Has The Global Rollback Of Covid Shots Begun?

Public health authorities in multiple countries have begun restricting access to or recommending against shots for some groups.

Biden administration says new COVID-19 shot will be annual dose, like the flu shot



Dr. Anthony Fauci and other top U.S. health officials said that COVID-19 vaccines will likely be administered yearly, similar to the annual flu shot, unless a "dramatically" different new variant of the virus appears.

At a White House press briefing Tuesday, officials said that one COVID-19 shot will be made available in the fall, once a year, that will be updated against the original strain of the virus and whichever strain is the dominant circulating strain that year.

The announcement came after the U.S. Centers for Disease Control and Prevention authorized new updated booster shots that are designed to combat the most prevalent Omicron subvariants, BA.4 and BA.5. The FDA and the CDC recommend these new booster shots for all Americans ages 12 and above, although they have never been tested on humans.

"It is becoming increasingly clear that, looking forward with the COVID-19 pandemic, in the absence of a dramatically different variant, we likely are moving towards a path with a vaccination cadence similar to that of the annual influenza vaccine, with annual, updated COVID-19 shots matched to the currently circulating strains for most of the population," Fauci said Tuesday.

He added that particularly vulnerable groups may need more frequent vaccination against COVID-19 before stressing the safety and efficacy of the vaccines against severe illness and death from the virus.

“Barring those variant curveballs, for a large majority of Americans, we are moving to the point where a single annual COVID shot should provide a high degree of protection against serious illness all year. That’s an important milestone," White House COVID-19 response coordinator Ashish Jha said at the briefing.

He added that it is "a good idea" to get both the COVID-19 shot and the flu shot at the same time.

"I really believe this is why God gave us two arms — one for the flu shot and the other one for the COVID shot," Jha said.

Officials said the Biden administration will ensure that vulnerable groups, including the immunocompromised and the elderly, will have access to additional shots as needed.

The Omicron variant continues to be the dominant circulating variant in the United States, according to the CDC.

CDC Director Rochelle Walensky said Tuesday that the seven-day average of hospital admissions is about 4,500 per day, a decrease of about 14 percent over the prior week.

"The seven-day average daily deaths are still too high, about 375 per day — well above the around 200 deaths a day we saw earlier this spring and, in my mind, far too high for a vaccine-preventable disease," Walensky said at the briefing.

She predicted that an uptake of annual updated COVID-19 vaccine doses could prevent as many as 100,000 hospitalizations and 9,000 deaths, in addition to saving billions of dollars in medical costs.

President Joe Biden said in statement the country is entering a "new phase" in our COVID-19 response."

"The new vaccines provide the strongest protection from the new Omicron strain of the COVID virus, which did not exist when the original vaccine was developed. As the virus continues to change, we will now be able to update our vaccines annually to target the dominant variant," Biden said.

"It’s simple, and it’s easy to understand: If you are vaccinated and 12 and older, get the new COVID-19 shot this fall. This once-a-year shot can reduce your risk of getting COVID-19, reduce your chance of spreading it to others, and dramatically reduce your risk of severe COVID-19."

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.

University of Denver adds flu shot requirement for all students and staff



When talk of COVID-19 vaccine mandates began to gain steam, many observers warned that the government's health requirements would not end there. If officials can make people take shots or wear masks for the sake of public health, what's to stop them from implementing new requirements for vaccines?

At the University of Denver, the answer to that question is apparently "nothing."

The state-run school announced this week that not only must students and staff get a COVID-19 vaccination, they now must also get a flu shot, KCNC-TV reported Tuesday.

What's happening?

Students and staff at the university have already been subject to strict policies against COVID-19. Not only are they required to be vaccinated, KCNC said, they are also required to take a saliva test every nine days. According to the school, this has kept the coronavirus positivity at below 1%.

Now with flu season on the horizon, the school is piling on to the health requirements — all in the name of "health and safety," as noted on the university's website:

As we enter cold and flu season, protecting the health and safety of our campus community is first and foremost on our minds at the University of Denver. Influenza and COVID-19 illness can include similar symptoms, occur simultaneously and pose serious health risks to members of our community. As a result, and as recommended by the Centers for Disease Control, the University of Denver will now require all students, faculty and staff who live, work and/or attend classes on campus, to get an annual influenza vaccination.

The Health and Counseling Center (HCC) remains committed during this public health crisis to promote student success by providing comprehensive and integrated healthcare, counseling, advocacy, health promotion, and recovery support and services.

"If history tells us anything, we would expect it is very likely going to be a pretty aggressive flu season," university Executive Director of Health and Counseling Michael LaFarr said. "It's a part of our overall plan to protect our community. The health and wellbeing of our community."

The school said that with COVID-19 and the flu having similar symptoms the school believes it "can't take chances," KCNC reported

"From people living in the residence halls to close proximity of the classrooms, it puts us at greater risk than other environments," LaFarr told the station. "So, we need as many safety mechanisms along the way to protect, and we've got a vaccine."

Colorado Gov. Jared Polis (D) told KCNC that he supports Centennial State residents getting the flu shot and hopes citizens will take advantage of it, but he said he is not interested in making the shot mandatory across the state.

Flu shot linked to less severe COVID-19 infections: Report



Those people who got a flu shot ahead of the 2019-20 flu season were reportedly less likely to suffer from severe COVID-19 requiring emergency room services, according to ABC News, citing a new report from medical journal Plos One.

What are the details?

New research states that people who got a flu shot may be "less likely to suffer a severe COVID-19 infection down the road."

Plos One's research, which was published Wednesday, took into consideration medical records of more than 74,700 COVID-positive people across the United States, United Kingdom, Italy, German, Israel, and Singapore.

Researchers determined that those people who had previously received the influenza vaccine during the previous six months were "less likely to have had health complications related to their COVID-19 infection."

Findings noted that those people who did not receive flu shots were up to 20% more likely to be admitted to the ICU, up to 58% more likely to visit the emergency room, up to 45% more likely to develop sepsis, up to 58% more likely to have a stroke, and 40% more likely to develop deep vein thrombosis when compared to those who had received an influenza vaccine.

The research, according to the outlet, corroborated the findings of several previous studies that found links between "better COVID-19 outcomes and flu shots."

"That prior research similarly didn't find the flu vaccine offered any protection against COVID-19 death," the outlet added. "Importantly, the flu shot's link to better COVID-19 outcomes doesn't necessarily mean it's protective against the novel coronavirus. While it's possible that the flu shot boosts immunity, it's also possible that people who opt to get the flu shot tend to be healthier overall than people who skip it, meaning they're already at lower risk for COVID-19 complications."

It remains unknown whether the flu shot — which changes annually — will have the same effect for the upcoming flu season.

In the research, study authors concluded, "Even patients who have already received SARS-CoV-2 vaccination may stand to benefit given that the SARS-CoV-2 vaccine does not convey complete immunity."