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Health Canada Approves Pfizer-BioNTech COVID Vaccine for Kids Under 5

CBC reported:

Pfizer-BioNTech’s COVID-19 vaccine for kids under five has been approved by Health Canada, making it the second vaccine option for children in this age group.

Health Canada has approved a three-dose primary series of three micrograms each of Pfizer-BioNTech’s vaccine for children aged six months to four years old.

That differs from Moderna’s vaccine for this age group, a two-dose series and a higher amount of vaccine per dose which was approved in July.

The government recently approved a newer version of Moderna’s vaccine that targets the Omicron variant of COVID-19, but its use has not yet been approved for the youngest cohort.

Fauci: ‘We Don’t Have Time’ to Run Clinical Trials for Updated Boosters

The Epoch Times reported:

Dr. Anthony Fauci is claiming that there was not enough time to wait for clinical trial data before clearing updated COVID-19 booster shots.

“We don’t have time to do a clinical trial because we need to get the vaccine out now,” Fauci said on CBC this week, pointing to how about 400 Americans are dying per day with COVID-19 and thousands of others are in hospitals with the disease.

Both shots contain elements of the Wuhan, BA.4 and BA.5 virus variants. No human data was or is available for the formulations. Pfizer and Moderna presented data on preclinical testing, done on mice. They also referenced human data for a different formulation, combinations of the Wuhan and BA.1 strains.

Dr. Harvey Risch, a professor of epidemiology at the Yale School of Public Health, said that Fauci’s comments were “reckless” in light of the fact that regulators didn’t rush to have vaccine companies update the vaccines during previous periods, such as when the Delta variant was dominant in 2021.

He also criticized Walensky’s remarks, pointing to how the CDC’s variant monitoring shows that BA.4.6, which is not part of the updated boosters, is growing in proportion in recent weeks.

You Can Still Get Long COVID If You’re Vaccinated and Boosted

Time reported:

By now, it’s clear that even people who are fully vaccinated and boosted can get Long COVID, and recent research suggests that vaccines aren’t the Long COVID shields people wished for.

Studies have come to very different estimates about the degree of protection vaccines offer against Long COVID. But some of the latest findings point to fairly disappointing protection. In one July report from the U.K.’s Office for National Statistics, more than 4% of vaccinated and boosted adults in the U.K. who were infected by Delta, Omicron BA.1 or BA.2 still had symptoms at least 12 weeks later.

A preprint posted online on Sept. 6 (which has not yet been peer-reviewed) suggests the situation isn’t any better in the U.S. Researchers surveyed people from June into July, as the BA.5 variant was taking over. Among those who said they’d had COVID-19 at least a month earlier, roughly 20% had symptoms that lasted at least four weeks, with little difference between vaccinated and unvaccinated people.

New York Declares State of Emergency Over Polio to Boost Low Vaccination Rates

CNBC reported:

New York Gov. Kathy Hochul on Friday declared a state of emergency over polio to boost vaccination rates in the state amid further evidence that the virus is spreading in communities.

Poliovirus has now been detected in sewage samples from four counties in the New York metropolitan area as well as the city itself. The counties include Rockland, Orange, Sullivan and now Nassau.

The emergency declaration will expand the network of vaccine administrators to include pharmacists, midwives and EMS workers in an effort to boost the immunization rate in areas where it has slipped.

U.S. Orders 100 Million COVID Tests, White House Says More Needed

Reuters reported:

The United States will boost its stockpile of at-home COVID-19 tests, ordering more than 100 million tests from domestic manufacturers, the White House said on Thursday but warned it was a short-term solution.

President Joe Biden‘s administration has repeatedly and unsuccessfully asked Congress for more pandemic money. It said last week it would request $22.4 billion in emergency funding for COVID-19 relief ahead of a potential case surge in autumn.

The administration has warned it would be unable to provide enough tests, vaccines and treatments without more funding. Thursday’s announcement comes a week after it suspended orders of free tests from its COVIDTests.gov website as of Sept. 2.

‘Don’t Wait’ to Get the New COVID Shot, White House Says

NBC News reported:

The Biden administration is making a major push to get the updated COVID vaccine in arms ahead of what could be another fall surge of the virus as children head back to the classroom, and employees return to the workplace.

The plans include the acquisition of more than 170 million doses of the new boosters, which will be available to consumers without an out-of-pocket cost. “We want Americans to know that the vaccine is here and that they shouldn’t wait” to get it, a senior administration official told NBC News on Thursday.

The plans urge schools across the United States to hold at least one vaccination clinic before Thanksgiving, as well as university-led vaccination campaigns this fall.

Overall, COVID cases have been falling in the U.S., down by 23.1% over the past two weeks, according to NBC News data. But some experts worry that with cooler weather and increased indoor gatherings the trend will be reversed.

Post-Paxlovid Rebounds Look Common, Contagious

Bloomberg reported:

I recently returned from vacation with COVID and though my symptoms were mild, my doctor prescribed Paxlovid as a precautionary measure. I quickly improved, but not for long. I became one more person stuck at home with a post-Paxlovid COVID rebound. At least I’m in good company.

Back in February, VA Boston Healthcare System Chief of Staff Michael Charness experienced a rebound after he took Paxlovid. He explored his illness the way a good physician-scientist does, storing his samples next to the yogurt in the family fridge and getting them analyzed. He even tweeted for the first time in his life to spread the word.

His and others’ findings are officially out now in the New England Journal of Medicine, joining a stream of recent research that has been turning what was once a collection of anecdotes into published data.

A spokesperson for Pfizer, the maker of Paxlovid, describes rebounds as “uncommon and not uniquely associated with any specific treatment.” The researchers’ findings, though, suggest a different story: Infectious disease specialists say the rebounds aren’t uncommon, and patients should watch for them. They should also feel reassured that symptoms are almost always mild when a rebound occurs.

End of Government Purchases May Make COVID Drugs Less Lucrative

Axios reported:

Dwindling public demand for COVID vaccines and private market pressures should combine to cost manufacturers billions of dollars once the federal government stops buying the shots, eating into Pfizer and Moderna‘s pandemic profits.

Between the lines: The federal government bought far more vaccines than Americans would ever use to ensure that vaccines would be accessible. But private purchasers won’t tolerate redundancy or waste.

Driving the news: Sometime next year, health providers will take over purchasing COVID treatments and vaccines, and Americans will start accessing COVID care the way they do other medical needs.

The big picture: Vaccines account for all of Moderna’s sales and have swelled Pfizer’s.

How Helpful Will the New COVID Booster Really Be?

Los Angeles Times reported:

Last week, the Food and Drug Administration approved Omicron-specific vaccines and the Centers for Disease Control and Prevention followed, recommending updated boosters for everyone age 12 and up who has gotten at least two doses of the original COVID vaccines.

The message to a nation still struggling with the pandemic: The cavalry — in the form of a shot — is coming over the hill.

But for people familiar with the business tactics of the pharmaceutical industry, that exuberant messaging — and the lack of completed studies — has raised an array of still-unanswered concerns.

As we move into the next phase of the pandemic, the pharmaceutical industry may be headed for familiar territory: developing products that may be a smidgen better than what came before, selling — sometimes overselling — their increased effectiveness absent adequate controlled studies or published data, advertising them as desirable for all when only some stand to benefit significantly, and, in all likelihood, raising the price.

Why so Few Young Kids Are Vaccinated Against COVID — and How to Change That

Scientific American reported:

The Food and Drug Administration authorized COVID vaccines for children six months through four years old — the last age group to become eligible — in June. Yet, just 3.5% of U.S. kids in that group have received at least one dose, according to the CDC. And only about a third of children ages five through 11 have received one or more doses.

In a Kaiser Family Foundation (KFF) survey of parents conducted in July, more than four in 10 of those with children aged six months through four years said they would “definitely not” get their child vaccinated against COVID. Others said they will only do so if school or childcare requires them to or that they want to wait and see how the vaccine is working.

Of parents of children in this age group, nearly two-thirds of Republicans and of people who are unvaccinated themselves said they would not vaccinate their child. But even among parents who are vaccinated themselves, more than a quarter said they would not make the same choice for their little ones.

“Pretty much everybody knows somebody who’s gotten COVID despite being vaccinated,” says survey co-author Liz Hamel, vice president and director of public opinion and survey research at KFF. “The promise of what the vaccine will do for you is different now.”

Potential to Confuse Omicron-Targeting COVID Booster With Conventional Vaccine Raises Concerns: Report

FOXBusiness reported:

Health experts are reportedly concerned about potential vaccine mix-ups between the Omicron-specific booster shots and vials of conventional COVID-19 vaccines, which are intended to protect only against the original coronavirus strain.

The Los Angeles Times reports the issue was raised both at a Centers for Disease Control and Prevention (CDC) meeting and a gathering of the Western States Scientific Safety Review Workgroup.

“The Workgroup remains concerned about the potential for errors in the administration of the various COVID-19 vaccines, given that formulations for different age groups look alike,” chair Dr. Arthur Reingold said.

“To minimize the frequency of such errors, which should be reported to VAERS (Vaccine Adverse Event Reporting System), it is imperative that clear COVID-19 vaccination guidelines be disseminated to all vaccine providers. The Workgroup reiterates the importance of reporting to VAERS any suspected adverse events following receipt of a COVID-19 vaccine, whether as part of an initial series or as a booster dose and continued national safety surveillance efforts.”

According to the Times, the potential for confusion stems from the color of the cap of the vials being identical, as well as vials containing the same amount of vaccine.

U.S. May Expand Monkeypox Vaccine Eligibility to Men With HIV

Associated Press reported:

U.S. officials are considering broadening recommendations for who gets vaccinated against monkeypox, possibly to include many men with HIV or those recently diagnosed with other sexually transmitted diseases.

Driving the discussion is a study released Thursday showing that a higher-than-expected share of monkeypox infections are in people with other sexually transmitted infections.

Dr. John T. Brooks, chief medical officer for the Centers for Disease Control and Prevention’s monkeypox outbreak response, said the report represents a “call to action.”

Brooks told The Associated Press on Thursday that he expected vaccine recommendations to expand and that “the White House, together with CDC, is working on a plan for what that will look like.”