New CDC director expects COVID vaccine will be like flu shots where you'll 'get your annual COVID shot'



Dr. Mandy Cohen – the new Director of the Centers for Disease Control and Prevention – said she expects the COVID vaccine to become an annual inoculation like the flu shot.

Spectrum News asked Cohen if the country is at a point where Americans should get one COVID shot each year.

Cohen responded, "We're just on the precipice of that, so I don’t want to get ahead of where our scientists are here and doing that evaluation work, but yes, we anticipate that COVID will become similar to flu shots, where it is going to be you get your annual flu shot and you get your annual COVID shot."

"That's where we're going to," she continued, and added, "We're not quite there yet."

The CDC director said an official guidance from the U.S. health agency regarding an annual COVID shot should arrive in early or mid-September.

Cohen – the previous secretary of health and human services in North Carolina – said she expects a new COVID booster by the fall.

The topic of trust in public health agencies plummeting during the COVID-19 pandemic was broached during the interview. In March, a Harvard T.H. Chan School of Public Health survey found that approximately a quarter of Americans have little-to-no trust in the CDC for health information.

Cohen – a Democrat – told Spectrum News, "While we saw trust go down in lots of institutions, we actually saw trust increase in North Carolina. We measured trust in the Department of Health and Human Services and saw that increase."

She added, "We still had respectful disagreement, but at least we're having a respectful conversation about how to approach hard, hard topics."

When asked if the CDC could have done things differently during the COVID-19 pandemic, she replied, "There were some early places where the CDC didn’t perform and execute in the way they needed to."

Cohen said she is concerned about distrust regarding vaccines.

"I'm very worried about parents not vaccinating kids," she said.

On the topic of proposed cuts to the CDC budget, Cohen said, "Just like we have a military to protect us here and around the world, we need a CDC that can protect us. We can’t see those cuts and have the national security assets we need here at the CDC."

Cohen became the CDC director earlier this month following the departure of her predecessor – Dr. Rochelle Walensky.

Earlier this month, Cohen told NBC News the CDC needs to have "an everyday, tactical plan" to "bringing the best evidence that we possibly can" to the public.

She admitted that the CDC had lost trust during the pandemic, but promised transparency at the health agency under her watch.

Cohen added, "You're going to hear us with some key messages, making sure that folks hear them over and over."

The outlet said Cohen's team in North Carolina "sometimes turned to faith leaders, NASCAR drivers, even TikTok influencers to get scientific information to the public."

NBC News said of Cohen, "But she works hard to focus instead on re-infusing a spark back into the work done at the CDC. On her first day, she played Alicia Keys and other music in the lobby to greet her new co-workers."

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FDA to authorize new COVID booster shots for Omicron before trials on humans, will instead rely on testing on mice



The Food and Drug Administration (FDA) is expected to authorize new COVID-19 booster shots this week. The booster shots will be released months before trials on humans are completed, according to a new report.

New COVID-19 booster shots that target the latest Omicron variant will be approved by the FDA this week, the Wall Street Journal reported. The new booster shot will be "bivalent" – which means it can target the original COVID-19 strain and the Omicron BA.5 subvariant.

The booster shot will likely be available to Americans despite not having been tested on humans. Instead, the FDA will rely on testing on mice, data from current COVID-19 vaccines, and earlier iterations of boosters.

The Wall Street Journal noted, "The Food and Drug Administration is expected to authorize new COVID-19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans."

FDA Commissioner Robert Califf issued a statement on Twitter regarding how the government agency will likely make a decision in granting emergency use authorization (EUA) for booster shots from Moderna and Pfizer.

"FDA will rely on the totality of the available evidence in making a decision, including: Clinical trial data from other bivalent mRNA COVID-19 boosters RWE from current COVID-19 vaccines administered to millions of people, non-clinical data for the bivalent BA.4/5 vaccines, bivalent and multivalent vaccines are very common and modifying a vaccine to include different virus strains often does not require a change in other ingredients," Califf said on Twitter.

Califf compared approving the mRNA booster shots to authorization of the annual flu vaccine.

"Real world evidence from the current mRNA COVID-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe," Califf added. "As we know from prior experience, strain changes can be made without affecting safety."

Califf declared that the FDA will not hold a meeting about the newest subvariant-targeting vaccines because the "agency feels confident in the extensive discussion that was held in June."

He said that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) "voted overwhelmingly to include an Omicron component in COVID-19 boosters," and that the FDA "has no new questions that warrant committee input."

In June, two health experts wrote an op-ed urging the FDA not to release the booster shots without proper research. The piece was written by John P. Moore – a virologist and professor of microbiology and immunology at Weill Cornell Medicine – and Paul A. Offit – a pediatrician, professor of pediatrics, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, and a member of the Vaccines and Related Biological Products Advisory Committee.

Offit told the Wall Street Journal, "I'm uncomfortable that we would move forward — that we would give millions or tens of millions of doses to people — based on mouse data."

Moderna has already begun human trials on the booster shots, and Pfizer is expected to begin theirs this month. Experts believe that trials likely wouldn't be completed until the spring.

Earlier this month, White House COVID-19 Response Coordinator Dr. Ashish Jha expected the boosters to be available by "early to mid-September."

Jha also said that the Omicron BA.5 subvariant represents 85% to 90% of all U.S. cases of COVID.

CDC data shows that less than 50% of Americans received the first booster shot, and 33% of Americans over the age of 50 got the second dose.

Report: NBA will force certain fully vaccinated players to submit to testing if they don't get booster shot



Who could have predicted it? The NBA announced Sunday new COVID-19 testing requirements for certain fully vaccinated players, effectively moving the goalposts yet again.

What is the background?

While the NBA does not require COVID-19 vaccination for players, the league has implemented stringent rules for unvaccinated players that go beyond the locker room.

Those rules include:

  • No dining with team members or other team personnel
  • Have a locker as far away from other team members as possible
  • Submit to daily testing when using team facilities
  • Submit to laboratory testing on game day
  • Maintain 6 feet of social distancing

ESPN additionally reported:

Unvaccinated players are required to remain at their residence during home games and at the team hotel for road contests. The only exceptions are for team and essential activities, such as buying groceries or taking their children to school. They are not allowed to go to any restaurants, bars, clubs, entertainment venues or large indoor gatherings, and can only have in-person interactions with non-family members with a "limited number of close personal guests" who have to be tested beforehand.

Meanwhile, vaccinated players are permitted to live normally, with the exception of wearing face masks inside team facilities.

What is happening now?

The NBA is recommending that players, coaches, staff, and referees obtain a COVID-19 booster shot if they were inoculated with the Johnson & Johnson single-shot COVID vaccine.

Although the league billed the development as a recommendation, players who received the J&J vaccine will be subjected to game-day testing if they do not receive a booster shot by Dec. 1.

"NBA informed teams today that all players who received the J&J vaccine at least two months ago will be subject to Game Day testing beginning Dec. 1 if they do not receive the additional booster shot," Shams Charania of the Athletic reported.

NBA informed teams today that all players who received the J&J vaccine at least two months ago will be subject to Game Day testing beginning Dec. 1 if they do not receive the additional booster shot.https://twitter.com/ShamsCharania/status/1457408376183345157\u00a0\u2026

— Shams Charania (@ShamsCharania) 1636308780

While the NBA also recommended that recipients of the Pfizer and Moderna vaccines get a booster shot, the league's justification for implementing testing on booster-less J&J recipients indicates the NBA may extend testing requirements to booster-less Pfizer and Moderna recipients in the coming months.

That is because, per the Associated Press' reporting, the NBA based its booster requirement on data allegedly showing J&J antibody levels decrease two months after inoculation, and after six months for recipients of the Pfizer and Moderna vaccines.

Up to 97% of NBA players are believed to be fully vaccinated, the AP reported.

Biden, Fauci considering speeding up COVID booster shot timeline to 5 months



President Joe Biden said Friday that he and Dr. Anthony Fauci have discussed moving up the timeline of COVID-19 booster shots to five months after Americans receive their second dose of the coronavirus vaccine. Previously, the plan by the Biden administration was to administer booster shots eight months after the second vaccination.

President Biden revealed that he was considering speeding up booster shots by three months during an Oval Office meeting with Israeli Prime Minister Naftali Bennett on Friday.

"The question raised is should it be shorter than eight months? Should it be as little as five months? That's being discussed," Biden told the press about the booster shot timeline. "I spoke with Dr. Fauci this morning about that."

Biden did not reveal what Fauci, who is the chief medical adviser to the president on COVID-19, recommended as far as the optimum booster shot time.

Biden said booster shots for Americans "will start here on Sept. 20 pending approval of the FDA and the CDC committee of outside experts."

In regard to the interval between the second and third COVID-19 shot, Biden said Bennett advised him to "start earlier."

Bloomberg reported that Biden's decision is "relying substantially on data from Israel."

Shortly after Biden made the comments to accelerate the booster shot timeframe, "a White House official said there had been no change in the plan to administer boosters after eight months," Bloomberg noted.

President Biden says there are discussion with federal health officials about offering COVID booster shots as early… https://t.co/KiWBJh1RPi

— CBS News (@CBSNews) 1630087617.0

Biden's senior health team announced on Aug. 18 that booster shots would be available on Sept. 20 for those who received their second vaccine dose eight months prior. On Aug. 25, the Wall Street Journal reported that the Biden administration was looking into having boosters available after six months from the second dose of the Pfizer-BioNTech or Moderna vaccines.

The booster timeline is still subject to authorization by the Food and Drug Administration.

Pfizer and BioNTech have requested FDA approval for a booster shot. Thus far, the FDA only approved emergency use authorizations for Pfizer-BioNTech and Moderna booster vaccines for "the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise."

The World Health Organization has pleaded with wealthy nations to hold off on booster shots so that the third world could get vaccinations.

"We need an urgent reversal from the majority of vaccines going to high-income countries, to the majority going to low income countries," WHO Director General Tedros Adhanom Ghebreyesus said at a press briefing earlier this month.