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Friday, June 4, 2021

Mexico to apply U.S.-supplied J&J shots to 18-40 year olds along border

 Mexico will administer the Johnson & Johnson vaccine shots it is getting from the United States to 18 to 40 year olds along the Mexico-U.S. border region with the aim of reopening the shared border by late June, Foreign Minister Marcelo Ebrard said on Friday.

Mexican President Andres Manuel Lopez Obrador said on Thursday that following a conversation with U.S. Vice President Kamala Harris, the United States had agreed to send Mexico one million doses of Johnson & Johnson's vaccine against COVID-19.

https://finance.yahoo.com/news/mexico-apply-u-supplied-j-121356060.html

Pakistan produces Chinese CanSinoBio COVID vaccine, brands it PakVac

  Pakistan has started producing the single dose Chinese CanSinoBio COVID-19 vaccine to be able to deliver 3 million doses a month, health officials said.

Branded PakVac, an initial batch of 118,000 doses of the vaccine is ready to be delivered to the government on Friday, the National Institute of Health (NIH) said two days after the inauguration of the production plant in Islamabad.

Pakistan signed a deal with CansinoBio late March to import a concentrate of the vaccine in bulk to process and package the vaccine locally.

"This is a co-production along with CanSino in Pakistan," professor Aamer Ikram, the NIH's executive director, told Reuters.

Ikram said the Chinese firm was supplying a vaccine concentrate which the plant then formulated, processed and packaged. CanSinBio had transferred some of its production technology to Pakistan and is supervising operations, he said.

Quality control was being carried out by Pakistan. "We've acquired technology and expertise to ensure quality control," he said.

The plant will start producing 3 million doses a month starting July, he said.

SELF RELIANCE

At the plant's inauguration on Tuesday, Health Minister Faisal Sultan described the local production a "milestone in the journey to achieve to self-reliance".

Both him and Ikram said the transfer of technology could help Pakistan to eventually manufacture the vaccine.

To be more cost effective, 10 doses of PakVac will be filled into one vial.

According to the officials PakVac will save around 25% on vaccine cost, which according to government figures amounts to $250 million so far.

Pakistan, which has a population of 220 million people, faced initial vaccination hesitancy and a shortage of vaccine supplies, but last week started mass vaccination for all adults.

It has so far relied heavily on its ally China in vaccine procurement and of the six vaccines approved for use in Pakistan, three - Sinopharm, SinoVac and CanSinoBio - are from China.

The government says it has procured over 18 million vaccine doses via purchases or donations from China and allocations from the World Health Organisation and the GAVI Vaccine Alliance.

The inoculation programme has administered 8.5 million doses of coronavirus vaccines so far, according to official figures. Pakistan reported more than 928,000 coronavirus infections and 21,105 deaths, with 1,893 cases and 83 fatalities on Friday.

Pakistan's biotech and pharmaceutical industry is underdeveloped and the country produces few vaccines.

"Our cooperation not only effectively contributes to Pakistan's efforts in fighting against the COVID-19 ... it reduces its dependence of the vaccine import," said Chinese ambassador to Pakistan Nong Rong said at the plant's inauguration.

https://news.trust.org/item/20210604135759-p1mmb/

Britain says G7 countries in health agreement for clinical trials boost

 Britain said that the G7 group of advanced economies agreed on Friday to speed up and share results from clinical trials on, for instance, vaccines to better tackle the COVID-19 pandemic and future threats to global health.

The G7 Therapeutics and Vaccines Clinical Trials charter sets out shared principles to accelerate the speed with which clinical trials generate evidence to enable timely and decisive action on findings, said Britain’s health ministry.

“It contains a series of measures to make us all safer by improving clinical trials, quicker and wider access to safe vaccines, better use of data, more accurate health surveillance tools and greater collaboration between countries,” British health minister Matt Hancock said in a statement on Friday.

https://www.metro.us/britain-says-g7-countries/

Resisting patent waiver, EU submits vaccine plan to WTO

 The European Union submitted to the World Trade Organization on Friday a plan it believes will more effectively broaden supply of COVID-19 vaccines than the intellectual property (IP) rights waiver backed by the United States.

India, South Africa and dozens of developing countries are demanding an IP rights waiver for COVID-19 vaccines and other treatments to address what they say is a "staggering inequity" in access to global public goods.

A surprise U.S. shift in May to support a patent waiver heaped pressure on remaining opponents, such as the European Union and Switzerland that are home to many drugmakers.

The European Commission, which oversees trade policy for the 27-nation EU, said on Friday it had submitted an alternative, stressing limits on export restrictions and existing WTO rules allowing countries to grant licences to producers.

WTO members discussed a revised waiver proposal on Monday, their 11th meeting on the topic since an initial proposal in October, though still with no breakthrough. Another meeting is planned for next Tuesday and Wednesday.

The EU plan, which it says could be put into action much quicker, consists of three elements.

Export restrictions should be kept to a minimum. The EU has stressed it has exported more than 200 million vaccine doses, a level not matched by others such as the United States.

The EU would encourage vaccine makers and developers to enter licensing and manufacturing deals with producers in developing countries and pledge increased supplies to vulnerable nations, as Pfizer/BioNTech, Johnson & Johnson and Moderna have done.

Thirdly, the EU plan highlights existing WTO rules allowing countries to grant licences to manufacturers even without the consent of the patent-holder, although they would still receive compensation. Such licences should help ensure vaccines are available at affordable prices.

https://finance.yahoo.com/news/1-resisting-patent-waiver-eu-112047638.html

NIH clinical trial evaluating mixed COVID-19 vaccine schedules begins

 The National Institutes of Health has started a Phase 1/2 clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens. The National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, is leading and funding the study through the Infectious Diseases Clinical Research Consortium, a clinical trials network that encompasses the Institute’s long-standing Vaccine and Treatment Evaluation Units (VTEUs).

“Although the vaccines currently authorized by the U.S. Food and Drug Administration offer strong protection against COVID-19, we need to prepare for the possibility of needing booster shots to counter waning immunity and to keep pace with an evolving virus,” said NIAID Director Anthony S. Fauci, M.D. “The results of this trial are intended to inform public health policy decisions on the potential use of mixed vaccine schedules should booster doses be indicated.”

The trial is led by principal investigators Robert L. Atmar, M.D., at Baylor College of Medicine, Houston, and Kirsten E. Lyke, M.D., at the University of Maryland, College Park. It will include approximately 150 individuals who already have received one of the three COVID-19 vaccine regimens currently available under FDA Emergency Use Authorization in the United States: the Janssen COVID-19 vaccine (also referred to as the Johnson & Johnson vaccine, or Ad26.COV2-S), the Moderna COVID-19 vaccine (also known as mRNA-1273), and the Pfizer-BioNTech COVID-19 vaccine (also known as (BNT162b2). Each vaccine group will enroll about 25 people ages 18 through 55 years and approximately 25 people age 56 years and older. Twelve to 20 weeks following their initial vaccination regimen, participants will receive a single booster dose of the Moderna COVID-19 vaccine as part of the trial.

People who have not yet received an FDA authorized COVID-19 vaccine are also eligible to enroll in the trial in a separate cohort. Initially, these volunteers will receive the two-dose Moderna COVID-19 vaccine regimen and will be assigned to receive a booster dose of a vaccine about 12 to 20 weeks later.

The trial has an adaptive design and may add arms as vaccines are awarded EUA and/or variant lineage vaccines become available for evaluation.

All trial participants will be followed for one year after receiving their last vaccination as part of the study. They will be asked to complete telephone check-ins and various in-person follow up visits. Trial investigators will evaluate participants for safety and any side effects post-vaccination. Participants also will be asked to provide blood samples periodically so that trial investigators can evaluate immune responses against current circulating strains of SARS-CoV-2, as well as emerging variants. If trial participants develop laboratory-confirmed symptomatic COVID-19, investigators will perform genetic sequence analyses on the participant samples to see if a variant strain of SARS-CoV-2 caused the infection.

Initial trial results are expected in late summer 2021. For more information about the trial, including a list of enrollment locations, please visit clinicaltrials.gov and search identifier NCT04889209.

https://www.nih.gov/news-events/news-releases/nih-clinical-trial-evaluating-mixed-covid-19-vaccine-schedules-begins

Fauci emails all the more reason for US to get to bottom of COVID origins

 So Dr. Anthony Fauci in the pandemic’s early months was casting doubt on the lab-leak theory of COVID’s origins — even as he was also receiving at least one alert from a genomic researcher that “some of the features look (potentially) engineered.” 

Notably, he forwarded “anti-conspiracy theory” articles that quoted Peter Daszak — the head of a US nonprofit that used some grant money from Fauci’s agency to fund coronavirus work at the Wuhan Institute of Virology — ­attacking the lab-leak idea. Daszak and others wrote Fauci personally to thank him for dumping on the theory. 

We still don’t know if the virus evolved normally and somehow jumped to humans, but Chinese researchers have been searching hard for evidence of the bug in some intermediate species (as the “natural” theory would require) and have so far come up empty. 

Meanwhile, Beijing refuses to cooperate in any meaningful independent investigation — and even launched a trade war with Australia after Aussie leaders called for such a probe. 

For a year, we’ve been told to “trust the science” — but Fauci, our leading scientist, made declarations that certain theories were “debunked” when they weren’t. Why did he back up Daszak’s self-serving dismissal of the lab theory with no real evidence — when, in fact, he was getting e-mail evidence to the contrary? 

These revelations don’t ease the growing concern that US taxpayer cash might have helped unleash this plague. 

Dr. Fauci received some notice last year that COVID-19 could have been manmade.
Dr. Fauci received some notice last year that COVID-19 could have been manmade.
AP

All of it is just more reason for the Biden administration to get to the bottom of the mystery — and make getting China to cooperate at last the No. 1 issue in talks with Beijing. And all the more reason, as we’ve argued before, that Fauci needs to stop being the spokesperson for America’s pandemic response. 

https://nypost.com/2021/06/02/fauci-emails-all-the-more-reason-for-us-to-get-to-bottom-of-covid-origins/

FDA grants swift approval to Cognoa’s digital device for autism diagnosis

 The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval.

Cognoa says the artificial intelligence (AI) based device is the first to be authorised by the US regulator that can help doctors diagnose autism in primary care, and will be launched “in the coming months”.

At the moment, autism can be difficult to diagnose as there are no medical markers to confirm its presence. Instead, doctors have to look at a child’s developmental history and behaviour over time before making a diagnosis.

While that process can be quite quick in severe cases of ASD, for the vast majority of children who are less affected it can take years to get a diagnosis, and in some countries waiting times for assessments are very long.

Cognoa thinks its Canvas Dx software as a medical device (SaaMD) could change this, providing an efficient and accurate assessment in primary care that would do away with the need for a lengthy referral to a specialist.

While autism can be reliably diagnosed in children as early as 18 months, the average age of autism diagnosis has remained at 4 to 5 years old for decades, according to the company.

It is estimated that ASD affects one in every 54 children in the US, with cases rocketing 178% since 2000 in part due to greater detection of milder forms, and increasing awareness of the neurodevelopmental condition.

“Autism spectrum disorder can delay a child’s physical, cognitive and social development, including motor skill development, learning, communication and interacting with others,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

“The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” he added.

It consists of a mobile app for caregivers to answer questions about behavioural problems and to upload videos of their child, plus a video analysis portal that allows specialists to view and analyse those videos.

It also includes a healthcare provider portal  that can be used to enter answers to questions about behaviour, track information provided by caregivers, and review results.

Canvas Dx has been approved by the FDA to diagnose children aged between 18 months and five years, based on a pivotal study published last autumn involving 425 children aged with concerns about their development, but with no formal assessment for autism.

The study compared the device’s ability to detect ASD by comparing its diagnostic output with the clinical reference standard made by a specialist clinician, and validated by specialist peers.

Cognoa said the results showed the device was highly accurate across males and females as well as ethnic and racial backgrounds, which could address a longstanding issue of disparities in autism diagnoses.

“The current system is already at a breaking point as it is unable to provide early diagnoses and intervention opportunities to many children and families,” said Dave Happel, Cognoa’s chief executive.

“With rapidly-rising autism rates, this crisis will only worsen without new approaches and innovations.”

https://pharmaphorum.com/news/fda-grants-swift-approval-to-cognoas-digital-device-for-autism-diagnosis/