FDA suggests future of COVID-19 vaccination may look like a more frequent flu shot



The U.S. Food and Drug Administration says that the currently approved COVID-19 vaccines may need to update their formulas to remain effective against the most recent strains of coronavirus, suggesting that the future of COVID-19 vaccination may be similar to the flu shot.

On Wednesday, the FDA's vaccine advisory committee will meet to discuss "the future course of the pandemic," including what the "optimal strain composition for COVID-19 vaccines" will be and the best schedule for vaccine booster doses among the general population and sub-groups that may be more vulnerable to the virus, according to a briefing document published ahead of the meeting.

The document acknowledges that the current authorized or approved COVID-19 vaccines in the U.S. "are based on the original Wuhan strain" and that "currently circulating SARS-CoV-2 variants harbor mutations" to the virus' spike protein, the feature of a virus that enables it to invade human cells. Studies have shown that these mutations, variants like the B.A. 2 Omicron strain, have reduced the effectiveness of the vaccines currently in use and also that the vaccines have waning efficacy over time, the FDA said.

"New variants are often more infectious, transmissible, and antigenically distinct from earlier virus strains due to accumulated mutations in the [spike] protein that also render them less susceptible to neutralization by antibodies elicited by current COVID-19 vaccines or prior infection by earlier strains of virus," the document states.

During Wednesday's meeting, the FDA's expert advisers will discuss how the agency can develop a transparent process to make recommendations for changing the current composition of the vaccines, if that becomes necessary.

"Although a complete understanding of how emerging SARS-CoV-2 variants impact the effectiveness of current COVID-19 vaccines is lacking, the accumulating data suggest that the composition of vaccines may need to be updated at some point to ensure the high level of efficacy demonstrated in the early vaccine clinical trials," the FDA said.

"An orderly, logical, and transparent process should be delineated for making recommendations for possible changes in COVID-19 vaccine composition and will require the cooperation and collaboration of vaccine manufacturers, vaccine regulators, and global public health laboratories."

When the vaccines were first approved, they showed a 90% efficacy against the original Wuhan strain of coronavirus, according to the U.S. Centers for Disease Control and Prevention. But after the emergence of new variants, including the Delta, Omicron, and B.A. 2 Omicron sub-variants, vaccine efficacy was shown to decline over time.

Citing data from the U.K. Health Security Agency, CNBC News reports that the effectiveness of Pfizer's or Moderna's two-dose vaccines against mild illness caused by the Omicron variant dropped from 70% to just 10% in 25 weeks after the second shot. A booster dose brought protection back up to 75% for about four weeks, but then it fell to between 25% and 40% after 15 weeks.

CDC data shows a corresponding waning efficacy for the vaccines' protection against hospitalization from Omicron. While two vaccine doses initially reduced the incidence of hospitalization by 71%, in five months the effectiveness fell to 54%. A booster dose brought protection back up to 91%, but then it fell again to 78% after four months.

Importantly, the vaccines remain effective at preventing most severe or life-threatening COVID-19 infections and hospitalizations.

For those who are unvaccinated but have previously contracted COVID-19, natural immunity gained from that infection appears to be of longer duration than vaccine-induced immunity, according to an Israeli study. Other studies have shown that the risk of COVID-19 reinfection is low in those with natural immunity and also that vaccination after prior infection can reduce the risk even further.

The Biden administration continues to recommend that all Americans eligible to get vaccinated and receive booster doses do so, especially people with pre-existing health conditions that make them more vulnerable to the virus.

Given uncertainty about how the coronavirus will mutate in the future, the FDA says that clinical trial data to determine safety and efficacy will be necessary before any changes to the current composition of the vaccines are approved. Pfizer and Moderna are currently conducting clinical trials for a new vaccine formula based on the Omicron variant and the BA.2 sub-variant, which has caused a surge of breakthrough infections associated with mild illness in both Europe and the United States.

The FDA briefing document also discusses the timing for additional COVID-19 vaccine booster shots and which groups of people will be eligible for those shots.

The document suggests that in the future, COVID-19 vaccination will be similar to the yearly flu shot, where scientists identify the most likely variant of the virus to circulate seasonally and base that year's vaccine dose on that variant.

"While influenza and coronaviruses are different viruses and will undoubtedly evolve and behave differently in the human population, the process for updating influenza vaccine composition may provide some useful guidelines and considerations for possible updating of COVID-19 vaccine composition," the FDA states.

However, there are important differences between the influenza virus and COVID-19. While the flu has a predictable pattern of emerging each winter, the FDA says "a predictable pattern for a SARS-CoV-2 surge of infections has yet to emerge; for example, Delta and Omicron virus surges in the U.S. were separated by only about 5 months." It is also unclear whether COVID-19 vaccine manufacturers can update the compositions of their vaccines and mass produce them quickly enough to keep up with the evolving virus. Additionally, the flu shot does not need to be tested for safety and efficacy each year, but the COVID-19 vaccines would need testing before each new composition.

These considerations, as well as the role of the World Health Organization in recommending each new COVID-19 vaccine composition, as it does for the flu shot, will be discussed Wednesday.

Last week, U.S. officials authorized a second COVID-19 booster shot (fourth dose) for all Americans over the age of 50, after data showed waning vaccine immunity against the Omicron variants. The FDA said this shot could be administered as early as four months after the first booster dose.

Dr. Peter Marks, an official who leads the FDA office responsible for vaccine safety, said last week that the U.S. may need to offer fourth booster shots for people under 50 in the fall and fifth boosters for those who have already received their fourth dose. He told reporters on a conference call that the extra doses may be necessary as vaccine-induced immunity continues to wane and new virus variants become seasonal.

“It would not be surprising if there is a potential need for people to get an additional booster in the fall along with a more general booster campaign if that takes place,” Marks said. “It may be that a decision is made that rather than the vaccines we currently have, which are called vaccines against the prototype virus, that we will move to a vaccine that is either against one of the variants or something else.”

According to federal data, roughly 45% of Americans who have completed their primary COVID-19 vaccination schedules have also received a booster dose.

Horowitz: The country the COVID cultists don’t want to discuss



It’s the dirty “I” word that shall not be named. And by that, I don’t mean ivermectin, but Israel.

During the lockdowns, the COVID cultists ignored the existence of Sweden as the ultimate control group on the greatest experiment on human civilization of all time. Now they don’t want to acknowledge the existence of Israel as the ultimate study group on the greatest experiment on the human body of all time.

Last September, Philip Dormitzer, the chief scientific officer at Pfizer, described Israel as “a sort of laboratory” to “see the effect” of his company’s vaccines. This was because, as he put it, Israel “immunized a very high proportion of the population very early — so it’s been a way that we can almost look ahead: What we see happening in Israel happens again in the US a couple months later.”

Well, now we have a full year of data from the most boosted country on earth and the only one to administer four doses. So what are the results?

What you are looking at is not just a case rate chart. This is an ICU admission chart. And this is the daily death chart:

It is true that Israel, with its younger population and lower obesity rate, has fared better than many other Western countries throughout the pandemic, but why is it experiencing its own worst wave now – much worse than before any of the shots were administered?

In other words, precisely after most of Israel’s population got the third shot and even many of the seniors got fourth shots is when they experienced their worst crisis ever – not just of mild infections but serious cases.

Israel's 4th booster shot is a roaring success pic.twitter.com/NmbZitx6NK
— Dr. Eli David (@Dr. Eli David) 1643828114

This would be disturbing enough if we were still dealing with the Delta variant, but presumably almost all the cases in Israel are from Omicron. How in the world is the most vaccinated country on earth – Pfizer’s private lab – worse off than ever before in the pandemic with the mildest variant? After all, a study from the Kaiser Permanente Southern California hospital system found that Omicron had a 74% lower ICU admission rate and a 91% lower mortality rate than Delta.

According to professor Yaakov Jerris, director of Ichilov Hospital’s coronavirus ward in Tel Aviv, “most of our severe cases are vaccinated.” “They had at least three injections,” Jerris told Channel 13 News in describing the typical COVID patient. “Between seventy and eighty percent of the serious cases are vaccinated. So, the vaccine has no significance regarding severe illness, which is why just twenty to twenty-five percent of our patients are unvaccinated.”

This explains why the vaccine is not blunting the trajectory of the wave, but could the vaccine perhaps explain why Israel appears to be getting it worse than other countries?

On the one hand, there have been a lot more overall cases of Omicron relative to the number of serious cases, but we should not be seeing these numbers of deaths and serious hospitalizations in the most vaccinated nation. Remember, this variant began in South Africa, a country with just 27% of the nation having gotten the shots, and barely any boosters in sight. Yet the country’s peak death rate per capita during the Omicron wave is about half that of Israel’s.

Covid deaths per capita in Israel are now twice the peak of the rate seen in South Africa.\n\nWhich is unprecedented.\n\nWhy is the relative performance deteriorating so much?pic.twitter.com/HMjNt8azjw
— Covid19Crusher (@Covid19Crusher) 1643525747

With the sky-high HIV rate in South Africa, I would sure bet that Israel is a much healthier country in general. Life expectancy in Israel is 83 (ranked #12 in the world), while in South Africa it is a morbid 65. So why is Israel having so much difficulty with what Hong Kong researchers found to be essentially an upper respiratory infection?

Is it that perhaps their problems are not despite the endless boostering but because of it? What if the problem for the vaccine is not Joe Rogan but its own track record? At this point, it’s hard to see how we are not experiencing some form of original antigenic sin, in which repeat boosters teach the body to respond improperly to a virus, particularly to one that is different from the original target of the vaccine, rendering the vaccine increasingly an off-target response to the pathogen before us.

I spoke with Dr. Dan Stock, an Indiana family physician who is an expert in functional medicine and immunology (he’s the doctor who gave a “viral” statement before a school board), to get his thoughts on why a leaky vaccine would potentially make people sicker from a respiratory virus. He explains how the sugar high of superficially high blood-based antibodies could actually harm the body’s effort to fight respiratory viruses, which tend to require more of a cytotoxic T cell response in the respiratory tract rather than generalized blood-based antibodies.

“One thing that can go wrong in a viral immune response is that to make antibodies, the immune system has to make fewer cytotoxic T cells, and therefore fightthe virus less effectively. In this case, the vaccine can tell the immune system to switch from a mostly cellular immune response with T cells to a mostly humoral immune response with antibodies. Then even if the antibodies are neutralizing and the proper type (not a given with experimental vaccines), the infection will go untreated and destroy tissue. ADE (antibody dependent disease enhancement) is characterized by much higher levels of antibody production than is seen with natural infection, and a much lower Tc response. It’s this second nuance of viral immune responses that misleads many to equate great antibody responses with immunity.”

So why did the vaccines appear to be effective on some level at first, but then wane, and why would Israel have more of a problem with waning immunity? This is where booster mania comes into play.

“Whatever the immune system is taught to do the first time it sees the pathogen’s components, it memorizes that response and gets better and better at doing that with each successive exposure to the virus, even if it’s wrong,” warns Stock. “With the failed RSV vaccine in the 1960s, Marek’s disease vaccine in chickens, and these COVID-19 vaccines, immune response appeared protective at first. Then, as the body gets better and better at responding the wrong way – constantly reinforced by boosters – all hell broke loose. The vaccine is likely to teach your broken immune system to react the wrong way, you’re stuck in ADE, and won’t see it until it’s too late. The hallmark of ADE is failing immune response against all strains of the pathogen as time goes on, as we saw with RSV and Dengue, and we’re seeing with COVID-19 vaccines.”

Thus, the more the virus changes, according to Stock, not only will this particular vaccine lose its efficacy, but it will go negative because the body won’t produce as many T cells in the parts of the body that are infected. Dr. Stock coauthored a more in-depth article explaining the concerns of original antigenic sin at Trial Site News several months ago.

Is this what is going on in Israel, and will this problem spread to the rest of the vaccinated Western world? Who knows? But if Israel was supposed to be the lab, and the experiment failed, why are we continuing it in the United States?

As Pfizer’s chief scientist warned, “What we see happening in Israel happens again in the US a couple months later.”