The Covid-19 Vaccine, Safe or Unsafe?

I have written several articles on the coronavirus and on masks. A series of links have been provided at the bottom of this article for your convenience. This article will, however address a different aspect of the virus. Links are provided for Dr. Fauci as well.

I have discussed the subject of vaccines for the coronavirus in brief. I will discuss this subject matter more in depth. I feel this is a good time to do so, since we are getting closer to the roll out of these vaccines. Typically it takes 2 to 3 years for a vaccine to be introduced for a new outbreak, if one comes out at all. We still do not have a vaccine for HIV, though we do have excellent therapeutics out. The diagnosis is no longer a death sentence. The flu vaccine has to be updated yearly due to mutations and new strains of the virus appearing. The coronavirus is an insidious virus, not only is it easily spread, it is quite lethal for certain high risk individuals. I have discussed the cornavirus thoroughly in a previous article on entitled “The Coronavirus Exposed”, so I won’t rehash that information. President Trump to speed up the creation of the vaccine has set up a task force called Warp Speed. He has authorized large amounts of funds and also has set up the production of the vaccine even before it has been thoroughly tested. As a result several pharmaceutical companies are doing final stages of testing.

While the president does have a lot of power, he is not a super hero like Dr. Strange. He can’t make events happen by the power of his mind. The companies that are working on these vaccines are reputable companies. They are being closely monitored by not only the US but the rest of the world as well. They are not going to do anything to jeopardize people’s health. Their are countless lawyers waiting for possible lawsuits from this vaccine. These companies know that. I also take exception with the news media, politicians and celebrities casting doubt on the safety of these vaccines, simply for political reasons. They are jeopardizing people’s health by doing so. I will get my vaccination shot as soon as it is available. I also get my yearly flu shot. I am an ICU nurse, so my situation is somewhat different. I can’t hide from the virus.

To allay these fears, I have included some more information on the development of the vaccine.

A vaccine to prevent coronavirus disease 2019 (COVID-19) is perhaps the best hope for ending the pandemic. Currently, there is no vaccine to prevent infection with the COVID-19 virus, but researchers are racing to create one.

Coronavirus vaccine research

Coronaviruses are a family of viruses that cause illnesses such as the common cold, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). COVID-19 is caused by a virus that’s closely related to the one that causes SARS. For this reason, scientists named the new virus SARS-CoV-2.

While vaccine development can take years, researchers aren’t starting from scratch to develop a COVID-19 vaccine. Past research on SARS and MERS vaccines has identified potential approaches.

Coronaviruses have a spike-like structure on their surface called an S protein. (The spikes create the corona-like, or crown-like, appearance that gives the viruses their name.) The S protein attaches to the surface of human cells. A vaccine that targets this protein would prevent it from binding to human cells and stop the virus from reproducing.

Coronavirus vaccine challenges

Past research on vaccines for coronaviruses has also identified some challenges to developing a COVID-19 vaccine, including:

  • Ensuring vaccine safety. Several vaccines for SARS have been tested in animals. Most of the vaccines improved the animals’ survival but didn’t prevent infection. Some vaccines also caused complications, such as lung damage. A COVID-19 vaccine will need to be thoroughly tested to make sure it’s safe for humans.
  • Providing long-term protection. After infection with coronaviruses, re-infection with the same virus — though usually mild and only happening in a fraction of people — is possible after a period of months or years. An effective COVID-19 vaccine will need to provide people with long-term infection protection.
  • Protecting older people. People older than age 50 are at higher risk of severe COVID-19. But older people usually don’t respond to vaccines as well as younger people. An ideal COVID-19 vaccine would work well for this age group.

Pathways to develop and produce a COVID-19 vaccine

Global health authorities and vaccine developers are currently partnering to support the technology needed to produce vaccines. Some approaches have been used before to create vaccines, but some are still quite new.

Live vaccines

Live vaccines use a weakened (attenuated) form of the germ that causes a disease. This kind of vaccine prompts an immune response without causing disease. The term attenuated means that the vaccine’s ability to cause disease has been reduced.

Live vaccines are used to protect against measles, mumps, rubella, smallpox and chickenpox. As a result, the infrastructure is in place to develop these kinds of vaccines.

However, live virus vaccines often need extensive safety testing. Some live viruses can be transmitted to a person who isn’t immunized. This is a concern for people who have weakened immune systems.

Inactivated vaccines

Inactivated vaccines use a killed (inactive) version of the germ that causes a disease. This kind of vaccine causes an immune response but not infection. Inactivated vaccines are used to prevent the flu, hepatitis A and rabies.

However, inactivated vaccines may not provide protection that’s as strong as that produced by live vaccines. This type of vaccine often requires multiple doses, followed by booster doses, to provide long-term immunity. Producing these types of vaccines might require the handling of large amounts of the infectious virus.

Genetically engineered vaccines

This type of vaccine uses genetically engineered RNA or DNA that has instructions for making copies of the S protein. These copies prompt an immune response to the virus. With this approach, no infectious virus needs to be handled. While genetically engineered vaccines are in the works, none has been licensed for human use.

The vaccine development timeline

The development of vaccines can take years. This is especially true when the vaccines involve new technologies that haven’t been tested for safety or adapted to allow for mass production.

Why does it take so long? First, a vaccine is tested in animals to see if it works and if it’s safe. This testing must follow strict lab guidelines and generally takes three to six months. The manufacturing of vaccines also must follow quality and safety practices.

Next comes testing in humans. Small phase I clinical trials evaluate the safety of the vaccine in a small group. During phase II, the formulation and doses of the vaccine are established to prove the vaccine’s effectiveness in a larger gropu. Finally, during phase III, the safety and efficacy of a vaccine need to be demonstrated in an even larger group of people.

Because of the seriousness of the COVID-19 pandemic, vaccine regulators might fast-track some of these steps. But it’s unlikely that a COVID-19 vaccine will become available sooner than six months after clinical trials start. Realistically, a vaccine will take 12 to 18 months or longer to develop and test in human clinical trials. And we don’t know yet whether an effective vaccine is possible for this virus.

If a vaccine is approved, it will take time to produce, distribute and administer to the global population. Because people have no immunity to the COVID-19 virus, it’s likely that two vaccinations will be needed, three to four weeks apart. People would likely start to achieve immunity to the COVID-19 virus one to two weeks after the second vaccination.

A lot of work remains. Still, the number of pharmaceutical companies, governments and other agencies working on a COVID-19 vaccine is cause for hope.

Below I have included as of August 10, the progress of the three leading pharmaceutical companies.

Moderna

Where is it now? The start of Moderna’s Phase 3 trial of its mRNA-1273 vaccine was announced just last week. It will involve 30,000 adults at 89 clinical research sites around the country. It is the first Phase 3 trial begun under Operation Warp Speed, according to the National Institutes of Health.Phase 2 was started in May.Trial results: So far, only Phase 1 results have been released. Those early results showed the vaccine brought about an immune response, which is what researchers wanted to see. The higher the dose, the higher the immune response was in the people who got it.How safe is it? More than half of participants had side effects, including fatigue, chills, headache, muscle pain and pain at the injection site. These are considered normal side effects for a vaccine. The higher the dose, the worse the side effects. The Phase 3 trial will use the middle dose.Who is developing it? Moderna, a biotech based in Cambridge, Massachusetts, developed the vaccine with help from the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health.

Pfizer

Where is it now? Pfizer has more than one vaccine candidate, being developed together with the German company BioNTech. It has moved into a combined Phase 2/3 trial, also started last week, with one of them, BNT162b2. That’s being carried out at about 120 sites worldwide, including 39 US states and Argentina, Brazil and Germany.When will we have it? If the trial is successful, Pfizer and BioNTech have said they are on track to seek regulatory review as early as October. If it gets emergency authorization from the FDA, as many as 100 million doses may be available by the end of the year, and about 1.3 billion by the end of 2021.The US Department of Health and Human Services and Department of Defense last month announced a $1.95 billion agreement with Pfizer to produce 100 million doses of the vaccine. The deal also allows the US government to acquire an additional 500 million doses.Trial results: In the combined Phase 1/2 trial, both vaccines brought about an immune response and produced antibodies, a “double-arm” approach that the companies hope will be more effective and provide longer protection. So far, only one has moved on to more advanced trials. Almost 120 people participated.How safe is it? Preliminary data from the Phase 1/2 trial showed “a favorable overall tolerability profile” for the vaccine, Pfizer said in a news release, “with generally mild to moderate” side effects that lasted one to two days, “such as fever, fatigue and chills and no serious adverse events.”

Novavax

Where is it now? Maryland-based biotechNovavax hopes to have its vaccine in Phase 3 trials next month.Trial results: Novavax released data from its Phase 1 trial Tuesday involving 131 participants. After two doses of the vaccine, participants had levels of antibodies that can fight off the virus that were four times higher, on average, than those developed by people who have recovered from Covid-19.The vaccine also brought about a response by immune cells, according to an analysis of 16 randomly selected volunteers.How safe is it? Of the 106 people who got the vaccine, and not a placebo, five had severe side effects, including muscle pain, nausea and joint pain, and one had a mild fever. The side effects lasted two days or less, on average.

A fourth Company has recently come on board,

Janssen Pharmaceutical Company of Johnson and Johnson

A fourth Phase 3 clinical trial evaluating an investigational vaccine for coronavirus disease 2019 (COVID-19) has begun enrolling adult volunteers. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.

The Janssen Pharmaceutical Companies of Johnson & Johnson developed the investigational vaccine (also known as Ad.26.COV2.S) and is leading the clinical trial as regulatory sponsor. Janssen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, are funding the trial.

U.S. and international trial sites part of the NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial. The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.

“Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia,” said NIAID Director Anthony S. Fauci, M.D. “It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose.”

The Janssen vaccine candidate is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells. Adenoviruses are a group of viruses that cause the common cold. However, the adenovirus vector used in the vaccine candidate has been modified so that it can no longer replicate in humans and cause disease. Janssen uses the same vector in the first dose of its prime-boost vaccine regimen against Ebola virus disease (Ad26.ZEBOV and MVA-BN-Filo) that was recently granted marketing authorization by the European Commission.

Resources:

mayoclinic.org, “COVID-19 (coronavirus) vaccine: Get the facts,”cnn.com, “These 3 Covid-19 vaccines have been in the news. Here’s what you need to know about them,” By Theresa Waldrop; nih.gov, “Fourth large-scale COVID-19 vaccine trial begins in the United States: Trial evaluating investigational Janssen COVID-19 vaccine;”

covid links
https://common-sense-in-america.com/2020/06/08/mask-or-no-mask-for-covid-19/
https://common-sense-in-america.com/2020/10/14/why-is-the-coronavirus-so-confusing/
https://common-sense-in-america.com/2020/10/14/the-corona-virus-exposed/
https://common-sense-in-america.com/2020/10/09/masks-how-they-work/
https://common-sense-in-america.com/2020/10/01/is-dr-fauci-a-devil-or-an-angel/
https://common-sense-in-america.com/2020/09/30/fauci-and-hiv-and-now-coronavirus-sounds-like-dejavu/
https://common-sense-in-america.com/2020/09/16/covid-19-manufactured-or-altered-that-is-the-question/
https://common-sense-in-america.com/2020/09/10/president-trump-acted-appropriately-and-in-a-timely-manner-with-regards-to-covid-19-part-1-of-2/
https://common-sense-in-america.com/2020/09/10/president-trump-acted-appropriately-and-in-a-timely-manner-with-regards-to-covid-19-part-2-of-2/
https://common-sense-in-america.com/2020/08/11/no-hazard-pay-for-covid-19-front-line-medical-professionals-while-hospitals-get-rescue-money/
https://common-sense-in-america.com/2020/07/18/covid-19-just-the-facts-please/
https://common-sense-in-america.com/2020/07/13/releasing-prisoners-early-for-covid-considerations-sets-a-bad-precedent/
https://common-sense-in-america.com/2020/06/16/hydroxychloroquine-is-it-the-medication-of-the-devil/
https://common-sense-in-america.com/2020/06/10/how-covid-19-is-spread-who-needs-who/

Dr. Fauci Postings
https://common-sense-in-america.com/2020/10/15/where-do-the-loyalties-of-the-cdc-lie/
https://common-sense-in-america.com/2020/10/01/is-dr-fauci-a-devil-or-an-angel/
https://common-sense-in-america.com/2020/07/30/is-the-fda-big-pharma-and-dr-fauci-playing-god/
https://common-sense-in-america.com/2020/06/21/dr-fauci-revisited-sour-grapes/

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