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FDA Approves a Third Vaccine Dose for People with a Compromised Immune System
By Carey
August 24, 2021
1,553 views
Table of Contents
In an important step, the Federal Drug Authority has pushed through an approval to get an additional dose of COVID-19 vaccines administered to the estimated 2.7 percent of adults in the United States who are immuno-compromised.The FDA approved a third vaccine dose for people with a compromised immune system; in Israel, the government is promoting a third dose for most citizens.Immuno-compromised individuals, specifically solid organ transplant recipients or those diagnosed with conditions that are considered to have an equivalent level of immuno-compromise, should now be able to receive the third dose. So far, this step is restricted to people who have already received two doses of either the Pfizer-BioNTech or the Moderna COVID-19 vaccine. It is not available yet for recipients of any other vaccine, due to the lack of testing to date.
What is the purpose of the additional dose?
For immuno-compromised people, this additional dose is not the same as the “booster” shot that is currently being administered in Israel, which has been leading the world in administering vaccines. The booster dose is meant to address an observed decline in the level of protection provided by the first two vaccinations over time.In initial trials, the Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines were shown to provide around 95% protection against severe infection requiring hospitalization. Subsequently, it has been found that this level of protection against hospitalization slips after six months to around 85%. However, the level of protection against actual infection, regardless of the level of symptoms, could now be down to around 40%. Furthermore, statistics are now coming out that the vaccine’s effectiveness at stopping any infection can have fallen as low as 16% for people vaccinated more than six months ago.
What does the new FDA approach to additional vaccine doses mean?
The FDA’s change regarding immunocompromised people does not apply to the general population, which has been the same since June 2021. An independent group of advisers to the CDC, called the Advisory Committee on Immunization Practices, decided that booster doses would be given only if protection from the vaccines was shown to fall below a defined threshold. However, at that point, scientists were still working to determine what that threshold should be.Later on, the US Center for Disease Control and Prevention (CDC), on July 7th, 2021, also warned people who are immuno-compromised that the Covid-19 vaccine may not have been effective for them and encouraged them to take precautions. According to the CDC’s website:“People who are immunocompromised should be counseled about the potential for reduced immune responses to COVID-19 vaccines and to follow current prevention measures (including wearing a mask, staying 6 feet apart from others they don’t live with, and avoiding crowds and poorly ventilated indoor spaces) to protect themselves against COVID-19 until advised otherwise by their healthcare provider.”
Why do immunocompromised people need a third dose of the COVID-19 vaccine?
For ordinary people, the proposed third dose of vaccines is appropriately termed a “booster” shot, which is intended to boost the declining level of immunity back up to the levels from which it has drifted.For immunocompromised people, the purpose of the third shot is not to act as a booster to restore the original levels of protection gained from the first two doses. Instead, it is designed to prevent severe and possibly life-threatening COVID-19 in people who may not have responded to their initial vaccine series. Some information suggests that a significant proportion of immuno-compromised people have low or no protection after two doses of mRNA vaccines. The purpose of the third dose is that they may have an improved response after an additional dose of the same vaccine. The projection is that this extra dose will create a level of immunity that is actually higher than was achieved by the first two doses.
Are there risks in vaccinating people with an additional dose?
The timeframe of all of these developments, happening in less than three months, has given little scope for a full investigation into all aspects of the vaccine regime. It has meant that there is limited knowledge about the risks of receiving an additional dose of vaccine. This is especially the case for additional doses of the COVID-19 vaccine in immuno-compromised people. The safety, efficacy, and benefits continue to be evaluated. The information so far, after a third mRNA dose, was similar to that of the two-dose series and there’s no reason to expect differences to any great degree. It is, therefore, the most effective way to raise your level of protection against the COVID-19 virus.
What can you do to boost protection if you are vulnerable to COVID-19?
As well as getting the now authorized third dose of vaccine, there are several other steps that you and any especially vulnerable members of your family can take to keep the virus away. As well as self-isolating and wearing a mask, it is now possible to create a barrier around you so that the virus cannot survive and begin to make you ill.Let’s make no mistakes here. We strongly advise anyone who can now get a third dose of the vaccine to get it done ASAP. It is by far the most effective thing you can do for yourself, your family, and for society. Talk to your healthcare providers about whatever else they feel can be done to provide extra protection.But you don’t have to wait around for the shot!Out of Israeli laboratories over the past few months, a revolutionary new product came onto the market that will add to your suit of protective armor against the virus.
The Enovid NONS (nitric oxide nasal spray) is brought to you by SaNOtize, a joint Canadian/Israeli biotechnology startup. It blocks the entry of viruses via the nose and also halts viral replication within the nasal cavity. It rapidly reduces the total viral load, which is linked to the spread of the virus in your body. Its overall effect is to prevent transmission and lower the severity of infection. Enovid works in two ways. Just spray into each nostril whenever you are coming into an area of high danger. Within two minutes, the spray will have killed 99% of any COVID-19 viruses it finds.
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