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Saturday, May 8, 2021

Biden move to share vaccine designed to spread US influence

 It won’t speed the manufacture of vaccines. It enraged the developers who delivered lifesaving doses in record time. But President Joe Biden’s decision to support waiving intellectual property rights for coronavirus shots had a broader purpose: to broadcast his administration’s commitment to global leadership.

More than a month of internal debate led up to Biden’s decision this week to endorse international calls to strip patent protections for vaccines.

The policy shift, embraced by many charitable service organizations around the world and liberals at home, wasn’t new. Biden endorsed it during his campaign for the White House. But the idea was the subject of pitched discussions inside the administration over how best to bring the pandemic to an end while restoring U.S. influence abroad.

In the best case, officials acknowledge it will take at least a year for any additional vaccines to be produced due to the change. Key European leaders are adamantly opposed to the waivers, and securing the required consensus at the World Trade Organization many never happen.

The specialized production, particularly of the cutting-edge mRNA vaccines made by Pfizer and Moderna, would take even longer. Moreover, the matter could become less pressing if vaccine manufacturers can produce enough to satisfy international demand themselves.

To Biden, White House officials said, that’s largely beside the point, as officials cast the decision as indicative of the president’s efforts to return the U.S. to the position of leadership after four years of unilateralism and protectionism under former President Donald Trump.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” U.S. Trade Representative Katherine Tai said Wednesday in announcing the move.

The announcement was met with surprise and disappointment by some of Biden’s closest European allies. German Chancellor Angela Merkel quickly weighed in against it, with a government spokesman saying it would cause “severe complications” for the production of vaccines.

The timing of the decision also blindsided the vaccine companies, which had aggressively discouraged the administration from making a choice they feel will hurt American producers.

Officials noted, however, that Tai held more than two dozen meetings with stakeholders, including the drug makers.

Commerce Secretary Gina Raimondo also opposed the plan, but was excluded from the final meeting, two people familiar with the decision-making process but not authorized to speak publicly about private deliberations said on condition of anonymity. Other White House officials highlighted the practical limitations of Biden’s decision, but the symbolism won the day.

Trade groups warned it could curtail future investment in lifesaving drugs, and vaccine manufacturers and some Republican lawmakers warned that it would amount to a giveaway of American technological knowhow to China. Vaccine manufacturing historically has not been a huge profit driver for drug makers.

“The Chinese Communist Party is already celebrating this gift from President Biden,” tweeted Arkansas Sen. Tom Cotton, as he highlighted a comment from a Chinese official praising Biden’s action.

A vaccine manufactured by a Chinese company was given emergency use authorization Friday by the World Health Organization, potentially creating a pathway for millions of the doses to reach needy countries through a U.N.-backed program rolling out coronavirus vaccines.

The decision by a WHO technical advisory group — a first for a Chinese vaccine — opens the possibility that Sinopharm’s offering could be included in the U.N.-backed COVAX program in coming weeks or months and distributed through UNICEF and the WHO’s Americas regional office.

But U.S. vaccine manufacturers also warned that the Biden administration’s move could hurt the global supply of shots in the near to moderate term.

The primary obstacle to vaccine production, they’ve argued, remains production bottlenecks and shortages of the specialized supplies needed to make the shots — a challenge that could become more acute if other countries hoard them in anticipation of trying to make their own doses at home. The Pfizer vaccine, for instance, has more than 200 components, many of which are in demand around the world.

Some in the Biden White House, in addition to noting that the president pledged to do this during the campaign, also believe that it creates a low stakes political victory. They said the decision, which has been applauded by some on the left, is good Democratic politics and that few will be outraged on the behalf of the drug companies, even though those firms have been praised as heroes of the pandemic.

White House aides maintain that Biden’s action is limited to COVID-19 vaccines because of the scale of the pandemic, but some progressives who have pushed to have the government regulate the price of prescription drugs saw an opening.

“Here’s why Pharma’s really really whining about the COVID vaccine patents: the government might finally have the spine to lower drug prices here at home,” tweeted Massachusetts Sen. Elizabeth Warren on Friday. “And it should.”

“President Biden can lower drug prices by producing drugs like insulin, naloxone, and EpiPens at low costs,” she said. “And he doesn’t need Congress to do it — he can use existing compulsory licensing and march-in authorities to bypass patents for public health needs.”

The debate over the inoculations comes as the administration set a new goal to deliver at least one shot to 70% of adult Americans by July Fourth as Biden tackles the vexing problem of winning over the skeptics and those unmotivated to get vaccinated.

Demand for vaccines has dropped off markedly nationwide, with some states leaving more than half their allotment of doses unordered. Already more than 56% of American adults have received at least one dose of a COVID-19 vaccine and nearly 105 million are fully vaccinated. The U.S. is currently administering first doses at a rate of about 965,000 per day — half the rate of three weeks ago, but almost twice as fast as needed to meet Biden’s target.

https://apnews.com/article/donald-trump-coronavirus-pandemic-coronavirus-vaccine-science-business-7475e7ce26cb1e07cc00fbc73895e1a1

How the U.S. locked up vaccine materials other nations urgently need

 

To fight the pandemic at home, the United States gave its own vaccine manufacturers priority access to American-made materials needed to make the shots.

As a result, the U.S. government laid claim not only to vast quantities of finished COVID-19 vaccines but also to vaccine components and equipment all along the supply chain, according to a Reuters review of more than a dozen contracts involving some major suppliers.

That has left some countries desperately in need of those supplies to scramble for substitutes, exacerbating international disparities in vaccine access, according to interviews with suppliers, foreign manufacturers and vaccine market experts.

On Wednesday, President Joe Biden threw his support behind waiving patents for COVID-19 vaccines, thrilling those who have been pressuring his administration to help speed production of doses worldwide. If adopted by the World Trade Organization, the move would let other countries make their own copies of the much-coveted shots.

But the waiver would not address a less conspicuous but equally pressing problem: the growing worldwide shortage of vaccine ingredients and manufacturing equipment. The United States has a tight grip on a significant amount of those materials, such as filters, tubing and specialized disposable bags essential to making vaccines.

Countries ravaged by the virus - including India, where a catastrophic explosion of cases has filled hospitals and morgues - cannot make vaccines without such supplies, even with access to manufacturers' cookbooks.

The problem stems from the U.S. reliance on a law dating to the Korean War in the 1950s, called the Defense Production Act (DPA), which gives federal agencies the power to prioritize procurement orders related to national defense. For decades, the law was used to supply the military as well as respond to everything from natural disasters to roadblocks in the decennial U.S. census.

The administration of former President Donald Trump invoked the act to put the U.S. government first in line to buy American-made vaccines as well as other products needed to fight the COVID-19 pandemic. In turn, vaccine makers have priority access to any supplies needed to fill U.S. orders.

Gavi - a vaccine alliance comprising international organizations, governments, drug companies and others - lauded the Biden administration's moves to increase global access to vaccines. Among other things, it cited the country's $4 billion commitment to COVAX, a global vaccine buying consortium Gavi co-leads with the World Health Organization.

But in response to questions about the DPA, Gavi said: "The greatest challenge to COVAX's goal of equitable access to vaccines is constrained global supply. Export controls on raw materials is a considerable contributor to this and ultimately only serve to prolong the pandemic."

A senior Biden administration official, speaking on condition of anonymity, said there is no export ban, and all U.S.-based suppliers continue to ship products abroad after giving priority to U.S. manufacturers. The official said the DPA has not caused the global shortages of vaccine materials, and the problems stem instead from overwhelming demand.

"There's just not enough to go around," the official said, noting that the administration is investing in increased raw material production.

On Wednesday, Katherine Tai, the U.S. trade representative, briefly mentioned in her statement about Biden's patent decision that the administration would "work to increase the raw materials needed" to make vaccines. She did not elaborate.

A PLEA FROM INDIA

Vaccine components are produced all over the globe - in countries including the United Kingdom and China. But some leading suppliers, including Thermo Fisher Scientific Inc, and the Danaher Corp units Cytiva and Pall, are based in the United States. Reuters could not determine precisely what share of vaccine materials and equipment are made in America.

The DPA has helped the United States build a huge vaccine production system, ensuring reliable access to finished doses for Americans, and driving up revenue for U.S. pharmaceutical companies.

About 45% of the U.S. population has received at least one dose of a COVID-19 vaccine. Dozens of other countries, from South Africa, to Guatemala, to Thailand, have vaccinated about 1% or less of their populations, according to data collected at the University of Oxford in the United Kingdom.

The DPA has drawn criticism from vaccine makers around the world, including the Serum Institute of India, the largest manufacturer globally.

On Twitter in late April, chief executive Adar Poonawalla requested "on behalf of the vaccine industry outside the United States" that America lift its hold on raw materials "if we are to truly unite in beating this virus."

Starting this month, the company had planned to produce a billion doses annually of a vaccine developed by U.S.-based Novavax Inc. But that output will be more than halved without American raw materials, according to a source familiar with the company's plans, speaking on condition of anonymity.

Serum is also manufacturing COVISHIELD, a licensed version of the AstraZeneca Plc vaccine.

After weeks of public appeals from the Serum, the United States last month offered India filters needed to produce COVISHIELD. But India's need for vaccines and supplies remains vast. Serum is also meant to be a top supplier to other low- and middle-income countries. COVISHIELD and the Novavax shot form the backbone of the COVAX program.

Serum, which declined to discuss the raw materials issue with Reuters, is not the only vaccine maker in need.

The South African vaccine maker Biovac Institute also relies on a U.S. company for bioreactor bags, needed for cell cultures. Biovac has been warned by its U.S. supplier that the usual lead time for bags may more than double to 14 months because of the U.S. DPA, chief executive Morena Makhoana told Reuters.

Manufacturers in some other countries say they are in better shape. Brazil's Butantan Institute has been able to buy supplies from both the United States and Europe, an executive told Reuters.

For instance, an order for supplies to make AstraZeneca's vaccine in the United States would be prioritized, even though the shot is not yet approved for use in the country. That could delay materials being sent to Serum, which is making the same vaccine for use in India and many other countries.

For now, three manufacturers' COVID-19 vaccines - Pfizer Inc, Moderna Inc and Johnson & Johnson - are approved for emergency use in the United States.

Asked about the global consequences of getting priority on U.S. supplies, AstraZeneca did not comment and Moderna and J&J declined to comment. Pfizer did not directly address the U.S. DPA but said "we have gone to enormous efforts ... as we seek to serve populations all over the world."

'UNPRECEDENTED DEMAND'

Some suppliers say the industry would do a better job than governments at managing limited resources to maximize access globally.

"If the end goal is, let's produce vaccines, then we're big believers that you need to let the industry connect the relevant parts so that we can deliver the end product," Thermo Fisher executive vice president Michel Lagarde told Reuters.

The Biden administration official said experts from various federal agencies discuss the use of the priority system during daily operations calls. Sometimes officials can change U.S. delivery dates to avoid disrupting other vaccine projects abroad.

But suppliers are planning to get ahead of demand. Leading purveyors Cytiva, Pall and Thermo Fisher are expanding manufacturing space in the United States and abroad. Thermo Fisher has nudged customers to clarify which needs are urgent and which can wait days or weeks, and the company tries to find time to fill orders even if they are not rated as priorities, Lagarde said.

Cytiva said in a statement that it is expanding production, but is itself limited by some raw materials shortages.

"The world is experiencing an unprecedented demand for biopharmaceutical products, technologies, and solutions," Cytiva said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/How-the-U-S-locked-up-vaccine-materials-other-nations-urgently-need-33197267/

Key EU countries rebuff Biden on sharing COVID vaccine patents

 

European countries distanced themselves on Friday from a proposal backed by U.S. President Joe Biden to waive patent rights on coronavirus vaccines, arguing that key to ending the COVID-19 pandemic was making and sharing vaccines more quickly.

French President Emmanuel Macron said the question of sharing patents was not the issue of the day, and called out Britain and the United States for blocking the export of vaccines and their ingredients to the wider world.

Leaders of the 27-nation bloc were due to discuss the suggestion to share vaccine intellectual property at a two-day summit that opened in the Portuguese city of Porto on Friday, but they were divided on its usefulness.

Experts say waivers could take years to negotiate, and would not address the immediate need to manufacture more doses fast.

"What is the current issue? It is not really about intellectual property. Can you give intellectual property to laboratories that do not know how to produce and will not produce tomorrow?" Macron said as he went into the summit.

"The main issue for solidarity is the distribution of doses," he said, adding that France was working hand in hand with Germany on the issue. Berlin expressed its opposition to the idea on Thursday.

The EU, which is among the biggest producers of vaccines in the world, is also the main exporter, with 200 million doses already shipped outside the bloc. The United States and Britain have not exported any of the vaccines they have made.

Macron lashed out at both.

"In order for the vaccine to circulate, the ingredients and the vaccines themselves cannot be blocked. Today the Anglo- Saxons block many of these ingredients and vaccines," he said.

European Commission President Ursula von der Leyen echoed that, telling a news conference after the first day of the Porto summit that the EU should be open to a discussion on the patents but sharing the technology was no quick remedy for the pandemic.

"In the short and medium term, the IP waiver will not solve the problems, it will not bring a single dose of vaccine in the short and medium term," she told a news conference.

Biden on Wednesday backed a call from India and South Africa to waive patent protection for COVID-19 vaccines, responding to pressure from Democratic lawmakers and more than 100 other countries, but angering pharmaceutical companies.

Some EU officials argue that it could take two years to agree on the waivers in the World Trade Organization (WTO), most likely making it irrelevant to the current pandemic.

DIFFICULT PROCESS

EU leaders are likely to hear advice from the bloc's executive, the European Commission, that a waiver would not help boost production, especially in poorer countries, as the manufacturing process requires advanced technologies and facilities, officials said.

The U.S. firm Moderna waived patent rights in October on its vaccine, which uses using the latest mRNA technology, but no other firm has yet announced that it will try to copy the shot.

Germany, home to BioNTech, which owns a patent on another mRNA vaccine developed jointly with Pfizer of the United States, opposes waivers, while Italy supports them, EU officials said.

While the pandemic rages, the chances are high that even more dangerous new variants of the coronavirus will emerge.

The pharmaceutical industry argues that the most expedient approach is to overcome existing production bottlenecks, and sell or donate vaccines to countries around the world. Several EU countries and institutions share that view.

"No one we will be safe until we all are. If vaccination takes place only in developed countries, our victory over COVID-19 will only be short-lived. We are seeing how quickly the virus is mutating, creating new variants that entail new challenges," the leaders of Belgium, Sweden, France, Denmark and Spain said in a joint letter to the Commission.

"Vaccines have become security policy and the EU cannot afford to lag behind; to this end, an increased European production capacity will be a key priority," they said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PHARMA-INDIA-46728868/news/AstraZeneca-Pharma-India-nbsp-Key-EU-countries-rebuff-Biden-on-sharing-COVID-vaccine-patents-33193534/

AstraZeneca Weighs Seeking Full U.S. OK for Covid Shot, Skipping Emergency Use

 AstraZeneca PLC could skip asking the Food and Drug Administration for emergency-use authorization for its Covid-19 vaccine, according to people familiar with the matter -- and instead pursue the more time-intensive application for a full-fledged license to sell the shot.

Such a move would further delay any rollout of AstraZeneca shots in the U.S., where the vaccine has already been made and stockpiled. But U.S. government and public-health officials have said they probably don't need AstraZeneca shots because of ample supplies of three other shots already authorized for use.

The British drugmaker said last week it intended to apply for the emergency go-ahead within weeks. But it has also been considering a different path to getting the drug approved in the U.S., according to these people. That would involve taking what could be several more months to compile and review data necessary for what is known as a biologics license, essentially a more comprehensive, nonemergency seal of approval from the FDA.

The full license is the path most new medicines take on their way to the U.S. market. But Covid-19 vaccine makers including Pfizer Inc., Moderna Inc. and Johnson & Johnson have all sought and received emergency-use authorization as a stopgap, encouraged by the government, with plans eventually to apply for full-blown approval for their respective shots. The emergency-use application allowed all three to win quicker FDA approval in the pandemic.

AstraZeneca has long said it would go down that same route, but delays stretched out as it has struggled to pull together the large amount of data from tens of millions of doses of the vaccine already administered in the U.K.

"AstraZeneca continues to progress its FDA submission," a company spokesman said Friday. "It is important to note the substantial size of the file -- in addition to the U.S. trial data, the filing will also include analyses and pharmacovigilance from all studies to date, in addition to real-world evidence data."

The shot has been accepted for emergency use in the U.K., across Europe and in more than a hundred other countries around the world. The FDA is requiring AstraZeneca to provide that data from real-world use, in addition to data from human clinical trials. Other shots weren't yet being used widely when they went before the FDA.

The AstraZeneca shot has also been linked in Europe and elsewhere to very rare, but sometimes-fatal, serious blood clotting, an issue that European regulators, AstraZeneca and outside researchers are still studying.

U.S. officials got into a rare, public spat in March over the precise efficacy of the shot in large-scale human trials in the U.S., an episode health experts expected to complicate any review.

In ongoing talks between AstraZeneca and the U.S. government, the prospect of skipping the quicker, narrower emergency authorization and instead going for the fuller license has gained favor inside AstraZeneca, some of the people said. The U.S. government, which helped fund AstraZeneca's vaccine U.S. testing and development, must sign off on any decision to skip an emergency-use application, according to a person close to the process and language in AstraZeneca's U.S. government contract. A senior company executive said last week AstraZeneca could skip the emergency-use filing if government officials told the company to apply for full approval instead.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Weighs-Seeking-Full-U-S-Approval-for-Covid-Shot-Skipping-Emergency-Use-Application-33198839/

Friday, May 7, 2021

Obstructive sleep apnea highly prevalent in COVID19 moderate to severe ARDS survivors

 Abhishek Goyal, Khushboo Saxena, Avishek Kar, Alkesh Khurana, Abhijit P Pakhare, Parneet Kaur Bhagtana, Chinta Siva Koti Rupa Sridevi

Bodies of Hundreds of New York COVID Victims Still in Trucks on Brooklyn Pier


A fleet of refrigerated trucks storing the bodies of people who died of COVID-19 sits near the Brooklyn waterfront in Sunset Park on Thursday, May 6, 2021.
A fleet of refrigerated trucks along the Brooklyn waterfront in Sunset Park stores the bodies of people who died of COVID-19.
 Hiram Alejandro Durán/THE CITY


The city still has the bodies of about 750 New Yorkers who died during the pandemic in refrigerated trucks at Brooklyn’s 39th Street Pier, with no timetable for when their remains will be moved to Hart Island or elsewhere, officials disclosed this week.

The city will try to reduce the number of bodies being held on the Sunset Park pier “in the near future” and let families know about the transfers, Dina Maniotis, a deputy commissioner with the Office of Chief Medical Examiner, told a City Council committee Wednesday.

Hundreds of bodies have been stored in trucks since April 2020, fluctuating between 500 and nearly 800, according to various medical examiner estimates compiled over the past 13 months by Columbia’s Stabile Center for Investigative Reporting and THE CITY as part of the MISSING THEM project.

Harts Island is home to the city’s massive public cemetery. April 25, 2020.
Harts Island is home to the city’s potters field.
 Evan El-Amin/Shutterstock

Most of the families of those in cold storage have told the city they would prefer to have their loved ones moved to Hart Island, the city’s potter’s field — or they have stopped “engaging” with officials entirely, Maniotis said, making it likely the bodies will end up on Hart Island.

“We will continue to work with families,” Maniotis told the Council’s health committee. “As soon as the family tells us they would like their loved one transferred to Hart Island, we do that very quickly.”

In a follow-up statement to THE CITY on Thursday, the medical examiner’s office said it would have “further discussion with the families on their final decision and the timeline.”

‘Why are We Delaying?’

Hart Island is the final resting place of more than one million New Yorkers, many of whom lacked the funds for a private burial. The island’s history as a public burial ground dates to the Civil War.

The medical examiner’s office said 2,666 burials were conducted on Hart Island in 2020 and 504 so far in 2021 — far above the typical annual total of 1,100 to 1,200 in recent years. Those numbers echo the burial figures analyzed by Columbia and THE CITY, which were referenced by Council members during the hearing and show that 1 in 10 New Yorkers who died of COVID-19 in 2020 were interred on the island.

Several Council members criticized the slow burial process for those in storage, while others questioned whether state and FEMA funeral assistance programs would meet the growing demand from families.

“Why do we have these temporary storage facilities?” asked City Councilmember Mark Gjonaj, a Democrat whose largely Bronx district includes Hart Island. “If there is capacity and those families have already expressed the willingness to have their loved ones buried in a public burial at Hart Island, why are we delaying that any longer than we have to?”

The city’s Human Resources Administration is evaluating bids to operate Hart Island through the Department of Parks and Recreation, after years of stewardship by the Department of Correction.

HRA said it couldn’t disclose any additional details about the bids, which closed March 5. Trips to Hart Island, which will be open to the public, are set to resume May 15. There are plans for about 20 trips a month, each capped at 10 people, according to the city.

https://www.thecity.nyc/missing-them/2021/5/6/22423844/new-york-covid-victims-still-in-trucks-on-brooklyn-pier

Hand Dermatitis in Two Thirds of Public Due to Frequent Hand Washing During COVID-19

 More than two-thirds of the public may now have hand dermatitis due to stringent hand washing and using alcohol-based rubs during the COVID-19 pandemic.

The dermatological impact of COVID-19 is a burning topic at EADV’s 2021 Spring Symposium. New research presented today highlights the effect that stringent hand hygiene during the pandemic has had on hand skin health.

Researchers at Father Muller Medical College, India, analyzed transepidermal water loss (TEWL — an essential parameter for measuring skin barrier function) from 582 people (291 healthcare professionals (HCPs) and 291 healthy individuals from the general population). Results indicated that hand dermatitis was now present among 92.6% of HCPs and 68.7% of the general population, despite only ~3% of HCPs and 2.4% of the general public in the study having reported a prior history of hand dermatitis (obtained through medical history and self-reported history). Higher mean TEWL (dryer skin) was also noted in females (65.4 g/m2h) and intensive care professionals (58.2 g/m2h), which was associated with high frequency of hand washing and use of alcohol-based hand rubs.

Both the HCPs and participants from the general public in this study stated that skin irritation and dryness was the main barrier to the consistent practice of hand hygiene (as reported by 72.1% of HCPs, and 50.8% of healthy volunteers).

Dr. Monisha Madhumita, Father Muller Medical College, India explains: “This research truly demonstrates the impact of increased hand washing and uptake of alcohol-based rubs on the hand skin health of HCPs and the general public. Moreover, we now know that using TEWL to measure skin barrier function can help us compare the efficacy of various barrier protective measures, and discover suitable modifications of hand hygiene practices and products to help prevent hand eczema. Finding suitable modifications to practices and products that may increase the accessibility of proper hand hygiene is something of vital importance to many in our community.”

Marie-Aleth Richard, EADV Board Member and Professor at the University Hospital of La Timone, Marseille, adds: “This research shows there is now a skin-disease epidemic within the COVID-19 pandemic. It is promising to see this problem being recognized, and I am excited to see how the dermatology community goes about finding potential solutions to this issue.”

Reference: “Challenges in curbing SARS-CoV2 – Overzealous Hand Hygiene and the Overlooked Skin Damage” by Madhumita, M.,, Bhat, R., EADV Spring Symposium 2021.

https://scitechdaily.com/hand-dermatitis-in-two-thirds-of-public-due-to-frequent-hand-washing-during-covid-19/