U.S. Cannot Say How Many Afghan Refugees, Situation 'Fluid'

 A senior U.S. official on Tuesday could not say how many Afghans have been evacuated to the United States, adding that the situation remains "fluid" because of the swiftness of the operation.

Pressed to provide numbers, the official said the U.S. government was "moving as quickly as we can to get them out of harm's way."

"I don't have exact numbers for you right now or a breakdown," the official told reporters during a phone briefing. "Even if I did, it would shift as this process continues."

President Joe Biden's administration has scrambled to evacuate U.S. citizens and Afghan allies amid the chaos at Kabul airport ahead of an Aug. 31 deadline https://www.reuters.com/world/asia-pacific/taliban-says-no-evacuation-extension-g7-meets-afghan-crisis-2021-08-24 for U.S. forces to pull out of Afghanistan.

In the rush, the Biden administration has not said exactly how many Afghans have been allowed to enter the United States, a figure that could show the country's commitment to resettling vulnerable Afghans but also potentially fuel concerns that Afghans could be entering the country without adequate security vetting.

Flights have arrived in the United States in recent days carrying U.S. citizens and Afghans.

After being tested for the coronavirus upon arrival, Americans can head to their homes, while others will go to a variety of U.S. military bases, where they will receive assistance in applying for work authorization, the senior official said on Tuesday.

The arriving Afghans will be connected with refugee resettlement organizations, said the official, who requested anonymity to discuss internal government operations.

Other Afghans evacuated by the United States have been sent to third-country transit points in Europe and Asia, the official said.

U.S. law enforcement and counterterrorism officials are carrying out "robust security processing" before those evacuees are allowed to enter the United States, including biometric and biographical checks, the official said.

https://www.usnews.com/news/world/articles/2021-08-24/us-will-test-all-evacuees-from-afghanistan-for-covid-19-us-official

Human clinical trials begun for promising, llama-derived COVID antibodies

 Human clinical trials have begun in study of so-called nano-bodies, a smaller, eminently stable version of coronavirus antibodies derived from llamas. Such antibodies may be the key to saving humanity from the novel coronavirus, research has shown. Now it’s being tested in people.

Lab-derived llama antibodies seem to blunt COVID-19 and its variants, showing promise both for supplementing vaccines in immunocompromised people, and in treating people who have contracted the virus.

Research conducted by a Belgian biomedical startup at the VIB-UGent Center for Medical Biotechnology in Ghent showed that antibodies extracted from a particular llama, name of Winter, had made SARS-CoV-2 – plus its variants – less virulent in laboratory tests, reported Reuters.

If the study is borne out, such treatment could add another layer of protections to vaccinated people with compromised immune systems, the researchers told Reuters. It could also be used to treat infected, hospitalized people and could potentially be a “game changer,” Dominique Tersago, chief medical officer of VIB-UGent spin-off ExeVir, told Reuters.

“At the moment we’re not seeing mutations of a high frequency anywhere near where the binding site is,” Tersago told the news agency.

Llama antibodies are unusually small and are thus able to squeeze in where others cannot and bind to specific parts of the virus’s protein spike, Reuters noted. Camels, alpacas and llamas are from the camelid family, known to create a particular kind of antibody that’s stable and small, as Stat News reported last year.

“Their small size... allows them to reach targets, reach parts of the virus that are difficult to access with conventional antibodies,” VIB-UGent group leader Xavier Saelens told Reuters.

Antibody treatment is no substitute for vaccines, the researchers emphasized. Prevention through vaccination and masking are much better at blunting COVID than trying to get rid of once it takes hold.

Researchers hope that clinical trials under way in healthy volunteers and hospitalized COVID patients as of last week, in conjunction with Belgian pharmaceutical company UCB, will be similarly effective.

The tantalizing prospect is being studied elsewhere as well, including the U.S., though not in human trials as of yet. Those antibodies, too, are showing promise, as a study last year from the University of Pittsburgh School of Medicine indicated. An earlier study published in the journal Cell in May 2020 by a team from the University of Texas at Austin, the National Institutes of Health and Ghent University in Belgium, which is also involved in the current trials, laid the groundwork.

The research pre-dates the pandemic by a few years, but scientists have pivoted to apply it directly to the coronavirus. The delta variant had not yet formed or been detected when the earlier research was conducted, but Winter’s antibodies show “strong neutralization activity” against it, Tersago told Reuters.

https://www.nydailynews.com/coronavirus/ny-covid-human-clinical-trials-begun-belgium-llama-antibodies-coronavirus-20210824-uxmikgspsfb3pes5mjgm4k72wa-story.html

Israel Lowers Age of Eligibility for COVID-19 Vaccine Booster to 30

 Israel expanded its COVID-19 vaccine booster shots to those over 30 years old on Tuesday, broadening its booster campaign to fend off the coronavirus Delta variant.

A statement from the Health Ministry said its decision to lower the age of eligibility for a third dose of the Pfizer/BioNtech vaccine from 40 to 30 followed a recommendation of its advising experts and its epidemiology task-force and vaccines committee. Boosters are administered to people who have received their second dose at least five months ago.

The announcement came as 9,831 new cases of infection were reported since Monday, according to the Health Ministry.

Findings published by the government on Sunday showed that a third dose of of the Pfizer vaccine significantly improved protection from infection and serious illness among people aged 60 and older in Israel, compared with those who received two shots.

https://www.algemeiner.com/2021/08/24/israel-lowers-age-of-eligibility-for-covid-19-vaccine-booster-to-30-health-ministry/

'We Don't Understand What's Really Happening'- CDC Under-Counting Covid 'Breakthroughs'

 A growing number of public health officials working at the state level are worried that the federal government isn't collecting enough accurate data about "breakthrough" infections, yet the Biden Administration has pushed ahead with plans to dole out booster shots, as well as other COVID policies.

According to Politico, 49 states are now regularly sending CDC information on hospitalized breakthrough patients. But more than a dozen have told Politico that they do not have the capacity to match hospital admission data with patients' immunization records, forcing states to rely on hospital administrators to report breakthrough infections.

The result is data that is often aggregated, inaccurate and missing critical details like which vaccine the consumer received . Instead, those states rely on hospital administrators to report breakthrough infections. The resulting data is often aggregated, inaccurate and omits critical details for teasing out trends, such as which vaccine a person received and whether they have been fully vaccinated, a dozen state officials said.

The fact that the CDC and public health departments across the country are still struggling to collect data on breakthrough infections is almost embarrassing, considering we're more than 18 months into the pandemic at this point, and scientists have repeatedly warned about the necessity of being prepared for the Omega Death Variant which is right around the corner, according to Dr. Fauci's latest fearmongering blitz.

“I think it would be really challenging [for the CDC] to interpret the results or to interpret the data when you have only some jurisdictions reporting [breakthrough infections],” said Theresa Sokol, lead epidemiologist for Louisiana’s state public health department, which is working closely with the CDC on studies of breakthrough infections. “I know that there are some jurisdictions that don't even have access to their vaccination data. They don't have the authority or their permission.”

Perhaps the biggest obstacle to collecting data on breakthrough infections is the balkanized nature of state health-care systems. States can't communicate with other states. For years, states have pleaded with the federal government to upgrade these systems to no avail.

Last year, the CDC allocated a small amount of money (described by Politico as "tens of millions of dollars") to help states upgrade their systems. But the CDC admits it will take years for the necessary upgrades to be made.

"Nothing has changed since the pandemic began,” one senior Biden health official said. "We’re still dealing with this patchwork system — and it continues to fail us."

Of particular concern for health officials now is how rapidly the Delta variant spreads, whether it is reducing the effectiveness of vaccines and whether it causes more severe disease. Tracking breakthrough infections is a critical step toward arriving at all of these assessments.

To complement data on hospitalized cases from the 50-state reporting network, the CDC is conducting a smaller study with a subset of states to examine all of their breakthrough infections, including mild cases that don’t send people to the hospital. The states participating in this smaller study have the ability to match lab reports with immunization records, but they don’t maintain their own databases of hospitalization data. ;

"We report what we have, but we know that it's limited because it's based on a direct report from a provider — as opposed to taking a data set of all hospitalizations and matching that against our vaccine registry,” said Sokol, the Louisiana epidemiologist. “We're not able to do that for hospitalization. We rely on individual reports from hospitals. And some report well, others do not. So we know that it's not complete."

[...]

“We don’t have a clear understanding of what the data actually says about the Delta variant, transmission and boosters,” one of those officials said.

To be sure, deliberately under-counting breakthrough infections has its advantages: for example, the Biden Administration can mask the number of breakthrough infections reported, making the vaccines appear more effective than they actually are.

https://www.zerohedge.com/covid-19/we-dont-understand-whats-really-happening-cdc-under-counting-breakthrough-covid-cases

BioLife Solutions Joins S&P SmallCap 600 Index

 BioLife Solutions, Inc. (Nasdaq: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of class-defining bioproduction products and services for cell and gene therapies and the broader biopharma market, today announced that its common stock will be added to the S&P SmallCap 600 Index effective prior to the opening of trading on Monday, August 30, 2021.

https://finance.yahoo.com/news/biolife-solutions-joins-p-smallcap-151400131.html

Aditxt Signs Intent to Acquire Firm Commercializing, Distributing Antiviral Oral Covid Therapy

 Aditxt, Inc. (Nasdaq: ADTX), a biotech innovation company with a mission to improve the health of the immune system, today announced that it has signed a letter of intent ("the LOI") to acquire a biopharmaceutical company, the "Target Company", commercializing COVID-19 antiviral oral therapy. The Target Company is currently selling its products under emergency and compassionate use, standard of care, and full approval in multiple countries internationally outside of the U.S. and Canada.

The acquisition is subject to the satisfaction of numerous conditions, including satisfactory due diligence, the negotiation and execution of definitive agreements and other closing conditions, including board and shareholder approval and approval by Nasdaq of the listing of shares proposed to be issued in the transaction. The parties have agreed to an exclusivity period until September 30, 2021, with a view to settling the definitive agreement. However, there can be no assurance that a definitive agreement will be entered into or that the proposed acquisition will be completed as proposed or at all.

Key terms of the proposed transaction as stated in the LOI include: the completion of a proposed $6.5M secured loan from Aditxt to the Target Company by August 31, 2021, as well as Aditxt issuing such number of shares of common stock that yields 50% of the number of Aditxt’s outstanding shares post-closing of the transaction.

https://finance.yahoo.com/news/aditxt-inc-signs-letter-intent-131600660.html

Pfizer, BioNTech Initiate Rolling Submission of Application to FDA for Covid Booster

 

• New Phase 3 data show booster (third) dose of COMIRNATY induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profile
• SARS-CoV-2 neutralizing titers against the wild-type strain one month after booster dose were 3.3 times the titers one month after the second dose
• Pfizer and BioNTech intend to file these data with the European Medicines Agency (EMA) and other regulatory authorities around the world in coming weeks

https://www.businesswire.com/news/home/20210825005638/en/Pfizer-and-BioNTech-Initiate-Rolling-Submission-of-Supplemental-Biologics-License-Application-to-U.S.-FDA-for-Booster-Dose-of-COMIRNATY%C2%AE-in-Individuals-16-and-Older