michael 

      Reply
  2. Wow. I was unaware of any of this information you provided in you article. 

    This covid-19 is some spooky stuff. I get worried about it from time to time with all of the unknowns and so many conflicting reports. Ugh.

    Your article has help me understand some more about the how the testing and development of new vaccines process is conducted. Very interesting!!!

    Stay Safe,

    Jordan

    Reply
    • Hi Jordan,

      Thank you for your comments. Covid-19, as we all know, has changed the world and indeed it is scary. The testing of the vaccines have not gone through their phases, and the other scary part is some of these vaccines are being administered to humans. We will not see any immediate side effects. For this reason, I think we should wait for the testing protocols to be completed.

      Best wishes,

      Michael

      Reply

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