‘Stay Protected’: CDC Doubles Down on Plans to Recommend Annual COVID-19 Shots

The U.S. Centers for Disease Control and Prevention (CDC) is still planning on recommending people receive a COVID-19 shot on an annual basis, the agency’s director says.

“We are likely to see this as a recommendation for an annual COVID shot, just like we have an annual flu shot,” Dr. Mandy Cohen, the director, said in a podcast episode released on Aug. 9. “And I think that will give more folks clarity about should they get one or not, because the answer is like, ‘Well, did you get one this year? If not, go get the new COVID shot.'”

“This will be an annual vaccine … to make sure that you stay protected,” Dr. Cohen said.

Dr. Cohen was commenting after Rep. Brad Wenstrup (R-Ohio), chairman of the U.S. House of Representatives Select Subcommittee on the Coronavirus Pandemic, questioned her over what data would support annual shots and asked for a briefing on the matter.

Dr. Wenstrup gave the CDC until Aug. 16 to provide answers. The agency has not done so yet, a spokesperson for the panel said.

Dr. Cohen had said in July, in one of her first interviews after becoming the CDC’s director, that the agency was poised to recommend annual shots.

U.S. officials initially said people would only need a primary series to protect themselves against COVID-19 but in 2021, less than a year after recommending vaccination for virtually everyone, they authorized and advised boosters to try to stem waning immunity.

As newer variants have emerged, the vaccines have performed even worse, leading to recommendations for additional boosters and, in the fall of 2022, the clearance of updated bivalent shots from Pfizer and Moderna. Those shots later replaced the companies’ old vaccines.

The U.S. Food and Drug Administration (FDA), which decides whether to clear vaccines, said in June that it was directing Pfizer and other manufacturers to update the shots again to target the XBB.1.5 strain because the vaccines “appear less effective against currently circulating variants (e.g., XBB-lineage viruses) than against previous strains of virus.”

But XBB.1.5 has already been largely displaced by other variants, including EG.5. That undercuts the new strategy, Dr. Harvey Risch told The Epoch Times in an email.

“The boosters will be out-of-date before they are even released,” Dr. Risch, professor emeritus of epidemiology at the Yale School of Public Health, said. “As well, CDC has already said that efficacy of new boosters in preventing spread is transient and wanes, thus there is little reason to see the boosters as beneficial.”

A CDC spokesperson told The Epoch Times via email: “Dr. Cohen’s expert opinion is based on the science, which indicates that vaccine-induced immunity wanes and the COVID-19 virus is likely to continue to evolve. As she has said before, if the science changes, the agency will adapt its recommendations.”

The COVID-19 vaccines have never been 100 percent effective. No trial efficacy data exists for the currently available vaccines, but observational data indicate they provide transient protection against infection and severe illness, even turning negative after several months.

There is no evidence supporting the idea that the shots provide protection for one year.

“Federal mandates did not stop the spread or transmission of the COVID-19 virus. Should the CDC issue a recommendation for an annual COVID-19 vaccine, it will mark a significant change in federal policy and guidance regarding the COVID-19 vaccines and how they are utilized,” a spokesperson for the House panel told The Epoch Times via email. “Serious questions remain as to whether the science would support such a recommendation.”

In support of the planned recommendation, the CDC pointed to a modeling study and a series of other studies highlighting waning immunity from the original shots, all of which were based on data from 2022 and earlier. The agency also cited a study that found the currently available boosters did not produce “robust neutralization” against newer variants.

Some of the papers concluded that people with so-called hybrid immunity, or vaccination on top of natural immunity, have the best protection. Other research has found that the latter protection, derived from recovering from COVID-19, is as good as or better than that from vaccines, though little data is available from recent months.

Executives with Pfizer and Novavax have said they expect the FDA to authorize the new shots by the end of August. Moderna also makes a COVID-19 vaccine. Johnson & Johnson’s shot is no longer authorized.

After the FDA authorizes the latest formulations, the U.S. government plans to phase out the older shots. according to a planning document from the U.S. Department of Health and Human Services, the parent agency of both the FDA and the CDC.

The FDA has indicated it will not require trial efficacy data before authorizing the new shots but will monitor observational data, similar to its stance on the influenza vaccines.

After the authorizations, the Advisory Committee on Immunization Practices (ACIP), the CDC’s vaccine advisers, plans to meet to discuss for whom they will advise the CDC to recommend the shots. The CDC does not have to accept the advice, but often does.

“The FDA anticipates taking timely action to authorize or approve updated COVID-19 vaccines in order to make vaccines available this fall. After their authorization or approval, ACIP will meet to make a recommendation outlining use of these updated vaccines this fall,” the CDC spokesperson said.

The CDC has recommended, including in its latest slate of recommendations, that virtually every person receive a primary series. The CDC did ease up on booster recommendations in the most recent recommendations, saying some people did not need additional shots, in the first formal recognition of the high levels of natural immunity in the population.

FDA Drops Ivermectin Bombshell

Doctors are free to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) said this week.

“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit.

The government is defending the FDA’s repeated exhortations to people to not take ivermectin for COVID-19, including a post that said “Stop it.”

The case was brought by three doctors who allege the FDA unlawfully interfered with their practice of medicine with the statements.

A federal judge dismissed the case in 2022, prompting an appeal.

“The fundamental issue in this case is straightforward. After the FDA approves the human drug for sale, does it then have the authority to interfere with how that drug is used within the doctor-patient relationship? The answer is no,” Jared Kelson, representing the doctors, told the appeals court.

The FDA on Aug. 21, 2021, wrote on X, formerly known as Twitter:

“You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

The post, which linked to an FDA page that says people shouldn’t use ivermectin to prevent or treat COVID-19, went viral.

Command or Not
“FDA made these statements in response to multiple reports of consumers being hospitalized, after self medicating with ivermectin intended for horses, which is available for purchase over the counter without the need for prescription,” Ms. Honold said.

A version of the drug for animals is available, but ivermectin is approved by the FDA for human use against diseases caused by parasites.

Ms. Honold said that the FDA didn’t purport to require anyone to do anything or to prohibit anyone from doing anything.

“What about when it said, ‘No, stop it’?” Circuit Judge Jennifer Walker Elrod, on the panel that is hearing the appeal, asked.

“Why isn’t that a command? If you were in English class, they would say that was a command.”

Ms. Honold described the statements as “merely quips.”

“Can you answer the question, please? Is that a command, ‘Stop it’?” Judge Elrod asked.

“In some contexts, those words could be construed as a command,” Ms. Honold said.

“But in this context, where FDA was simply using these words in the context of a quippy tweet meant to share its informational article, those statements do not rise to the level of a command.”

The statements “don’t prohibit doctors from prescribing ivermectin to treat COVID or for any other purpose” Ms. Honold said. She noted that the FDA, along with the statements, said that people should consult their health care providers about COVID-19 treatments and that they could take medicine if it was prescribed by the provider.

“FDA is clearly acknowledging that doctors have the authority to prescribe human ivermectin to treat COVID. So they are not interfering with the authority of doctors to prescribe drugs or to practice medicine,” she said.

Judge Elrod is on the panel with Circuit Judges Edith Brown Clement and Don Willett. All three were appointed under President Donald Trump.

Federal Law
The plaintiffs are Drs. Paul Marik, Mary Bowden, and Robert Apter. They say they were professionally harmed by the FDA’s statements, including being terminated over efforts to prescribe ivermectin to patients.

Dr. Marik has noted that a number of studies support using ivermectin against COVID-19, as the FDA itself has acknowledged. Some other studies show little to no effect.

Federal law enables the FDA to provide information, such as reports of adverse reactions to drugs, but not medical advice, Mr. Kelson said.

“This is something the FDA has never been able to do. And it’s a bright line,” he told the court, adding later:

“The clearest examples of where they have gone over the line are when they say things like, ‘You are not a horse, you are not a cow. Seriously, y’all. Stop it.’”

Judges indicated they agree that the FDA lacks the power to give medical advice; Judge Clement said, “You’re not authorized to give medical advice.”

But Ms. Honold said the government “isn’t conceding that in this case.”

She also argued that Congress has empowered the FDA to protect public health and make sure regulated products are safe and effective, giving it the “inherent authority to further its mission by communicating information to the public about safe uses of drugs.”

A ruling in favor of the doctors would prevent the FDA from reporting on consumers suffering after cooking chicken with NyQuil or that opioid addiction is a problem, she claimed.

Mr. Kelson said that wasn’t accurate. “It’s when they step beyond that [and] start telling people how they should or should not be using approved drugs,” he said.

Ms. Honold also said that the courts can’t hold agencies accountable when they provide false or misleading information: “The FDA is politically accountable, just like all other executive agencies.”

https://www.zerohedge.com/covid-19/fda-drops-ivermectin-bombshell

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