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The Biden Administration Has Been Sidelining Vaccine Experts

The Washington Post reported:

The U.S. government, over the past few weeks, has made three important decisions on vaccines without consulting independent panels of experts.

On Nov. 19, the Food and Drug Administration authorized boosters for all adults — regardless of their job or any underlying health conditions.

On Nov. 29, the Centers for Disease Control and Prevention announced that everyone 18 and above should get a booster shot, a revision of previous guidance that strongly recommended boosters only for those 50 and older.

Then, on Dec. 9, the FDA authorized booster shots (of Pfizer) for 16- and 17-year-olds, moving the age of eligibility down from 18.

Before last month, the standard practice was for the agencies to convene standing outside advisory committees, whose members inspect the relevant data, debate it and vote. That did not happen in these cases, meaning that the costs and benefits of these policy moves, from a medical perspective, were not fully aired publicly and discussed in advance.

48 Test Positive for COVID on a Royal Caribbean Cruise Ship

Forbes reported:

Four dozen passengers and crew tested positive for COVID-19 at the end of a weeklong Royal Caribbean cruise aboard Symphony of the Seas that sailed into Miami yesterday, reported the South Florida Sun-Sentinel.

But breakthrough cases happen so routinely on cruise ships these days, it’s become something of a trend.

​​All of the ship’s passengers age 12 and older were required to be fully vaccinated and to test negative to board the cruise, which left Miami on Dec. 11. Children too young to be vaccinated were also required to test negative before sailing.

In response to rising infection rates due to the Omicron variant of the coronavirus, Royal Caribbean tightened its mask policy this week to require that all passengers, regardless of vaccination status, wear masks in all indoor public areas unless actively eating or drinking.

Omicron Spreading and Infecting the Vaccinated — WHO

Reuters reported:

The Omicron variant of the coronavirus is spreading faster than the Delta variant and is causing infections in people already vaccinated or who have recovered from the COVID-19 disease, the head of the World Health Organization (WHO) said on Monday.

“There is now consistent evidence that Omicron is spreading significantly faster than the Delta variant,” WHO director-general Tedros Adhanom Ghebreyesus told a news briefing for Geneva-based journalists, held at its new headquarters building.

New Zealand Says Man’s Death May Be Linked to Pfizer Vaccine

Bloomberg reported:

New Zealand health authorities said they believe a man’s death may be linked to the Pfizer COVID-19 vaccine.

The 26-year-old man died within two weeks of his first dose of Pfizer and preliminary post-mortem information suggests the probable cause was myocarditis, an inflammation of the heart muscle wall that is a rare side effect of some COVID-19 vaccines, New Zealand’s COVID-19 Vaccine Independent Safety Monitoring Board said in an emailed statement on Monday.

It is New Zealand’s second reported death linked to the vaccine after the board said in late August that a woman’s myocarditis was probably due to vaccination. It said today that another two people had died with potential myocarditis following vaccination. Further information was needed in the case of a 13-year-old child, while the death of a man in his 60s was unlikely related to the vaccine, it said.

Moderna Halts Patent Fight Over Coronavirus Vaccine With Federal Government

The Washington Post reported:

Moderna is pausing a patent dispute with the federal government over its groundbreaking coronavirus vaccine, saying it is “grateful” to government scientists who collaborated with the company and wants to “avoid any distraction” in the fight against the Omicron variant.

The decision could have implications for the Biden administration’s global vaccination strategy, as officials look for leverage to share mRNA vaccine discoveries with developing countries in an effort to ramp up worldwide supply.

It is also expected to turn down the heat on the Cambridge, Mass., vaccine maker, which projected as much as $18 billion in sales from its vaccine this year, and has received stinging criticism for doing too little to share its breakthroughs with poorer nations.

NBA Postpones 5 More Games; Young, Vogel Enter Protocols

Associated Press reported:

The NBA on Sunday postponed a total of five games involving nine teams in response to rising coronavirus numbers, raising the number of contests that have been pushed back this season to seven.

Called off were three Sunday games: Cleveland at Atlanta, Denver at Brooklyn and New Orleans at Philadelphia. Also shelved were Orlando’s game at Toronto on Monday and Washington’s game at Brooklyn on Tuesday.

Leaguewide, through Sunday evening, there were at least 75 players from 20 teams who have either been ruled out to play — or in the case of the postponed games, would have been ruled out — because they are in the protocols.

U.S. officials are expecting a wave of breakthrough infections among the vaccinated given the surge of holiday travelers and gatherings expected in the coming days. The NBA has said 97% of players are fully vaccinated and somewhere around 60% had received boosters as of last week.

Claim Alleging Injury or Death From a COVID Countermeasure to Be Compensated

The Epoch Times reported:

For the first time amid the pandemic, the U.S. government compensation program will pay out one of the 4,751 claims alleging injuries or death arising from the administration of a covered countermeasure used to diagnose, treat or prevent COVID-19.

Countermeasures may include emergency authorized or federally approved vaccines, drugs, and medical devices that the Food and Drug Administration allows for use during a public health emergency.

A total of 5,242 claims have been filed with the CICP from 2010 to Nov. 1, 2021, of which 4,751 claims are related to injuries or death from COVID-19 countermeasures, specifically 2,297 claims are for COVID-19 vaccines and 2,454 for other countermeasures.

‘It Is Embarrassing’: CDC Struggles to Track COVID Cases as Omicron Looms

Politico reported:

As the world experiences new, more transmissible COVID-19 variants, scientists and health officials in the U.S. are still struggling to gather accurate and timely domestic data to help inform policy decisions to safeguard Americans.

Continuing gaps in the CDC’s data collection program, which almost two years into the pandemic still relies on state health departments who use a mix of often incompatible and outdated state systems to identify cases, impedes the nation’s understanding of where and how fast the virus is spreading, according to more than a dozen state and federal officials involved in tracking cases.

In interagency health and high-level White House meetings, health and White House COVID-19 officials have lamented that U.S. epidemiological data is lacking in speed and accuracy and have advocated that the administration use data collected by international allies while considering policies on vaccinations and booster shots, those sources said.

Moderna’s Third Dose Boosts Antibodies Against Omicron

Bloomberg reported:

A third dose of Moderna Inc.’s COVID-19 vaccine increased antibody levels against the Omicron variant, results the company described as reassuring while it works on a shot tailored to the new strain.

A 50-microgram booster dose — the authorized amount, which is half the dose used for primary immunization — saw a 37-fold increase in neutralizing antibodies, the company said in a statement Monday. The company also tested a 100-microgram dose, which increased antibody levels 83-fold compared with the primary two-dose course.

The results add to a growing body of evidence that three shots will be needed to neutralize the fast-spreading Omicron.

The Pandemic Could Drive Another National Health Crisis, GAO Warns: Anxiety

The Washington Post reported:

“The pandemic is potentially driving another national crisis related to its effects on behavioral health, with people experiencing new or exacerbated behavioral health symptoms or conditions.” That’s the stark warning in the first paragraph of a letter to Congress in a new Government Accountability Office (GAO) report.

The expansive impact of the pandemic is demonstrated by this statistic: More than four out of 10 adults, 43%, told a Census Bureau pulse survey in November 2020 they suffered from anxiety or depression.

Citing an August 2020 Centers for Disease Control and Prevention (CDC) study, the GAO said 13% of adults responding to a survey admitted “having started or increased substance use to cope with stress or emotions related to COVID-19.”

Therapists know “behavioral health problems are often under reported,” said Lynn Bufka, the American Psychological Association’s senior director of practice transformation and quality.

“We’re seeing a large increase in demand for anxiety and depression treatment” by mental health professionals who report long wait times for clients seeking care, Bufka said.

Omicron May Sideline Two Leading Drugs Against COVID

Associated Press reported:

As strained U.S. hospitals brace for a new surge of COVID-19 cases caused by the fast-spreading Omicron variant, doctors are warning of yet another challenge: the two standard drugs they’ve used to fight infections are unlikely to work against the new strain.

For more than a year antibody drugs from Regeneron and Eli Lilly have been the go-to treatments for early COVID-19, thanks to their ability to head off severe disease and keep patients out of the hospital.

But both drugmakers recently warned that laboratory testing suggests their therapies will be much less potent against Omicron, which contains dozens of mutations that make it harder for antibodies to attack the virus. And while the companies say they can quickly develop new Omicron-targeting antibodies, those aren’t expected to launch for at least several months.

Children Receive Unapproved COVID Vaccine

RT News reported:

Police in Germany are investigating after at least three children under 12 were “incorrectly” given the Moderna vaccine at a COVID-19 vaccination center. Parents have reportedly sought assault charges against a staffer.

The incident occurred on Sunday at a center in the town of Attendorn in the state of North Rhine-Westphalia (NRW). The children who received the Moderna shot apparently exhibited no ill effects after they left the vaccination center. The incident was reported to the police at the parents’ request.

According to the district administration, it was not yet clear if the staff member was the only one at the center to have injected children with the wrong shot or if other employees had done the same. It was also not known whether the children administered the incorrect vaccine were given an adult dose.

The authorities noted that around 365 children had been vaccinated in general against COVID in the town, with parents being told to monitor them for any adverse effects. Only the Pfizer-BioNTech vaccine has been greenlighted by the agency for children aged between five and 11 in the bloc so far.

French Health Regulator Approves Pfizer Vaccine for 5- to 11-Year-Olds

Reuters reported:

France’s Haute Autorite de Sante (HAS) health regulator approved the Pfizer-BioNTech COVID-19 vaccine for all children aged 5-11 on Monday.

Last week France started vaccinating 5- to 11-year-olds with medical conditions that require special protection and ramped up logistics to roll out vaccination of all children in the age group once the HAS approves the move.

French President Emmanuel Macron said last week that he was in favor of vaccinating children, but added that this needed to remain the decision of parents.