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FDA Authorizes New Updated COVID Vaccines

U.S. News & World Report reported:

The Food and Drug Administration on Monday authorized updated COVID-19 shots that could roll out as soon as this week.

The shots target XBB.1.5, which was responsible for about 3% of coronavirus infections in the U.S. in recent weeks, according to estimates from the Centers for Disease Control and Prevention.

The CDC’s committee of outside vaccine experts will meet Tuesday to recommend who should receive the new shots. Once the CDC’s director signs off on the recommendations, shots can be administered.

FBI, HHS Stonewalling Congress Over Illegal Chinese COVID Lab in California

ZeroHedge reported:

The Chairman of the House Select Subcommittee on the Coronavirus Pandemic has threatened to subpoena the Federal Bureau of Investigation (FBI) and the U.S. Department of Health and Human Services (HHS) after they refused to produce information on an illegal Chinese lab that was “caught red-handed conducting dangerous research related to COVID-19 and other deadly diseases without a license by FBI agents and California officials.”

In Thursday’s letters to the agencies (FBI letter, HHS letter), Rep. Brad Wenstrup (R-OH) noted their failure to respond to prior requests for information, and said that if they fail to comply with oversight, “we will be forced to evaluate the use of the compulsory process.”

The letter also puts the agencies on notice that the Subcommittee may request that employees sit for voluntary transcribed interviews.

As we previously noted, the lab was found in what was thought to be an empty storage building in Reedley, California — located in the central San Joaquin Valley.

Public Health staff also observed blood, tissue and other bodily fluid samples and serums; and thousands of vials of unlabeled fluids and suspected biological material. Additionally, they found 900 genetically engineered mice, engineered to catch and carry COVID-19, living in “inhumane” conditions.

CORONAVIRUS/Taiwan Man to Receive NT$450,000 Payout in COVID Vaccine Case

Focus Taiwan reported:

A man who developed an autoimmune disease after he was vaccinated against COVID-19 will receive a payout of NT$450,000 (US$14,023), according to information released Saturday by Taiwan’s Centers for Disease Control (CDC).

The 56-year-old, a resident of Taipei identified by his last name Tsai developed limb numbness, difficulty breathing and unsteady walking after getting a dose of the AstraZeneca vaccine, CDC Deputy Director General Tseng Shu-hui said.

Tsai immediately sought medical attention, and was later diagnosed as having Guillain-Barré syndrome, a rare disorder caused by an immune attack on the nerve cells, Tseng said.

While there is no conclusive evidence directly linking Tsai’s symptoms to the AstraZeneca vaccine he received, he will be given compensation under the Vaccine Injury Compensation Program (VICP), the CDC said.

COVID Booster Warning From Florida Surgeon General, Who Advises People Not to Get New Vaccine

Fox News reported:

While speaking at a Thursday news conference for Gov. Ron DeSantis in Jacksonville, Florida, Dr. Joseph Ladapo, that state’s surgeon general, advised people to steer clear of the updated booster vaccine for COVID-19.

“There’s a new vaccine that’s coming around the corner, a new mRNA COVID-19 vaccine, and there’s essentially no evidence for it,” Ladapo said during the news conference, according to local news outlets.

“There’s been no clinical trial done in human beings showing that it benefits people,” he said. “There’s been no clinical trial showing that it is a safe product for people — and not only that but then there are a lot of red flags.”

In terms of specific concerns, Ladapo warned that the updated vaccines “actually cause cardiac injury in many people.”

U.S. CDC Says Existing Antibodies Can Work Against New COVID Variant

Reuters reported:

Early research data has shown that antibodies produced by prior infection or existing vaccines against the coronavirus were sufficient to protect against the new BA.2.86 variant, the U.S. Centers for Disease Control and Prevention (CDC) said on Friday.

Since the CDC’s initial risk assessment last month, BA.2.86 has been identified in nine U.S. states as of Friday. The Omicron offshoot has also been identified from both human and wastewater specimens in countries including Japan, U.K. and Canada.

This is in contrast to the CDC’s comments in August that the new variant may be more capable than older variants in causing infection in people who have previously had COVID-19 or who have received vaccines.

Pfizer and Moderna Are Pushing the New COVID Booster. Should You Get It? The CDC Is About to Decide.

KFF Health News reported:

A small percentage of Americans got the most recent COVID-19 booster shot, and even fewer probably realize the federal government is preparing to recommend yet another shot as early as Tuesday.

Until a week or two ago, William Schaffner read that indifference as a sign the Centers for Disease Control and Prevention should advocate vaccinating only those most at risk from the virus. But then Schaffner, an infectious disease specialist at Vanderbilt University Medical Center, changed his mind.

Members of the CDC’s Advisory Committee on Immunization Practices won him over to the argument that the vaccine be recommended for all Americans above 6 months of age, he said in an interview. The committee, which sets U.S. vaccination policy and helps determine insurance coverage for vaccines, will vote on the question Tuesday as it weighs the benefits of updated vaccines from Pfizer, Moderna, and Novavax.

Some of Schaffner’s scientific colleagues argue the government should be recommending the shot only for frail, older, sick, and immunocompromised people. Over 95% of the U.S. population are already COVID-immunized through vaccination, infection, or both, and the risks of serious illness for healthy younger people are not great.

The new vaccine is “not remotely a game changer,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College.

Fauci: We ‘Need to Be Prepared’ for Likely COVID Uptick This Winter

Politico reported:

Dr. Anthony Fauci, the former top infectious disease expert in the U.S., isn’t sounding alarm bells on the rising number of coronavirus cases in the U.S. yet, but he did caution that the trend will continue into the fall and winter months.

“I wouldn’t say that I’m alarmed but I’m certainly keeping an eye on it,” Fauci said on ABC’s “This Week” on Sunday. The former head of the National Institute of Allergy and Infectious Diseases is now a professor at Georgetown University.

COVID Vaccine Rollout Begins Early in the U.K. With New Variant Under Watch

CNBC reported:

England on Monday began its winter COVID-19 and flu vaccination campaign ahead of schedule as it monitors a new variant and seeks to avoid another “twindemic” straining the healthcare system.

National Health Service (NHS) England said the program was brought forward based on the latest expert advice. Flu vaccines are available to all, while COVID vaccines will be offered to eligible groups including care home residents, over-65s, front-line health and social care workers, and those at clinical risk.

The early start was criticized by the Royal Pharmaceutical Society for coming at short notice and potentially creating confusion for pharmacists and the public. Winter vaccination campaigns also begin this month in Scotland and Northern Ireland, with Wales starting last week.

Research published Saturday said the variant had not been proven to have a “growth advantage” compared with other variants in circulation. The U.K. Health Security Agency also said there was insufficient evidence to link it to early indicators of increased COVID-19 transmission in the U.K. or to judge its severity.

Amid Another Rise in Cases, COVID’s New Normal Has Set in

STAT News reported:

Among people who are still paying attention to COVID-19, there’s been a recent surge — not just in viral activity but in the concern once again being paid to COVID.

While the angst is understandable, there’s something we need to grasp at this point in our coexistence with SARS-CoV-2: This is our life now.

“COVID’s never going to be over. You need to set expectations accordingly. It is never going to be over,” Jennifer Nuzzo, an epidemiologist and director of Brown University’s Pandemic Center, told STAT.

COVID is now like influenza, RSV, rhinoviruses, and a large number of other pathogens that will at some point or points in a year increase in transmission activity and then decline, ceding the stage to something else that can make people cough, sneeze, run a fever, feel lousy, and sometimes require medical care and can on occasion lead to death.