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Trump White House Exerted Pressure on FDA for COVID Emergency Use Authorizations, House Report Finds

Politico reported:

The Trump administration pressured the Food and Drug Administration, including former FDA Commissioner Stephen Hahn, to authorize unproven treatments for COVID-19 and the first COVID-19 vaccines on an accelerated timeline, according to a report released Wednesday by Democrats on the House Select Subcommittee on the Coronavirus Crisis.

Senior Trump administration officials fought for the reauthorization of hydroxychloroquine, a drug normally used to treat malaria and lupus, after the FDA revoked its emergency clearance of the drug because data showed it was ineffective against COVID-19 and could lead to potentially dangerous side effects, the report found.

The Democrats’ investigation also documents potential influence from former White House officials regarding the FDA’s decision to authorize convalescent plasma, and White House attempts to block the FDA from collecting additional safety data on COVID-19 vaccines in order to get them to the public before the 2020 presidential election.

What a Joke: Fauci Says He Never Flip-Flopped, It Was Just ‘the Evolution of the Science’

The Daily Wire reported:

Outgoing Dr. Anthony Fauci was against masking before he was for it. He calls flip-flops like that the “evolution of the science.” He seems to think that anybody who questions his comments simply must not understand how the scientific theory works — but conservatives aren’t letting him get away with that sleight of hand.

On Monday night, Fauci told MSNBC, “With COVID, I mean, the things that we thought we knew in the beginning turned out, as the months went by, to not be the case, which really forced us to adapt and to change some of our policies and recommendations.”

“That was interpreted by many as flip-flopping, or not really knowing what’s going on,” he added. “When it really was the evolution of the science.”

“His falsehoods were used to fire people — including veterans — from their jobs. He’s the disgusting villain of COVID,” said Buck Sexton, co-host of Clay & Buck. Cultural critic Chef Andrew Gruel also argued, “If science is always evolving, every aspect of COVID policy should have been treated with an open mind, but instead it was mandate, mandate, mandate; ban those who ask questions.”

Exclusive: Vaccinated Making up Higher Proportion of COVID Metrics in U.S.

The Epoch Times reported:

Vaccinated people are more likely than the unvaccinated in recent months to be a COVID-19 case, hospitalization or death in 25 states, according to an Epoch Times investigation.

In Kentucky in June, for example, 67% of the deaths were among the vaccinated, according to data obtained by The Epoch Times. That same month, the vaccinated made up 65% of COVID-19 cases, 64% of COVID-19 hospitalizations, and 66% of COVID-19 deaths in Wisconsin. The numbers are a drastic change from 2021.

The statistics underline how vaccines have increasingly performed worse as newer virus variants emerged, according to some experts.

They are “clear evidence that the vaccines are not working to prevent disease and death,” Dr. Robert Malone, who helped invent the messenger RNA utilized in the two most widely-administered vaccines, told The Epoch Times.

Moderna Seeks FDA OK for Updated COVID Booster

The Hill reported:

Moderna on Tuesday said it submitted a request for the Food and Drug Administration (FDA) to authorize an updated version of its COVID-19 vaccine targeting the latest Omicron subvariants.

The application comes ahead of a fall booster shot campaign. Assuming the FDA signs off, the company said its shots will be ready to ship in September. The application, per instructions previously given by the FDA, is for a “bivalent” vaccine that targets the BA.4 and BA.5 subvariants of Omicron currently circulating, as well as the original form of the virus.

Moderna’s vaccine is intended for adults aged 18 and older. Pfizer’s vaccine will be for adults and adolescents aged 12 and older. Pfizer submitted its request for FDA authorization on Monday.

First Lady Jill Biden Tests Positive for COVID Again in Rebound Case

New York Daily News reported:

First Lady Jill Biden has caught a rebound case of  COVID-19, just three days after leaving quarantine.

Biden tested positive again Wednesday, her office announced, but she’s not showing any symptoms. She will stay in Delaware in isolation until she clears protocols again.

The first lady, who is double-vaccinated and received two boosters, first tested positive last week when she began experiencing mild “cold-like” symptoms, according to her spokeswoman. She was treated with Paxlovid and isolated for five days before testing negative on two tests Sunday.

FDA Plans to Authorize Bivalent Boosters by Labor Day, Sources Say

NBC News reported:

The Food and Drug Administration plans to authorize updated versions of Pfizer-BioNTech’s and Moderna’s COVID boosters around Labor Day, said two people familiar with the discussions.

The Biden administration is preparing to distribute the updated booster shots to teenagers and adults as part of its fall booster campaign.

Both Pfizer’s and Moderna’s so-called bivalent vaccines target the BA.4 and BA.5 Omicron subvariants, in addition to the original coronavirus strain in a single shot. BA.5 is responsible for nearly 90% of all new COVID cases in the U.S., according to data from the Centers for Disease Control and Prevention.

Pfizer is seeking authorization for people 12 and older, while Moderna is seeking authorization for all adults.

Exclusive: AstraZeneca May Not Stay in Vaccines, but CEO Has No COVID Regrets

Reuters reported:

AstraZeneca (AZN.L) may not stay in the vaccine business in the long run, its CEO told Reuters on Tuesday, showing how quickly fortunes have changed for the drugmaker that produced one of the first COVID-19 shots but has since lost out to rivals.

Production delays, probes by regulators following rare cases of severe side effects, and concerns about its relatively short shelf life compared with other shots have stymied the adoption of the company’s COVID-19 vaccine.

Now, in the third year of the pandemic amid a global vaccine supply glut, its use has diminished in much of the developed world as countries have inoculated large numbers of people and prefer Pfizer and Moderna‘s mRNA vaccines as boosters.

AstraZeneca’s COVID vaccine has still not won U.S. approval.

SARS-CoV-2 Has Evolved an Incubation Time More Like Seasonal Coronaviruses

Ars Technica reported:

The incubation period for COVID-19 — the time between when SARS-CoV-2 first infects a person and when resulting COVID-19 symptoms first appear — has gradually shortened as the pandemic has stretched on and the virus has mutated. That’s according to a new meta-analysis published this week in JAMA Network Openby researchers in Beijing, who harvested data on over 8,000 patients from 142 COVID-19 studies.

When the original version of the novel virus mushroomed out of Wuhan, China, the mean incubation period was 6.65 days, according to pooled data from 119 studies. But then, the incubation period got shorter as the variants evolved. The Alpha variant had a mean incubation of 5 days, according to one study; Beta, 4.5 days, according to another; Delta had a mean of 4.41 days, according to pooled data from six studies; and now with Omicron, the incubation period has shrunk to 3.42 days, according to data from five studies.

The current shortened incubation period now puts SARS-CoV-2 more in line with commonplace respiratory viruses, including the four human coronaviruses that circulate seasonally and cause mild infections similar to the common cold.

What Should Schools Do About Monkeypox? New CDC Guidelines Weigh in

CBS News reported:

Schools and child care centers generally do not need to take extra steps to curb the spread of monkeypox, the Centers for Disease Control and Prevention says. It advises that they can rely on “their everyday operational guidance” to do things like ensure handwashing and clean surfaces, which help reduce the risk of potential cases from the outbreak this fall.

The agency’s new recommendations were published in a series of Frequently Asked Questions on the CDC’s website, and come as local health departments across the country are issuing their own recommendations for schools as students return to the classroom.

“At this time, the risk of monkeypox to children and adolescents in the United States is low,” the CDC’s guidance says.